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FDA Adds Hundreds of Products to Import Alert for Unapproved Drugs

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 staff and the public that a product is eligible for Detention Without Physical Examination (DWPE) for violating FDA regulations. Many of the products in this case made claims on either their packaging or in their marketing that made them eligible to be considered drug products by FDA, thus requiring the products to be registered as drugs and in compliance with applicable drug regulations. FDA has strict rules for what claims a product can make; any deviation can be considered misbranding and result in regulatory action.

Claims for Non-Drug Products                                          

If you are marketing a food product and want to address its health benefits without it being regulated as a drug, there are claims you can make. Food products can make structure/function claims that relate an ingredient to affecting or maintaining the structure or function of the body. Claims about nutrient deficiency related health conditions (e.g. scurvy and Vitamin C) or promoting general well-being can also be used if they are applicable and are not misleading.

A product that claims to diagnose, cure, mitigate, treat, or prevent a disease will be regulated as a drug by FDA. Therefore, any food product making a disease claim about treating or all together preventing a disease would be viewed as a new drug by FDA and would thus require authorization and approval.

Many of the products placed on import alert were being marketed as a food product, a dietary supplement, or a cosmetic. However, these products made claims that qualified them as a drug. Some companies marketed dietary supplements with claims that they could “Help reduce excessive blood sugar” and could act as an “effective ayurvedic medicine.” Another product marketed as a food claims that it “makes stressed erythrocytes ‘Red Blood Cells’ (RBC’s) more flexible.” These claims are about curing and mitigating disease and are therefore considered drugs by FDA and regulated as such.

Products containing active pharmaceutical ingredients are also considered drugs by FDA. One product marketed as a dietary supplement contained the active ingredient Bufotenine, which is classified as a drug. One company marketed its nicotine patch as a cosmetic, but FDA regulates nicotine patches as OTC drugs. Ingredients must be considered before going to market in the U.S. to avoid a similar compliance issue. Registrar Corp’s infographic provides common examples of ingredients that would cause cosmetics to be regulated as drugs.

What does FDA Consider Labeling?

FDA defines labeling as any written, printed, or graphic matter upon any article or any of it containers, wrappers, or accompanying materials. FDA considers an article to be misbranded if either the physical label or any advertising is misleading to the form or function of the product. Advertising can include a wide range of materials from:

  • TV, print, or online advertisements
  • Content on a product’s website
  • Content on a product’s social media (Facebook, Twitter, etc.)
  • Published consumer or professional testimonials

Any claims or descriptions from a product’s advertising that are not consistent with the product information on the physical label could be considered misbranding. Some of the products placed on this import alert made claims that qualified their products as drugs on their websites or on social media platforms. FDA still considers these as part of the product’s labeling and reviews them when regulating products. When promoting your product, it is important to remain uniform in claims and descriptions made with what is directly on the label.

How Can Registrar Corp Help?

Registrar Corp is a private company that assists businesses in complying with FDA regulations. Our label review service can help determine if your labels are FDA compliant and evaluate claims made on your labeling. If your company is listed on the import alert, our specialists can help you petition for removal. For products that are appropriately marketed as drugs, we can assist in registering these facilities as drug establishments and create drug listings for these products.

Using our FDA Compliance Monitor, you can track your company and your supplier’s compliance status with FDA, allowing you to see if you or your suppliers are on an import alert, have a warning letter, or an expired registration. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livehelp.

Registrar Corp Announces Acquisition of Registration and Licensing Systems, Inc.

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 only expands our customer base, but RLS clients will inherit the year-round benefits we offer as part of our registration and U.S. Agent services,” Lennarz said.  Registrar Corp clients benefit from free Prior Notice submissions, detention support, FDA compliance monitoring, and more.

“With this acquisition, we take yet another step toward our goal of becoming an all-encompassing solution to address export barriers,” Lennarz added. “The more companies we are able to work with, the more we can understand the industry’s overarching regulatory needs and build solutions around those needs.”

“I know I’m leaving my clients in good hands,” said RLS Founder Peter Tutini.  He added, “Registrar’s skilled workforce and diverse offering of compliance services allow them to greatly expand what I was able to offer my clients, further supporting their needs for successful operation in the US market.”  While RLS solely offered FDA registration-related services, Registrar Corp offers assistance with additional regulatory requirements, including food labeling, Food Safety Modernization Act (FSMA) compliance, and inspection preparation. 

