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Assistance with U.S. FDA Regulations

Drugs

FDA Issues Import Alert on Alcohol-Based Hand Sanitizer products from Mexico

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 first time FDA has issued a country-wide import alert for a drug product.

Most hand sanitizers are classified as over-the-counter (OTC) drugs by the FDA. During the COVID-19 pandemic, the demand for hand sanitizers greatly increased, so FDA created several temporary policies to allow non-traditional companies to create alcohol-based hand sanitizers. Facilities producing and selling hand sanitizers under these policies are still required to register with FDA and follow certain FDA guidelines, specifically those regarding the ingredients in these hand sanitizers.

Basis for Import Alert 62-08

Import Alerts occur when FDA notices a pattern of non-compliance from a particular company, country, or product type. All shipments of products listed on an Import Alert are subject to Detention Without Physical Examination (DWPE).

FDA issued Import Alert 62-08: Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico due to many sanitizer imports from Mexico containing unacceptable levels of methanol.

According to the alert, FDA found that 84% of sanitizers they sampled from Mexico were non-compliant. Of the 112 samples FDA tested, more than half contained dangerous amounts of methanol. Both isopropyl alcohol and ethyl (containing ethanol) alcohol sanitizers are safe for use. Methanol is a poisonous variant of alcohol. When absorbed through the skin, methanol can lead to blindness and other serious health concerns, and when ingested it can cause death.

With more people using alcohol-based hand sanitizers due to the pandemic, FDA has increased scrutiny on these products. FDA has continued issuing recalls for non-compliant hand sanitizers and has also issued 14 Warning Letters for hand sanitizer products since July 2020.

What This Means for Importers and Exporters

Import Alerts can cause major delays and costs for both importers and exporters. Import Alert 62-08 will apply to all sanitizers being shipped from Mexico to the U.S., including those that were manufactured in another country and sent to Mexico for labeling or other purposes before being shipped to the United States. Exporters of hand sanitizers from Mexico are now required to provide evidence that every shipment of sanitizers are manufactured under Current Good Manufacturing Practices (CGMPs) to be permitted entry into the US.

FDA often requires that shipments under Import Alert be held at the U.S. port of entry until the Agency decides whether to allow the shipment to proceed.  Many holding facilities will charge fees for holding a shipment at the border after a certain period of time. Who pays these fees is determined by the contract between the importer and exporter, but the costs can add up quickly.

For exporters, it is imperative to follow the necessary CGMPs in advance of shipping that will allow products to move more quickly through U.S. Customs. Without proper documentation of compliance with FDA’s temporary sanitizer policies, your products may be rejected and destroyed. Mexican hand sanitizer manufacturers may petition to be placed on the Green List for this alert, which will exempt their sanitizers from DWPE. The petition process for Import Alert 62-08 requires the company to provide records of all active ingredients in the sanitizer, records of the manufacturing site, proof that the hand sanitizer and the facility it is crafted in are meeting compliance standards, and more. Until a manufacturer is on the Green List, every one of their sanitizer shipments may be stopped at the U.S. port of entry. Cyan Labs S.A. de C.V. is currently the only establishment on the Green List for this alert.

If an importer wishes to continue buying from a supplier exporting from Mexico, it is important to make sure that the supplier has written evidence that they are following the proper CGMPs or is on the Green List. Even for suppliers with documentation, importers should expect delays and potential holding fees to account for FDA’s time spent reviewing of the shipment.

In many cases, it may be prudent for importers to seek alternative sources for sanitizer products. Registrar Corp’s FDA Compliance Monitor  can help evaluate a potential supplier’s compliance status, by informing you of whether the supplier is on an import alert, has a warning letter, and more. By verifying your new suppliers’ compliance statuses before importing from them, you can make informed buying decisions and reduce the risk that your shipments will be delayed or refused at entry to the US.

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 launches new Document Management System for FDA-Regulated Goods

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 needed documentation (food safety plans, product labels, certifications, etc.) while monitoring supplier compliance in a single, secure system.

“The FDA Compliance Monitor has facilitated our facility management, supplier review, and FSVP compliance management,” said Georgina Jaramillo Robles, Quality Assurance and Food Safety Manager at West Pak Avocado. “It has it all- the portal is easy to navigate, you can quickly add more facilities to your monitor plan, reports are easy to generate, training materials are available, and you can find all of this in a single portal. This is a great tool!”

