Registrar Corp has come a long way in 20 years. From our humble beginnings in Hampton, Virginia with a handful of regulatory compliance specialists to a global operation with 30,000 clients proudly served each year, we couldn’t be more thrilled to celebrate this occasion.  We know we couldn’t have achieved this without the strong culture

FDA continues to ramp up its regulations in the food and beverage industry with tighter regulations like food traceability and the recent update to the Food Code. Even California is attempting to push nationwide changes by passing greater legislation that places more controls on foods sold in the state in the hopes it promotes adoption

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is transforming the cosmetics industry. Signed into law in December 2022, the MoCRA act increases the U.S. Food and Drug Administration’s (FDA’s) regulatory authority over cosmetics and establishes regulations that will ripple throughout the cosmetic supply chain.   MoCRA’s new requirements will have a global impact

Read the EIN Presswire release here.  Hampton, Virginia, June 21, 2023 (EIN Presswire) – Leading FDA service, software, and training firm, Registrar Corp, is proud to announce it has reached an exciting milestone, celebrating 20 years of delivering regulatory compliance services to companies across the globe. Registrar Corp helps over 30,000 clients a year achieve

Supply chain diversification is a powerful strategy for any importer. Whether you want to navigate a vendor’s increasing costs, avoid disruptions, or change suppliers when one goes out of compliance, the ability to pivot with your suppliers is a game changer.    Diversifying your supply chain isn’t about making vendors compete with each other for the

With the Food Safety Modernization Act’s section 204 (FSMA 204), FDA intends to strengthen overall supply chain traceability within the food and beverage industry by mandating the tracking of certain food products. Companies who have focused solely on their single link in the supply chain are now exposing their business to exceptional risks. It’s no

Read the PRNewswire release here.  Hampton, Virginia, June 14, 2023 (PRNewswire) – Today, leading FDA service, software, and training firm, Registrar Corp, announced the launch of a new, 100% online cosmetics Good Manufacturing Practices (GMP) training course. The Cosmetics GMP Online Training course covers ISO 22176 guidelines for GMPs in the production of cosmetics, ensuring high

Assembly Bill (AB) 418 has been passed and is now expected to be reviewed by the California State Senate for official legislation. If it’s approved, California will be the first state that would outright ban the use of certain dangerous additives and toxic chemicals added to foods and drinks. How Does AB 418 Affect Manufacturing

Buried within the 4155 pages of the Consolidated Appropriations Act, a mere 36 pages redefine the standards within the U.S. beauty industry: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). For the first time in 85 years, Congress has finally passed legislation that drastically alters the Food, Drug, and Cosmetic (FD&C) Act and it

On March 24, 2023, the U.S. Food and Drug Administration (FDA) finalized two guidances for transitioning medical devices from certain policies and operations instated during the COVID-19 Public Health Emergency (PHE). The guidances provide an overview of the steps FDA recommends for companies transitioning their devices out of PHE-era policies and operations into “normal operations”

Read the GLOBE NEWSWIRE release here.  Hampton, Virginia, May 11, 2023 (GLOBE NEWSWIRE) – Registrar Corp, the leading compliance services and software firm, has been approved by FDA to become a recognized Better Process Control School (BPCS) training provider. Registrar Corp’s Online Training Course uses the 9th Edition “Canned Foods: Principles of Thermal Process Control, Acidification, and

Read the GLOBE NEWSWIRE release here.  Hampton, Virginia, May 04, 2023 (GLOBE NEWSWIRE) — Leading FDA service, software, and training firm, Registrar Corp, recently announced the release of the Buyer Insights feature within Automated Compliance, Registrar Corp’s proprietary supplier management system. Buyer Insights gives importers access to never-before-seen supplier data that increases visibility into their supply chains,

Read the GLOBE NEWSWIRE release here.  Hampton, Virginia, April 19, 2023 (GLOBE NEWSWIRE) — Registrar Corp, leading provider of services, software, and training for regulatory compliance, announces the addition of Jaclyn Bellomo as the Director of Cosmetic Services and Software. Bellomo started the newly created position in November 2022 and is leading the company in cosmetics

In a constituent update released on March 27, 2023, FDA announced it has stopped accepting and processing submissions to the Voluntary Cosmetics Registration Program (VCRP).    Instead, FDA is developing a program that cosmetic companies will use to submit facility registrations and cosmetic product listings, as required by the Modernization of Cosmetics Regulation Act of 2022

The U.S. Food and Drug Administration (FDA) is amping up enforcement for facilities that failed to renew their 2023 FDA registration and for food facilities that didn’t provide a DUNS number in their registration renewal.  FDA is actively removing facilities with invalid registrations from its databases, effectively cancelling their registrations. FDA-regulated products shipped to the

Read the GLOBE NEWSWIRE release here.  Hampton, Virginia, March 08, 2023 (GLOBE NEWSWIRE) — Leading FDA service, software, and training firm, Registrar Corp, recently announced the release of a Cosmetic Product Safety Report (CPSR) feature within Cosmetri, Registrar Corp’s comprehensive regulatory and formulation software for cosmetics businesses. This tool, within Cosmetri’s Product Manager application, fully integrates cosmetic Product

In January 2023, the U.S. Food and Drug Administration (FDA) released its final guidance on Foreign Supplier Verification Programs (FSVP) for importers of food for humans and animals. The guidance added questions and answers to help the industry understand FSVP requirements.   Fabiola Negrón, Registrar Corp’s Food Safety Department Manager, has over 10 years of food

New studies have found that medical devices citing predicates in their 510(k) submissions are more likely to be recalled if the predicates have previously been recalled. The research, conducted by the University of Minnesota and published in the Journal of the American Medical Association on January 10, 2023, evaluated the correlation between cited predicates and

The U.S. Food and Drug Administration (FDA) released its annual Inspection Observation Data for the Fiscal Year (FY) 2022. This data depicts how frequently FDA cited violations during food facility inspections between October 2021 and September 2022.   Here are the top 5 violations cited in the FDA Inspection Classification Database in FY 2022.  Need Help

The United States Congress recently passed the Consolidated Appropriations Act, which includes updates to U.S. cosmetics regulations. Years in the making, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant reform of cosmetics law in recent U.S. history. MoCRA expands the U.S. Food and Drug Administration’s (FDA’s) regulatory authority over the

On December 23, 2022, the United States Congress passed a bill that grants the U.S. Food and Drug Administration (FDA) regulatory authority over the personal care products industry. The legislation includes significant cosmetics provisions found in the Modernization of Cosmetics Regulation Act. This is the first time Congress has updated legislation to federal law regulating

The Food and Drug Administration (FDA) recently issued a   to amend color additive regulations to increase fees for certification services. FDA states that the fee increase would allow the agency “to continue to maintain an adequate color certification program as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).” If the rule

Updated May 1, 2023 The U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB) has issued a temporary rule  amending tax assignment regulations based on procedural changes to the administration of the Craft Beverage Modernization Act (CBMA). Foreign producers of distilled spirits, wine, hard cider, and beer are now required to register with TTB to

Read the EIN Presswire release here.  HAMPTON, Virginia, November 22, 2022: Leading FDA advisory and training firm, Registrar Corp, announced today the release of online training courses for the newest version of BRCGS, Issue 9.  The fully online and self-paced courses provide training for facilities interested in learning more about BRCGS. In-depth training is also

The U.S. Food and Drug Administration (FDA) has proposed a rule that would update requirements for food labels bearing a claim that the product is “healthy.” FDA has the authority to permit or not permit the use of the “healthy” claim on food labels. When a food label contains the claim, FDA considers the label

Read the GlobeNewswire release here.  HAMPTON, Virginia, November 10, 2022: Registrar Corp (registrarcorp.com), the leading provider of U.S. Food and Drug Administration (FDA) compliance software and services, is pleased to announce its acquisition of A la Calc. A la Calc provides SaaS solutions for recipe and nutrition analysis to over 10,000 industry professionals worldwide. A

The U.S. Food and Drug Administration (FDA) requires the filing of Prior Notice for all food, beverage, and dietary supplements shipments entering the United States. Prior Notice provides FDA with important information about food shipments arriving into the U.S., helping FDA to ensure food safety for humans and animals.   Shipments without Prior Notice will likely

On September 30, 2022, the Association of American Feed Control Officials (AAFCO) announced that their Pet Food Committee was proposing substantial changes to their Model Regulations to update how ingredients, nutrition information, safe handling, and nutritional adequacy statements should be presented on pet food. One of the most significant proposed changes is the display of

In July 2022, the U.S. Food and Drug Administration (FDA) updated its guidance on Unique Device Identifier (UDI) requirements. The guidance now includes Global Unique Device Identification Database (GUDID) submission requirements for certain Class 1 devices FDA considers consumer health products. FDA does not intend to enforce GUDID submission requirements for these devices when their

FDA will start requiring food facilities to provide a Unique Facility Identifier (UFI) as part of their registration renewals in 2022. Data Universal Numbering System (DUNS) numbers are currently the only UFIs FDA recognizes.     You can submit a request to receive a DUNS number online. It is important that the information contained in DUNS

The U.S. Food and Drug Administration (FDA) has announced the Fiscal Year (FY) 2023 fees under the Medical Device User Fee Amendments (MDUFA).  The fiscal year begins October 1st, 2022 and ends September 30th, 2023. Medical device facilities must pay the fees to maintain a compliant FDA status.  Medical Device Fees  FDA requires fees for

In  Factors That Affect Your Shipments to the US – Part 1, we discussed PREDICT, the system the U.S. Food and Drug Administration (FDA) uses to forecast which shipments to examine or sample at the U.S. port of entry. We considered how inherent product risk and a history with compliance issues can raise a company’s

The U.S. Food and Drug Administration (FDA) recently released a draft guidance detailing its implementation of Remote Regulatory Assessments (RRAs). The draft, “Conducting Remote Regulatory Assessments: Questions and Answers,” outlines FDA’s use of RRAs to continue regulatory oversight both during and beyond the COVID-19 pandemic. The guidance states that RRAs, which allowed FDA to assess

