New FDA User Fee Bill Contains Addendum That Would Permanently Change FDA Cosmetics Regulations | Locke Lord LLP

On May 26, Senators Murray and Burr introduced S.4348 (p.97). The primary purpose of the bill was to pass reauthorizations of the FDA’s critical user fee programs for drugs, medical devices and biologics, which are due to expire this fall. Attached to this User Fee Reauthorization Bill, a separate Cosmetics Modernization Bill follows the punitive approach to cosmetics regulation advocated by NGOs who have for years been spreading the inaccurate narrative that cosmetics are dangerous. The cosmetics, however, have an excellent safety record backed by the FDA’s own voluntary reporting program. In fact, when the FDA opted for a risk-based program for resource allocation, the FDA specifically found that cosmetics had by far the lowest risk of all FDA-regulated products. This new bill would forever change FDA cosmetics regulations in a way that is inconsistent with previous bills considered by Congress.

Legislative history of cosmetic modernization

Over the past 12 years, numerous bills have proposed to modernize and change cosmetic regulations in the United States, beginning with a bill originally proposed by the FDA that was heavily influenced by NGOs that were FDA Silent Partners of the Year. lengthy meetings with the industry on cosmetic reform. Meetings with the FDA failed primarily due to the FDA’s refusal to support a bill with strong federal preemption and the inability to reach consensus on non-serious adverse event reporting, as the FDA does not was unable to define a non-serious adverse event.

Following the failure of discussions on the FDA’s proposed bill, numerous cosmetic reform bills were introduced. These bills fell into two basic categories. First, the bills that created draconian new enforcement provisions allowing the FDA to sue cosmetic companies through administrative proceedings as opposed to the court process required by current law. These bills also proposed high user fees, serial review of cosmetic ingredients and non-functional constituents. These bills generally did not include any federal preemption or ingredient review preemption.

One of the difficulties presented by these bills allowed states to pursue the review of ingredients based on risks to human health and safety. This approach can lead to inconsistent state ingredient decisions that could prohibit the sale of the same product formulation in all 50 states. In fact, the EU issued the Cosmetics Directive to avoid this problem by creating a single EU review body to make decisions on ingredient safety that would apply to all EU countries.

The other approach to modernization was taken by the sessions of members of Congress in the IBA-backed Sessions Bill. The Sessions Bill recognized the need to provide true modernization by requiring mandatory registration of facilities and formulas, reporting of serious and unexpected adverse events, and issuance of mandatory cosmetic GMPs. The Sessions approach continued the enforcement mechanisms of the current FDCA and recognized the need for industry to have the freedom to make simple structural function claims for cosmetic products without changing the regulatory status of a product from a cosmetic to a medicine. Unlike the other approaches, the sessional bill provided strong federal preemption, so there would be one set of laws governing cosmetics, not 50.

S. 4348: A punitive approach to the modernization of cosmetic regulations

Although S. 4348 is a bipartisan proposal, it appears to have diverged from the two previous approaches to cosmetic regulatory modernization. For example, the bill appears to have been heavily influenced by NGOs in a way not seen in previous bills, as NGOs have explicitly exempted themselves from FDA oversight for cosmetic products, if they choose to sell themselves cosmetics directly to consumers. NGOs have also reserved superior rights to industry regarding their role in working with the FDA to issue mandatory GMPs for cosmetics. The new bill also appears to protect the bar from plaintiffs by rejecting a strong preemption for matters that would fall under federal obligations and matters that fall exclusively under FDA enforcement.

Under S. 4348, the FDA would be able to

  • Cancel your facility and formula registrations, which will result in the closure of marketing businesses and facilities based on an assertion of a reasonable likelihood of a serious adverse event. The FDA can also order a mandatory recall and stop distribution of the product without requiring evidence to be provided by the FDA showing that there is in fact a reasonable basis for the assertion.
  • Cancel a company’s registration if it violates bad brand image for false or misleading claims without the need for substantial proof of falsity.

S. 4348 will also change the way cosmetics companies do business in the following ways:

  • S. 4348 would require companies to keep consumer records for six years for complaints suggesting a health effect from product use — which will be open for review by FDA inspectors.
  • The bill would set a heightened standard for substantiation of safety, from the current standard of no harm to users under normal use conditions to a reasonable certainty of safety – which will require larger studies to meet the new standard.
  • Cosmetic GMP regulations will also extend the inspection authority of the FDA.
  • FDA rights would be extended to inspect ingredient and product records if there is a reasonable belief that an ingredient or product is likely to cause a serious adverse event.
  • The FDA would be allowed to reissue fragrance allergen labeling without preemption on states that may still adopt different fragrances requiring warnings.

Conclusion

If passed as currently presented, S. 4348 would represent a complete overhaul of the FDA’s ability to regulate the cosmetics industry with increased enforcement power balanced by few controls. Industry stakeholders should pay close attention to this proposal and their own internal practices to ensure that they will be in compliance if adopted without further revision. Particularly in the area of ​​security justification, as the new law provides for a heightened standard for security justification.

S. 4348 also does not provide a federal preemption that will support a uniform national program for cosmetics that supports uniform distribution of ingredients across all 50 states, which can only be achieved by preventing states from enacting or enforce laws that prohibit or restrict cosmetic ingredients for human use. health and security. As long as states can continue to regulate these ingredients state by state, the ability of cosmetic companies to market the same formulation in all 50 states will remain an impossibility.

Earnest L. Veasey