Mr.Tutini also noted that Registrar Corp’s 18 overseas offices will benefit his clients abroad.  “My largest client base is in France, and now they’ll have the opportunity to work with local representatives in Registrar Corp’s Auray office.”

The investment in RLS is the second add-on acquisition completed by Registrar Corp, following the company’s acquisition of FDA Agents last year.  Registrar Corp, in collaboration with investor Bertram Capital, will continue to actively target add-on acquisitions of regulatory compliance firms that can expand Registrar’s client base and range of services.

“Registrar Corp will continue to build out its capabilities to support the global and developing compliance needs of our customers and we’re all very excited to welcome RLS and their valued customers to the Registrar family,” said Tom Beerle, Partner at Bertram Capital.

FDA Issuing Warning Letters for Preventive Controls and FSVP Violations

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 or ingredients. Most of the compliance deadlines for these rules have passed and the U.S. Food and Drug Administration (FDA) has been increasing enforcement of these rules during facility inspections. It should be expected that FDA will continue to ramp up enforcement efforts, meaning it’s prudent to have your Food Safety Plan and/or FSVP in place to avoid a compliance issue with FDA. 

Once the initial deadlines had passed, FDA focused on educating facilities to make them aware of the new rules and understand what was expected of them. In 2018, FDA more actively cited violations of FSMA regulations during facility inspections.  In fact, failure to develop an FSVP was the most frequently cited violation that year.  FDA has continued to enforce these rules in 2019, issuing several warning letters addressing companies for FSMA violations.

Having a Compliant Food Safety Plan and Executing It

For some facilities, not having a Food Safety Plan is still an issue. In this warning letter, FDA notes that the company has been required to develop a Food Safety Plan since September 18, 2017. With a reasonable amount of time having passed since the deadline, FDA will likely check to see if your facility has a Food Safety Plan in place. A complete Food Safety Plan identifies all potential biological, chemical (including radiological), and physical hazards to a food’s production and then establishes controls to contain or eliminate these hazards.

It is necessary to be thorough when creating your Food Safety Plan, as it is a common problem to leave out a component of the plan or to not identify all of the potential hazards in a facility and establish controls for those hazards. In this letter, the facility failed to identify potential environmental hazards or establish allergen controls, both required components of a complete Food Safety Plan. Facilities are also required to maintain written records on monitoring, corrective actions, and verification of the controls. Failure to adhere to any of these or other requirements of a Food Safety Plan can result in a citation or warning letter.

Once your facility’s Food Safety Plan is written and in place, you must continually execute it and keep it up to date. You should implement the plan as a part of your facility’s standard operating procedure, incorporating it into your facility’s every day activities. You should reevaluate the plan at least once every three years or if any issues arise. All employees should be trained on what is required and what their role and responsibility is towards executing the plan. FDA may check to make sure your employees are executing your Food Safety Plan even if it is written. Failure to actually execute the plan can result in a warning letter or other regulatory action.

FSVP Violations

U.S. importers are required to verify and approve that their suppliers products meet the food safety standards of the United States. Importers must establish and follow written procedures to import products only from approved suppliers. Importers are responsible for confirming that the products they import follow applicable FDA regulations, such as Preventive Controls rules or Current Good Manufacturing Practices. These need to be developed for every individual product that is imported. Suppliers must be re-evaluated at least once every 3 years.

FDA recently issued their first warning letter for failure to comply with the FSVP rule. According to FDA, “Moving forward, the FDA will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk”. If a facility receives a warning letter for FSVP violations, they are required to respond to the letter within 15 days with corrections to the violations. FDA may subject the importer to Import Alert #99-41, Detention without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the FSVP Regulation. FDA is taking FSVP enforcement seriously, and importers should ensure they have compliant FSVPs in place immediately.

Registrar Corp is a private company that assists businesses in complying with FDA. We can assist you in ensuring your Food Safety Plan is FDA compliant so your inspections will go smoothly. We can also help importers develop a FSVP.  For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livehelp.

Registrar Corp Announces Expansion of Hampton Headquarters

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 past few years, such as the Food Safety Modernization Act (FSMA) and new labeling regulations, the expansion seeks to provide for continued corporate growth, and will better allow Registrar Corp to provide high quality compliance services for FDA-regulated companies.

