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The Future of U.S. Cosmetics Regulations

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 current regulations and resources limit what the Agency can do to effectively prevent potentially harmful cosmetics from entering U.S. distribution.

It is probable that, in the unexamined shipments, many non-compliant and potentially harmful products evaded enforcement and made their way to shelves.

Sometimes companies will recall these harmful products, but by then, the cosmetics have already fallen into the hands of consumers. In December 2021, Proctor and Gamble (P&G) recalled more than 30 aerosol hair products due to the presence of benzene, a chemical that can cause cancer. More brands initiated recalls for the same reason in the following months. Despite the recalls, independent lab testing performed in October 2022 revealed that 70% of tested dry shampoos still contained benzene.

Solutions For Proactive Regulations

Current FDA regulations for cosmetics are reactive, often addressing compliance issues after a product has already entered U.S. distribution. FDA can issue Warning Letters for non-compliance and refuse cosmetics in port, but the Federal Food, Drug, and Cosmetics (FD&C) Act does not give the Agency authority to order a mandatory recall of a cosmetic.

Other products under FDA’s authority such as food, medical devices, and drugs are more proactively regulated. These products are subject to pre-market submissions and facility requirements that not only help the Agency prevent significantly more non-compliant products from entering the U.S., but also better enforce action against them when they do.

In order to provide comparable regulations for cosmetics, the U.S. Congress  introduced The Personal Care Products Safety Act. This act is not the first of its kind, but similar bills like the FDA Cosmetic Safety and Modernization Act (S.2003) and the recent Safe Cosmetics and Personal Care Products Act of 2018 (H.R.6903) have not made it past Congress committees. They share some commonalties that illustrate the direction U.S. cosmetics regulations may take in the next decade.

In May 2022, FDA released a discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act, which includes steps to strengthen oversight of cosmetics based on provisions laid out in the Personal Care Products Safety Act. This article will discuss major changes industry should expect if the  Personal Care Products Safety Act or a similar bill becomes a law.

Learn about Registrar Corp’s cosmetics services.

Mandatory Registration of Cosmetic Facilities

FDA requires businesses in most industries under its authority to register or report to the Agency prior to marketing their products in the United States.  Under current regulations, FDA does not require cosmetic establishments to register, but allows them to do so voluntarily.

The proposed bills would require facilities that manufacture, process, or (in some cases) distribute cosmetics for use in the United States to register with FDA.  Previously proposed bills have specified differing annual or biennial registration renewal requirements. The 2022 discussion draft included a provision for requiring cosmetics facilities to renew their registration annually..  Similar to past bills, the Act would require facilities located outside of the United States to designate an agent physically located in the United States to communicate with FDA on the facility’s behalf.

Mandatory registration of cosmetics facilities would provide FDA a paper trail of who is marketing cosmetics in the United States and would grant the Agency authority to detain or refuse products from unregistered establishments.  If this bill passes, FDA could suspend the registrations of facilities that violate regulations, effectively prohibiting them from marketing their products in the United States.

Cosmetic Ingredient Statements

This new bill would require cosmetic facilities to submit a statement to FDA for each cosmetic intended to be marketed in the United States. The statement would contain, among other requirements, information on the facility manufacturing a cosmetic as well as the cosmetic’s ingredients and applicable warnings. FDA would require these statements be submitted within 60 days of marketing or reformulating the product and then annually (this is similar to a proposal under S.1113).

Cosmetic ingredient statements would notify FDA which products a particular facility processes and would allow the Agency to prohibit a cosmetic from being marketed without a valid statement.

Currently, cosmetics companies only need to report ingredients under certain circumstances. The California Safe Cosmetics Act of 2005 lists ingredients suspected to cause cancer or reproductive harm and requires companies that market products in California containing any of these ingredients to report the products to the state.

Another act that only applies to cosmetics marketed in California is the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA), which went into effect on January 1, 2022. CFFIRKA designates a subset of ingredients called “fragrance allergens” and specific ingredients that companies must report if being used as a fragrance ingredient (regardless of their function). The company named on the label must report these ingredients when present at a concentration of 0.01% (rinse-off cosmetics) or 0.001% (leave-on cosmetics).

