Operating in the U.S. can be confusing for cosmetic manufacturers. While products and ingredients, apart from color additives, are not approved by the Federal Drug Administration (FDA), they are regulated through laws concerning interstate commerce. How do companies ensure they comply with the right regulations?
The global cosmetics market is challenging for manufacturers. While it is expected to see unprecedented growth in the next few years – the global skincare market alone is predicted to grow by USD $45.58 billion between 2019 and 2023 – it is dominated by a few premium brands. To succeed, manufacturers must focus on supplying safe products that deliver on their claims.
The key to succeeding is compliance with the relevant regulations designed to protect consumers and the environment. During Q4 of 2019, the total number of cosmetic, personal care and household products recalled in the European Union increased by 30%, in comparison to Q3. During the same period, recalls in the U.S. remained constant, despite there being a 4% increase over the third quarter. In both regions, the main reason for the recalls was chemical.
In addition to recalls, the FDA can pursue enforcement actions in relation to non-compliant products that are on the market. They can pursue an action through the Department of Justice in the federal court system, requiring the removal of adulterated or misbranded cosmetics. In addition, a restraining order can be issued against manufacturers or distributors of violative cosmetics and supplies may be seized. Finally, they can also initiate criminal actions against persons or companies violating the law.
The FDA also works closely with U.S. Customs and Border Protection to monitor imports. When a cosmetic product is brought into the U.S. it is subject to an FDA review, under section 801(a) of the “Federal Food, Drug, and Cosmetic Act” (FD&C Act). Products will be refused entry to the U.S. if they fail to comply with FDA laws and regulations. They must then either be brought to compliance, destroyed, or re-exported.
A primary reason for non-compliance is ‘adulteration’. This refers to a violation involving product composition, coming from the ingredients, contamination, processing, packaging, or shipping and handling.
The FD&C Act states a product has been adulterated if:
1. “It bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under conditions of use as are customary and usual” (with an exception made for coal-tar hair dyes )
2. “It consists in whole or in part of any filthy, putrid, or decomposed substance”
3. “It has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health”
4. “Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health”
5. “It is, or it bears or contains, a color additive which is unsafe within the meaning of section 721(a)” of the FD&C Act. (FD&C Act, sec. 601) (exception — coal-tar hair dyes)
Stakeholders should also be aware that cosmetic products may also be in violation if they are deemed to be ‘misbranded’. This refers to improper labeling or deceptive packaging. In addition to the rules found in the FD&C Act, cosmetics must also comply with the requirements of the Fair Packaging and Labeling Act (FPLA). Under this act, the U.S. FDA requires a list of ingredients for cosmetics marketed on a retail basis to consumers (Title 21, Code of Federal Regulations (CFR), section 701.3). Cosmetics that fail to comply with the FPLA are considered ‘misbranded’ under the FD&C Act. (FPLA, section 1456)
Legal responsibility for ensuring safety and compliance rests with the companies and individuals who manufacture and market cosmetic products. In the US, there is no legal or regulatory requirement to perform specified tests to demonstrate the safety of products or ingredients. The law does not even require the manufacturer or distributor to share safety information with the FDA.
When considering what tests to perform to ensure legal and regulatory compliance, it is advisable to look at the FDA’s own statement on the subject:
“The safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information.”
The FDA is essentially advising manufacturers to use whatever testing solutions are necessary to ensure their products and ingredients are safe.
SGS offers a comprehensive range of services to help cosmetic manufacturers access global markets. To ensure compliance with regulatory standards, SGS offers the Cosmetics Good Manufacturing Practice (GMP) Audit. This can be adapted to meet the GMP references used by different markets. References may include:
In addition to ensuring compliance with the applicable GMP requirements, utilizing SGS’s Cosmetics GMP Audit service also helps manufacturers:
Learn more about SGS Cosmetic GMP Audits