Policy & Regulation

The incoming Trump Administration’s “Department Of Government Efficiency” has big plans for sweeping cuts to the federal bureaucracy and regulation. The US FDA likely will feel some effects, but could avoid the most damaging mandates.

Martin Makary prides himself on following the data, but some health policy experts said his positions sometimes stray from or distort the evidence, which could create trust issues.

The Washington Department of Ecology hasn’t backed down on its targeting of formaldehyde-releasing preservatives under the state’s Toxic-Free Cosmetics Act, as industry still awaits a draft final rule. In a recent webinar, attorney Angela Deisch of Amin Wasserman Gurnani, LLP said the department has also not provided clarity on penalties under the law, which goes into effect 1 January.

Personal care packaging producers should be prepared for Washington state’s 1 January deadline for ensuring personal care product containers are made up of at least 15% post-consumer recycled material, notes Angela Diesch, attorney at Amin Wasserman Gurnani, LLP, during a webinar hosted by Global Victoria, the trade facilitation agency for the state of Victoria in Australia.

The US FDA has generally not sent out enforcement letters to stakeholders of the Modernization of Cosmetics Regulation Act, but that doesn’t mean it’s not happening, says Amin Wasserman Gurnani, LLP attorney Angela Diesch, during a 19 November webinar hosted by Global Victoria, the trade facilitation agency for the state of Victoria in Australia.

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.”