The U.S. Food and Drug Administration (FDA) reviews more than 45 million shipments being offered for import each year. FDA aims to ensure that it possesses complete information about every shipment to determine whether the product complies with U.S. laws and regulations before it is marketed in the U.S. This information can determine how likely

On August 17, 2022, the U.S. Food and Drug Administration (FDA) issued a final rule establishing a new over-the-counter (OTC) category of hearing aids for consumers with perceived mild to moderate hearing impairment. The rule, effective October 17, 2022, will allow consumers to purchase hearing aids from online retailers and stores without a prescription, medical exam or

Registrar Corp often receives questions from food manufacturers about whether other companies can view their food facility’s U.S. Food and Drug Administration (FDA) registration. Unlike medical device and drug facilities, FDA Food Facility Registration data is not publicly available. FDA does not provide certification to registered food facilities and food facility registrations are not subject

In this 3-part series, we explore the basic foundations of FDA’s regulation of Medical Devices. Topics include Controls and Classifications, Premarket Notification 510(k), and Premarket Approval (PMA).   All medical devices intended for distribution in the U.S. are subject to controls regulated by the U.S. Food and Drug Administration (FDA). In Medical Devices 101: Controls and

With U.S. consumers seeking products to boost a healthy lifestyle, the dietary supplement market is thriving. Because many consumers struggle to incorporate recommended amounts of vitamins and minerals into their diets, they often rely on dietary supplements to fill the nutritional gaps. The accessibility of dietary supplements contributes to their popularity, as they are sold

As part of the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) requires most food facilities and U.S. importers to conduct certain supplier verification activities through implementation of a Supply Chain Program or Foreign Supplier Verification Program (FSVP), respectively, to ensure that hazards that can only be controlled by their supplier

Over-the-counter (OTC) drugs adorn the shelves of many retail outlets in the U.S., including pharmacies, grocery stores, and convenience stores. OTC drugs do not require a written prescription from a medical professional, making them highly accessible. Though there are similarities in the regulations the U.S Food and Drug Administration (FDA) enforces for both prescription drugs

In this 3-part series, we explore the basic foundations of FDA’s regulation of Medical Devices. Topics include Controls and Classifications, Premarket Notification 510(k), and Premarket Approval (PMA).   A Premarket Notification 510(k) is an application submitted to FDA to demonstrate that a medical device is at least as safe and effective (substantially equivalent) as a legally

On July 22, 2022, the U.S. Food and Drug Administration (FDA) announced a proposed rule to revise the ten-digit format for national drug codes (NDCs) to a uniform 12-digit format. This rule, Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), would change FDA’s regulations on foreign and domestic establishment

The U.S. Food and Drug Administration (FDA) recently warned consumers that certain brands of ultraviolet (UV) wands could pose a potential risk of injury upon use. These wands are used to disinfect surfaces and eliminate germs in settings outside of most health care settings, such as in residential properties. FDA says that the affected products

In this 3-part series, we explore the basic foundations of FDA’s regulation of Medical Devices. Topics include Controls and Classifications, Premarket Notification 510(k), and Premarket Approval (PMA).   Before marketing a medical device in the United States, manufacturers should first gain a solid understanding of how the U.S. Food and Drug Administration (FDA) classifies medical devices. 

On July 12, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to four companies selling honey-based products that were tainted with hidden active drug ingredients. These products were marketed as food, but laboratory testing conducted on samples detected the presence of ingredients that meet FDA’s drug definition. These ingredients include the active

The Food Safety Modernization Act (FSMA) was enacted on January 4, 2011, affecting every step of the food supply chain, and shifting the focus from reacting to food safety crises to preventing them. Generally, foreign and domestic facilities that manufacture, process, pack, or hold food for human consumption in the United States must register with

Food additives are a common inclusion in foods distributed in the United States. Food manufacturers often depend on additives to enhance their food products in various ways. These additives can be used to achieve aesthetic purposes or can be functional, preserving the quality of the product or making it safer to consume. The U.S. Food

U.S. consumers regularly purchase food and drink products to meet the nutritional standards set forth by popular diets. As people seek to follow these guidelines consistently, the demand for additional products provides opportunity for marketplace expansion. Currently, three of the most popular diets in the U.S. are keto, vegan, and plant-based diets. Get assistance with

The Food and Drug Administration (FDA) defines a food contact substance (FCS) as “any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food.” Packaging or equipment that come into contact

U.S. consumers often look for expiration dates when deciding if a product is safe to consume or use. Dates appear on many products, but the U.S. Food and Drug Administration (FDA) does not regulate most of these dates, so their meaning is based on the manufacturer’s interpretation. Products that do not require dates could include

Animal feed is food intended for animal consumption, including food and treats for pets and food for farm animals. The U.S. FDA’s Center for Veterinary Medicine (CVM) is responsible for regulating animal feed intended for consumption in the U.S., including feed for chickens, turkeys, cows, pigs, sheep, fish, dogs, cats, and horses. It is their

A food color additive is any dye, pigment, or other substance that can impart color to a food product. The U.S. Food and Drug Administration (FDA) regulates food color additives, including both synthetic substances and substances derived from natural sources. Color additives must undergo FDA’s approval process before being used in food. FDA may take

Caffeine is a stimulant many consumers in the U.S. incorporate into their daily lives. Coffee and tea are among the most popular caffeine sources, as are energy drinks and carbonated soft drinks. Though caffeine is considered safe for most adults in moderate amounts, excessive amounts of caffeine consumed in a short period of time can

Recently, parents of infants made an unpleasant discovery about the complexity and limitations of supply chains for products as specialized as infant formula. As a result of product contamination that resulted in two infant deaths, the nation’s largest manufacturer of infant formula (Abbott Nutrition) was forced to close one of its factories, cease production, and

Generally speaking, FDA regulates color additives in all FDA-regulated products, including in medical devices. However, because of the different nature of medical devices compared to the other products FDA regulates, the agency has a special approach to determining when color additives must be approved for use in devices. Even to a layman, it would make

Updated May 1, 2023 Allergic reactions are a common issue in the U.S., often occurring when someone comes into contact with a substance that their body perceives is harmful. Whether the person is consuming an allergen through food or drink or contacting the substance with their skin, if the individual’s immune system attempts to fight

Updated April 14, 2023 Under the Foreign Supplier Verification Program (FSVP) Rule, the U.S. Food and Drug Administration (FDA) requires most U.S. importers to develop FSVPs to provide adequate assurances that their foreign suppliers are producing food that is safe for consumption. Importers are responsible for gathering supplier compliance data and using that data to

The U.S. Food and Drug Administration’s (FDA’s) labeling regulations generally require that firms list all ingredients present in a food product on the product’s label. However, certain circumstances can allow an exemption from this regulation. An example of a substance that may be exempt from labeling requirements is an incidental additive. Get assistance with FDA

Labeling errors are among the most common U.S. Food and Drug Administration (FDA) violations for food companies. There are scores of FDA labeling regulations that may be applied to your product, and any error could cause FDA to deem your product “misbranded”. If your product is misbranded, you could be subject to FDA enforcement actions.

The U.S. Food and Drug Administration (FDA) works in conjunction with the U.S. Department of Agriculture (USDA) to regulate many food products distributed in the United States. Although USDA regulates a large portion of meat products, FDA sometimes regulates similar products, leading to confusion amongst agencies. One issue agencies often find ambiguous is dietary supplement

The U.S. Food and Drug Administration (FDA) recently issued a guidance outlining a regulation change affecting certain ophthalmic dispenser products. The new regulation will require certain products previously regulated as drugs to adhere to requirements applicable for drug-device combination products. The regulation change will apply to companies with pending applications, marketed products, and OTC monograph

Obesity and overweight are health conditions that plague millions of people in the United States. Products marketed for weight loss contain ingredients that claim to help consumers lose weight in different ways, depending on the type of product. The types of claims that can be made about a product are impacted significantly by its classification

The U.S. Food and Drug Administration (FDA) recently placed additional firms on Import Alert 89-08 on charges of adulteration or misbranding. Products added to the Import Alert include COVID-19 testing kits, personal protective masks, dermabrasion devices, and infrared thermometers, among others. FDA has determined these products lack either a 510(k), Pre-Market Approval (PMA), or an

The U.S. Food and Drug Administration (FDA) shares responsibility with the Alcohol and Tobacco Tax and Trade Bureau (TTB) in regulating alcoholic beverages in the U.S. All establishments that produce alcoholic beverages for U.S. distribution must register with FDA, but the government agency that regulates the product’s labeling depends on certain criteria. Understanding these criteria

Aromatherapy products contain essential oils with fragrances aimed at achieving certain purposes. Many aromatherapy products are used for cosmetic purposes, but some are intended to be used to improve a health condition, making them drug products. FDA regulates aromatherapy products according to the intended use of a product. Knowing whether FDA considers your product a

The deadline for discontinuing distribution of certain alcohol-based hand sanitizers produced under temporary policies during the COVID-19 public health emergency (PHE) is March 31, 2022. On this date, manufacturers must also cease usage of ethanol prepared under COVID-19 PHE policies to manufacture a finished alcohol-based hand sanitizer. The U.S. Food and Drug Administration (FDA) instituted

Products marketed as “holistic” have become increasingly popular in the United States. With more people aiming to incorporate natural products into their lifestyle, companies are striving to meet the demand. Holistic products come in many forms, from detox teas and skin creams to dietary supplements and weight-loss pills. FDA does not regulate the use of

On March 14, 2022, the U.S. Food and Drug Administration (FDA) announced new fees for the Over-the-Counter (OTC) Monograph Drug User Fees (OMUFA) program for fiscal year (FY) 2022. Facility fees for FY 2022 are due June 1, 2022. In 2021, FDA began collecting annual facility fees from covered OTC drug facilities under the OMUFA

