FDA Issues Long-Awaited Draft Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products Under MoCRA

MoCRA’s long-awaited rollout continues as today FDA released draft guidance to assist persons submitting cosmetic product facility registrations and product listings under newly-added Section 607 of the federal Food, Drug, and Cosmetic Act (FD&C Act).

Background

Section 607(a) of the FD&C Act requires every person that owns or operates a facility that “engages in the manufacturing or processing of a cosmetic product for distribution in the United States” to register each facility with FDA, update content within 60 days of any changes, and renew their registration every two years.

As of March 27, 2023, FDA ended its voluntary cosmetics registration program (VCRP), and advised that information submitted to VCRP would not be transferred over to any new system.

Section 607(c) of the FD&C Act further requires that for each cosmetic product, the responsible person must submit to FDA annually “a cosmetic product listing,” including ingredients. 

MoCRA defines a “responsible person” as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act (FPLA).

Key takeaways from Today’s FDA Draft Guidance:

Small Business Exemption: Small businesses, as defined by Section 612 of the FD&C Act (average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1 million, adjusted for inflation, and who do not manufacture or process certain cosmetic products described in Section 612(b)), are not required to register facilities and list cosmetic product(s).

Electronic Submission Portal: FDA’s new electronic submission portal is expected to be available in October 2023, with FDA strongly encouraging electronic submissions. FDA is developing a paper form as an alternative submission tool.

Definitions: The Draft Guidance defines “contract manufacturer,” “cosmetic products,” “facility,” “manufacturing or processing,” “operator,” “owner,” “responsible person,” and “small business.”

Who Makes the Submissions: Every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States to register each facility and submit a cosmetic product listing unless:

    • it is exempt as a “small business”; or
    • the cosmetic product is also a drug or device subject to the requirements of Chapter V of the FD&C Act.

What Information to Include (Registration):

    • the name of the owner and/or operator of the facility;
    • the facility’s name, physical address, email address, and telephone number;
    •  with respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact
      information (email);
    • the facility registration number, if any, previously assigned;
    • all brand names under which cosmetic products manufactured or processed in the facility are sold;
    • the product category or categories (listed in Appendix A of the Draft Guidance) and responsible person for each cosmetic product manufactured or processed at the facility; and
    • type of submission (initial, amended, biennial renewal, or abbreviated renewal)

FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. The e owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.

FDA also requests that the following additional optional information be submitted:
• parent company name (if applicable);
• facility DUNS Number; and
• additional contact information for individuals associated with the registration.

What Information to Include (Product Listing):

    • the facility registration number of each facility where the cosmetic product is manufactured or processed;
    • the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
    • the applicable cosmetic category or categories for the cosmetic product (listed in Appendix A of the Draft Guidance)
    • a list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient;
    • the product listing number, if any previously assigned; and type of submission (initial, update to content (annual), abbreviated renewal)

FDA also requests that the following additional optional information be submitted:

    • parent company name (if applicable);
    • type of business (as listed on the label), i.e., manufacturer, packer, or distributor;
    • image of the label;
    • product webpage link;
    • whether the cosmetic product is for professional use only;
    • Responsible person DUNS Number (Dun & Bradstreet number) for address listed on product label;
    • Unique Ingredient Identifiers (UNIIs); and
    • additional contact information for individuals associated with the listing.

Multiple Listings: Under Section 607(c)4()B), a single listing for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents

Attestation: FDA requests that individuals submitting registration and listing information to attest to the accuracy and veracity of the information submitted.

How/When to Submit: Stakeholders should plan to register and list in advance of the December 29, 2023 statutory deadline.

Fees: There is no fee to submit a registration or product listing to FDA under section 607 of the FD&C Act.

Public Disclosure: Under section 607 of the FD&C Act, FDA will not disclose information from a facility registration on the brand names under which cosmetic products manufactured or processed in the facility are sold, or from a product listing on the facility registration number of the facility where the cosmetic product is manufactured or processed, in response to a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552).

All other information from cosmetic product facility registration and listing would be available for public disclosure consistent with the FOIA, FDA’s disclosure regulations under 21 CFR Part 20, and other applicable federal law.

Drugs AND Cosmetics?: Cosmetic products that are also drugs under Chapter V of the FD&C Act are not subject to listing requirements. Likewise, a facility that manufactures or processes cosmetic products that are also drugs is not subject to registration requirement  unless it also manufactures or processes cosmetic products that are not also drugs.

Enforceability: As a reminder,  FDA’s guidance documents do not establish legally enforceable responsibilities, but are intended to describe FDA’s current thinking and should be viewed as recommendations.

Conclusion

Today’s Draft Guidance provides much-needed clarity regarding MoCRA’s requirements and upcoming registration and listing deadlines. However, we expect further guidance in the upcoming months as to MoCRA’s additional December 2023 deadlines, and feedback with FDA regarding any flexibility in meeting these deadlines.

