The Federal Food, Drug and Cosmetic Act (FFDCA) prohibits the introduction, or delivery for introduction, into interstate commerce of cosmetics that are "adulterated" or "misbranded."1 In the past, the FDA published GMP guidelines mainly based on the International Organization for Standardization (ISO) standard for cosmetics - ISO 22716:2007.2 Among other things, the FDA GMP guidelines provide recommendations for documentation, records, buildings and facilities, equipment, personnel, raw materials, production, laboratory controls, internal audits, complaints, adverse events, and recalls.3 It is important to note that while FDA investigators rely on the GMP guidelines during an inspection, the current GMP guidelines are not FDA regulations and are therefore non-binding.
Against this backdrop, MoCRA added section 606 to the FFDCA and for the first time, the FDA has been required to establish GMP regulations for cosmetic products.4 In particular, the FDA is required by the statute to issue a proposed rule on these GMPs by 29 December 2024 and a final rule by 29 December 2025.
On 1 June 2023, the FDA held a listening session for the GMP section of MoCRA to consult cosmetic manufacturers and the public to assist the FDA's efforts in developing the new regulations.5 We provide below a high-level overview of some of the GMP frameworks shared by the FDA during the session, as well as an overarching commentary from the industry.
In more detail
Exemptions from GMP Regulations and Flexibility for "Small Businesses"
With the addition of section 612 to the FFDCA, MoCRA added an exemption for certain small businesses (a business with average gross annual sales for the previous three-year period of less than USD 1,000,000) from the coverage of the GMPs.6 The exemptions do not apply to manufacturers or facilities that manufacture the following cosmetic products:7
- Products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use
- Products that are injected
- Products that are intended for internal use
- Products that are intended to alter the appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such use
During the listening session, many commentators raised concerns that the GMPs could result in an undue burden or financial impact on "small businesses".8 Notably, in establishing regulations for GMPs, MoCRA makes it clear that the regulations must "take into account the size and scope of the businesses engaged in the manufacture of cosmetics and the risks to public health posed by such cosmetics. It should provide sufficient flexibility to be practicable for all sizes and types of facilities to which such regulations will apply".9
Specifically, detailed requirements for compliance based on the size of the manufacturing company are thought to provide flexibility to ensure regulations are practicable for all facilities. There were suggestions that small businesses may benefit from extended compliance dates due to staffing and documentation issues and that there should be suitable accommodations or exemptions for small businesses to comply with requirements that may be impossible or impracticable to meet. A small business support program or website could also assist efforts to implement GMPs consistent with such standards. Concerns were also raised that the GMP standards will increase expenses and create undue economic hardships associated with testing laboratories for raw materials and finished products or private certification agencies. Allowing small businesses to use Certificates of Analysis (COAs) from ingredient suppliers instead of having to send every ingredient for testing could potentially simplify the GMP requirements to ensure regulations do not impose undue economic hardships.
Other national ("non-US") or international cosmetic GMP standards
MoCRA requires the FDA to establish by regulation "good manufacturing practices for facilities that are consistent, to the extent practicable, and appropriate, with national and international standards".10 To facilitate inputs related to these national and international standards, the FDA posted a series of topics for the listening session, including a topic to identify any national or international standards for GMPs and to the extent to which it would be practicable for cosmetic products to be consistent with the standards. In response, the FDA is urged to consider the international ISO 22716:2007 standard for GMP compliance. It was noted that these standards could be practicable as some companies are already certified under these standards due to their international recognition as existing GMP standards (including acceptance in Europe). These companies are already audited and certified under the ISO standards. They are also already familiar with the certification process such that compliance with these standards may represent a less burdensome alternative compared to adopting new standards.
Further, it may be cumbersome and add additional costs and barriers to business growth for US companies to enter a market with different or more stringent GMP standards compared to requirements for the US market. Establishing standardized GMP regulations could also help clarify the requirements for foreign companies planning to enter the US market. As such, adopting a harmonized standard would aid in both the import and export of cosmetic products.
Cosmetic facility registration and compliance timelines
With the upcoming enactment of MoCRA in December 2023, some commentators expressed concerns with the resources available to meet compliance timeframes. Examples of these concerns include what site or platform will be made available to the industry to effectuate the facility registration and product listing requirements and whether there would be any distinctions in the process for contract manufacturers, especially foreign entities, who manufacture for multiple US clients. Notably, the FDA made it clear that it would no longer accept submissions to the Voluntary Cosmetic Registration Program (VCRP) as of 27 March 2023 as a result of its plan to develop a program for the submission of the facility registration and product listings requirements mandated by MoCRA.}
To date, the FDA has yet to announce the availability of the new registration system. Meanwhile, the deadline for the registration and product listing requirements is fast-approaching. For existing facilities that manufacture or process cosmetic products for distribution in the United States at the time of the enactment of MoCRA (29 December 2022), registration is required no later than 29 December 2023. For more information regarding the new registration and product listing requirements, please see Part I of this series available here.
The FDA is required by the statute to issue a proposed rule on these GMPs by 29 December 2024 and a final rule by 29 December 2025. The industry will have the opportunity to submit comments during the FDA rule-making process.
Key takeaways
- The FDA will consider the size and scope of the businesses that will be subject to the new GMP regulations and provide flexibility to ensure facilities of all sizes and types can comply.
- Despite these efforts, compliance with the new GMPs regulations will likely require the industry to implement additional measures and safeguards to ensure compliant manufacturing practices, including renegotiating contracts with ingredient suppliers or contract manufacturers, or conducting due diligence on such entities, to ensure compliance with the new standards.
- For the new GMP regulations, the FDA does not need to reinvent the wheel and can rely on its existing GMP guidelines that have been used by FDA inspectors. The industry also seems to welcome a more harmonized standard based on national and international standards, in particular ISO 22716:2007.
- It will take time for the industry to come into full compliance with the new standards. To minimize disruptions to trade, companies should more proactively ensure compliance with the new regulatory requirements and closely monitor the FDA's implementation of MoCRA and the new GMP regulations.
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1 21 U.S.C. § 331(a).
2 FDA Draft Guidance for Industry, Cosmetic Good Manufacturing Practices, available here.
3 Id.
4 H.R. 2617-1389, Subtitle E - “Modernization of Cosmetics Regulation Act of 2022” (MoCRA), § 606.
5 FDA Public Meeting: Good manufacturing Practices for Cosmetics Products webpage available here.
6 H.R. 2617-1389, Subtitle E - “Modernization of Cosmetics Regulation Act of 2022” (MoCRA), sec. 612(a).
7 H.R. 2617-1389, Subtitle E - “Modernization of Cosmetics Regulation Act of 2022” (MoCRA), sec. 612(b).
8 By "small business," we assume these commentators are referring to a business that is not otherwise exempt from the GMPs under MoCRA.
9 H.R. 2617-1389, Subtitle E - “Modernization of Cosmetics Regulation Act of 2022” (MoCRA), sec. 606(b).
10 H.R. 2617-1389, Subtitle E - “Modernization of Cosmetics Regulation Act of 2022” (MoCRA), sec. 606(a).