The United States Patent and Trademark Office (USPTO) has granted leading U.S. Food and Drug Administration (FDA) compliance firm Registrar Corp a patent for the technology that powers RegiScore, the Food Industry’s leading compliance risk assessment tool. RegiScore is a first-of-its kind compliance scoring system that uses predictive analytics to evaluate supplier risk for buyers

The drug industry is raising concerns about the timeframe of the U.S. Food and Drug Administration’s (FDA) new drug reporting requirements. The requirements, created as part of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), call for FDA-registered drug establishments to submit annual reports to FDA of the amount of each listed drug

Health experts are recommending that the U.S. public upgrade from cloth masks to surgical masks or N95 respirators due to the surge of the highly contagious COVID-19 variant, Omicron. Cloth masks have been generally preferred due to comfort and aesthetics, but experts believe cloth masks do not provide adequate protection from Omicron. As the advice

In 2021, the U.S. Food and Drug Administration (FDA) took enforcement actions against multiple establishments listing Cannabidiol (CBD) as an inactive ingredient in over-the-counter (OTC) drugs. FDA has not formally approved any cannabis-derived compound as an active ingredient for OTC drug use, and has not evaluated CBD under the agency’s OTC Drug Review, the process

The U.S. Food and Drug Administration (FDA) released its annual Inspection Observation Data for the Fiscal Year (FY) 2021. This data depicts how frequently FDA cited particular violations during food facility inspections between October 2020 and September 2021. Read on to learn about the top 5 violations that FDA inspectors cited in FY 2021. FSVP

Leading U.S. Food and Drug Administration (FDA) compliance firm Registrar Corp introduces Marketplace, a digital platform that seamlessly connects importers and suppliers of FDA regulated products. Marketplace is an addition to Registrar Corp’s suite of compliance solutions. Marketplace can be used independently or as a convenient add-on to Registrar Corp’s FDA Compliance Monitor. Users can

Proctor and Gamble (P&G) recently recalled more than 30 aerosol hair products due to the presence of benzene, a chemical that can cause cancer. The affected products include dry shampoos, dry conditioners, and various styling products. The recall occurs as drafts of the Personal Care Products Safety Act remains with legislative sponsors. If passed, the

The U.S. Food and Drug Administration (FDA) will resume a pilot program that will lead to unannounced onsite inspections in India and China. FDA intends to start the inspections in early 2022. Elizabeth Miller, in FDA’s Office of Regulatory Affairs (ORA), announced the forthcoming inspections during a virtual conference hosted by the Food and Drug

UPDATED 12/20/2021 In April 2021, the General Administration of Customs of China (GACC) announced new registration requirements for facilities providing food for export to China, effective January 1, 2022. These requirements, described in China’s Decree 248, will affect facilities that manufacture, process, or store food products exported to China. On December 6, 2021, The U.S.

On November 22, 2021, the U.S. Food and Drug Administration (FDA) issued 2 final orders on blood lancet devices. One order reclassified certain blood lancet devices from class I (general controls), exempt from premarket notification, into class II (special controls), subject to premarket notification. The order also reclassified certain class I devices into class III

FDA requires most FDA-registered food establishments to create and implement a Hazard Analysis and Risk-Based Preventive Controls (HARPC) Food Safety Plan. Companies subject to the Preventive Controls Rule (21 CFR 117) must designate a Preventive Controls Qualified Individual (PCQI) to develop the HARPC Plan. Companies often ask Registrar Corp if their Food Canning Establishment (FCE)

The U.S. Food and Drug Administration (FDA) has released details regarding new annual reporting requirements that the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) set forth for drug registrants. On March 27, 2020, the CARES Act amended a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require registered drug

On September 20, 2021, the U.S. Food and Drug Administration (FDA) released an initial batch of final administrative orders for Over-The-Counter (OTC) drug monographs, the first to emerge from the OTC Monograph Reform. FDA established the reform on March 7, 2020, under the Coronavirus Aid, Relief, and Economic Security (CARES) Act. FDA released the first

The U.S. Food and Drug Administration (FDA) will move forward with its repeal of lead acetate from the certified list of color additives in cosmetics intended for coloring hair on the scalp. A stay to the final rule entitled “Termination of Listing of Color Additives Exempt From Certification; Lead Acetate” had been in place in

Maintaining a Food Safety Management System (FSMS) such as FSSC 22000, SQF, or ISO 22000 includes conducting internal audits to ensure systems are implemented as intended. Internal auditors compare processes to documented policies and identify nonconformances that suggest the system is not operating as planned or meeting the standard’s requirements. The ultimate purpose of an

In September 2021, the U.S. Food and Drug Administration (FDA) updated its enforcement policy for masks and respirators during the COVID-19 pandemic that was originally issued in April 2020. The initial policy provided flexibility in regards to certain regulatory requirements for these products under certain circumstances by including a blanket Emergency Use Authorization (EUA) for

The U.S. Food and Drug Administration (FDA) requires medical device and drug establishments that produce and distribute products for use within the United States to renew their FDA registration annually. These businesses must renew their registrations for 2022 between October 1, 2021 and December 31, 2021. Continue reading to learn about renewal requirements and what

The U.S. Food and Drug Administration (FDA) requires most registered food facilities to comply with Food Safety Modernization Act (FSMA) Preventive Control regulations. Likewise, most U.S. food importers need to comply with Foreign Supplier Verification Program (FSVP) requirements. However, meeting the eligibility requirements for a Qualified Facility or a Very Small Importer (VSI) might exempt

Many companies selling food online through platforms like Amazon have asked Registrar Corp what steps they can take to assure they comply with U.S. Food and Drug Administration (FDA) standards. Companies selling food products online to customers in the United States are typically subject to the same FDA requirements as food companies selling through traditional

The U.S. Food and Drug Administration (FDA) has announced the Fiscal Year (FY) 2022 fees under the Generic Drug User Fee Amendments (GDUFA) and the Medical Device User Fee Amendments (MDUFA). The fiscal year begins October 1st, 2021 and ends September 30th, 2022. Drug and device facilities must pay the fees to maintain a compliant

Updated November 10, 2022 The multi-billion-dollar U.S. cosmetics industry is booming.  The U.S. Food and Drug Administration (FDA), which regulates cosmetics in the United States, reports through its data dashboard that over 3 million cosmetic line-items entered U.S. ports in Fiscal Year (FY) 2021.   However, this immense volume of cosmetic imports poses certain challenges as

In the aftermath of COVID-19, the U.S. is experiencing a shortage of many alcoholic beverages. With States steadily easing restrictions, experts are predicting the demand will likely continue to outpace the U.S. inventories. Read on to learn what led to this shortage as well as what it means for alcohol suppliers. Get Help With FDA

Updated February 28, 2023 Food manufacturers are now required to list sesame as an allergen on their food labels. The new regulation was set forth by the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER), a bill Congress enacted in April 2021. The bill states that sesame-containing foods introduced into interstate commerce

In recent years, the marketing of cannabidiol (CBD) products in the United States has grown exponentially. With this rise in popularity, Registrar Corp often receives questions about the legality and regulation around CBD products and marketing them to consumers in the United States. Despite widespread CBD inventory in US stores, the U.S. Food and Drug

In February 2021, the U.S. Food and Drug Administration (FDA) issued an import alert on all alcohol-based hand sanitizers from Mexico. This means that most hand sanitizers exported to the United States from Mexico will be detained at the U.S. port of entry regardless of whether they are compliant with FDA requirements. This marks the

Registrar Corp’s FDA Compliance Monitor, a supply chain risk management automation tool, is used by nearly a thousand importers daily to monitor their suppliers’ compliance activity and make informed purchasing decisions with predictive analytics tools. Read on to learn the different ways three U.S. Importers are using the FDA Compliance Monitor to save time and

On March 26, 2021, the U.S. Food and Drug Administration (FDA) published new Over-the-Counter (OTC) Monograph user fees for fiscal year (FY) 2021.  Beginning this year, FDA will require covered OTC drug facilities to pay an annual facility fee under the OTC Monograph User Fee Program (OMUFA), which was established by the passage of the

The International HACCP Alliance has approved Registrar Corp’s 100% online, self-paced HACCP Development course.  Industry can now learn to implement and maintain a HACCP Plan on their own time and from the comfort of their home or office.  Course takers will complete interactive exercises and audit a sample HACCP Plan.  They will finish the course

In February 2021, the U.S. Food and Drug Administration (FDA) removed 13,455 medical device establishments and their associated device listings from its registration database.  This resulted in a 31% decrease in the total number of medical device establishments registered with FDA.   Medical device establishments are required to renew their FDA registrations annually between October 1 and December 31.

