The Regulatory Landscape Under MoCRA
The Modernization of Cosmetics Regulation Act of 2022 ("MoCRA") represents the most significant overhaul of federal cosmetics oversight since the Federal Food, Drug, and Cosmetic Act was first enacted. For the first time, cosmetic manufacturers and processors operating in the United States are required to register their facilities with the FDA and submit product listings for each cosmetic product marketed in interstate commerce.
This new infrastructure has generated a predictable byproduct: a facility registration number and a corresponding product listing number for each cosmetic SKU. Sophisticated compliance teams understand these numbers for what they are — administrative identifiers. Unfortunately, a growing number of brands, distributors, and even some contract manufacturers have begun treating these numbers as marketing assets, prominently displaying them on packaging, websites, and investor materials as though they signify FDA approval or a governmental stamp of safety.
This conflation is not merely a marketing misstep. It is a legal exposure point with real enforcement consequences.
What FDA Registration Actually Confirms
Under MoCRA, facility registration and product listing serve a narrow, administrative function. They allow the FDA to:
- Maintain a current inventory of who is manufacturing or processing cosmetics for the U.S. market
- Identify which products are associated with which facilities
- Facilitate traceability during adverse event investigations or recalls
- Support the agency's risk-based inspection priorities
Notably absent from this list is any substantive review of product formulation, safety data, or labeling claims prior to assignment of a registration or listing number. The FDA does not test, evaluate, or approve the ingredients, manufacturing process, or safety profile of a cosmetic product as a condition of registration. The process is intake-oriented, not evaluative.
The Critical Distinction: Registration Versus Approval
Cosmetics have never been subject to the premarket approval regime that governs drugs and certain medical devices. MoCRA did not change that fundamental architecture. What it added was a registration and listing obligation layered onto the existing framework, which still relies primarily on:
- Manufacturer responsibility for ensuring product safety
- Adequate substantiation of safety prior to marketing
- Truthful and non-misleading labeling
- Post-market surveillance, including new mandatory adverse event reporting requirements
Because registration is not synonymous with approval, any suggestion — express or implied — that an FDA registration number constitutes a safety certification, quality guarantee, or endorsement misrepresents the legal reality of the regulatory scheme. This is true even when the misrepresentation is unintentional or born of an internal marketing team's misunderstanding of the underlying regulation.
Where Enforcement Risk Arises
The FDA has been explicit, both in guidance and in public statements accompanying MoCRA implementation, that registration numbers do not signify FDA approval of a cosmetic product. Firms that market registration status in a manner suggesting otherwise expose themselves to several overlapping risks.
Misbranding exposure. Labeling or advertising that creates a false or misleading impression regarding FDA endorsement can implicate the misbranding provisions of the FDCA. A product need not contain an affirmatively false statement to run afoul of these provisions — an implication created through placement, emphasis, or context can be sufficient.
FTC Act exposure. Because cosmetic advertising claims are also subject to Federal Trade Commission oversight, deceptive or unsubstantiated implications of governmental approval can trigger a parallel FTC inquiry, independent of any FDA action.
Reputational and enforcement escalation risk. Once an agency identifies a labeling or advertising practice that overstates the significance of a registration number, that finding often becomes the entry point for a broader review of the company's compliance posture — including its safety substantiation files, adverse event reporting practices, and facility registration accuracy.
State consumer protection exposure. Many state unfair and deceptive trade practices statutes mirror the FTC Act's prohibition on misleading commercial claims, creating an additional layer of potential liability, including private rights of action in some jurisdictions.
Practical Guidance for Cosmetic Companies
Given this landscape, cosmetic firms and their counsel should consider the following measures:
- Audit existing marketing materials, packaging, and digital assets to identify any language suggesting FDA approval, certification, or endorsement tied to registration or listing numbers.
- Train marketing, regulatory affairs, and sales teams on the precise legal meaning of facility registration and product listing under MoCRA, distinguishing these terms from "FDA approved" or "FDA certified."
- Review claims substantiation files independently of registration status — safety substantiation remains the manufacturer's affirmative obligation under MoCRA and should not be conflated with or replaced by the act of registering.
- Establish internal sign-off protocols requiring legal or regulatory review of any packaging or advertising copy referencing FDA registration status.
- Monitor distributor and retailer-generated content, since third-party marketing of a brand's registration status can create liability exposure for the manufacturer even where the manufacturer did not directly author the offending claim.
Conclusion
MoCRA's registration and listing framework is a meaningful step toward greater transparency and traceability in the cosmetics industry, but it was never designed to function as a safety certification system. Companies that blur this distinction — whether through careless labeling, aggressive marketing, or simple misunderstanding of the statute — invite scrutiny from the FDA, the FTC, and potentially state regulators.
Sophisticated market participants should treat their registration and listing numbers as what they are: compliance infrastructure, not competitive advantage. A disciplined, legally accurate approach to describing regulatory status is not merely a matter of technical correctness — it is a foundational element of enforcement risk management under the post-MoCRA regulatory regime.