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Cosmetics

FDA COSMETICS REGULATIONS: Just You Know

Firms importing products considered to be solely cosmetics in the United States are not required to register.

However, the FDA encourages both domestic and foreign cosmetic firms to register their establishments and file Cosmetic Product Ingredient Statements with the Voluntary Cosmetic Registration Program (VCRP).

Please note that the VCRP can only accept Cosmetic Product Ingredient Statements for cosmetics that are already on the market in the United States.

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:

1

cosmetic-type products marketed with therapeutic claims that cause them to be considered unapproved new drugs under the law

2

cosmetics that are adulterated because of microbial contamination, failure to meet U.S. requirements for color additives

3

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.

What else?

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 & Drug Administration (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 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.

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