In January 2021, the U.S. Food and Drug Administration (FDA) removed 59,420 food facilities from its registration database, resulting in a 25% decrease in the total number of food facilities registered with FDA. Food facilities are required to renew their FDA registrations between October 1 and December 31 of each even numbered year. FDA considers

The U.S. Food and Drug Administration (FDA) released its annual Inspection Observation Data for the Fiscal Year (FY) 2020. This data depicts how frequently particular violations were found during FDA food facility inspections between October 2019 and September 2020. The following are the top five violations cited by FDA inspectors in FY 2020. Be Ready

Registrar Corp often receives inquiries about who needs to register with the U.S. Food and Drug Administration (FDA), many of which come from food importers. Food importers are not required to register with FDA unless they manufacture, process, pack, or store foods in addition to importing. For some importers, the confusion stems from the requirement

The U.S. Food and Drug Administration (FDA) requires most U.S. importers to develop Foreign Supplier Verification Programs (FSVPs) for each food product that they import from foreign suppliers. Common myths can lead to misunderstandings regarding when or how facilities need to develop FSVPs. Failing to develop FSVPs can lead to FDA enforcement such as product

Updated March 9, 2023 The U.S. Food and Drug Administration (FDA) recently finalized an eighth rule under the Food Safety Modernization Act (FSMA) known as Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule). The Rule is intended to fulfill recordkeeping requirements under FSMA that help FDA quickly identify recipients of adulterated

Introducing an all-in-one solution for supplier monitoring and document management. Leading U.S. Food and Drug Administration (FDA) compliance firm Registrar Corp is introducing a new Document Management System (DMS) add-on to the FDA Compliance Monitor, making the Monitor the only complete solution for supplier monitoring and document management.  Users can now request, approve, and manage

Before the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) was largely responsible for ensuring that companies exporting food to the United States were complying with U.S. food safety regulations.  For the most part, importers of these food products went unregulated in terms of food safety. FSMA introduced the Foreign Supplier

The U.S. Food and Drug Administration (FDA) requires all facilities that manufacture, process, pack, or store food for U.S. consumption to renew their facility registrations between October 1st and December 31st, 2020.  This includes facilities that registered this year. Even if a facility registers as late as September 30th, 2020, they will still be required

The U.S. Food and Drug Administration (FDA) often inspects food importers for compliance with the Foreign Supplier Verification Program (FSVP) rule. During these inspections, FDA may ensure that importers have established an FSVP. So far this year, 7% (31 letters) of Warning Letters that FDA has issued were related to FSVP violations. This represents an

The U.S. Food and Drug Administration (FDA) regulates certain products that are commonly considered cosmetics as drugs. FDA regulations for drug products are strict and more comprehensive than regulations for traditional cosmetics, which can often cause confusion for manufacturers. The distinction between a drug and cosmetic product is based upon the product’s ingredients as well

The U.S. Food and Drug Administration announced that it will raise re-inspection fees for domestic and foreign food facilities during the Fiscal Year (FY) of 2021. The fee for re-inspection of a foreign facility in FY 2021 will be $310/hr, an increase from $301/hr in FY 2020. The fee for re-inspection of a domestic facility

Leading FDA advisory and training firm Registrar Corp announced today the release of the first ever fully online and self-paced “FSPCA Preventive Controls for Human Food” course approved by the Food Safety Preventive Controls Alliance (FSPCA) and which includes the FSPCA certificate. This course uses the standardized curriculum recognized by the U.S. Food and Drug

MARCH 2021 UPDATE: FDA extended the deadline to obtain a Unique Facility Identifier to December 31, 2022.  Learn more here. -- The U.S. Food and Drug Administration (FDA) has indicated that food facilities will be required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing an FDA registration beginning October 1,

Update: FDA published the FY 2021 OMUFA Facility Fees on December 29, 2020. — In March 2020, the US President signed a COVID-19 relief legislation titled the CARES Act. This legislation included an initiative that “reforms and modernizes the way certain nonprescription, over-the-counter (or OTC) drugs are regulated in the United States.” One of the key

On July 6, two of Registrar Corp’s 100% online FSSC 22000 training courses were approved by the FSSC 22000 food safety certification program: Understanding FSSC 22000 Implementing FSSC 22000 Registrar Corp is an FSSC 22000 licensed Training Organization. FSSC 22000 Training Organizations are monitored under the FSSC 22000 Integrity Program. The program and course approval

Registrar Corp recognizes that there are many concerns and questions about how COVID is affecting the food industry.  In this article we will discuss how the pandemic is affecting food safety and supply. COVID-19 Is Not a Food Borne Illness One of the top concerns surrounding the food industry during COVID-19 has been whether the

Due to growing concerns over the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) has decided to postpone most onsite inspections of food facilities worldwide. Inspections are on hold at least through April but may be postponed longer if safety concerns persist. What does this mean for me? While food facility inspections are currently

On April 3, 2020, the U.S. Food and Drug Administration announced it will inspect importers for compliance with the Foreign Supplier Verification Program (FSVP) rule remotely during the COVID-19 public health emergency. “Under the FSVP regulation FDA has the authority to make written requests for importers to provide records to the agency electronically or by

In response to high demand for hand sanitizer products associated with the COVID-19 outbreak in the United States, the U.S. Food and Drug Administration (FDA) published two guidance documents outlining conditions under which compounding pharmacies and firms not typically regulated by FDA may prepare alcohol-based hand sanitizers for use by consumers and healthcare professionals. The

Registrar Corp, a leading provider of U.S. Food and Drug Administration (FDA) compliance services, is proud to announce its acquisition of Vinca, LLC (www.22000-Tools.com).  Vinca has provided online training for food safety management systems since 2001.  Over 10,000 global users have utilized their 100% online courses, which cover topics including ISO 22000, FSSC 22000, SQF,

Registrar Corp, a leading provider of U.S. Food and Drug Administration (FDA) compliance services, is proud to announce its acquisition of Vinca, LLC (www.22000-Tools.com).  Vinca has provided online training for food safety management systems since 2001.  Over 10,000 global users have utilized their 100% online courses, which cover topics including ISO 22000, FSSC 22000, SQF,

Registrar Corp, a leading provider of U.S. Food and Drug Administration (FDA) compliance services, recently received data from FDA detailing the number of registered food facilities in the Agency’s database.  The data reveals that as of December 31, 2019, there are 221,843 FDA-registered food facilities, 127,420 (57%) of which are located outside of the United

COVID-19 has made its way to the United States and has led to a nationwide shortage of face masks. Registrar Corp has received many requests from global manufacturers for assistance with U.S. Food and Drug Administration (FDA) regulations for exporting masks and other infection control devices to the USA in response. Despite Surgeon General requests

Registrar Corp, a leading provider of U.S. Food and Drug Administration (FDA) compliance services, has announced its acquisition of Batavia Solutions Inc. (dba ‘Register-FDA’). Register-FDA has over 20 years of combined experience providing FDA compliance services, including registration and U.S. Agent services for food, medical device and drug establishments, as well as Food Safety Modernization

Registrar Corp, a leading provider of U.S. Food and Drug Administration (FDA) compliance services to FDA-regulated facilities around the world, has announced a partnership with Business Sweden. Business Sweden will collaborate with Registrar Corp to provide regulatory assistance to Swedish food and medical device clients seeking to export to the United States. This strategic partnership

The U.S. Food and Drug Administration (FDA) issued a press release detailing its continued efforts to prevent the sale of misbranded, adulterated, or otherwise illegal drug and device products in the United States. This includes a court ordered seizure of 4,229 Internet domain names for selling misbranded or adulterated products. Understanding what makes a product

Registrar Corp, an industry leader in FDA compliance services, has recently acquired certain assets of K Squared International, LLC (dba US Agent Services), of Ada, Michigan.  K Squared has provided FDA regulatory services, including U.S. Agent services, for their worldwide customer base of food, drug, and medical device companies. This is Registrar Corp’s third acquisition

The U.S. Food and Drug Administration (FDA) recently updated the Voluntary Malfunction Summary Reporting (VMSR) program eligibility status of several medical device product codes. Some previously eligible devices are now ineligible for VMSR, meaning manufacturers must now submit standard individual Medical Device Reports (MDRs) for the newly ineligible products. FDA notified companies with affected products

On September 13, 2019, the U.S. Food and Drug Administration (FDA) added or updated hundreds of products and companies to its Import Alert 66-41: Detention Without Physical Examination of Unapproved New Drugs Promoted in the U.S. This is an abnormally high number of updates and additions for a single day. An import alert informs FDA

Registrar Corp has acquired Registration and Licensing Systems, Inc. (“RLS”).   RLS has provided FDA registration and U.S. Agent services to domestic and foreign food facilities since 2003 and supports hundreds of clients around the world.  Registrar Corp President David Lennarz sees the acquisition as advantageous to both Registrar and to RLS clients. “This acquisition not

Under the Food Safety Modernization Act (FSMA), most food facilities operating in or exporting to the U.S. are required to have a Food Safety Plan following the Hazard Analysis and Risk Based Preventive Controls (HARPC) method. The Act also requires U.S. importers to have a Foreign Supplier Verification Program (FSVP) for all imported food products

On August 28, Mayor Donnie Tuck joined Registrar Corp to celebrate the expansion of its headquarters in Hampton, Virginia. Registrar Corp, a leading provider of U.S. Food and Drug Administration (FDA) compliance services to FDA-regulated facilities worldwide, has bolstered their workforce in order to meet increasing industry needs. With FDA mandating several new regulations over

The U.S. Food and Drug Administration (FDA) announced the new fee schedules for the Generic Drug User Fee Amendments (GDUFA) and the Medical Device User Fee Amendments (MDUFA) for the Fiscal Year (FY) of 2020. Additionally, FDA announced the new rates for human drug compounding outsourcing facilities. All of the new fees take effect October

The U.S. Food and Drug Administration (FDA) announced they will raise the fee for re-inspections of applicable domestic and foreign food facilities and US importers for the Fiscal Year (FY) 2020. The fee for re-inspection of a foreign facility in FY 2020 will be $301/hr, an increase from $282/hr in FY 2019. The fee for

Approximately 32 million Americans suffer from food allergies. In response, Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) which requires food labels to list all ingredients that may cause allergic reactions.  The law identifies eight major food allergens, one of which is tree nuts. The U.S. Food and Drug Administration

Registrar Corp has added U.S. Food and Drug Administration (FDA) registration numbers to its FDA Compliance Monitor. In an effort to prevent delays and detentions, users can now verify their suppliers’ registration status prior to import. Food, drug, and medical device establishments are required to register with FDA before selling their products in the United

Under the Preventive Control Rules, most food and beverage facilities that operate in the U.S. or export to the U.S. market must develop and implement written Food Safety Plans using the Hazard Analysis and Risk Based Preventive Controls (HARPC) method mandated by the U.S. Food and Drug Administration (FDA).  A complete Food Safety Plan must

Updated February 24, 2023 Amazon previously revealed it has over 100 million Amazon Prime members on its site, representing one of the largest potential markets available. Amazon has made a concerted effort to make cosmetics a larger part of its sales, seeing tremendous growth in the category each of the past three years. However, selling

In March 2019, the U.S. Food and Drug Administration (FDA) removed approximately 2,551 medical device establishment registrations from its database, a decrease of 9% from the 27,289 registrations that were in the database in February 2019. Why Did FDA Remove These Registrations? Establishments that manufacture or distribute medical devices intended for use in the U.S.

