Each Spring and Fall, the Office of Information and Regulatory Affairs publishes the Unified Agenda of Regulatory and Deregulatory Actions. The Fall 2024 Unified Agenda was published on December 13, 2024.
The FDA has 66 rules included in the agenda. Two of those are from the mandates included in MoCRA: fragrance allergens and cosmetic GMP. There are two others that affect cosmetics: formaldehyde-releasing chemicals in hair straighteners and product recall procedures.
Fragrance Allergens
MoCRA mandated that the FDA identify substances that are fragrance allergens and require labeling of these individual substances on finished cosmetic products. The legal deadline set in MoCRA to issue the proposed rule was June 29, 2024, with the final rule to be issued within 180 days (6 months) after the comment period ends. The final rule would likely have additional time for companies to implement the label changes. The June 29 deadline was not met.
In the Spring 2024 Unified Agenda, the FDA moved the expected date for the proposed rule to October 2024. The October deadline was not met, either.
The new timetable for the proposed rule, according to the Fall 2024 Unified Agenda, is January 2025.
New in this agenda is a statement that the FDA is considering an “alternative labeling requirement,” such as a “more general allergen statement.” That could mean they will put off identifying specific fragrance allergens that must be individually identified on the label in favor of something more general. That could certainly make things easier!
In addition, the FDA has said that they may consider an earlier compliance date for making the required labeling changes.
Cosmetic Good Manufacturing Practices
MoCRA mandated that the FDA establish regulations for good manufacturing practices for cosmetics. The legal deadline for issuing the proposed rule is December 29, 2024, and for issuing the final rule is December 29, 2025.
In the Fall 2024 Unified Agenda, the new timetable for the proposed rule is now October 2025.
In addition, the FDA has stated they will consider different options in order to minimize costs to industry. The example given was delaying compliance for some affected entities. We’ll have to wait for the proposed rule to see what that means.
Cosmetic GMP will only be required for companies that are NOT exempt as small businesses (businesses that make less than $1 million per year and do not make high-risk items).
Hair Straighteners
The FDA is planning to issue a proposed rule banning the use of formaldehyde and formaldehyde-releasing ingredients in hair smoothing or hair straightening products marketed in the United States.
Per the Fall 2024 Unified Agenda, the proposed rule is scheduled for March 2025.
Product Recall Procedures
The Fall 2024 Unified Agenda also includes an advance notice of proposed rulemaking regarding the recall process for products subject to FDA jurisdiction. This has been in the Unified Agenda since Spring 2023.
MoCRA gave the FDA the authority to issue mandatory recalls of adulterated cosmetic products.
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