MoCRA Good Manufacturing Practices for Cosmetics: What Foreign Manufacturers Should Prepare For

The Modernization of Cosmetics Regulation Act gave the FDA authority to establish mandatory Good Manufacturing Practice requirements for cosmetic products — the first time in US regulatory history that cosmetics will be subject to enforceable GMP standards. While the final GMP regulations have not yet been published as of mid-2026, the FDA has signaled clearly that they will draw heavily from existing international standards, particularly ISO 22716:2007 (Cosmetics — Good Manufacturing Practices), which is already widely adopted in Europe and parts of Asia. Foreign manufacturers who wait for the final rule before taking action will find themselves scrambling to comply. The time to prepare is now.

What GMP means in the context of cosmetics

Good Manufacturing Practices are the minimum standards a facility must meet for production, quality control, storage, and distribution of finished products. In the food and drug context, GMP has been enforceable for decades under 21 CFR Parts 110, 111, 117, and 211. Cosmetics historically had no equivalent. Under MoCRA, cosmetics join the regulated product categories that must demonstrate systematic control over manufacturing conditions. GMP for cosmetics will cover facility design and maintenance, equipment qualification and cleaning, raw material controls, production procedures, quality control testing, documentation and record-keeping, personnel hygiene and training, and complaint handling.

Why ISO 22716 is the practical starting point

The FDA has referenced ISO 22716:2007 in multiple public statements as a benchmark standard for cosmetic GMP. This standard is already mandatory for cosmetics sold in the European Union under Regulation 1223/2009 — meaning any foreign manufacturer who already exports to Europe likely has ISO 22716 documentation in place. The standard covers 17 areas including personnel, premises, equipment, raw materials, production, finished products, quality control laboratory, treatment of out-of-specification products, waste, subcontracting, deviations, complaints, recalls, change control, internal audit, and documentation. Manufacturers who comply with ISO 22716 will be well positioned when the FDA finalizes its GMP rule. Manufacturers who do not currently follow any GMP framework should begin implementing ISO 22716 immediately rather than waiting for a US-specific rule that will require the same types of controls.

How GMP enforcement will work under MoCRA

Under MoCRA, the FDA gained the authority to inspect cosmetic manufacturing facilities — both domestic and foreign — and to take enforcement action against facilities that do not comply with GMP requirements. This is a significant change from the pre-MoCRA environment, where the FDA had limited authority to inspect cosmetic facilities and essentially no mechanism to enforce manufacturing standards. Foreign facilities that are registered under MoCRA can expect FDA inspections, and the inspection process will likely follow the same general framework used for food and drug facility inspections: a pre-announced or unannounced visit, a review of records and documentation, a walkthrough of the facility, and a written report of observations (FDA Form 483) if deficiencies are found.

Small business exemption for GMP

MoCRA exempts small businesses — those with average gross annual US cosmetic sales below one million dollars over the preceding three years — from GMP requirements. However, the exemption does not apply to manufacturers of products that contact the mucous membranes of the eye, products that are injected, products intended for internal use, or products that alter appearance for more than 24 hours and are not normally removed by consumers. A small manufacturer producing eyelash adhesives, semi-permanent hair dyes, or injectable fillers is not exempt regardless of revenue. And critically, the exemption is based on US sales, not global revenue — a large manufacturer with minimal US presence could qualify, while a small manufacturer with a US-focused business might not.

How FDABridge helps cosmetic manufacturers prepare for GMP

FDABridge assists foreign cosmetic manufacturers with MoCRA facility registration, product listing, US Agent designation, and GMP readiness assessment. Our team understands both the US MoCRA framework and the ISO 22716 standard, so we can help you identify gaps in your current manufacturing practices and prioritize corrective actions before the final rule is published. Visit fdabridge.com/cosmetics to learn about our cosmetics services or fdabridge.com/contact to start a conversation.