Serious Adverse Event Reporting

The Personal Care Products Safety Act would require cosmetics businesses to submit serious adverse event reports to FDA. The bill’s definition for “serious adverse events” are generally health-related events associated with the use of a cosmetic that result in or require medical intervention. It also requires annual reporting of adverse health events such as rashes.

Like both S.1113 and S.2003, the Personal Care Products Safety Act would require the label of a cosmetic product to bear contact information for an entity located in the U.S. to receive notification of adverse events from consumers. A product not containing this information would be considered misbranded, subjecting it to detention or refusal at the U.S. border.

Good Manufacturing Practices

The Personal Care Products Safety Act would give FDA the authority to establish good manufacturing practices (GMPs) for cosmetics based on “current industry standards.” In other FDA-regulated industries, GMPs regulate production aspects such as sanitary conditions, hazard controls, and record-keeping. For cosmetics, GMPs would provide enforceable standards for FDA to reference during inspections. Violation of GMPs could result in regulatory actions such as Warning Letters, Import Alerts, and Import Refusals.

GMPs for cosmetics would be determined through FDA rulemaking. During rulemaking, FDA proposes a rule and allows industry and consumers to provide comment. Depending on the comments FDA receives, the Agency may issue an additional proposed rule for further comments, cease rulemaking, or issue a final rule.

A final rule contains compliance deadlines for industry, which are often determined by the size of businesses covered under the rule. It may take years for industry to see a rule’s full implementation as FDA prepares guidance and provides businesses time to process and comply with requirements.

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Ingredient Review

The Personal Care Products Safety Act would also establish an annual review of cosmetic ingredients by FDA.  FDA would analyze safety data surrounding certain cosmetic ingredients to determine whether they are safe for use without restriction, safe under certain conditions or uses, or not safe for use at all.  FDA would then use these determinations to establish regulations that either permit or prohibit the use of certain ingredients in cosmetics.

The bill would even immediately prohibit products containing products that use harmful polyfluoroalkyl substances.

As more resources would be allocated to evaluating cosmetics’ safety, FDA may forbid or restrict the use of certain ingredients currently used in cosmetics. Businesses using these ingredients would need to reformulate their product to remain compliant.

In Conclusion

While the Personal Care Product Safety Act is not yet close to being passed, the push for the above requirements is supported by congressional Democrats and Republicans, and the proposed regulations bear significant resemblance to existing requirements in other FDA-regulated industries. Not only is reform supported by many elected representatives, but some cosmetic companies are also arguing for increased regulation of their own products. The Personal Care Product Safety Act has received support from several major cosmetic manufacturers, including Burt’s Bees Company, Johnson and Johnson, L’Oreal, and more.

Based on the consistency of proposed cosmetics safety bills, it is likely that one may be enacted within the next several years. If this change is realized, industry will need to adapt and adjust to continue business in the United States.

Get Assistance with Cosmetics Compliance

For assistance with FDA’s cosmetics regulations, contact leading FDA compliance consultant, Registrar Corp. Our Regulatory Specialists can review your labeling for compliance, register your cosmetics establishment with FDA, assist with reporting under the California Safe Cosmetics Act, and more

Looking for a software solution? Try Cosmetri, software designed to simplify compliance for cosmetic companies.

Sesame Declared a Major Allergen

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 on or after January 1, 2023 must must include “sesame” in their allergens declaration. This change updates the existing Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

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The Nine Major Allergens

With the addition of sesame, FALCPA now applies to nine food groups that were chosen because they account for over 90% of all food allergies in the United States.

The nine major allergens are:

  • Milk
  • Eggs
  • Fish
  • Crustacean shellfish
  • Tree nuts (including coconut)
  • Peanuts
  • Wheat
  • Soybeans
  • Sesame

Sesame Allergen Labeling Guidance

Sesame allergies and sensitivities are on the rise in America. While most products that contain sesame do list it on their allergen statement, sesame does not currently have to be listed when it is used as a spice or flavor. This puts many Americans at risk of adverse reactions without the knowledge of sesame being present.

Although the FASTER Act did not take effect until January 2023, FDA previously urged manufactures to begin the voluntary practice of including sesame in ingredient lists on food labels ahead of the regulatory shift.

FDA released a draft guidance in November 2020 to help manufactures incorporate this practice. In the guidance, FDA reports that “of the reports [they] received, 44% of adverse reactions to sesame were described as severe and nearly 50% resulted in physician or hospital visits”.