The U.S. Food and Drug Administration (FDA) has the authority to inspect any FDA-registered facility.  Facilities located outside the U.S. that refuse an FDA inspection may be placed on Import Alert 99-32, “Detention Without Physical Examination of Products from Firms Refusing FDA Foreign Establishment Inspection”.   All products exported to the U.S. by a facility on

In February 2019, the U.S. Food and Drug Administration (FDA) removed 47,635 food facilities from its database, resulting in over a 20% decrease in registrations. This was likely caused by facilities failing to properly renew their registrations before the December 2018 renewal deadline. FDA removes all facilities that did not renew shortly after each renewal

On February 26, 2019, the U.S. Food and Drug Administration (FDA) published a proposed rule to establish final monograph regulations for over-the-counter (OTC) sunscreen drug products.  If finalized, the rule will update conditions under which OTC sunscreen products may be marketed in the United States. Since issuing an indefinite stay on a 1999 final monograph,

The U.S. Food and Drug Administration (FDA) requires Nutrition Facts labeling on food products sold in the United States, whether they are produced domestically or outside of the United States. Coffee, tea, and spices may be exempt from FDA nutrition labeling requirements if they contain “insignificant” (by FDA’s definition of the term) amounts of all

The U.S. Food and Drug Administration (FDA) recently released its Fiscal Year (FY) 2018 Inspection Observation Data.  The data aggregates violations documented during FDA inspections from October 2017 through September 2018.  During this period, FDA cited 289 U.S. importers of food and beverages for not developing Foreign Supplier Verification Programs (FSVP), making it the most

The U.S. Food and Drug Administration (FDA) requires all food, beverage, and dietary supplement labels to bear declarations called “statements of identity.”  Companies attempting to comply with this requirement will likely encounter a similar term called “standard of identity.” The two are closely related, and understanding what must be included in a statement of identity

Registrar Corp has acquired FDA Agents.  FDA Agents has provided FDA registration, U.S. Agent, and product listing services to domestic and foreign FDA-regulated facilities since 2003 and supports more than 1,000 clients worldwide. “Our goal is to expand Registrar’s reach across the FDA-regulated market,” said David Lennarz, Registrar Corp’s President of Business Development and Operations.

Beginning October 1, 2018, the U.S. Food and Drug Administration (FDA) will require electronic format for new Veterinary Master File (VMF) submissions, including amendments.  FDA states that it will not accept paper VMF submissions after this deadline. What Is A VMF? FDA defines a VMF as “a submission that provides confidential detailed information about facilities,

Registrar Corp added recalls to their FDA Compliance Monitor.  Users can now view the recall history of their own company, their suppliers, and potential suppliers, including: The description of the recalled product. The recall classification (the level of health risk involved). The reason for the recall. The current status of the recall (ongoing, completed, etc.).

U.S. FDA Deadline Approaching for Prescription Drug Labels: New Product Identifier Requirements Under the Drug Supply Chain Security Act (DSCSA), manufacturers, packagers, and repackagers of human prescription drugs must affix or imprint a “product identifier” to each package and homogenous case of product intended to be introduced in a transaction into US commerce. This process

The U.S. Food and Drug Administration (FDA) recently published the Fiscal Year (FY) 2019 fee schedules for the Generic Drug User Fee Amendments (GDUFA) and Medical Device User Fee Amendments (MDUFA). FY 2019 rates for both amendments take effect on October 1, 2018. To keep industry updated on these requirements, Registrar Corp outlines upcoming changes

The U.S. Food and Drug Administration (FDA) has finalized a number of rules under the Food Safety Modernization Act (FSMA) that address topics such as: Preventive controls for human and animal food Foreign supplier verification programs Prevention of intentional adulteration of the food supply The registration of food facilities Many of the deadlines for complying

In a recent guidance document, the U.S. Food and Drug Administration (FDA) announced the intention to permit eight isolated or synthetic non-digestible carbohydrates to be declared as dietary fiber on the nutrition facts label.  Pending rulemaking, FDA intends to exercise enforcement discretion when the following are included in a label’s dietary fiber declaration: Mixed plant

Registrar Corp is committed to keeping industry up to date on FDA’s Unique Device Identifier  (UDI) requirements and recently attended the 2018 UDI Conference in Baltimore. The following blog summarizes new and updated information related to UDI and Global Unique Device Identification Database (GUDID) regulations. Background In September 2013, the U.S. Food and Drug Administration

Registrar Corp has partnered with Export Access to offer localized assistance with U.S. Food and Drug Administration (FDA) regulations in the United Kingdom (UK).  Export Access is a UK-based company that provides worldwide market access training and logistics services to exporters in the region. “Given the parallel goals of our companies, we see this as

As part of the U.S. Food and Drug Administration’s (FDA) Revision of the Nutrition and Supplement Facts Labels Final Rule, many foods, beverages, and dietary supplements are required to bear a declaration for “added sugars.”  The requirement is perhaps one of the most perplexing aspects of the rule, leaving many businesses with a lot of

On April 3rd, 2018, the U.S. Food and Drug Administration (FDA) ordered a mandatory recall of all food products that contain powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC. The Agency issued the order after several samples of kratom products manufactured by the Las Vegas based company tested positive for salmonella, a

Dietary supplement companies often come to us unsure of how the U.S. Food and Drug Administration (FDA) regulates their products.  The requirements are not immediately clear, especially when label claims and terms such as “nutraceuticals” or “functional foods” (not recognized by FDA) can blur the distinction between supplement and drug.  In fact, FDA regulations for dietary

The U.S. Food and Drug Administration (FDA) recently published a draft guidance on how to determine whether a business is a “small business” under the Preventive Controls for Human and Animal Food Rules.  The rules define a “small business” as having fewer than 500 “full-time equivalent employees.” Small businesses are subject to different compliance deadlines

*Update: In January 2019, FDA extended the eCTD compliance date for Type III DMFs to May 5, 2020. Beginning May 5, 2018, the U.S. Food and Drug Administration (FDA) will require electronic common technical document (eCTD) format for all new Drug Master File (DMF) submissions, including reports and amendments.  FDA states that it will reject

The U.S. Food and Drug Administration (FDA) removed 2,546 medical device establishments from its active registration database.  As of February 19, 2018, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on February 2, 2018. Why Were These Registrations Removed? Establishments are typically removed due to failure to renew their annual FDA

Online vendors such as Amazon require documentation of a U.S. Food and Drug Administration (FDA) accession number for certain laser products sold through their online platforms.  An accession number is a unique identifier that FDA uses to track reports from specific models of radiation-emitting electronic devices (RED).  FDA requires manufacturers of certain RED products to

Medical device manufacturers commonly question whether the U.S. Food and Drug Administration (FDA) considers their product a medical device “component” or “accessory.”  Given that accessories can be classified separately from the parent devices they function with, the distinction is important.  In December, FDA issued a guidance on accessory classification policy that helps clarify this distinction.

On January 2, 2018, the U.S. Food and Drug Administration (FDA) removed all drug establishments that did not renew their FDA registrations for 2018 from its active registration database. The Agency also removed all uncertified drug product listings from publication. FDA removed 1,256 of the 10,496 drug establishments in FDA’s database as of December 31,

On December 20, 2017, The U.S. Food and Drug Administration (FDA) published a final rule that will prohibit the inclusion of commonly used ingredient triclosan and 23 other active ingredients in antiseptics for health care environments.  Following the rule’s compliance deadline of December 20, 2018, health care antiseptics containing any of the covered ingredients will

Once small and specialized, homeopathic drugs now comprise a nearly $3 billion industry.  Following an increase in reported health concerns stemming from these products and a flurry of unsubstantiated health claims surrounding the industry, the U.S. Food and Drug Administration (FDA) is taking new measures to curb the widespread distribution of potentially harmful drugs labeled

The U.S. Food and Drug Administration (FDA) requires devices intended to be reprocessed or devices intended to be used more than once by multiple patients to physically bear a permanent unique device identifier (UDI) marking that lasts the duration of the devices’ expected lifetime.  This is known as UDI direct marking.  FDA recently published a

The U.S. Food and Drug Administration (FDA) recently proposed to revoke an authorized health claim regarding the relationship between soy protein and decreased risk of coronary heart disease (CHD). According to a statement from Dr. Susan Mayne, FDA drafted this proposal after observing inconsistencies in published scientific data surrounding the claim. Why is FDA changing

Drug establishments registered with the U.S. Food and Drug Administration (FDA) are required to renew their registrations with every year between October 1 and December 31.  The 2017 renewal period marks the first time that registered establishments must submit a “blanket no change certification” for all drug product listings that required no updates within the

More consumers are joining the clean label movement and turning away from artificial ingredients, preservatives, antibiotics and other man-made food modifiers. According to Nielsen, 48 percent of U.S. consumers choose local, natural and organic products when possible, and a study in the Journal of Food Science found consumers are willing to pay more for foods

As of May 30, 2017, most U.S. importers of food and beverages for human and animal consumption are required to comply with the U.S. Food and Drug Administration’s (FDA) Foreign Supplier Verification Program (FSVP) rule.  Since the compliance deadline, Registrar Corp is aware that importers have begun receiving emails from FDA with the subject line:

On February 14, Registrar Corp, a U.S. Food and Drug Administration (FDA) consulting firm, launched two free tools to assist food facilities in complying with FDA requirements for Low-Acid Canned and Acidified Foods. Most facilities that manufacture, process, pack, or store food intended for consumption in the United States are required to register with U.S. FDA as food

