Policy & Regulation

The US FTC has published its ‘Rule Concerning Recurring Subscriptions and Other Negative Option Programs’ in the Federal Register 15 November. However, legal challenges and the Trump Administration make its fate uncertain.

President-elect Trump’s nomination of Robert F. Kennedy Jr. as HHS secretary could be a focal point of change for FDA’s approach to Congress.

“MoCRA confirms in many ways FDA’s adherence to a risk-based cosmetics regulatory framework, and in that way, it’s very positive,” says Francine Lamoriello, global strategies executive vice president at the Personal Care Products Council.

The FDA's current leader, whose term will end with Donald Trump’s second inauguration, also described three qualities the agency’s next commissioner will need to succeed, including "believing that there is such a thing as expertise."

Tariffs are expected again under a second Trump Administration and the future of the Americas Partnership for Economic Prosperity is uncertain, says the Personal Care Products Council, which will continue to push for regulatory alignment and lower trade barriers.

E.l.f. Beauty isn’t worried about potential tariffs imposed under the incoming Trump Administration, as it is less reliant on products from China than it was during 2018/2019 tariffs and has a playbook ‘and a number of levers at our disposal’ to mitigate the cost impact.

Whether Democrat Harris or Republican Trump is in White House or which party has majority in either chamber of Congress, the FDA’s conundrum will continue around a regulatory pathway for allowing use of ingredients derived from hemp in supplements.

The European Chemicals Agency’s Forum for Exchange of Information on Enforcement is encouraging cosmetics companies to brush up on the provisions of REACH and a European regulation on persistent organic pollutants after it found 6.4% of nearly 4,500 cosmetic products contain banned hazardous chemicals.

Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.

Independent and small cosmetic companies may decide to pull their products from the state of Washington due to the 1ppm lead limit imposed by the Toxic-Free Cosmetics Act, says consultant Karen Yarussi, who has managed regulatory affairs for Avon and Burt’s Bees. She cites the cost of testing colorants as a major issue for companies.

California authorities say predominance of retailers licensed to sell hemp are compliant with ban published effective on 3 October through emergency regulation. But hemp industry’s contesting the regulation in state court, arguing state authorities inappropriately used emergency action to change state law on hemp products legislature passed in 2021.

Plaintiffs in California federal courts seek restitution, damages, and other relief on behalf of themselves and consumers nationwide, whom allegedly were deceived by “Plant-Based” representations on Aveeno and Neutrogena Makeup Removing Wipes.

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework.

Now that reporting of cosmetic ingredient use to FDA is no longer voluntary, the Cosmetic Ingredient Review is wading through a tide of data generated by MoCRA registration and listing deadlines.

The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”

Toxic-Free Cosmetics Act planner Shari Franjevic acknowledges the Washington State Department of Ecology is authorized to use enforcement discretion regarding the new law’s 1ppm limit on trace lead in cosmetic products, effective 1 January 2025, or raise the ceiling via rulemaking. But it does not seem inclined to do either based on data known to the department at present. 

Cosmetics Europe’s John Chave highlights the important role that industry must have in educating the public about chemicals used in cosmetic products. The association’s COSMILE Europe database launched last year is one such measure to combat misinformation while industry braces for potential impacts resulting from new hazard categories under the Classification, Labeling and Packaging (CLP) regulation.

Cosmetics Europe hopes a more “competitive” spirit will define the 2024-2029 regime. Director-general John Chave discusses the association’s outlook on planned revisions to REACH and the Cosmetic Products Regulation in the new EU institutional mandate.

Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”

Nonbinding forecast, fourth for the program, includes risks associated with codeine-containing cough medicine as a topic FDA will include in ongoing evaluation of GRASE for pediatric cough cold drug products marketed under monograph for cold, cough, allergy, bronchodilator and anti-asthmatic OTC drugs.