On April 5, 2024, the U.S. Food and Drug Administration (FDA) confirmed that its third-party testing of cosmetic talc products for 2023 identified no traces of asbestos in any of the 50 cosmetic samples tested. FDA’s 2023 results, which were reported in a Cosmetics Constituent Update, are consistent with its testing for 2022 and 2021, which also failed to detect asbestos in any of the 50 cosmetic samples tested for those years. Read the full Alert on Duane Morris’ website.
House of Representatives Introduces Ban Water Beads Act
By Paul Rosenlund and Steven Perelman
On November 21, 2023, Representative Robin Kelly (D-IL), Representative Brittany Pettersen (D-CO) and Representative Frank Pallone, Jr. (D-NJ), introduced the Ban Water Beads Act (H.R. 6468) to ban water beads marketed towards children. Water beads are super-absorbent polymer chemical spheres sometimes marketed as toys. This legislation would add water bead products to Section 8 of the existing Consumer Product Safety Act (CPSA) as a banned hazardous product. Therefore, the Consumer Product Safety Commission (CPSC) would be directed to enforce a ban on all water beads marketed as a toy, educational material, or art material or art product. Continue reading “House of Representatives Introduces Ban Water Beads Act”
How Will The EU’s AI Legislation Influence the Fashion Industry?
Europe’s strides in AI legislation have reached a historic milestone as the European Parliament greenlights the AI Act, setting a global precedent for comprehensive regulation in artificial intelligence development and use. This landmark legislation not only shapes the future of technology within the European Union but also holds significant implications for various sectors, including the fashion industry. […]
Duane Morris partner Agatha Liu emphasizes the need for fashion brands to adopt a customer-centric approach, prioritizing transparency and providing consumers with comprehensive insights into AI-driven processes. The Act’s focus on eradicating bias underscores the importance of inclusive AI models within the fashion industry.
Clean Beauty False Advertising Complaint Dismissed by NY Federal Court
As expected (and blogged about previously here), a NY federal court dismissed the “Clean at Sephora” class action complaint, concluding that plaintiff Lindsay Finster “failed to plausibly allege that Sephora misled reasonable consumers when it marketed and sold its ‘Clean at Sephora’ cosmetics,” or that Sephora “made any explicit or implied promises that its ‘Clean at Sephora’ cosmetics were all-natural and free of any potentially harmful ingredients.”
In his fourteen-page opinion, issued today, Judge David Hurd of the U.S. District Court for the Northern District of New York dismissed Finster’s NY GBL §§ 349 and 350 false advertising claims:
Finster’s allegations fall short of the objective standard imposed on GBL §§ 349 and 350 claims. Plaintiff’s complaint leaves the Court guessing as to how a reasonable consumer could mistake the “Clean at Sephora” labeling and/or marketing to reasonably believe that the cosmetics contain no synthetic or harmful ingredients whatsoever. Plaintiff cites to advertising from defendant which states: “consumers who see the Clean seal can be assured that the product is formulated without specific ingredients that are known or suspected to be potentially harmful to human health and/or the environment.” …. Yet, nowhere on the label or in the marketing materials plaintiff cites does defendant make any claim that the products are free of all synthetic or harmful ingredients.
The court also rejected Finster’s breach of warranty claims under the New York Uniform Commercial Code (“UCC”) and Magnuson Moss Warranty Act (“MMWA”) where Finster “cannot point to an express or implicit fact or promise by Sephora that its ‘Clean at Sephora’ cosmetics were free of all synthetic or harmful ingredients.”
The court dismissed Finster’s remaining claims for fraud as insufficiently pleaded because Finster failed to identify an intentionally false material statement, and claim for unjust enrichment .
The court will allow Finster to file an amended complaint on or before March 2029, 2024.