Need Assistance with Allergens Labeling?

Registrar Corp’s Regulatory Specialists help companies comply with FDA regulations for declaring allergens on food labels.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: [email protected], or chat with a Regulatory Advisor 24-hours a day: regstaging.wpengine.com/livechat.

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FAQ Friday: Can I Market Food and Beverages with CBD in the U.S.

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 Administration (FDA) prohibits the marketing of CBD food and supplement products in the United States.

What is CBD?

CBD is a single compound of the cannabis plant. It is often extracted as an oil and then applied to foods, beverages, lotions, and supplements. Some claim that CBD can reduce pain, depression, anxiety, and other ailments.  However, FDA has not permitted CBD for these intended uses due to concerns about the full effects of CBD consumption. FDA warns that CBD can cause liver damage, changes to alertness, and may interact with other medications in a harmful way.

FDA and CBD Regulation

According to FDA, “It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.” FDA is uncertain about to the impact of long-term daily use, how different methods of consumption may affect users, and how it may affect children. The Agency continues to explore the benefits and adverse effects of CBD.

Conventional food ingredients must be approved by FDA as food additives or be “generally recognized as safe” (GRAS). FDA has published statements that CBD is neither and is illegal to market in a food in interstate commerce.

Dietary ingredients (the key ingredient in a supplement) are not subject to food additive/GRAS regulation, but are subject to other limitations including whether it was ever the subject of clinical investigations as an investigational new drug. Currently, FDA has approved CBD as an ingredient for use in one drug product, Epidiolex, which is used to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.

FDA prohibits the use of CBD in dietary supplements as it violates the definition of a dietary supplement under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Act states “if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved … or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.” Since CBD is considered an active ingredient in Epidiolex, it is prohibited from use in dietary supplements.

FDA “is committed to setting sound, science-based policy. The FDA is raising these safety, marketing, and labeling concerns because we want you to know what we know.” Should research determine that CBD meets FDA safety standards, these regulations could change.

Legality of CBD

While only one CBD Product is approved by FDA, nearly all U.S. states allow CBD products in one form or another.  However, even for states in which CBD products are legal, many provide additional provisions on its uses. For example, in many states (like California, New York, and Pennsylvania) CBD is prohibited for use in food and beverages, while other states (Florida, Texas, Indiana) are implementing labeling requirements or have implemented age limits similar to those of tobacco or alcohol. CBD is illegal in any form in Idaho, Iowa, and South Dakota.

Additionally, under the Agricultural Improvement Act of 2018, CBD is no longer federally illegal to make or possess in the United States. However, CBD does not conform to the regulations that govern conventional food ingredients or dietary supplements. The conditions of the 2018 Farm Bill do not alter the requirement that CBD meet the requirements of the FD&C Act if incorporated into a food or dietary supplement.

More questions?

The CBD industry is relatively new and evolving rapidly. Subscribe to Registrar Corp’s blog to stay up to date on FDA regulations surrounding CBD products.

Registrar Corp is a private company that assists businesses in complying with FDA regulations.  Our Regulatory Specialists can help businesses register with FDA, meet FDA labeling requirements, and more. 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.

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.

“An invaluable tool”, “the perfect solution” — U.S. Importers Applaud Registrar Corp’s FDA Compliance Monitor

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 money and reduce the risk involved in their compliance and sourcing activities.

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The Monitor was built in 2016 with U.S. Food and Drug Administration (FDA) regulations in mind. The FDA Foreign Supplier Verification Program (FSVP) rule requires that U.S. food importers monitor and document their foreign suppliers’ compliance, including identifying any warning letter, import alert, or other FDA compliance action related to food safety. The FDA Compliance Monitor facilitates FSVP compliance by checking suppliers against six FDA databases daily, notifies users when compliance information changes, and archives monthly compliance reports.

After considering several solutions for complying with FSVP requirements, Limson Trading Inc. determined that Registrar Corp’s FDA Compliance Monitor was the perfect solution. “All of the areas we need to monitor are located in one easy to access place, and it’s simple to download the data to a spreadsheet if we needed it,” said Steve Brunsting, Vendor Compliance and Sourcing Manager at Limson Trading Inc. “The implementation of RegiScore improved the product even more.”

