FDA Cosmetic Compliance Requirements: What You Need to Know

The FDA regulates cosmetics to ensure consumer safety. Manufacturers, importers, or sellers in the US must comply.

Here's an overview, with condensed points and brief explanations where key concepts need clarification.

What Counts as a Cosmetic?

The FDA defines cosmetics as products for cleansing, beautifying, enhancing attractiveness, or altering appearance.

Examples include:

• Makeup (e.g., lipstick, foundation, mascara) and skincare (e.g., moisturizers, cleansers, serums)

• Hair products (e.g., shampoo, conditioner, styling aids) and fragrances/perfumes

• Nail products, deodorants/antiperspirants, and bath items (e.g., soap, body wash, salts)

Products claiming to treat/prevent disease are drugs; dual-claim products must meet both cosmetic and drug rules. 

(Explanation: This distinction prevents misclassification—e.g., an acne cream claiming to "cure" is a drug, requiring stricter FDA approval.)

Facility Registration Requirements

Under MoCRA, cosmetic facilities must register with the FDA.

Who must register:

• Manufacturers of finished products, processors (packaging/labeling/modifying), and contract manufacturers

• Foreign facilities exporting to the US

Registration process:

• Register online via FDA's Cosmetics Direct with name, address, contact, and activity types

• Renew every two years; update changes within 60 days

Exemptions:

• Storage/distribution-only facilities and retail stores not manufacturing

• Beauty salons using professional products (Explanation: Exemptions focus on non-production roles to streamline regulations for smaller operations.)

Product Listing Requirements

The "responsible person" (label-named company) must list each product with FDA.

Required information:

• Product name/category, full INCI ingredient list, responsible person contact, and manufacturing details

Key points:

• List variations separately (shades/sizes/formulations); update annually

• Use INCI names; submit via Cosmetics Direct (Explanation: INCI ensures global standardization, aiding allergy checks and international trade.)

Safety Requirements

Ensure cosmetics are safe pre-market; FDA doesn't pre-approve, but you're accountable.

Safety obligations:

• Perform safety testing, keep records, use approved colors, avoid prohibited ingredients, follow GMPs

Prohibited ingredients:

• Mercury compounds (except traces in eye makeup), chloroform, vinyl chloride

• Halogenated salicylanilides, zirconium in aerosols, chlorofluorocarbon propellants

Restricted ingredients:

• Hexachlorophene (limited uses), methylene chloride (prohibited), lead acetate (hair dyes with labeling) (Explanation: Restrictions/prohibitions prevent health risks like toxicity or environmental harm.)

Labeling Requirements

Labels must include specific, legible information.

Principal Display Panel (front):

• Product identity and net quantity; clearly visible

Information Panel (back/side):

• Ingredients in descending order, manufacturer/packer/distributor name/address, warnings

Ingredient listing rules:

• INCI names; >1% in descending order, <1% any order; colors at end

• Fragrance/flavor generically (Explanation: Order reflects predominance, helping consumers identify main components.)

Special labeling:

• Warnings/directions as needed, "external use only," batch codes recommended

Good Manufacturing Practices (GMPs)

Though not mandatory yet, FDA expects GMP adherence.

Key elements:

• Sanitary facilities, equipment maintenance, employee hygiene/training

• Quality controls, contamination prevention, record keeping

Facility requirements:

• Adequate space/ventilation/lighting, clean water, waste/pest systems

Personnel requirements:

• Health/hygiene programs, training, protective gear, handwashing (Explanation: GMPs minimize contamination risks, similar to food industry standards.)

Adverse Event Reporting

Report serious adverse events to FDA within 15 business days.

What to report:

• Death, life-threatening issues, hospitalization, disability/permanent damage

• Medical interventions preventing damage

Reporting process:

• Submit via safety portal with event/product/batch details; keep records (Explanation: Timely reporting enables FDA to identify patterns and issue recalls if needed.)

Import Requirements

Importers must comply additionally.

Obligations:

• Register foreign facilities, ensure US labeling, maintain records, prepare for port inspections

Common issues:

• Unregistered facilities, incorrect labeling (language/format/info)

• Prohibited ingredients, contamination (Explanation: Imports face extra scrutiny to align with domestic safety standards.)

Enforcement and Penalties

FDA enforces via:

• Warning letters, seizures, inspections, import alerts

• Injunctions, criminal prosecution

Common violations:

• Unregistered facilities/unlisted products, improper labeling/safety issues

• Prohibited ingredients, unsupported claims (Explanation: Penalties escalate from warnings to legal action based on violation severity.)

Color Additives

Must be FDA-approved for use.

Requirements:

• Approved colors only, follow limits/applications, proper labeling

Categories:

• Certified (synthetic, batch-certified), exempt (natural, no certification)

• Provisional (temporary, phasing out) (Explanation: Certification verifies purity to avoid harmful impurities.)

Claims and Marketing

Claims must be cosmetic-appropriate.

Acceptable:

• Cleanses/beautifies, moisturizes/conditions, enhances appearance

Avoid drug claims:

• Treats/cures disease, affects structure/function, therapeutic benefits

Substantiation:

• Evidence for claims, testing records, no misleading statements (Explanation: Substantiation prevents false advertising, protecting consumers from unproven promises.)

Getting Help

Seek professionals if:

• New to industry, complex operations, or post-enforcement

• Multi-country imports or unclear requirements

Services:

• Regulatory attorneys, chemists/formulators, FDA compliance consultants

• Testing labs (Explanation: Experts navigate evolving rules, reducing non-compliance risks.)

Key Takeaways

Compliance involves:

• Registration/listing, safe products with substantiation

• Proper labeling/GMPs, adverse reporting

• Import compliance for supply chain

The rules apply to everyone in the cosmetic supply chain. Whether you manufacture, import, or private label cosmetics, you have compliance obligations.

Stay current with FDA guidance and regulations. The cosmetic regulatory landscape continues to evolve, and new requirements may affect your business.

When in doubt, seek professional guidance. The cost of compliance is always less than the cost of enforcement action.