Omnibus Bill for Fiscal Year 2023 (H.R. 2617) – Cosmetics Summary
On December 20, 2022, Congress published H.R. 2617, a $1.7 trillion Omnibus Spending Bill. At present, the plan is for the Senate to vote on the bill this week before sending it to the House for approval before Friday, December 23rd, 2022, when federal funding runs out. There are many provisions in the bill beyond appropriations, but one significant feature is a change to the Federal Food, Drug and Cosmetic Act’s laws pertaining to cosmetics. This article points out some of the more significant features in the “Modernization of Cosmetics Regulation Act,” which is one of the many stand-alone bills incorporated in the spending bill. If passed, there will be several new requirements for the U.S. Food and Drug Administration (FDA) and for cosmetic manufacturers. We will watch the omnibus bill’s progress and update you regarding the provisions on cosmetics that remain in the version of the bill that is passed.
The Modernization of Cosmetics Regulation Act (MCRA)
- Registration (Section 607): The MCRA requires cosmetic manufacturers to register all facilities within one year of the Act’s enactment and renew registrations biennially.
- Product Listing (Section 607): The bill requires that manufacturers submit a “cosmetic product listing” for each cosmetic product within one year and update the listing annually.
- A listing must include, among other things, a list of ingredients, including any fragrances, flavors, or colors, and the facility registration number where the cosmetic product is manufactured.
- Safety Substantiation (Section 608): Manufacturers must maintain records supporting that there is an adequate substantiation of safety of the cosmetic product.
- This refers to tests or studies, research, analyses, or other evidence and information that is considered by qualified experts to evaluate the safety of cosmetic products and their ingredients, sufficient to support a “reasonable certainty” that a cosmetic product is safe.
- Suspension of Registration (Section 607): The bill authorizes FDA to suspend registration of a facility if FDA determines that a cosmetic product manufactured by the facility has a “reasonable probability of causing serious adverse health consequences or death to humans” and FDA has a “reasonable belief” that other products manufactured by the facility may be similarly affected.
- Mandatory Recall (Section 611): If FDA determines there is a “reasonable probability” that a cosmetic is adulterated and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, FDA may ask manufacturers to voluntarily cease distribution or recall the cosmetic. If a manufacturer refuses to do so, FDA can require manufacturers to immediately cease distribution.
- Preemption (Section 614): The preemption provision precludes states and local governments from implementing or enforcing any other requirement for cosmetics with respect to registration and product listing, good manufacturing practice, records, recalls, adverse event reporting, or safety substantiation. The provision does not prevent states from prohibiting the use or limiting the amount of an ingredient in a cosmetic product or from continuing to enforce an ingredient reporting requirement that is in effect at the time the MCRA is enacted.
- Talc-containing cosmetics (Section 3505): FDA must publish a proposed rule within one year to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing products.
- PFAS in cosmetics (Section 3506): Within three years, FDA must assess the use of PFAS substances in cosmetic products and the scientific evidence regarding the safety of such use, including any associated risks, and publish a report summarizing the results.
- Animal Testing (Section 3507): Congress suggests that animal testing should not be used for the purpose of safety testing cosmetic products and that it should be phased out with certain exceptions.