Having a detailed project plan in place at the beginning of your SQF/FSSC 22000 or ISO 22000 project will help you meet your goals efficiently and keep the project on track for a successful completion. A good project plan will include Your overall goal tasks to be completed responsibilities timeline training plan We recommend using

The Federal Trade Commission (FTC) recently announced a new enforcement policy for homeopathic drugs. The policy requires homeopathic drug packaging to display the following disclaimers in cases where marketers cannot adequately substantiate their claims: There is no scientific evidence that the product works. The product’s claims are based only on theories of homeopathy from the

The USDA Food Safety Inspection Service (FSIS) recently announced that it will allow voluntary use of the U.S. Food and Drug Administration (FDA) new Nutrition Facts format for food labels on meat and poultry labels. This announcement comes as FSIS works to finalize its own nutrition labeling and serving size regulations. FSIS’s goal is to

If you are wondering how to become an SQF Practitioner, you are not alone. There is no shortage of confusion around this question. There used to be an Certified SQF Practitioner. However, SQF does not certify practitioners or require certification of practitioners. There are 3 requirements that you need to meet to be qualified to be

On September 28, 2016, the U.S. Food and Drug Administration (FDA) opened the term “healthy” to public comment through a “request for information.”  The agency’s goal is to promote the development of healthier foods and to assist consumers in making food choices that are consistent with current public health recommendations.  Food manufactures may continue using

A person does not actually become certified as a PCQI, although you will see many incorrect references to begin “certified”. Anyone can attend a recognized training course for the Preventive controls qualified individual and meet the training requirements for a PCQI. There are no prerequisites, although a food safety background is useful. The course will

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule on the effectiveness and safety of over-the-counter (OTC) antibacterial soaps. This final rule affects consumer antiseptic wash products for both hands and body which contain the frequently used ingredients triclosan and triclocarban as well as 17 other active ingredients (See

What is the difference between ISO 22000 and FSSC 22000? ISO 22000 is not recognized by GFSI. (what is GFSI?) ISO 22000 is broad in scope. FSSC 22000 is recognized by GFSI. FSSC has a more limited scope. Current scopes included are: farming, perishable animal products, food processing, feed production, food ingredients and food packaging material manufacturing.

In 2011, President Obama signed FSMA — a body of regulatory works that quickly became the most sweeping reform of the U.S. food safety system in over 70 years — into law. The FDA published seven major rules under FSMA, each of which created new requirements that put more responsibility on industry to prevent contamination

What is a PCQI? A Preventive controls qualified individual “means a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food

On June 9, 2016, the U.S. Customs and Border Protection (CBP) hosted a webinar on filing import entries through the Automated Commercial Environment (ACE) portal.  The webinar was organized by the U.S. Food and Drug Administration (FDA) and the National Customs Brokers and Forwarders Association of America (NCBFAA). What is ACE? Customs brokers and self-filing

On May 27, 2016, the U.S. Food and Drug Administration (FDA) published its final rule for “Mitigation Strategies To Protect Food Against Intentional Adulteration,” the last of the seven major rules under FDA’s Food Safety Modernization Act (FSMA).  The rule requires most food facilities that must register with FDA to develop and implement a written

*Update – On September 29, 2017, FDA proposed to extend the compliance date to January 1, 2020.  Small businesses will have until January 1, 2021. On May 20, 2016, the U.S. Food and Drug Administration (FDA) finalized two new rules that mandate significant changes to Nutrition Facts Labels for food and beverages.  FDA’s goals of updating

On April 18, 2016, the U.S. Food and Drug Administration (FDA) issued a new Import Alert for “Aquacultured Shrimp and Prawns from Peninsular Malaysia Due to Presence of Drug Residues from Unapproved Animal Drugs or the Presence of Unsafe Food Additives (Import Alert 16-136).”  FDA testing revealed that approximately one-third of shrimp and prawn imports from peninsular

On November 27th, 2015, the U.S. Food and Drug Administration (FDA) published a final rule establishing the Foreign Supplier Verification Program (FSVP), one of the seven major rules of FDA’s Food Safety Modernization Act (FSMA).  FSVP regulations place new responsibilities upon importers to verify that the food they import into the United States has been produced

On February 19, 2016, the U.S. Food and Drug Administration (FDA) removed Import Alert 02-01, “Detention Without Physical Examination of White or Brown Basmati Rice From India”.  Registrar Corp was alerted of the removal by the FDA Compliance Monitor.  Before the alert was removed, all basmati rice shipped from India was subject to Detention Without

On December 28, 2015, U.S. President Barack Obama signed into law the Microbead-Free Waters Act of 2015.  Introduced in March 2015, the act amends the Federal Food, Drug, and Cosmetic Act to prohibit the manufacture and distribution of rinse-off cosmetics (including toothpastes) that contain plastic microbeads.  The ban takes effect on: July 1, 2017 for

  In 2015, the drug and medical device industries saw a turn toward digital. The U.S. Food and Drug Administration (FDA) established new regulations requiring certain documents to be submitted electronically, including pharmaceutical product applications and adverse event reports for devices. FDA also opened an online database for the public to obtain information about devices.

  The U.S. Food and Drug Administration (FDA) took many steps toward improving consumer health in 2015.  The agency finalized four of the seven major Food Safety Modernization Act (FSMA) rules, which aim to decrease the instances of foodborne illness by taking a preventive approach to food safety.  FDA also proposed regulations to ensure consumers

  On December 1, 2015, snack company KIND LLC filed a Citizen Petition urging the U.S. Food and Drug Administration (FDA) to reconsider its regulations regarding use of the term “healthy” as a nutrient content claim on food labeling.  According to KIND, FDA’s current regulations prevent foods like almonds, avocados, and salmon to use the

On November 6, 2015, the U.S. Food and Drug Administration (FDA) published a guidance document regarding FDA’s fortification policy.  FDA allows manufacturers to fortify (add nutrients to) certain food products in order to: correct a dietary insufficiency; restore nutrient levels to those prior to storage, handling, and processing (FDA says if you restore one essential

Did you know the U.S. is among the top ten chocolate consuming countries? Being a host of millions of chocolate lovers makes the U.S. a great market for chocolate manufacturers around the world.  Before you ship chocolate products to the U.S., it's important to comply with FDA chocolate regulations. These include determining whether your product

  Each Wednesday, the U.S. Food and Drug Administration (FDA) publishes an enforcement report that identifies recalls for the previous week.   The report details the products and lots that were recalled, the companies that recalled the products, the reason each product was recalled, and the classification of each recall. There are three different recall classifications:

On September 18, 2015, two women filed a class action lawsuit against Welch Foods for misleading consumers to believe the company’s Welch’s Fruit Snacks are healthier than they are.  Welch’s Fruit Snacks packaging states that the snacks contain 100% Vitamin C and 25% Vitamin A & E.  The plaintiffs alleged that Welch’s Fruit Snacks break

Under the FDA Export Reform and Enhancement Act of 1996 (EREA), medical device companies can request export certificates from the U.S. Food and Drug Administration (FDA).  The cost for an initial export certificate is $175.  Subsequent copies of the certificate for use in the same country are offered for a reduced fee.    On August 18,

The U.S. Food and Drug Administration (FDA) extended the Global Unique Device Identification Database (GUDID) submission compliance date for all labelers required to submit data to the GUDID by September 24, 2015 to October 24, 2015. The extension is the result of GUDID security vulnerability issues that have caused FDA to temporarily take the GUDID

The U.S. Food and Drug Administration (FDA) issued a warning letter to Duchesnay, Inc after a social media endorsement posted by U.S. celebrity Kim Kardashian was reported through FDA’s Bad Ad program.  Kardashian published a lengthy post on her Instagram describing her successful experience with Duchesnay Inc’s product DICLEGIS, a prescription morning sickness medicine. “It’s

The September 24, 2015 Unique Device Identifier (UDI) compliance date is quickly approaching. Life-supporting and life-sustaining device labelers, as well as most contact and intraocular lens labelers, have only two months left to comply with the U.S. Food and Drug Administration’s (FDA) UDI labeling and Global Unique Device Identification System (GUDID) requirements. Implantable device labelers

On July 16, 2015, U.S. Food and Drug Administration (FDA) Facility Reviewer Denise DiGuilio presented a seminar titled “What to Expect During a FDA Drug Manufacturing Inspection.”  The seminar was part of a two-day regulatory education event held in Silver Spring, Maryland, USA.  During her presentation, DiGuilio discussed the various types of FDA Current Good

In order to help food companies properly label their products for U.S. distribution, Registrar Corp compiled a list of the top five U.S. Food and Drug Administration (FDA) food and beverage labeling regulations. 1. Labels must bear a Statement of Identity Every food label must bear a statement of identity, also known as the name

The Canadian Food Inspection Agency (CFIA) and the U.S. Food and Drug Administration (FDA) are in the process of assessing each other’s food safety systems (excluding meat, poultry and eggs products) and establishing a food safety systems recognition arrangement.  The two agencies plan to finalize and sign the Canada-FDA Food Safety Systems Recognition Arrangement by

On June 23, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance regarding the placement of unique device identifiers (UDIs) directly onto devices.  Most devices will soon be required to bear a UDI on their labels and packaging.  For a device that is intended to be used more than once and intended

The United States is the largest candy consuming country in the world.  According to the National Confectioners Association, Americans spend over 30 billion dollars on confectionery products each year and annual sales are expected to grow.   With all that demand, it’s no wonder that countries around the world export billions of dollars’ worth of confectionery

On March 17, 2015, the U.S. Food and Drug Administration (FDA) sent a warning letter to KIND, LLC regarding the labeling of four of its products: KIND Fruit & Nut Almond & Apricot, KIND Fruit & Nut Almond & Coconut, KIND Plus Peanut Butter Dark Chocolate + Protein, and KIND Plus Dark Chocolate Cherry Cashew

