FDA Cosmetic Regulations: New Mandated Compliance Programs For Cosmetic Companies
In Mid-December 2023, the FDA published its final guidance under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which was incorporated in the Food and Drug Omnibus Reform Act (FDORA). This law, among other things, created more stringent requirements for cosmetics manufacturers, as cosmetics manufacturers move away from voluntary cooperation to mandatory compliance.
The Problem With New Cosmetic Compliance Programs
Cosmetics companies are likely not staffed appropriately to meet these enhanced requirements. Personnel who have worked their careers in the cosmetics industry may have a limited background in recall processes, regulatory filings, and safety documentation.
This type of work requires a person with a background in pharmaceuticals and/or foods to understand and apply these new directives. The good news is Compliance Team can assist. Our consultants have the background to facilitate compliance with these rules by updating site documentation, assisting with safety substantiations, helping with site/product registrations and listings, and performing general training for your facility.
What Cosmetic Companies Can Expect
Cosmetic companies should anticipate significant changes with the introduction of new compliance programs.
Establishments Registered & Products Listed
The first notable difference for cosmetics manufacturers is that establishments must be registered, and products, along with their ingredients, listed with the FDA. The FDA has provided for this with three tools:
- The electronic submissions portal, Cosmetics Direct
- In January 2024, the FDA also enabled the Electronic Submissions Gateway to facilitate SPL-formatted submissions
- Paper submissions will also be accepted through FDA Forms 5066 and 5067
Similar to existing drug and device facilities, the FDA will be using an FEI (FDA Establishment Identifier) number to identify the facility. For establishments that already have an FEI number (for example, when facilities made both cosmetics and OTC drugs) a new number need not be requested.
Deadline For Requirement
Under FDA enforcement discretion, the deadline before the FDA enforces this requirement is June 29, 2024, or July 1, 2024, for products initially marketed after December 29, 2023.
Certain exemptions for smaller companies (such as hair salons or home-based businesses under $1 MM in sales) marketing low-risk products (i.e., topical; no internal or mucus membrane contact) may exist. Safety and GMP requirements for these products still exist – see below.
Manufacturing Under GMP Conditions
In addition to enforcing product registration and listing, the FDA also requires manufacturing of cosmetics under GMP conditions, similar to requirements of ISO 22716. The rules for these requirements have yet to be finalized and should be final by 2025.
In the meantime, the draft guidance on cosmetics GMP, “Cosmetic Good Manufacturing Practices” and the ISO standard should serve as a good guide. This means that a cosmetics manufacturing facility already registered under ISO 22716 has a high probability of meeting most, but not all FDA requirements because the FDA reserves the right to update from ISO 22716 based on its industry experience.
Complaint Handling Process
In addition to licensing and registration, the law now requires a complaint handling process. Similar to requirements for pharmaceuticals and medical devices, the complaint handling process will feed into an adverse event reporting process and voluntary recall process.
The FDA also carries authority to suspend a site registration for failure to voluntarily recall in the event of product adulteration, misbranding, risk of severe adverse health consequences. In this case, the FDA also has authority to issue a mandatory product recall.
Labeling, Testing & Content Requirements
Specific rules for labeling, testing and content limits for specific substances with known hazards are required such as fragrance allergens, asbestos in talc, and PFAS (such as Teflon®). Overall, labeling requirements are enhanced, with a requirement for ingredient listing, identification of allergens, and a specific requirement for labeling of product if it is solely for use by licensed professionals.
Safety Substantiation
Furthermore, each product must have a Responsible Person provide a Safety Substantiation for each cosmetic product, based on (1) listed conditions of use and (2) studies, research, analysis, or other evidence. Given the very technical nature of substantiating safety, the FDA may have an expectation of validation that is not yet explicitly codified but may become important as the reliability of such data is questioned.
Records & Facilities Inspection Coverage
FDA has always had inspectional authority over cosmetics establishments, but now, the law specifically provides for the fact that FDA inspection shall cover records as well as the facilities themselves, and such records may cover any of the above information (GMPs complaints, adverse events reporting, etc.). Records inspection excludes data unrelated to product safety such as financial records and proprietary formulas.
Is Your Cosmetic Company Compliant?
Our consultants have the background to facilitate compliance with these rules by updating site documentation, assisting with safety substantiations, helping with site/product registrations and listings, and performing general training for your facility so a cosmetics facility can sustain its compliance with the new regulations for the long-term.