Automate FSVP Compliance

Registrar Corp’s DMS addresses the requirements of FDA’s Foreign Supplier Verification Program (FSVP) rule, which requires US food importers to maintain written FSVPs that verify food imported from foreign suppliers meets FDA food safety standards. Importers must develop FSVPs for each individual food imported from each supplier.

Importers commonly choose to review their suppliers’ food safety plans in order to meet FSVP requirements, but may also collect other verification documents including sampling and testing reports, monitoring records, and third-party audits.  FDA requires FSVP documentation to be stored for at least two years.  The DMS makes it easy for importers to request, store, and quickly retrieve food safety plans and other documentation for each food they import.

“Based on feedback from our importer and retailer customers, we came up with a workflow automation system to efficiently manage all FSVP related compliance processes,” said Ankit Kumar, Vice President of Product Management at Registrar Corp. “You no longer have to review disparate and disconnected systems like Excel, Sharepoint, email, and calendars to see what documents are expiring or missing. It allows for a proactive approach to managing food safety documents and compliance events.”

DMS Key Features

 

Filters – Importers can easily filter by supplier, documentation type, and request status (valid, awaiting review, missing, etc.) to quickly access the information they need.

 

 

Templates – The DMS comes complete with a robust library of templated documents for importers to use. Users may also create their own document types with custom attachments.

 

 

Notifications – The FSVP rule requires importers to re-evaluate the risks posed by food they import at least every three years.  The DMS allows you to set validity dates for approved documentation.  The system will then notify you when a validity date is approaching, so you never miss a re-evaluation deadline.

 

 

Security – Data is stored in a secure SOC 2 compliant environment with end-to-end encryption, instant rollout of security packages, role-based access control, and backup systems.

 

 

FDA’s New FSMA Rule on Traceability 

In September 2020, FDA proposed a new rule under the Food Safety Modernization Act (FSMA) entitled “Requirements for Additional Traceability Records for Certain Foods” (also known as the “Food Traceability Proposed Rule”).  When finalized, this rule will require persons who manufacture, process, pack, or hold high-risk foods to maintain documentation of certain activities surrounding those foods (for example, bills of lading, records containing the location of the previous supplier, etc.).  In most cases, these records must be stored for two or more years.

Persons covered under the Food Traceability Proposed Rule will find Registrar Corp’s DMS to be the perfect solution for requesting and storing required documentation and Key Data Elements for each of the products they handle.

The FDA Compliance Monitor

The DMS is available as an add-on for Registrar Corp’s FDA Compliance Monitor, a tool that allows importers to monitor and document their suppliers’ FDA registration status and compliance history, including recalls, inspection results, and more. Users are notified anytime there is a change in a monitored supplier’s compliance.

The DMS follows the launch of RegiScore, which was added to the FDA Compliance Monitor in February 2020.  RegiScore provides risk scores for suppliers and their individual products based on data from over three hundred million shipments of FDA-regulated goods.  With both of these additions, importers can immediately gauge the risk of buying specific products from a supplier, monitor changes in their suppliers’ compliance, and manage their suppliers’ documentation all within one simple and secure system.

To learn more about the FDA Compliance Monitor and Document Management System, contact Registrar Corp by phone: (757) 224-0177, by email: [email protected], or schedule a free demo to see the software in action.

Frequently Asked Friday: Does FDA consider my product a cosmetic or drug?

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 as its intended use. Marketing a cosmetic product that may be subject to FDA drug regulations can result in the product being considered an unapproved drug.  Marketing unapproved drugs is violation of the Food, Drug, and Cosmetic (FD&C) Act and can result in criminal and civil penalties, warning letters, and other FDA enforcement action.

Drug vs Cosmetic Regulations

The difference in FDA regulations between cosmetics and drugs is significant. Cosmetic products may generally be marketed without FDA approval if they do not contain prohibited ingredients and appropriate claims are made. Cosmetic manufacturers are not required to register their facilities with FDA (although they may voluntarily), nor do they need to list their products.

On the other hand, drug facilities and products have stricter requirements. Drug facilities must register with FDA and list the drugs handled at the facility. It is important to note that registering with FDA does not mean you have obtained FDA approval.  Drug products must either conform to an over-the-counter (OTC) monograph or undergo the FDA approval process through a new drug application (NDA) to be marketed in the United States.

However, these differences may change in the near future. In September 2019, a bill called the Safe Cosmetics and Personal Care Products Act of 2019 was re-introduced to the U.S. House of Representatives. If passed, this bill would enact stricter regulation of cosmetics companies, including mandatory registration, standard good manufacturing practices, and ingredient statements.