In 2020, Registrar Corp introduced a proprietary risk evaluation tool known as RegiScore. RegiScore empowers importers to easily gauge the risk an existing or potential supplier presents based on their compliance and shipment history, similarly to how FDA utilizes PREDICT to make decisions on what products to inspect at U.S. ports of entry.

Mr. Brunsting said Limson was “looking at a great deal of time and money needing to be spent to manually research and track over 150 suppliers in our importing business” before implementing the Monitor.  Use this savings calculator to see how much time and money the Monitor could save you by automating your supplier monitoring efforts.

The latest addition to the FDA Compliance Monitor is the Document Management System (DMS). This tool facilitates compliance with FSVP record keeping and supplier documentation requirements. With this enhancement, users can easily request, evaluate, approve documentation from their suppliers, including Food Safety Plans, labels, inspection reports, and more–all from within one secure system.

“We were very appreciative of learning about the newly available Document Management System (DMS) as a timely solution to an increasingly difficult issue of following up on supplier document submissions as our supplier base grows”, said Frederick Robinson, Director of R&D and Co-pack Quality at Jasper Wyman & Son, a long-time Monitor user.  “A top feature is the ability to link the document system with the existing multi-supplier monitoring.”

Mr. Robinson and his team have begun implementation of the DMS which will replace their internal filling and database management system for supplier follow-ups.

The Monitor has also proved to be an important support for food safety scheme certification audits.

“The FDA Compliance Monitor was invaluable during our SQF Audit,” said Emma Raven, Quality Compliance Manager from Capstone Nutrition. “We were able to display our supply chain and show auditors the level of our due diligence on our suppliers. Auditors were impressed and we passed our audit.”

See the FDA Compliance Monitor In Action

As Registrar Corp continues to expand on its leading FSVP compliance solution, learn how it can transform your FSVP compliance today.

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FDA Publishes New OTC Monograph Drug Facility User Fees

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 March 2020 CARES Act.  FDA states that facility fees for FY 2021 are due 45 days after publication of the Federal Register Notice (May 10, 2021).

This replaces a former Notice published in December 2020 that was withdrawn by FDA.

Who Must Pay OMUFA Facility Fees?

FDA will now require facilities that manufacture or process a finished dosage form of an OTC monograph drug to pay an annual monograph drug facility (MDF) fee.  The MDF fee for FY 2021 is $20,322.  Contract manufacturing organizations (CMOs), which are MDFs where the owner or affiliates do not sell their finished drug directly to wholesalers, retailers, or consumers, are required to pay two-thirds of the regular MDF fee.  The CMO fee for FY 2021 is $13,548.

FDA expects to collect these fees from MDFs and CMOs that registered with FDA or renewed their FDA registrations between January 1 and December 31, 2020.  Establishments that have registered with FDA for the first time on or after January 1, 2021 do not need to pay the FY 2021 OMUFA fees, but will be subject to the FY 2022 fees once published.

The fees in this March 2021 Notice are higher than those published in the original December 2020 Notice, which stated $14,060 for MDFs and $9,373 for CMOs.  The fee amounts were determined based on the estimated fees necessary to support the cost of operating OTC monograph drug activities and the estimated number of establishments paying the fee.  Under the new March Notice, “FDA will not assess OMUFA facility fees upon firms that first registered with FDA on or after the January 27, 2020 declaration of the COVID-19 public health emergency (PHE) solely to manufacture OTC hand sanitizer products during the PHE”. In an email to industry, FDA stated that “because certain hand sanitizer product facilities will not be assessed fees, the facility fees for the remaining payors have increased for FY21, since the number of manufacturers subject to OMUFA facility fees has decreased.”

The OMUFA fees do not apply to facilities that only manufacture active pharmaceutical ingredients (APIs), produce clinical research supplies, conduct testing, or place outer packaging on already packaged products for use in a kit.  Likewise, facility fees do not apply if a drug establishment’s registration indicates it has ceased all activities related to OTC monograph drugs prior to December 31, 2019.

Assistance with New OTC Monograph Drug User Fees

Not sure which fees may apply to your drug establishment?  Registrar Corp can help determine your applicable fees and facilitate payment to FDA as part of our U.S. Agent and Registrant Contact services.  Contact Registrar Corp by email at [email protected] or by phone at +1-757-224-0177.  Alternatively, you can chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat