Detailed Cosmetic FDA Regulations in the U.S

Cosmetic FDA regulations changed dramatically when the U.S. Congress passed the Modernization of Cosmetics Regulation Act (MoCRA), giving FDA new powers over the cosmetics industry. Now, MoCRA primarily defines the framework for how cosmetic products are registered, labeled, and sold.

In this guide, we discuss everything from facility registration to adverse event reporting for cosmetic brands, helping manufacturers understand FDA requirements and avoid regulatory penalties in the US market.

Facility Registration: The First Compliance Box to Check

Every manufacturer or processor of cosmetic products sold in the U.S. must register their facility with the FDA. This includes both domestic and foreign facilities. Registrations must be renewed every two years

• Deadline Watch: New facilities must register within 60 days of beginning manufacturing or processing activities.
• Rolling Clock: Registrations must be renewed every two years to keep compliance active.
• Registrations are submitted through FDA’s Cosmetics Direct portal or via paper Forms FDA 5066 (for product listing) and 5067 (for facility registration).
• Each facility receives an FDA Establishment Identifier (FEI) number.

Who Gets a Pass?

MoCRA carves out exemptions for certain small businesses, but these come with important caveats.

However, this exemption does NOT apply if the business manufactures or processes:

• Cosmetics intended for use near or in the eye (mascara, eyeliner, etc.)
• Products for internal use (cosmetic injections, oral cosmetics, beauty supplements, etc.)
• Products that alter appearance for over 24 hours (dyes, acrylic/gel nails, etc.)

Check Out: ISO 22716 Certification – CGA GMP Process

Product Listing: Tell the FDA What You’re Selling

The “responsible person” (defined as the manufacturer, packer, or distributor whose name appears on the product label) must submit a listing for each marketed cosmetic product. 

• What to Include: Each listing must include the product name, category, ingredients (including fragrances and colorants), and the facility where it’s made.
• Even free samples and gift-with-purchase items generally require a product listing.
• Multiple buildings can share one FEI number if they are within 3 miles of each other, under common management, and inspectable in a single FDA visit.
• Listings must be updated annually and whenever a product is discontinued.

Every Word On The Labeling Is Regulated

Cosmetic labeling in the U.S. is governed by the FD&C Act, the Fair Packaging and Labeling (FP&L) Act, and MoCRA. 

The Non-Negotiable Label Elements

• Product identity: What it is (e.g., “moisturizing lotion”)
• Net quantity of contents – in both metric and U.S. customary units
• Name and place of business of the responsible person
• Domestic contact information (as of Dec 29, 2024 under MoCRA) so consumers can report adverse events directly.
• Ingredient declaration: Ingredients must be listed in descending order of predominance using INCI (International Nomenclature of Cosmetic Ingredients) names
• Any required warnings – such as for products containing alpha hydroxy acids (AHAs) or professional-use items
• Labels must be clear and prominent

Common Labeling Mistakes That Trigger FDA Action

30-40% of cosmetics in the US market have to face recalls due to branding and labelling discrepancies. Common reasons include:

• Using incorrect INCI names or listing ingredients out of descending order = labeling violation
• Making drug claims like saying your serum “treats eczema” or “regenerates cells” immediately reclassifies your product as a drug, requiring full FDA drug approval.
• Making “organic” claims. You must comply with USDA regulations on top of FDA requirements
• The term “cosmeceutical” has no legal standing; don’t use it on your label
• Missing warning statements

Explore: Gluten-Free Certification for Cosmetics 

Safety Substantiation: Prove Your Product Won’t Cause Harm

Cosmetic FDA regulations as per MoCRA require that every product be substantiated for safety before it hits the market. 

This means maintaining records that demonstrate a reasonable certainty of safety under the product’s intended conditions of use and making those records available to the FDA upon request. 

• What Records to Keep: Safety substantiation records must support both the product as a whole and its individual ingredients at their used concentrations.
• Testing data, published literature, supplier safety data sheets, and expert toxicological assessments all count as supporting documentation.
• No formal FDA-approved testing protocol for cosmetics is mandated, but your evidence must be credible and complete.

