Haynes Boone Associate Kayla Cristales spoke with HBW Insight as 2026 is expected to bring greater clarity, with key MoCRA rulemakings anticipated and the U.S. Food and Drug Administration’s enforcement approach becoming more defined.
Read an excerpt from Cristales below.
2026 will be the year of clarity.
With regard to the FDA’s regulation of cosmetic products, 2025 may have actually left industry with more questions than answers. As we enter 2026, I am optimistic that we will start to get answers to some of the questions that have made it difficult for beauty brands to move their compliance programs forward to align with MoCRA. For example:
- Is FDA actually going to enforce MoCRA?
- What fragrance allergens will require label disclosures under MoCRA?
- When will we see a proposed good manufacturing practice (GMP) rule?
- Will a new Talc Rule be issued, and how will it be different than the withdrawn version?
- How will FDA address the increasing number of state laws prohibiting or restricting ‘toxic’ cosmetic ingredients, if at all?
- Will there be a federal ban on any currently permitted ingredients?
- If so, will any such bans have a preemptive effect on state laws with different or additional requirements?
After delays, postponements, and withdrawals of MoCRA-related initiatives, FDA seemed to be gaining momentum in the final weeks of 2025, as it published draft Questions and Answers Regarding Mandatory Cosmetics Recalls on December 18 and the MoCRA-mandated Report on the Use of PFAS in Cosmetic Products and Associated Risks on December 29.
We expect this trend to continue in 2026, as FDA’s Unified Agenda indicated the Agency’s plan to issue a (1) proposed rule prohibiting the use of formaldehyde and formaldehyde-releasing chemicals in certain hair products in December 2025 (suggesting it may be announced early in 2026); (2) final rule establishing testing standards for talc-containing cosmetics in March 2026; and (3) proposed rule on fragrance allergen labeling in May 2026. The December 2025 proposal to add bemotrizinol as an authorized active ingredient under the OTC monograph for sunscreen was a welcome surprise to round out the year.
It remains to be seen whether and when these and other federal efforts to bring the regulation of cosmetics and personal care products out from the gray and closer to black-and-white will come to fruition and what impact any such actions will have on related challenges for industry, such as the overwhelming number of consumer-protection class actions that cosmetic and personal care companies continue to face. But, as of this first month of the new year, we remain hopeful that 2026 will provide greater clarity and certainty for the many companies that 2025 left up the torrential creek that is selling cosmetics in the U.S. without a paddle.
To read the full article from HBW Insight, click here.