 

Duane Morris Attorney Kelly Bonner Talks Cosmetics Regulations and More on This Week’s Episode of “Fat Mascara” Beauty Podcast

Join Duane Morris attorney Kelly Bonner as she discusses America’s complex system of cosmetics regulation on the award-winning beauty podcast, Fat Mascara, hosted by Jennifer Sullivan (beauty columnist, The Cut) and Jessica Matlin (beauty director, Moda Operandi).

Links to Episode 474: How Cosmetics Are Regulated, with Kelly Bonner, below

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INFORM Consumer Act Designed to Curb Counterfeits

In March 2021, the Senate reintroduced a revised version of a bill calling for online retailers to publish specific, verified information concerning high-volume third-party sellers of consumer products for their customers. The Integrity, Notification and Fairness in Online Retail Marketplaces (INFORM) for Consumers Act is directed toward putting an end to the online sale of stolen, counterfeit and unsafe consumer products.

In particular, online marketplaces that include high-volume third-party sellers would be required to authenticate vendors’ identities through essential identification and contact information in the hopes of preventing not only anonymous online sales of counterfeit goods, but also preventing organized retail crime rings from stealing from stores and reselling items online.

To read the full text of this Duane Morris Alert, please visit the firm website.

Diverse Design – Enabling Innovation and Profitability While Creating an Inclusive World

This post was co-authored by Heidi Lunasin and Yalda Hajavi, and it is the first installment of a multipart series.

Around the world, companies are leaving money on the table.  Lack of diversity and inclusion in “The Room Where It Happens,” whether the “IT” is a board-room, an innovation team, or a design team, repeatedly has been shown to affect the bottom line.  In the realm of innovation alone, experts have estimated that “the size of the economy could be roughly 3 to 4 percent higher if women and underrepresented minorities were included in the innovative process from beginning to end.”[1]  This goes beyond merely showing diversity and rather requires inclusion and input at all levels and areas of the innovation process.  A further benefit may be that diverse teams encourage design and innovation that is likely more inclusive of a greater portion of the population.

Continue reading “Diverse Design – Enabling Innovation and Profitability While Creating an Inclusive World”

Protecting Your Brand and Customers During a Pandemic

This post was co-authored by Nicole Candelori and Christiane Schuman Campbell, and it is the first installment of a multipart series.

As most brick and mortar stores across the U.S. remain closed due to the COVID-19 pandemic, phishing scammers have ample opportunities to attack the retail industry online by stealing customer data. One common method scammers use to steal information involves purchasing a domain name that includes (or is confusingly similar to) the name of a well-known business. For example, “typosquatters” might purchase a domain name similar to your business’ domain name, but it could include a common typo that a customer might make when searching for your legitimate website. The fake website might look similar to your legitimate site and prompt customers to input a username, password, credit card number, or other personal information that the scammer could then steal to use or sell.

During a time like this when customers are increasingly looking to purchase consumer goods online (e.g. home décor, kitchen appliances, and home office furniture), businesses selling these goods should be extra vigilant of these misleading (and often, infringing) websites. Businesses can hire trademark watch companies to monitor for any new domains that encompass their trademark or variants thereof. If your business becomes aware of a domain name that encompasses its trademark (or something confusingly similar) in an attempt to mislead consumers, there are a number of steps you can take to protect your brand and customers. Continue reading “Protecting Your Brand and Customers During a Pandemic”

Personal Care Products Sector Gets Boost From New North American Trade Deal

On January 29, 2020, President Trump signed the U.S.-Mexico-Canada Agreement (USMCA) into law, with key commitments impacting the personal care products sector.

The 2,082-page pact, which updates the 26-year-old North American Free Trade  Agreement (NAFTA), comes after more than two years of   negotiations, and was overwhelmingly ratified by the U.S. Senate on January 16, 2020.

Significantly, the USMCA contains a new Cosmetic Products Annex, which promotes greater regulatory compatibility and shared best regulatory practices in the personal care products sector.

Continue reading “Personal Care Products Sector Gets Boost From New North American Trade Deal”

FDA To Host Day-Long Public Forum On Asbestos-Contaminated Talc

On January 9, 2020, the U.S. Food and Drug Administration announced that it will host an all-day public forum to discuss testing methods for asbestos in talc and cosmetic products containing talc on February 4, 2020.

According to the FDA, the purpose of the meeting is to discuss testing methods, terminology, and criteria that can be used to characterize and measure asbestos, as well as what the FDA preliminarily states may be “other potentially harmful elongate mineral particles (EMPs)” that may contaminate talc and cosmetics products that contain talc.

Continue reading “FDA To Host Day-Long Public Forum On Asbestos-Contaminated Talc”

Nanette Heide Comments on the Future of Private Equity Firms and Small Beauty Brands

Nanette Heide, Duane Morris partner and Fashion/Retail/Consumer Branded Products Group senior advisory partner, is quoted in Glossy article, “Private Equity Firms Will Get Comfortable With Small Beauty Brands in 2020.”

“The trend will be private equity companies getting involved in brands earlier and taking on a minority stake versus majority control,” she said. “They’ll blur the lines of venture capital in order to make sure they are in early enough, because then brands can catch fire and sell within 16 months.”

To read the full article, visit the Glossy website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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