Adverse Event Reporting: When Things Go Wrong, You Have 15 Days

Under MoCRA, responsible persons must submit reports of serious adverse events to the FDA within 15 business days of receiving a consumer complaint. A “serious adverse event” includes bodily harm requiring medical treatment, hospitalization, disability, or life-threatening outcomes.

• The report must be filed using MedWatch Form 3500A.
• Maintain records of both serious and non-serious adverse events.

Good Manufacturing Practices (GMP), FDA, and MoCRA: Pending Laws

The Modernization of Cosmetics Regulation Act (MoCRA) authorizes the FDA to establish mandatory Good Manufacturing Practice (GMP) regulations for cosmetic products. However, the FDA has not yet issued a final GMP rule, and mandatory GMP requirements for cosmetics are not currently in effect.

FDA does outline certain GMP regulations under the Federal Food, Drug and Cosmetic Act. As per these guidelines,

• Everything from buildings and equipment to labelling, complaints, and ingredient management are to be regulated as per GMP laws. 
• Products that do not follow GMP requirements are to be adulterated under the FD&C Act sec. 601(f). 

Until the FDA issues the final GMP rule, there is no mandatory federal GMP standard for cosmetics, though voluntary compliance with ISO 22716:2007 is widely recommended. 

Explore GMP certifications in more detail here.

What’s Banned and What’s Being Watched

Unlike many jurisdictions, the FDA does not pre-approve most cosmetic ingredients, except for color additives and a limited number of prohibited or restricted substances. Besides these, products from any raw material can be used and marketed as cosmetics.

• Ingredients prohibited by the FDA include bithionol, mercury compounds, vinyl chloride, halogenated salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene.
• Many ingredients are also currently under scrutiny owing to health concerns.

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Navigating the State-by-State Regulations

One of the major compliance challenges for cosmetic brands is the growing patchwork of state-level regulations. 

MoCRA preempts certain state requirements but allows states to adopt additional ingredient restrictions and consumer protection measures in specific areas.

• Washington’s Toxic-Free Cosmetics Act (TFCA): Restricts PFAS, formaldehyde-releasing preservatives, phthalates, and other harmful substances.
• California’s Safe Cosmetics Program: Requires disclosure of ingredients linked to cancer, birth defects, or reproductive harm, with its own reporting portal California Safe Cosmetics Program.
• New York & Maine: Have introduced restrictions on PFAS and require transparency labeling that go beyond federal minimums.

If you’re selling nationwide, your compliance team needs to track both the FDA rulebook and active state legislation simultaneously. 

Cosmetic vs. Drug: The Line That Can Upend Your Entire Business

This is arguably the most dangerous gray area in the industry.

• How FDA defines a cosmetic: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]” (Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) | FDA)
• How FDA defines a drug: “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

The moment a cosmetic product claim crosses into preventing or treating a disease, or affecting body structure or function, it becomes a drug.

Claim Comparison:

Crossing this line, even unintentionally, can trigger mandatory drug approval requirements, FDA warning letters, and import holds. Review every touchpoint: product labels, website copy, social media, and influencer briefs.

Check Out: Vegan Certification for Cosmetics: Benefits & Process 

Importing Cosmetics? Here’s What Customs Is Looking For

Cosmetics offered for import into the U.S. must comply with the exact same cosmetic FDA regulations as domestically produced products.

At the border, FDA entry reviewers verify compliance using your entry transmission data.

• Declared manufacturer, importer/consignee, product description, and Affirmation of Compliance (A of C) codes are all cross-referenced against FDA’s internal systems.
• Labeling must be in English (Spanish in Puerto Rico), declare all required information truthfully, and contain no drug claims.

What to Expect in 2026 and 2027?

Passed in 2022, MoCRA regulations have been becoming more stringent over time. Here’s what to expect in the coming months.

• Disclosing fragrance allergens: Compliance deadlines expected around late 2026 or early 2027.
• Renew Registrations: MoCRA facility registrations require renewal every two years.
• Prepare for Talc Testing: Review testing procedures and maintain supporting records.
• Track New FDA Rules: Monitor upcoming GMP and fragrance allergen regulations.