Since being founded in 2003 with 4 employees, Registrar Corp has experienced a tremendous increase in their staff.  They have grown from 104 employees in 2017 to 140 today. The expansion will increase the size of the office space by 2400 sq. feet, which will allow it to continue to broaden its services to adapt to future changes in regulation and give new space for current and future employees.

The diverse community surrounding Registrar Corp has proved invaluable to the company’s growth and success, as the majority of Registrar Corp’s clients are located outside of the United States.

 “Hampton Roads has a strong military presence, providing us with a culturally diverse candidate pool”, said Tatiana Rodriguez, Human Resources Director at Registrar Corp. “Military veterans, their spouses and dependents typically come from a variety of backgrounds with great language skills and work experience.” Registrar Corp has assisted thousands of companies in over 175 countries and employees speak 29 different languages in the Hampton office alone.

Registrar Corp not only cultivates a diverse workforce, but employs many with niche skill sets in order to effectively assist companies with the multitude of FDA regulations. Registrar Corp employs people from a variety of backgrounds, including food safety, biology and chemistry credentials, and many others.

 “We are extremely excited about Registrar Corp’s expansion in The City of Hampton”, said Donnie R. Tuck, Mayor of The City of Hampton. “Our strategic location and nearby proximity to resources such as Langley Air Force Base and the Port of Virginia aid in the growth of companies like Registrar Corp in Hampton.”

 “Hampton has contributed a lot to our company’s growth over the years”, said David Lennarz, Registrar Corp’s President of Business Development and Operations. “It has allowed us to bring in highly qualified people from Virginia Beach, Williamsburg, Norfolk, and of course Hampton and Newport News.”

“Food, medical device, cosmetics, and drug safety is an issue that permeates all of our lives as Americans”, Lennarz continued. “It is an issue that is completely bipartisan. With FDA regulating more than 20 cents of every dollar spent by U.S. consumers, our goal is help our clients meet FDA’s various regulatory requirements.”

About Registrar Corp

Registrar Corp was founded in 2003 to help businesses comply with U.S. FDA regulations. Since opening its headquarters in Hampton, Virginia, USA, Registrar Corp has expanded to 19 international offices and has aided more than 30,000 companies across 160 countries. Employees include former U.S. FDA officials, scientists, and industry experts. Registrar Corp offers FDA compliance assistance for the food and beverage, medical device, drugs, cosmetics, electronics, and tobacco industries. Visit regstaging.wpengine.com for more information.

FDA Announces New Medical Device, Generic Drug, and Human Drug Compounding User Fees for FY 2020

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 1, 2019. These fees are a required part of FDA registration.

Drug Facility Fees

Under GDUFA, FDA assesses and collects fees from Active Pharmaceutical Ingredient (API) facilities, Finished Dosage Form (FDF) facilities, and Contract Manufacturing Organization (CMO) facilities named in an approved drug application on October 1, 2019. These fees are to be paid on October 1, 2019. The fees for foreign facilities are higher to compensate for the additional cost of inspections outside the United States. FDA also collects fees based on the number of approved Abbreviated New Drug Applications (ANDA) a facility holds and a one-time fee for new Type II Drug Master File submission. These funds are used to increase the speed of the delivery of generic drugs to the public and improve the predictability of the review process. FDA anticipates more ANDAs to be filed this year than last, causing a decrease in ANDA fees compared to 2019. This is likely welcome news after ANDA fees saw an increase of 17% from 2018 to 2019.

FY 2020 GDUFA Fees

Fee Class Rates for FY 2020
Facilities Domestic Foreign
Active Pharmaceutical Ingredient (API) $44,400 $59,400
Finished Dosage Form (FDF) $195,662 $210,662
Contract Manufacturing Organization (CMO) $65,221 $80,221
Applications
Abbreviated New Drug Application (ANDA) $176,237
Drug Master File (DMF) $57,795
ANDA Program Fees
Large (20 or more) $1,661,684
Medium (6-19) $664,674
Small (5 or less) $166,168

Human Drug Compounding Outsourcing Facility Fees

Facilities that compound human drugs and register as outsourcing facilities are exempt from certain sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act), but must pay an additional annual establishment fee and re-inspection fee if a re-inspection is required. Facilities with total sales of $1 million or less in the previous year may qualify for a reduced rate as a ‘small business’ as long as a small business reduction application was submitted by April 30, 2019 and approved by FDA.

