On December 23, 2022, the U.S. Congress enacted the first major statutory change to the Food and Drug Administration (FDA)’s ability to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act of 1938, and the passage of the Fair Packaging and Labeling Act (FPLA) in 1966.
Indeed, the Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rulemaking and enforcement authority over cosmetics, and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.
So, what’s new?
MoCRA
▪ requires any facility that manufactures or processes cosmetic products intended for sale in the United States, to register with FDA.
▪ requires manufacturers, packers, and distributors of cosmetics intended for sale in the United States to submit to FDA, lists of products and ingredient information, including location of manufacture and the ingredients of any fragrances or flavors.
▪ imposes greater recordkeeping obligations regarding product safety and reporting, documenting, and following up on serious adverse events with an expanded definition of what constitutes a serious adverse event.
▪ imposes new labeling requirements, including providing contact information for adverse event reporting and notifications for products intended for professional use.
▪ requires FDA to enact regulations addressing good manufacturing practices (GMP), the identification of fragrance allergens that must be disclosed on cosmetics labels, and standardized testing methods for detecting and identifying asbestos in talc-containing products.
Under MoCRA
▪ FDA has now the mandatory recall authority if it determines that:
there is a reasonable probability that cosmetics are adulterated or misbranded.
exposure will cause serious adverse health consequences.
▪ The agency may access records pertaining to product safety and request a list of ingredients in the fragrances or flavors.
▪ A responsible person is required to report serious adverse events associated with the use of cosmetic products to the FDA within 15 business days after receiving the report.
Finally, MoCRA exempts certain small businesses from GMP, registration, and product listing requirements. However, there are some limitations.
The FDA stopped accepting and processing submissions to the voluntary registration program for cosmetics establishments and products. The agency is developing a program for submission of the facility registrations and product listings mandated by MoCRA, and will provide further updates on its forthcoming availability.
If your products are drugs, or both cosmetics and drugs, they are subject to requirements for drug registration.
Among the products addressed in Import Alerts are:
cosmetic-type products marketed with therapeutic claims that cause them to be considered unapproved new drugs under the law
cosmetics that are adulterated because of microbial contamination, failure to meet U.S. requirements for color additives
bulk shipments of high-risk bovine tissue from BSE (bovine spongiform encephalopathy) countries
Foreign cosmetics that appear to be adulterated or misbranded may be refused entry into the United States. They must be brought into compliance, destroyed, or re-exported.
Cosmetic products and ingredients are not subject to premarket approval by FDA, with the exception of color additives. However, they must be safe for consumers under labeled or customary conditions of use, and they must be properly labeled.
Color additives must be approved for the intended use. Some must be from batches certified by FDA. Firms and individuals who manufacture or market cosmetics are responsible for ensuring that their products are in compliance.
The U.S. Food and Drug Administration (U.S. FDA) does not define or regulate the term “organic,” as it applies to cosmetics, body care, or personal care products.
Just because it’s “organic,” it does not make a cosmetic product safe.
The Agricultural Marketing Service of the U.S. Department of Agriculture (USDA) oversees the National Organic Program (NOP). The NOP regulations include a definition of “organic” and provide for certification that agricultural ingredients have been produced under conditions that would meet the definition. They also include labeling standards based on the percentage of organic ingredients in a product. For more information on “organic” labeling for cosmetics, see the NOP publication.
The European Union – European Medicines Agency (EMA) – defines drugs and cosmetics differently from the United States. For example, sunscreens are regulated as cosmetics. In the United States, they are regulated as drugs.
Hair restoration, skin protectant, pain relief, anti-aging effects that involve the structure or function of the skin, and treatment of acne, dandruff, eczema, or irritated skin are other examples of claims that would cause products to be regulated as drugs (or in some cases, both cosmetics and drugs) in the United States.
