Cosmetics

Cosmetic Regulation and Labeling in the U.S.

Like all FDA-related products, cosmetics are defined by their “intended uses” as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance. It is critical that the cosmetics manufacturer or importer understand and properly apply the FDA cosmetic regulations. Cosmetics distributed in the USA must have correct cosmetic labeling, contain safe, permitted cosmetic ingredients and be pure and of high quality. Specific FDA cosmetic regulations also include where, how and for how long a cosmetic may be applied to the body.

Is it a Cosmetic or a Drug?

FDA regulations apply different marketing requirements to cosmetics than to drugs. FDA regulates some products as drugs even though the product manufacturers or importers initially thought the products could be marketed as cosmetics. This often happens because the products contain active drug ingredients or labeling or marketing claims on the cosmetic labeling or in the product’s internet advertising or promotional materials that are considered drug claims in the U.S. FDA regulates such products as drugs, which increases the FDA requirements for U.S. distribution.

The cosmetic label, advertising and ingredients dictate how FDA will regulate the product. Any claims that a product can prevent disease (for instance, as a sun protection (SPF) cosmetic) or that it will affect the structure or function of the human body (for instance, as an anti-wrinkle cosmetic cream) are drug claims. Such claims are not permitted. Some common examples of impermissible drug claims include hair restoration claims, cellulite reduction claims, varicose vein treatments, skin whiteners, wrinkle reducing products or wrinkle removal creams (e.g., anti-wrinkle creams).

Sunscreens and Other Cosmetic/Drug Products

There are some products that meet the legal definitions of both cosmetics and drugs. This may happen when a product has two lawful intended uses. One of the primary cosmetic/drug combinations are cosmetic moisturizers and cosmetic creams marketed with sun-protection factor (SPF) claims. Cosmetics that bear SPF labeling claims or SPF ingredients are regulated by FDA as both cosmetics and as over the counter (OTC) SPF drugs. In these special cases, the products must comply with FDA cosmetic regulations and drug regulations.

Other product examples include anti-dandruff shampoo, where the shampoo is a cosmetic (intended use to clean hair) and the antidandruff treatment is a drug (intended use to treat dandruff) and toothpaste with fluoride. Industry uses a term, cosmeceutical, to describe cosmetic products that have drug-like benefits; however, FDA does not recognize that term.

OTC drugs are subject to FDA drug listing and facility registration requirements, and (for foreign drug manufacturers) FDA U.S. Agent requirements. In addition, the products must comply with FDA cosmetic and drug labeling regulations. Complying with only the cosmetic regulations for an article that is also a drug will result in FDA import detentions, refusals, and sometimes recalls.

Labeling and Marketing Claims

Correct cosmetic labels and cosmetic marketing claims are critical to successfully importing cosmetics into the United States. The easiest cosmetic violation for FDA to find is an improper drug claim on a cosmetic product’s label or a cosmetic product’s internet site. Cosmetic importers and manufacturers must also be aware of individual U.S. state cosmetic labeling regulations.

All cosmetic packaging must include certain specific panels containing mandatory declarations, such as the cosmetic ingredients contained in the product. Cosmetic marketing claims and information may also be present on cosmetic labeling, but all claims must be truthful, not misleading, and must not be improper drug claims. Cosmetic labeling may also contain information in languages other than English, so long as all the mandatory label declarations are stated in English and any other languages also appearing on the label. This is called “dual language labeling” or “multiple language labeling.”

Cosmetic marketing companies should know that internet marketing sites where cosmetics are sold are regulated by both FDA and the Federal Trade Commission (FTC), and are often searched and reviewed by FDA investigators and compliance officers who are on the hunt for false, misleading or unapproved cosmetic claims. Once they find the illegal information, inspectors then look for imported cosmetics from those sites or from the companies who are marketing the products.

Product Ingredient Reviews and Safety

FDA cosmetic regulations require that cosmetic ingredients be safe for their intended uses. When FDA evaluates cosmetic products for safety, they first analyze the cosmetic labeling: does the product contain any prohibited ingredients,  like unsafe color additives or active drug ingredients, or other ingredients only safe for use in “wash off” products but which are found in “leave on” cosmetics. Aside from a few exceptions, cosmetic labels must declare all the ingredients in the product’s formulation. FDA also samples and tests imported cosmetics looking for unsafe or illegal cosmetic ingredients.