Active Drug Ingredients in Cosmetics

FDA regulates cosmetic products as drugs when they contain active drug ingredients. For example, anti-perspirant deodorants contain Aluminum Zirconium Tetrachlorohydrex, an ingredient intended to prevent sweating (a function of the body). Other examples include anti-dandruff shampoos and acne-fighting cosmetics (Salicylic Acid), sunscreen and SPF face creams (octyl salicylate), and anti-cavity toothpastes (fluoride).

If an unapproved product containing active drug ingredients is marketed in the United States, the facility may face FDA enforcement action including detentions, import refusals, and Warning Letters. In the past year alone, FDA has refused nearly 3,000 drugs for lack of necessary approval, many of which are bath soaps, detergents, botox products, cleansers, deodorants and other “cosmetic” products.

Drug Product Claims on Cosmetics

Another common reason cosmetic products are regulated as drugs is because they make claims that they “diagnose, mitigate, treat, or prevent disease, or affect the structure or function of the body.” For example, some anti-aging creams claim to slow the process of aging by increasing the user’s production of collagen (a function of the body). Other examples include products that claim to repair skin or diminish irritation.

FDA has published a list of warning letters addressing products marketed as cosmetics that make drug claims.  In this warning letter issued to Health Habits, LLC, FDA states the following product description is evidence that the facility’s product is intended for use as a drug: “DermaTox® is an all-purpose skin wellness formula. Our customers tell us that they use DermaTox® daily to nourish their skin, speed healing, soothe the pain of a burn or bed sores, diminish irritation associated with eczema, psoriasis, rashes, cuts, bites, scrapes, spray on liver spots, moles, etc…”

Warning Letters are available to the public and thus can hurt your brand and reputation.  Typically, FDA gives facilities 15 working days to respond to a warning letter explaining how and when they will correct the noted issues.  Failure to respond to a Warning Letter within the allotted time can result in seizure of products.

Stay Compliant

Registrar Corp can help determine if your cosmetic products are regulated as drugs and help you to bring your products into compliance. Our Regulatory Specialists can assist you with FDA registration, labeling and ingredient reviews, and more.  For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

FDA Introduces Annual Fee for OTC Monograph Drug Facilities

Update: FDA published the FY 2021 OMUFA Facility Fees on December 29, 2020.

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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 components of this OTC reform is the Over-the-Counter Monograph User Fee Act, or “OMUFA”, which introduces annual facility fees for OTC monograph drug facilities, including contract manufacturing facilities. The new facility fees are intended to provide FDA with additional resources to conduct OTC monograph activities, such as reviewing submissions, in a timely manner.

What is an OTC Monograph Drug Facility?

The U.S. Food and Drug Administration (FDA) defines an OTC Monograph Drug Facility as a facility that manufactures or processes the finished dosage form of a nonprescription, over-the-counter drug that may be marketed without an approved drug application (known as an OTC monograph drug). This also includes “finished dosage form manufacturer facilities in contractual relationships with the sponsor of one or more OTC monograph.”

Additionally, OTC contract manufacturing organizations (CMOs) are OTC drug facilities where neither the owner of the facility nor his or her affiliates sell the OTC drug to retailers, wholesalers, or consumers in the US.

According to FDA, businesses whose manufacturing or processing activities include only the following are not considered OTC Monograph Drug facilities: “production of clinical research supplies; testing; or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.”

How much are the fees?

FDA has not yet stated the cost of facility fees. However, the Administration has stated that the fee for CMOs will be two-thirds the cost of the total facility fee.  Facility fees will be due 45 days after the FY 2021 fee amounts are published in the Federal Register.

How to Prepare

FDA will assess fees for a drug establishment based on the business operation qualifiers selected in the establishment’s registration.  Registered drug establishments should review the qualifiers selected in their registrations and ensure they accurate in advance of FY 2021, which begins October 1, 2020.

Assistance with OMUFA and other OTC Requirements

Registrar Corp is committed to providing you with high quality regulatory assistance. Contact us if you need help determining how FDA’s new fees affect your facility.

Registrar Corp can register your OTC Monograph Facility with FDA, list your OTC drugs, serve as your Adverse Event Contact, and more. To learn more about Registrar Corp’s OTC Monograph Drug services, contact us at  +1-757-224-0177 or email us at [email protected].