Takeaways
Given Finster’s emphasis on the delta between what the retailer expressly communicated versus what the consumer perceived, it remains to be seen what, if any impact, today’s decision will have on the bigger debate over the meaning of clean beauty. Nevertheless, the decision serves as a reminder that there are competing understandings of clean beauty in today’s cosmetics industry, and that it is important for brands to be transparent about how they are applying the term.
How Beauty Companies Can Mitigate Risks Associated with AI Technology Use
From L’Oreal and Olay to Procter & Gamble and Shiseido, companies across the beauty industry are embracing AI technology with open arms. But what are the risks of incorporating AI technology into business practices, and how can beauty companies protect themselves? […]
For answers to these questions and a closer look at this rapidly growing segment of the beauty industry, CosmeticsDesign spoke to attorneys Kelly Bonner and Agatha Liu of Duane Morris LLP, for their insights and experience. Kelly Bonner’s practice focuses on litigation risk and regulatory issues affecting businesses in the cosmetics and personal care industries, as well as cross-jurisdictional and complex commercial disputes involving FDA-regulated and consumer-branded products, and Agatha Liu has assisted clients with AI-related legal needs.
Continue reading “How Beauty Companies Can Mitigate Risks Associated with AI Technology Use”
Balancing Innovation and AI Regulations in the Beauty Market
Duane Morris’ Agatha Liu and Kelly Bonner were interviewed by Personal Care Insights about the challenges and opportunities beauty companies face while using AI to appeal to younger consumer demographics. Below is an excerpt of the article.
How does the competitive landscape of the beauty industry impact businesses’ use of AI technologies, especially when it comes to targeting younger consumer segments?
Bonner: The highly competitive nature of the beauty industry, with its desire to appeal to younger consumers, is certainly a key driver in beauty brands embracing AI tools to offer enhanced customer shopping experiences.
Can you provide some context about US AI regulations that the beauty industry should know? What do you expect is coming, especially considering the AI Act in the EU?
Liu: The EU AI Act imposes specific obligations on the providers and deployers of so-called high-risk AI systems, including testing, documentation, transparency and notification duties.
To read the full interview, please visit the Personal Care Insights page.
Beauty Is in the AI of the Beholder
Duane Morris partner Agatha Liu spoke with Personal Care Insights on potential risks, including personalization, appearance bias and regulatory compliance, as beauty companies integrate AI technologies.
What steps do you advise beauty companies to take to reduce the legal risks that could arise from implementing AI?
Liu: Very generally, companies should understand the technology they’re adopting and implementing and balance the benefits of the technology against potential legal pitfalls. That means liaising with outside counsel and privacy teams to obtain clarity and mitigate risks. […]
Read the full interview on the Personal Care Insights website.
2023 Regulatory Roundup: MoCRA
Updated deadlines, the announcement of a newly developed draft submission portal, and the release of several different draft guidance documents are just some of the developments that have occurred this year regarding MoCRA’s implementation of cosmetic safety regulations. As 2023 draws to a close, CosmeticsDesign spoke to attorney Kelly Bonner to review what’s happened so far with the Modernization of Cosmetics Regulation Act (MoCRA) and to understand what’s ahead.
To read the full text of this article, please visit the CosmeticsDesign website.
U.S. House Reps Reintroduce Federal Bill Banning Intentionally Added PFAS in Cosmetics
On November 30, 23, U.S. Representatives Debbie Dingell (D-MI), Brian Fitzpatrick (R-PA) and Annie Kuster (D-NH) reintroduced H.R. 6519–the “No PFAS in Cosmetics Act“–which would require the Food and Drug Administration (FDA) to ban use of “intentionally added per- and polyfluoroalkyl substances” (PFAS) in cosmetics.
According to the Environmental Protection Agency, PFAS are a group of long lasting manufactured chemicals that have been widely used in industry and consumer products since the 1940s because of their useful properties. There are thousands of different PFAS, some of which have been more widely used and studied than others.