Except for cosmetic color additives, there is no FDA approval required prior to adding a cosmetic ingredient to a product. Instead, FDA uses several regulatory “substitutes” for making safety determinations related to cosmetic ingredients. For instance, FDA cosmetic regulations permit the Agency to guide its enforcement discretion by the scientific and safety-related conclusions of industry-based trade groups. Ultimately, under FDA regulations, cosmetic manufacturers must ensure cosmetic ingredient safety. Cosmetics containing unsafe cosmetic ingredients violate federal law and FDA cosmetic regulations. Unsafe cosmetics found in the U.S. domestic market are subject to cosmetic recalls and the manufacturer can become subject to additional legal liability. Imported cosmetics containing unsafe ingredients are subject to FDA import detention and refusal of admission and can subject the importer to additional legal liability. In each of these cases, using unsafe ingredients prohibited by FDA cosmetic regulations costs companies valuable time and money.

Some U.S. states, such as California, have additional requirements related to cosmetic ingredient safety. For instance, where there is some evidence that a chemical in a product increases the risk that it is a cancer causing cosmetic, distributors must include additional cosmetics label warnings and report to the state health authorities the quantities of such cosmetics distributed within a particular state.

Cosmetic Colors

Cosmetic color additive selection is one of the most important product features for cosmetic formulation. All cosmetic color ingredients must be FDA approved for their specific uses in cosmetics and must meet specific composition requirements and ingredient naming regulations.

FDA approves color additives for their specific intended uses. For example, when making eye shadows, eye liners, eyelash applications or similar cosmetics, you may only use color additives that specifically permit use around the eye.

Cosmetic colors additives are either

• FDA approved colors for particular cosmetic uses,
• FDA certified colors (on a color batch basis), or
• expressly exempted from FDA color certification for cosmetic use. FDA’s Office of Cosmetics and Colors evaluates cosmetic colors through its “batch certification” process, by which it evaluates the composition and manufacturer of all colors subject to certification.

Finally, FDA regulations govern the precise cosmetic color and ingredient names that may be used on product labels. Thus, for cosmetics marketed in the United States, Colour Index (CI) numbers alone do not suffice to designate colors.

Cosmetics that contain colors intended for unapproved uses, unapproved colors, or labels with improperly declared color names are subject to the full range of FDA enforcement actions, which invariably costs firms time and money. In fact, when importing cosmetic products into the United States, these types of color additive violations are some of the most common reasons for FDA import detentions and refusals of admission.

Cosmetics and Import Alerts

FDA’s Import Alert system stops products from being imported into the U.S. because of specific violations. The most common reasons for cosmetics are:

• Import Alert 53-06: Detention Without Physical Examination of Cosmetics Containing Illegal Colors
• Import Alert 53-17: Detention Without Physical Examination of Cosmetics Due to Microbiological Contamination.

FDA can review product labels and identify suspicious colors. Countries have different laws in the use and declaration of color additives and the cosmetics’ manufacturers sometimes are not aware of the compliance hurdle hidden in color additives. Another frequent FDA charge is contamination by heavy metals and/or microbial.

Are Cosmetic Manufacturers required to register with FDA?

Under “Modernization of Cosmetics Regulation Act of 2022,” (or, MOCRA), FDA has issued new guidance that requires cosmetic manufacturers and processors to register their facilities with FDA.

Facilities that manufacture or process cosmetics intended for sale in the U.S. must be registered with FDA, including listing all cosmetics produced or modified at these facilities. Foreign establishments must also identify a U.S. agent and importers when registering. Cosmetic manufacturers must submit registration information for their establishments, submit listing information, and update their information every two years.

FDA also requires annual reporting by cosmetic registrants for listed cosmetic products manufactured or processed for commercial distribution in the U.S.

Facilities are registered with FDA’s online registration system. Many companies find the FDA registration and listing processes difficult to manage, even those which were registered in the past. FDAImports can take care of your registration requirements and act as U.S. Agent for foreign facilities. Read more about registration and listing.

We apply our expertise and experience in FDA cosmetic labeling regulations and FTC cosmetic marketing regulations to ensure your cosmetics comply with federal requirements, while bearing useful claims for marketing purposes. By providing a regulatory review of your cosmetic ingredients and evaluating the ingredient declarations on the cosmetic labeling, we can help your company avoid costly mistakes involving unsafe cosmetic ingredients. For high quality cosmetic products, we find the way through to the U.S. market, helping you to create high quality and successful cosmetic brands.