FY 2020 Outsourcing Facility Fees

Fee Class Rates for FY 2020
Qualified Small Business Establishment $5,599
Non-Small Business Establishment $18,288
Re-inspection $16,798

Medical Device Establishment Fees

FDA requires fees for certain medical device applications, periodic reporting on class III devices, and for the annual registration of establishments. Businesses with total sales of less than $100 million for the most recent tax year can qualify as a ‘small business’ for a reduced fee on applications. Businesses with total sales of less than $30 million can receive a waiver of first premarket applications or reports. If you qualified for a reduced or waived fee in FY 2019, you must resubmit your information during renewal to FDA to remain qualified.

There is no fee deduction on establishment registrations for small businesses.  The establishment registration is the same for businesses of all sizes and FDA will not consider a registration complete until it is paid. Additionally, this fee applies to every physical location that a company owns that handles certain functions on medical devices and is not paid just paid once for multiple establishments.  The fees have generally increased 7-9% from FY 2019, a larger jump than the 3-4% increase industry saw from 2018 to 2019.

FY 2020 MDUFA Fees

Fee Class Rates for FY 2020
Annual Establishment Registration $5,236
Applications Standard Small Business
Panel-Track Supplement $255,747 $63,937
De Novo Classification $102,299 $25,575
180-Day Supplements $51,149 $12,787
Real-Time Supplements $23,870 $5,968
510(k)s $11,594 $2,899
513(g) $4,603 $2,302
30-Day Notice $5,456 $2,728
PMA Annual Report $11,935 $2,984
PMA, PDP, PMR, BLA $340,995 $85,249

Registrar Corp is a private company that assists businesses in complying with FDA regulations. We can help to determine what fees your facility is subject to and facilitate payment to FDA. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livehelp.

FDA Announces Higher Re-Inspection Fees for FY 2020

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 re-inspection of a domestic facility in FY 2020 will be $258/hr, an increase from $253/hr in FY 2019. The new fees will be effective October 1, 2019 through September 30, 2020.

There is no fee for routine inspections, but if FDA finds significant violations related to food safety, they may conduct a re-inspection to ensure that appropriate corrective actions are taken to rectify the compliance issues. The Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect hourly fees for re-inspections of non-compliant facilities to cover the cost of salary, travel, and anything else related to conducting the re-inspection. Each year, FDA estimates its costs related to re-inspections and adjusts for inflation and increased costs for the following year. These fees are assessed for any time spent on “whatever components of such an inspection are deemed necessary” and the final cost can easily climb into the thousands of dollars.

Inspections and Common Food Safety Violations

When registering your food facility with FDA, you consent to allowing FDA to conduct routine inspections of your facility for compliance with regulations. During these inspections, FDA assesses your facility’s compliance with Current Good Manufacturing Practices (cGMPs) and your Food Safety Plan, among other things.

At the conclusion of the inspection, if a compliance issue is found, the inspector will provide a Form 483, or a Notice of Inspectional Observations, to the facility. The facility is given 15 days to respond to the problems laid out in the Form 483. After review, FDA issues a final classification of compliance status. If “significant objectionable conditions” are found, FDA issues an Official Action Indicated (OAI) classification. This can lead to regulatory action and in cases of the issues being directly tied to physical food safety, a re-inspection may occur. Non-material food safety requirements, such as having non-compliant labels would not require a re-inspection.

Common food safety violations include not properly excluding pests, not establishing appropriate controls for food hazards, not maintaining cleanliness in a facility, and having issues related to personnel. FDA is issuing a growing number of citations relating to Food Safety Plans since a reasonable amount of time has passed since the deadlines for most food facilities. FDA will also re-inspect juice and seafood facilities with HACCP plans or dietary supplement facilities with significant violations. With the fees for re-inspections increasing, it has only become more critical to be compliant with FDA food safety requirements and be prepared for an inspection when the time comes. FDA can also issue regulatory action such as warning letters, detentions, and suspensions of registration for infractions, causing further delays and costs.

Registrar Corp is a private company that assists businesses in complying with FDA regulations. We can help your facility prepare for an FDA inspection with our Mock Inspection service as well as assist your facility in developing a HARPC food safety plan or a HACCP food safety plan to avoid citations. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livehelp.