Registrar Corp often receives questions regarding U.S. Food and Drug Administration (FDA) regulations.  This week, we’re answering a question about FDA requirements for calling a product “ice cream.” Question: Why does the FDA allow Ice Cream that has no cream in it, contains thickeners, emulsifiers and artificial processed ingredients to be called “Ice Cream”?  Margarine

According to the U.S. Department of Agriculture (USDA), consumer demand for organic food products is on the rise.  Studies have shown that the increased demand is due to health and environmental concerns, as well as concern for the humane treatment of animals.  The growing market makes labeling a product as organic an appealing option, but

The PAS 220 and 223 documents were originally used along with ISO 22000 to make up the requirements for FSSC 22000 certification. They have both been replaced with ISO Technical Specifications. The PAS documents played an important role in GFSI recognition for an ISO based certification scheme. The PAS documents contained prerequisite program requirements for

On Monday, February 16, 2015, the U.S. Food and Drug Administration (FDA) purged approximately 2,628 medical device establishments that did not complete their annual registrations by the deadline from its registration database.  Owners and operators of companies that produce and distribute medical devices for use in the United States are required to register with FDA

Registrar Corp is often asked about how to obtain U.S. Food and Drug Administration (FDA) approval for a variety of products.  While FDA has extensive regulations for food, drugs, medical device, and cosmetics marketed in the U.S., many products do not require FDA approval.  In fact, in some cases it’s a prohibited act to claim

Did you know that newer Food Canning Establishment (FCE) processing technologies, specifically retort systems, may require a special review by the U.S. Food and Drug Administration (FDA) before they may be used?  FDA regulations state that certain retort systems may be used in the processing of low-acid and acidified canned foods, but many firms are

On January 16, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance regarding FDA’s Center for Devices and Radiological Health’s (CDRH) compliance policy for general wellness products.  According to the guidance, CDRH does not plan to regulate general wellness products for compliance with medical device regulations, including registration, listing, premarket notification, labeling,

The U.S. Food and Drug Administration (FDA) hosted two webinars on January 14, 2015.  Yesterday, Registrar Corp published a summary of the first webinar, “UDI 101.”  Today we’re summarizing FDA’s second webinar, “Getting Ready for GUDID.” “Getting Ready for GUDID” was presented by Indira R. Konduri, FDA’s GUDID Program Manager.  She offered a list of

Over the past two days, Registrar Corp has published year in review blogs about FDA regulations for food and drug companies. Today we’re reviewing FDA’s medical device regulations and guidances established in 2014. August 1:  FDA proposed to exempt over 100 devices from 510(k) requirements.  FDA indicated that it will not enforce 510(k) requirements for

The classification of a medical device can change as more information is gathered about the device.  In order to have a device reclassified to a lower class, the device manufacturer must prove to the U.S. Food and Drug Administration (FDA) that lower class requirements will provide adequate safety and effectiveness through a petition.   On December

On December 22, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance regarding the transfer of a premarket notification (510(k)) clearance.  If a medical device establishment sells a device that is not 510(k)-exempt to another company, it can include the 510(k) clearance for the device along with  the sale.  As long as

On December 22, 2014, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the labeling of beers regulated by FDA.  The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates the labeling of distilled spirits, wines, and malted beverages.  TTB’s regulations are contained in the Federal Alcohol Administration Act (FAA Act).  While

Facilities that store food intended for consumption by humans or animals in the United States are required to register with the U.S. Food and Drug Administration (FDA).   This includes distribution centers and public warehouses.  Though a public warehouse may not consider itself a food facility, the warehouse may need to be registered if it stores

All color additives must be approved by the U.S. Food and Drug Administration (FDA) before they are used in food, drugs, cosmetics, or medical devices that come in contact with a human or animal body for a significant period of time.  What many people don’t realize is that many of these color additives also require

As consumers walk down grocery store aisles, they see a Nutrition Facts Chart on the majority of the products surrounding them.   One exception is wine bottles.  People often wonder why wine labels are not required to state calorie and other nutritional information as most other beverages are.  Registrar Corp is bringing you the answer. The

On December 2, 2014, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the labeling of products and packaging that are not made with natural rubber latex.  If a manufacturer wishes to state that his product and its packaging do not contain latex, FDA recommends that he use the following statement when

According to U.S. Food and Drug Administration (FDA) records obtained by Registrar Corp through a Freedom of Information Act request on October 20, 2014, FDA received approximately 368 petitions to be removed from an import alert red list in 2013. This may seem like a substantial amount, but there are approximately 13,000 companies currently on

In November 2014, the U.S. Food and Drug Administration published “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.” The Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law in July 2012, directed the Secretary of Health and Human Services (who then delegated FDA) to specify a UFI system

All facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register with the U.S. Food and Drug Administration (FDA), but food facilities that work with Acidified or Low Acid canned foods are considered to be Food Canning Establishments (FCE) and need an additional registration.

The U.S. Food and Drug Administration (FDA) is currently in the process of removing duplicate food facility registrations from its system.  Though the registration system will technically allow a facility to register multiple times, FDA only allows facilities to maintain one registration. Why is this important? Duplicate registrations can lead to unexpected problems.  For one,

Labeling violations are one of the leading causes of food import refusals to the United States by the U.S. Food and Drug Administration (FDA).  According to OASIS, FDA’s import refusal database, FDA has identified approximately 5,029 labeling violations on products being offered for import so far in 2014 alone.  Registrar Corp has compiled a list

On October 2, FDA announced on its blog a new data dashboard where users can view data regarding FDA inspections and enforcement.  The dashboard currently contains data for fiscal year (FY) 2009 to FY 2013, and FDA plans to update the database twice a year.  For now, the datasets only include final actions.  Some of

The U.S. Food and Drug Administration (FDA) requires that all food facilities registered with FDA report when there is a reasonable probability that the use of or exposure to an article of food will cause serious adverse health consequences or death to humans or animals via the Reportable Food Registry (RFR).  Federal, state, and local

The U.S. Food and Drug Administration (FDA) Medical Device Registration and Listing Module (DRLM) will be unavailable from 6PM EDT on Friday, September 26, 2014 until 12AM EDT on Wednesday, October 1, 2014.  Users will not be able to register, list, or update information during this time.  Once the DRLM is available on Wednesday, users

The U.S. Food and Drug Administration (FDA) recently updated its Food Facility Registration Module (FFRM) so that it no longer allows food facilities to submit a P.O. Box as the facility’s physical address.  This is important with the 2014 FDA registration renewal period beginning next week.  Any facility that currently lists a P.O. Box as

Signed into law in 2011, the Food Safety Modernization Act (FSMA) expanded the preexisting U.S. Food and Drug Administration (FDA) registration requirements to include biennial registration renewals.  Food facilities must now renew their FDA registration between October 1 and December 31 of each even numbered year.  Registrar Corp put together the need-to-know facts about registration

On June 27, 2014, the U.S. Food and Drug Administration (FDA) issued a warning letter to Zarbee’s Inc. regarding claims the company made on its website and social media.  According to FDA, the health claims made about some of the products that Zarbee’s sells online “cause the products to be drugs under section 201(g)(1)(B) of

On August 18, 2014, the U.S. Food and Drug Administration (FDA) published  “FDA Decisions for Investigational Device Exemption Clinical Investigations”, a draft guidance that details FDA decision making when it comes to approving or disapproving investigational device exemption (IDE) applications and provides information about steps sponsors may take after FDA makes a certain decision. In

On August 1, 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.” FDA has identified certain class I and II devices for which risks, safety, and effectiveness have been established well enough for the agency

With the first of many compliance dates for the new rule quickly approaching, Registrar Corp decided to share with you the need-to-know basics of UDI regulations. What is a UDI? A UDI is a numeric or alphanumeric code that consists of two parts: a device identifier (DI) and a production identifier (PI).  The DI is

On August 9, 2014 the FDA’s United Registration and Listing System (FURLS) Food Facility Registration Module (FFRM) underwent system maintenance. FFRM users now have the ability to edit a food facility’s name and address in previously submitted registrations. In the past, FDA’s food facility registration system did not permit modifications to a facility’s name or

The City of Hampton, Virginia featured Registrar Corp as part of their Choose Hampton campaign. Take a couple minutes to check out the video and hear Registrar Corp Vice President and Co-Founder David Lennarz talk about the founding of the company. Are you looking for a career in Hampton, Virginia? Registrar Corp has career opportunities

All shipments entering the U.S. containing food, beverages, and dietary supplements are required to submit prior notice to the U.S. Food and Drug Administration (FDA). Prior notice may be submitted by anyone with knowledge of the shipment, including shippers, importers, U.S. Agents, and Customs brokers. Because the FDA uses prior notice submissions to best decide

Recalls require products to be removed from the market until the issue in question is resolved. Companies can initiate a recall themselves, but the U.S. Food and Drug Administration (FDA) can also request or order a recall. This situation can be a financial burden for a company. Products being off the market can lead to

The Food and Drug Administration (FDA) requires proper documentation stating that sunglasses and lenses shipped to the U.S. meet requirements for impact resistance. FDA regulation requires testing a “statistically significant sampling of lenses from each production batch” (21 CFR 801.410(c)(3)) of all non-prescription lenses and plastic prescription lenses using a method known as a “Drop

The U.S. Food and Drug Administration (FDA) recently started including reinspection fee information on emails sent to U.S. Agents of newly registered foreign food facilities. The new emails now broadcast the possibility of reinspection fees and prominently define what they entail. “Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect

On June 14, 2011, the United States Food and Drug Administration (FDA) published a final rule for sunscreen Over the Counter (OTC) drug products that mandated revised SPF, Water Resistance and Broad Spectrum testing procedures. The final rule requires specific labeling statements based on the results of these tests. As of December 17, 2013, all

Ever walk down a store’s pasta aisle and wonder how the different pastas got their names? Well, as it turns out, pasta names are dictated by U.S. Code of Federal Regulations. The United States Food and Drug Administration (FDA) establishes definitions of certain products, which are referred to as “standards of identity.” In order to

The U.S. Food and Drug Administration (FDA) finalized “Distinguishing Liquid Dietary Supplements from Beverages,” a guidance aimed at helping manufacturers to determine whether a product in liquid form is a dietary supplement or a beverage. The Food, Drug, and Cosmetic Act (FD&C Act) defines beverages as conventional foods.  Under the FD&C Act, dietary supplements cannot

FDA regulatory consultancy firm, Registrar Corp, received a 5 out of 5 stars rating as a desired workplace. Registrar Corp was the only firm in the Hampton Roads area of Virginia to receive a perfect score. The company was founded in 2003 to assist businesses comply with U.S. Food and Drug Administration (U.S. FDA) regulations.