The “No PFAS in Cosmetics Act,” which was previously introduced in Congress in June 2021, and referred to the House Committee on Energy and Commerce on November 30, 2023, would amend the Food, Drug, and Cosmetic Act (FDCA) to require FDA to prohibit intentionally added PFAS in cosmetics within 270 days of the bill’s enactment.
Notably, the bill does not define PFAS beyond “intentionally added” perfluoroalkyl and polyfluoroalkyl substances. Nor does the bill differentiate which chemicals in the PFAS group–for example, Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS), two of the most widely used and studied chemicals in the PFAS group–should be banned.
Last year’s Modernization of Cosmetics Regulation Act (MOCRA) requires FDA to publish a report within three years (i.e., by end of year 2025) assessing the use of PFAS in cosmetics and their safety, signaling the possibility of further legislation or regulation, if warranted. Senate appropriators also have directed FDA “to develop a plan outlining research needed to inform regulatory decision-making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics.”
The proposed bill reflects the growing number of state legislatures that have enacted or are considering legislation banning the intentional use of PFAS in cosmetics, as well as other consumer products such as children’s products, menstrual products, cleaning ingredients, dental floss, and textiles. For example:
- In 2021, Maine became the first state to require manufacturers of products with intentionally added PFAS to report to the Maine Department of Environmental Protection (DEP) documenting the purpose and amount of each PFAS compound used. The law aims to phase out the use of PFAS in cosmetics, among other new consumer products, by 2030.
- Starting on January 1, 2025, California and Maryland will prohibit the manufacturing, sale, or delivery of cosmetic products containing certain intentionally added PFAS in cosmetics, including PFOA and PFOS, unless they contain technically unavoidable trace quantities of the substances stemming from impurities of natural or synthetic ingredients.
- Starting January 1, 2025, Minnesota and Colorado will prohibit the sale or distribution of cosmetics (among other consumer products) that contain intentionally added PFAS.
- Beginning January 1, 2025, Washington State will prohibit the manufacturing, knowing sale, or distribution of cosmetic products containing PFAS, defined as “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”
- Oregon’s Toxic Free Cosmetics Act, which bans the sale or distribution of cosmetics that contain intentionally added PFAS (among other chemicals) is scheduled to take effect on January 1, 2027.
New York, which last year banned the use of intentionally added PFAS in apparel, effective January 1, 2025, is considering several bills that would prohibit the sale or distribution of cosmetics (among other consumer products) that contain intentionally added PFAS.
FDA Updates Instructions for Serious Adverse Event Reporting for Cosmetic Products under MoCRA
On December 14, 2023, FDA published updated instructions for reporting serious adverse events for cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), enforceable starting December 29, 2023.
FDA recommends that industry “responsible persons” as defined by MoCRA report serious adverse event reports for cosmetic products by using the current MedWatch Form 3500A , which is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program – Mandatory (PDF).
FDA has updated the form’s instructions to make it easier for the responsible person to complete the form , and requests that the completed form (along with any information to support the report) be submitted to FDA via email at: CosmeticAERS@fda.hhs.gov or by mail to:
FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993
FDA strongly encourages electronic submission of serious adverse event reports to facilitate efficiency and timeliness of data submission and management for the agency.
FDA is developing a process for submitting electronic mandatory adverse event reports for cosmetics, and will provide more information on the launch date for this process in the coming months.
As a reminder, MoCRA requires that a “responsible person” must report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days, and include a copy of the label on or within the retail packaging of such cosmetic product.
If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, the responsible person must submit this new information to FDA within 15 business days.
MoCRA defines the “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 Food, Drug, and Cosmetic Act or section 4(a) of the Fair Packaging and Labeling Act.
Additionally, MoCRA expands the definition of “serious adverse event” ” to include infections or “significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other
than as intended, under conditions of use that are customary or usual.”
Products will not be considered “injurious” if they cause minor or transient reactions to certain users.
This expanded definition still includes previously identified adverse events such as death; a life-threatening experience; in-patient hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; or medical or surgical intervention to prevent any of these outcomes.