FDA Publishes Temporary Policies for Alcohol-Based Hand Sanitizer Amid COVID-19

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 Agency states that it does not intend to take enforcement action against companies that do not comply with certain regulations, such as current good manufacturing practice requirements, provided the firms adhere to the recommendations in these temporary policies.  The policies will remain in effect for the duration of the public health emergency brought on by COVID-19.

What are the Policy Conditions?

FDA’s documents outline several key guidelines to which hand sanitizer products under these policies should conform:

  • Manufacturers should prepare hand sanitizer only from a specific formulation using United States Pharmacopoeia (USP) grade ingredients:
    • Isopropyl Alcohol (75%, v/v) in an aqueous solution or Alcohol (ethanol) (80%, volume/volume (v/v)) in an aqueous solution.
      • Alcohol (ethanol) should be denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in CFR part 20.
    • Glycerol (1.45% v/v)
    • Hydrogen peroxide (0.125% v/v)
    • Sterile distilled water or boiled cold water
  • Manufacturers should ensure their sanitizers contain the proper amount of ethanol or isopropyl alcohol. Firms should use the most accurate method available to analyze the alcohol content of their finished products prior to distributing each batch.
  • The sanitizers should be prepared in sanitary conditions with appropriate equipment.
  • Product labeling should be consistent with specific content and formatting outlined in FDA’s guidance documents.
  • Firms that are not compounding pharmacies must register with FDA and list their sanitizers prior to marketing them in the U.S.
  • Firms must have a space on their label that includes a U.S. based address or phone number to receive reports of adverse events as well as a method to submit those reports to FDA.

Products that do not meet these conditions may need to comply with FDA’s standard drug requirements such as conformance to an FDA monograph or FDA approval of a new drug application (NDA).  Marketing other types of hand sanitizers not in compliance with applicable FDA requirements may result in enforcement action, including detentions, refusals, Warning Letters, and more.

Registrar Corp assists with U.S. FDA compliance.  Our Regulatory Specialists can help you register and list sanitizers and other drug products with FDA, review your labeling for compliance, and more.  For assistance, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7.

FDA Intensifying Enforcement Efforts for Misbranded or Adulterated Drug and Device Products

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 misbranded or adulterated is necessary to keep your products compliant and unaffected by FDA’s increased enforcement.

FDA reviews the claims and ingredients of products it regulates closely to keep misbranded or adulterated products out of the U.S. market where they could potentially harm consumers. Any product deemed misbranded or adulterated by FDA can be subject to regulatory action such as detentions, suspensions of registration, or being placed on import alert.

Misbranding of Products

FDA has strict rules on what kinds of claims a product can make and what information can be included on the labeling. Certain claims, such as disease claims that state a product can cure or prevent a disease or ailment, must be approved by FDA. When products such as food or dietary supplements make these kinds of claims, FDA requires them to adhere to drug regulations. FDA considers all advertising and web pages for a product in evaluating whether a product is making a claim that requires to be regulated as a drug.

Any deviation from FDA’s strict and expansive labeling rules can result in a product being considered misbranded.

FDA Approval for Drugs and Devices

FDA requires the approval of some drug products being marketed in the United States. When producing a drug product, you must first determine whether it falls under an existing monograph or is considered a new drug product. A monograph is a set of established rules for an existing drug product that identifies ingredients that are generally recognized as safe and effective (known as GRASE) for a given use,  as well as testing, labeling, and other requirements to bring the product to market. Only ingredients that fall under GRASE are permissible in drug products. Having unapproved ingredients in your drug product without an approved application can result in the product being considered adulterated by FDA.

Drugs that fall under a monograph do not require approval. For drugs that do not fall under an existing monograph, companies must file for approval directly with FDA. The approval process establishes whether the product is safe and effective, has appropriate labeling, and can be consistently manufactured safely.

Class III and some Class II medical devices also require approval before being marketed in the United States. These devices require premarket approval (PMA); obtaining PMA involves rigorous testing to ensure the safety of the device. FDA considers drugs and devices marketed without required approval to be adulterated.

FDA has strengthened their efforts towards limiting unapproved drug and device products in the U.S., making it pertinent to comply now before an issue arises. Compliance issues can cause expensive delays and even criminal charges in extreme cases.

Registrar Corp is a private company that assists businesses in complying with FDA regulations. Registrar Corp’s Regulatory Advisors can help determine if your product’s labeling and ingredients are compliant with FDA regulations. We can also help determine whether your product requires approval from FDA. For more information, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livehelp.