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Helen Ogunyanwo

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For years, cosmetics and other personal care companies have faced calls for “cleaner” products and more transparent labeling. And every day, new ingredients get added to the “naughty” list. Recently, per- and polyfluoroalkul substances  (PFAS)—a group of manmade chemicals used primarily for their conditioning properties—have come under fire. Even as research indicating the dangers of PFAS is limited, the widespread use of PFAS has led to state restrictions on use in personal care products, and proposed legislation that would ban PFAS in cosmetics on a federal level.

Continue Reading PFAS Litigation: Another Headache for the Beauty Industry
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For many years, personal care companies have used a wide variety of ingredients that are now under scrutiny. Recently, Per- and Polyfluoroalkyl substances (PFAS) have received increased attention. Once intentionally added to products, several state laws ban or modify the total amount of these ingredients permitted in various products. Now, a new bill introduced in U.S. Congress late last year aims to follow suit.

Continue Reading What’s In and What’s Out? Cosmetic Companies Face Ingredient Compliance Conundrum
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On December 18, 2023, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, the electronic submission portal for facility registration and product listing required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) and published a User Guide for the portal.[1] Cosmetics Direct contains user friendly data entry forms, performs initial validations, creates and saves the structured product labeling (SPL) submission, and submits the SPL to FDA.

Continue Reading FDA Launches Cosmetics Direct and Issues Final Guidance on Facility Registration & Product Listings Required under MoCRA
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On December 14, 2023, the FDA issued an update with further instructions on  serious adverse event reporting under the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”), which is enforceable starting December 29, 2023.

Continue Reading FDA Provides Updated Instructions for Reporting Serious Adverse Events under MoCRA
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On October 13, 2023 The FDA announced that two of the requirements set forth in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA)— facility registration and product listing—will be included as part of the Structured Product Labeling (SPL) framework. SPL is a document formatting standard adopted by FDA for exchanging product-related information. 

Continue Reading FDA Publishes SPL Guide for MoCRA Facility Registration and Product Listings
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In December 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”)—the most significant expansion of the U.S. Food and Drug Administration’s authority to regulate cosmetics in nearly 85 years—was signed into law. Among other things, MoCRA gives the FDA authority to require facility registration and reporting of serious adverse events, impose certain record-keeping obligations, recall cosmetic products, and establish good manufacturing practices. With many of MoCRA’s provisions going into effect at the end of this year, cosmetics companies need to prepare to address these requirements and regulations, which may also have a considerable impact on the litigation landscape.

Crowell’s Product Risk Management team has written two publications to help cosmetics companies prepare for the big changes ahead.

Continue Reading Modernization of Cosmetics Regulation Act (“MoCRA”) White Paper
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New considerations have emerged for advertisers who publish reviews or endorsements. On June 29, 2023, the FTC finalized its updated Endorsement Guides, which provide insights to businesses on how the use of reviews and endorsements might be considered unfair or deceptive in violation of Section 5 of the FTC Act. Over the past several months, the FTC sought public comments on proposed updates to the Endorsement Guides to accurately reflect the modern landscape of advertising, which includes reliance on social media and content creators.

Continue Reading Reviews and Endorsements Say What? FTC Finalizes Updates to Endorsement Guidelines
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The Federal Trade Commission (“FTC” or “Commission”) recently announced that it has adjusted the maximum civil penalty dollar amounts for violations of 16 provisions that the Commission enforces. The increase is required by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, and is intended to account for inflation. The act directs agencies to implement annual inflation adjustments based on a prescribed formula. Given the uptick in FTC enforcement actions, companies are likely to begin feeling the impact of the increased penalties in the coming year.

As our readers likely recall, the Supreme Court’s 2021 ruling in AMG Capital Management LLC v. Federal Trade Commission removed a powerful tool that the FTC had previously relied on to pursue monetary relief in federal court. The Supreme Court unanimously held that the Federal Trade Commission cannot obtain equitable monetary relief, such as disgorgement or restitution, when it pursues district court litigation directly under Section 13(b) of the Federal Trade Commission Act (“FTC Act” or “Act”). Rather, to obtain such relief, the FTC must first follow its administrative adjudication procedures under Section 5 of the Act.

Continue Reading How Much Could Violating a FTC Rule Cost You? $50,120 Per Violation?

On May 20, 2022 the Federal Trade Commission’s (“FTC”) Commissioners unanimously approved a request for public comment on proposed updates to its Guides Concerning the Use of Endorsements and Testimonials in Advertising (“Endorsement Guides” or “Guides”). In the draft revisions, released last week, the FTC seeks to update the Endorsement Guides and provide new examples that reflect advertisers’ growing reliance on social media advertising. The Endorsement Guides were last revised in 2009. See 16 CFR pt 255.

The Endorsement Guides require advertisers that feature endorsements made by endorsers with an unanticipated material connection to the advertiser—for example, monetary payment, a sweepstakes entry, or something else of value—to disclose that connection in the advertising. In addition, endorsements must be truthful and accurate, reflecting the endorser’s actual experience with the product. Marketers that fail to comply with the Endorsement Guides violate Section 5 of the FTC Act.

Continue Reading FTC Issues Long-Awaited Updates to the Endorsement Guides