With only 7 days until the deadline for compliance with U.S. Food and Drug Administration (FDA) OTC Sunscreen labeling regulations, Registrar Corp would like to remind industry of the regulation requirements. On June 14, 2011, the FDA issued new rules for labeling and testing of sunscreen products. Also, U.S. FDA issued an additional proposed rule

On July 26, 2013, FDA issued the new proposed regulation, the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP), in accordance with section 301 of the Food Safety Modernization Act (FSMA). In the proposed rule, FDA has asked interested parties to comment on various aspects of the proposed regulation. The

The U.S. Food and Drug Administration recently removed medical device companies that failed to renew their FDA Medical Device Establishment Registrations by December 31 from the online Medical Device Establishment Database. The U.S. Food and Drug Administration (FDA) requires an annual renewal of Medical Device Establishment Registrations. Each year, the U.S. FDA requires medical device

The U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) requires all food and beverage manufacturers to renew their FDA food facility registration by December 31, 2012. Due to system delays, FDA exercised enforcement discretion with food facility registration renewals, granting companies until January 31, 2013. Companies that were required to renew their

The U.S. Food and Drug Administration (FDA) recently published new draft guidance for FDA staff regarding Sec. 100.250 Food Facility Registration – Human and Animal Food. This FDA guidance, though not final, serves as a reminder to industry of the consequences of not meeting FDA Food Facility Registration Renewal deadline in the Food Safety Modernization

U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), have seized multiple dietary supplement products from a Florida distributor (Globe All Wellness, LLC.) on the grounds that the products are unapproved new drugs and contain illegal and undeclared active pharmaceutical ingredients. The distinction between dietary supplements and drugs is often confusing.

Over the past several months, the U.S. Department of Health of the state of Massachusetts inspected a series of pharmaceutical compounding plants after an outbreak of fungal meningitis. Yesterday, Massachusetts officials ordered the partial or complete closure of 11 pharmacies. These surprise inspections are linked back to a meningitis outbreak that occurred late last year.

Registrar Corp‘s Food Safety Department is in South Korea this week to provide pre-inspection assistance in advance of a formal U.S. Food and Drug Administration (FDA) inspection. All food facilities should be prepared for a U.S. FDA inspection since the Food Safety Modernization Act (FSMA) requires the U.S. FDA to double the number of Foreign

There is often confusion about the relationship between GFSI and SQF or FSSC 22000 Certification. We will try to clear that up. GFSI is a global food network made up of hundreds of retailers and manufacturers worldwide. The GFSI organization determined which set of requirements would be essential to a good food safety management system.

The Federal Food, Drug, and Cosmetic Act authorizes the U.S. Food and Drug Administration (FDA) to refuse admission of articles to the U.S. that appear to be in violation of U.S. FDA regulations. When evidence exists to suggest that a company’s future shipments will also be in violation, FDA may place the company on an

The United States Food and Drug Administration (FDA) announced for the first time that it recognized a foreign food safety system as comparable. On December 10, 2012, FDA and New Zealand’s Ministry for Primary Industries signed an agreement recognizing each other’s food safety systems as comparable to each other. FDA’s agreement with New Zealand comes

If one is compliant with SQF, is it safe to say that one is also compliant with the FDA? Not necessarily. The requirements emphasize different aspects. The FDA is regulatory, the SQF code emphasizes food safety management. SQF does require that you comply with all applicable regulations, such as FDA. So a certified company is

SQF and HACCP both address food safety, so what is the difference between them? SQF is a food safety management system and requires that a HACCP program is used as part of the food safety management program. SQF also requires food safety management system processes and procedures to manage all aspects of food safety throughout

Under the new U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), any company that manufactures, processes or packs food, beverages & dietary supplements is required to renew their facility’s registration between October 1 – December 31, 2012 and consent to FDA inspections. Additionally, all registered facilities outside the United States must appoint

When a company sets out to become SQF Certified, it is necessary to appoint an SQF Practitioner to be the lead for the implementation of the SQF system. The company must give that person the authority to lead the development of the Food Safety Fundamentals and the Food Safety Plan. Role of the SQF Practitioner:

There are many important benefits of SQF Certification. The benefits extend to lowered costs, increased profits and market share and lowered risk of product recalls. The benefits include: Greater opportunities and market access Reduces audit burdens from buyer audits Improves processes and efficiencies Savings from reduced recalls Recognized worldwide Promotes confidence Enhances image Manages risk

The Global Food Safety Initiative, GFSI is an organization run by the Consumer Goods Forum. One of its main purposes is to benchmark existing food standards against food safety criteria and recognize those that meet the criteria outlined in the GFSI Guidance Document. The Global Food Safety Initiative (GFSI) is coordinated by The Food Business

Recently, U.S. consumer groups have begun questioning the safety of a caramel coloring agent used in Coca-Cola, Pepsi-Cola and other popular soft drinks. In a letter to the U.S. Food and Drug Administration, the Center for Science in the Public Interest petitions FDA to ban ammonia-sulfite “caramel coloring” as a possible carcinogen. This is the

In an effort to better ensure the safety of the American food supply, President Obama passed the Food Safety Modernization Act (FSMA). FSMA increases the powers and activities of the Food and Drug Administration (FDA) with the goal of preventing food safety problems. FSMA also grants the FDA more enforcement authority to increase rates of

The Food and Drug Administration (FDA) reviews shipments of sunglasses and lenses to check for proper documentation. FDA requires shipments of glasses and/or lenses include the “Drop Ball Test” certificate with it. The FDA regulates eye wear products to ensure their safety. Impact resistance is an essential criterion for U.S. bound glasses and/or lenses. The

FDA permits certain claims on conventional foods and dietary supplements. Typically, there are three categories of permitted claims: • Nutrient Content Claims • Health Claims • Structure/Function Claims According to U.S. FDA, “Health Claims” are those that describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease

The U.S. Food and Drug Administration (FDA) regulates food and dietary supplement labels. There are strict FDA guidelines regarding what are considered appropriate statements for each category, and companies often have difficulty determining what type of claims may be made for their products. FDA acceptable labeling claims are often dependent upon whether your product is

The National Association for the Specialty Food Trade (NASFT) will host its 37th annual Winter Fancy Food Show this weekend (January 15th-17th). NASFT is an international organization composed of domestic and foreign manufacturers, importers, distributors, brokers, retailers, restaurateurs, caterers and others in the specialty foods business. Their annual Winter Fancy Food Show attracts more than

An import “detention” occurs when FDA (or U.S. Customs and Border Patrol, acting for the FDA), in examining an FDA-regulated product offered for import, halts the entry for further examination. Further examination often requires laboratory analysis or scientific and technical data concerning the product. Import detentions are costly even where the product ultimately is released

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A recent amendment proposed by Senator Dianne Feinstein (D-Calif) to the long-gestating bill to improve food safety has come under fire from the food industry and major business groups. The amendment would ban bisphenol-A from being used in food and beverage containers. More on this story: charlottesville.injuryboard.com

FSSC 22000: Management Responsibility The standard requires that top management is involved with and committed to the food safety management system, recognizing that without top management commitment it would be unlikely that the FSMS would get the resources and support needed to ensure that it is an effective system. As part of this commitment management

Food Safety Team Tasks The food safety team has important responsibilities throughout the implementation of your ISO or FSSC 22000 food safety management system. For a successful project it is important that they have the tools they need to collect preliminary information, carry out hazard analysis and implement the HACCP and PRP programs. The ISO

A major food-safety bill pending on Capitol Hill would require regular inspections for all food facilities and give the FDA significant new enforcement powers. The bill easily passed the House in July but has been stuck in the Senate. Food-safety laws have not changed markedly since 1938, when Congress gave the FDA the power to

Reimbursement program for certifying employees: To promote food safety certification for members, the International Dairy-Deli-Bakery Association (IDDBA) has developed the Food Safety Certification Reimbursement Program. This IDDBA program will reimburse IDDBA retail members for their cost for food safety certification exams. Eligible employees are supermarket dairy, deli, and bakery managers and associates at store-level who

At the core of your Food Safety Management system is your Hazard Analysis-Critical Control Points. The FSSC 22000 standard covers it in two parts: Preliminary steps to enable hazard analysis, and Hazard Analysis. Preliminary steps to enable hazard analysis: As you build your system, you will need to identify information that is needed to conduct

How does a company start down the path to GFSI recognized Certification  There are different answers to this question that depend on your companies current food safety management system. Do you have a management system in place? Are you using HACCP now? If the answer to either one of these is yes, you will have a

Project Leaders The different standards have different titles for the lead role in the implementation team and management system. For SQF you will have an SQF Practitioner, for BRC a HACCP Team Leader and for FSSC 22000 you will need a Food Safety Team Leader. The roles are similar, all have responsibilities for leading the

HACCP plays a large role in all of the food safety management systems: SQF, BRC and FSSC 22000. This means that if your company already has HACCP in place you are one step closer to certification to one of these systems. But what if your organization is not using HACCP and not familiar with it?