On December 22, 2022, U.S. House and Senate leaders passed the long-awaited $1.7 trillion FY2023 omnibus spending bill. This blog provides information on the significant changes to cosmetics regulation with the passage of the Omnibus bill and the Food Drug and Cosmetic Act amendments. We encourage you to contact Diaz Trade Law to assess the implications of the significant changes.
With the passage of the Omnibus bill recently, the Food Drug and Cosmetic Act is also amended to include significant changes to cosmetics regulation, including:
- Cosmetic Registration & Ingredient Listing (becomes mandatory, it is currently voluntary)
- Required in 1-year from enactment (this will be signed very soon).
- For products developed after enactment, 120 days of first marketing.
- Serious Adverse Events
- Cosmetics will have a Serious Adverse Events requirement (same as OTC drugs and dietary supplements). Thus, the labels will need a U.S. phone number or mailing address to receive reports and the company identified on the label will report to FDA, as needed. “Serious Adverse Events” are events where your customer ends up harmed or having to go to the doctor. We can develop a system for this reporting requirement.
- Required 2 years from enactment.
- Fragrance Allergen Declarations
- Labels must declare fragrance allergens (a change from merely declaring “fragrance”).
- Required 18 months from enactment.
- Substantiation of Safety
- The legal standard is “adequate substantiation of safety,” which means data (tests, studies, research, analysis) considered sufficient by qualified experts to support “a reasonable certainty that a cosmetic is safe.” “Safe” does not require the cosmetic or ingredient to cause no minor or transient irritation. The new law codifies FDA’s approach.
- We do not expect this requirement to be enforced often, absent serious safety concerns, or as a stand-alone charge. Much like the dietary supplement New Dietary Ingredient Notification requirements that mostly get enforced with there is a public safety concern. FDA will likely produce guidance on this, but we don’t think we should expect much enforcement without a significant resource allocation to enforcement.
- Effective 1 year after enactment.
- Good Manufacturing Practice (GMP)s for Cosmetics
- FDA will establish GMPs for cosmetics.
- Will take more 3 years to establish regulations.
- Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Recommendations
- FDA will assess PFAS substances within 3 years.
- Various states have enacted laws regarding food and cosmetics packaging with intentionally-added PFAS.
- Expect PFAS to be banned widely.
- FDA gains mandatory recall authority
- Record keeping and records inspection rules
Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at [email protected] today to assist in assessing the impacts of the Omnibus bill and the Food Drug and Cosmetic Act amendments on the regulation of your cosmetic products.