FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which added Section 606 of the Federal Food, Drug, and Cosmetic Act requiring FDA to establish GMP regulations for cosmetics.
The listening session aims to gather input from cosmetics manufacturers, small businesses, contract manufacturers, consumer organizations, and other experts to help FDA develop GMP regulations for facilities that manufacture or process cosmetics sold in the United States. FDA has three years to finalize the statutorily required GMP regulations.
The virtual session will take place on June 1, 2023 from 10:00 am to 4:00 pm ET. Registration is open to all, but stakeholders that wish to speak during the event must register by 6:00 pm ET on May 18, 2023 and submit all presentation materials to FDA by May 22, 2023. Written comments can be submitted through July 3, 2023 (Docket No. FDA-2023-N-1466).
To facilitate the discussion, FDA has developed a series of topics covering the types of information that it seeks.
GMP-Related Topics
- Identify any national or international standard (e.g., International Organization for Standardization (ISO) Standard 22716:2007) and the extent to which it would be practicable for GMP regulations for cosmetic products to be consistent with such standard. Include whether there are specific items in the standard that are perceived to be burdensome or for which a less burdensome alternative exists that would protect the public health and ensure that cosmetics are not adulterated.
- Describe what constitutes sufficient flexibility within GMPs to ensure regulations are practicable for all sizes and types of facilities to which such practices may apply, while accounting for the risks to public health posed by cosmetic products.
- Describe what constitutes simplified GMP requirements for cosmetic products for smaller businesses to ensure regulations do not impose undue economic hardship.
- Describe appropriate compliance timelines for GMP regulations.
Economic Impact–Related Topics
- Describe to what extent manufacturers of cosmetic products are already following a national or international standard for GMPs; for manufacturers that are not currently following a national or international standard, what would it cost to implement GMPs consistent with such standards?
- Provide reports or examples of adverse events or recalls associated with a cosmetic product that were linked to manufacturing practices: How would implementing GMPs impact the likelihood of a cosmetic product recall or consumers experiencing adverse events from the use of cosmetic products? Would these impacts differ by cosmetic product type?
Background on MoCRA
MoCRA enhances FDA’s authority and imposes significant new requirements on cosmetics manufacturers that will bring personal care products into alignment with other FDA-regulated industries such as over-the-counter drugs and food products. Manufacturers and private-label distributors of cosmetics will be subject to extensive regulatory compliance obligations in the coming years.
After consulting with manufacturers, small businesses, consumer organizations, and other experts, FDA must publish a proposed rule on GMPs within two years and a final rule within three years.
In doing so, FDA must consider the size and scope of the businesses engaged in the manufacture of cosmetics and the type of public health risks posed by cosmetics. FDA must also provide flexibility to ensure that the regulation is practicable for facilities of all sizes and types, including “simplified” GMPs for smaller businesses. These regulations must align with national and international standards and protect public health by ensuring cosmetics are not adulterated.
GMP compliance will require industry stakeholders to carefully consider their contracts with ingredient suppliers, conduct due diligence on contract manufacturers, prepare for records inspections and potential recalls, and establish procedures for ensuring ongoing compliance.
These requirements are likely to disrupt the supply chain of cosmetic products in the short term as manufacturers, packers, distributors, and importers of finished products and ingredients adapt to the new rules, create new partnerships, and realign their supply chains.
In addition to GMP compliance, MoCRA imposes several new requirements on the cosmetics industry. For example, the law requires biennial registration for establishments (including establishments of importers) that manufacture or process cosmetics by December 29, 2023. MoCRA also requires “responsible persons” (defined as the manufacturer, packer, distributor, or importer of a cosmetic product whose name appears on the product label) to list each cosmetic product with FDA.
Each listing must identify the product ingredients and the related manufacturing facility, among other details. Responsible persons must also ensure product safety and maintain records showing adequate substantiation of safety for each cosmetic product.
Notably, MoCRA will require cosmetics companies to keep records of health-related adverse events. Responsible persons are now required to report to FDA the occurrence of a “serious adverse event” within 15 business days after receiving the information.
The definition of a “serious adverse event” is very broad and includes any adverse event that (1) results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or significant disfigurement, or (2) requires a medical or surgical intervention to prevent one of those outcomes. Follow-up reports of any new and material medical information must be submitted for the subsequent year.
Related recordkeeping is required for six years and is subject to FDA inspection. Effective two years from the date of the statute’s enactment (December 29, 2024), cosmetic product labels must include contact information through which the company can receive adverse event reports.
Key Takeaways
MoCRA represents a sea change for the personal care products industry by strengthening FDA’s oversight of cosmetics, introducing substantial new obligations for cosmetic manufacturers, and aligning cosmetics regulation more closely with other FDA-regulated products.
It is likely that FDA will seek to impose and interpret the new regulatory requirements through the lens of the robust regulatory regimes that it has had in place for decades covering foods, drugs, and medical devices, rather than tailoring the new cosmetic regulations to that industry and the consumers it serves.
Specifically, the concepts of facility registration, product listing, adverse event reporting, safety substantiation, recalls, records inspections, and GMPs reflect those governing other highly regulated industries. For that reason, cosmetics makers should become familiar with FDA’s existing regulatory regimes when preparing their compliance functions in the near and long term.
As a first step, cosmetics manufacturing facilities and responsible persons should prepare for the facility registration and product listing requirements that are required by December 29, 2023, although FDA does not yet have a registration program in place.
Cosmetics companies should examine MoCRA’s requirements concerning product safety substantiation, adverse event reporting, recordkeeping, and labeling. FDA is set to begin rulemaking on these various compliance areas, so companies can anticipate further guidance and regulations in the coming months and years.
Companies will need to routinely evaluate their products, safety data, policies, and procedures to ensure adaptability to the new rules that FDA will introduce. Companies should begin considering their supply chains and vendors and prepare operating procedures for qualification of vendors and suppliers.
Stakeholders are encouraged to submit comments to FDA as the agency prepares regulations on GMPs and guidance to implement the law’s numerous requirements.