FDA Cosmetics Regulation and the MoCRA Framework
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most significant overhaul of federal cosmetics law since the Food, Drug, and Cosmetic Act of 1938. Signed into law as part of the Consolidated Appropriations Act, 2023, MoCRA granted the FDA authority it had not previously held over cosmetic products — including mandatory facility registration, product listing, and safety substantiation requirements. This page covers the scope of that framework, how its requirements operate in practice, the scenarios in which they apply, and the boundaries that distinguish cosmetics from adjacent product categories under federal law.
Definition and scope
MoCRA amended Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish a new statutory foundation for cosmetics oversight in the United States. Under 21 U.S.C. § 321(i), a cosmetic is defined as an article intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance — without affecting the body's structure or function. This definition is the primary boundary marker separating cosmetics from drugs, which require premarket approval.
MoCRA applies to any person or business that manufactures or processes a cosmetic product for distribution in the United States. The law covers both domestic and foreign facilities that export cosmetics to U.S. markets. Small businesses — defined under the law as those with average gross sales of cosmetics under $1 million over the prior 3-year period — receive modified obligations, including exemption from facility registration in certain circumstances (FDA MoCRA Overview).
The FDA's cosmetics regulation framework now encompasses six core obligations for responsible persons and facilities:
- Facility registration — All facilities manufacturing or processing cosmetics must register with the FDA by the applicable deadline established under MoCRA.
- Product listing — Each cosmetic product must be listed with the FDA, including a list of ingredients.
- Safety substantiation — Responsible persons must ensure that each cosmetic product is adequately substantiated for safety before marketing.
- Serious adverse event reporting — Responsible persons must report serious adverse events to the FDA within 15 business days of receiving the report (21 U.S.C. § 364i).
- Recordkeeping — Records supporting safety substantiation must be maintained and made available to FDA upon request.
- Labeling for professional-use products — Professional salon products must include directions for safe use.
How it works
Prior to MoCRA, the FDA's authority over cosmetics was primarily reactive — the agency could act against adulterated or misbranded products already in commerce but lacked the power to require premarket registration, safety testing documentation, or mandatory adverse event reporting. MoCRA changed that structure by creating affirmative, ongoing obligations.
Facility registration must be renewed biennially. The FDA maintains a public registry of registered facilities. Foreign facilities must designate a United States agent. Failure to register a facility subjects the facility's products to potential detention or refusal of admission at U.S. ports of entry, a mechanism detailed under the broader FDA import regulations and detentions framework.
Serious adverse event reporting triggers when a cosmetic is associated with an event that results in death, a life-threatening experience, inpatient hospitalization, significant or permanent disability, a congenital anomaly, or requires medical or surgical intervention to prevent such outcomes. This 15-business-day reporting window aligns the cosmetics category more closely with the FDA adverse event reporting infrastructure already governing drugs and devices.
Contaminant authority is another new element. MoCRA explicitly authorizes the FDA to issue regulations prohibiting or restricting a cosmetic ingredient if it presents an unreasonable risk of harm. This is a departure from the pre-MoCRA framework, under which the FDA had no direct statutory authority to ban cosmetic ingredients (that function was largely performed by industry self-regulation through the Cosmetic Ingredient Review panel).
The FDA's enforcement tools under MoCRA include mandatory recall authority — previously absent for cosmetics — allowing the agency to order a recall when a cosmetic product presents a reasonable probability of serious adverse health consequences or death (FDA MoCRA Recall Authority).
Common scenarios
Scenario 1: Domestic manufacturer of personal care products
A U.S.-based company producing shampoos, conditioners, and body washes must register each manufacturing facility with the FDA and submit a product listing for each formulation, including the complete ingredient list. If a consumer contacts the company reporting a hospitalization attributed to product use, the company — as the responsible person — must file an adverse event report with the FDA within 15 business days.
Scenario 2: Foreign facility exporting to the U.S.
A cosmetic manufacturer based outside the United States that ships lip balm and moisturizers to U.S. distributors must register its facility with the FDA and designate a U.S. agent. Non-compliance can result in products being refused entry at the border.
Scenario 3: Small indie beauty brand
A brand with annual gross cosmetics sales of $800,000 averaged over 3 years may qualify for the small business exemption from facility registration. However, serious adverse event reporting obligations and safety substantiation requirements still apply regardless of business size.
Scenario 4: Professional salon product
A hair straightening treatment sold exclusively to licensed cosmetologists is still subject to MoCRA. Professional-use-only products must include adequate directions and warnings on labeling to ensure safe use in salon settings.
Decision boundaries
The most operationally significant decision boundary under MoCRA is the cosmetic vs. drug distinction. A product is regulated as a drug — and subject to the far more intensive FDA drug approval process — if it is intended to affect the structure or function of the body, or if it bears claims of treating, curing, mitigating, or preventing disease. Anti-dandruff shampoos, fluoride toothpastes, and sunscreens with SPF claims are classified as drugs (or drug-cosmetic combination products) under 21 U.S.C. § 321(g), regardless of their cosmetic-adjacent marketing.
A second boundary separates cosmetics from dietary supplements, which are governed under a separate subchapter of the FD&C Act. Topical products with claimed physiological effects cross into drug territory; orally ingested products with structure/function claims fall under supplement regulation covered in the FDA dietary supplement regulation framework.
Responsible person vs. facility operator is a third distinction MoCRA codifies. The responsible person — defined as the manufacturer, packer, or distributor whose name appears on the label — bears the primary obligations for adverse event reporting and safety substantiation. A contract manufacturer operating a registered facility carries registration obligations but does not necessarily bear the responsible person's reporting duties unless that role is contractually or legally assigned.
The FDA's authority overview at the agency level situates MoCRA within the broader statutory expansion of FDA jurisdiction that has occurred incrementally across product categories since the original 1938 act. MoCRA does not require premarket approval for cosmetics, preserving a fundamental structural difference from the drug and biological product pathways — but it closes the gap in post-market surveillance and facility accountability that defined cosmetics oversight for over eight decades.