Cosmetic Regulation in the United States

The importation, manufacture and distribution of cosmetics in the United States is booming and the industry has enjoyed a fairly open and flexible regulatory climate over the last few decades. Americans are using more and more cosmetic products each year and the opportunities are only increasing for companies entering the U.S. marketplace. Recent trends in both government legislation and popular culture, however, have led to increased scrutiny of cosmetics, especially with ingredient safety and labeling. Recently, a government panel considered testimony from the industry, FDA and consumers regarding the development of new cosmetic legislation covering everything from user-fees and facility registration to labeling guidelines. FDA’s attention is more and more focused on cosmetics and all tolerance for labeling violations will rapidly diminish. The time is now for cosmetic companies to get compliant and prepare for increased scrutiny.

Common Challenges with Cosmetics

Cosmetic manufacturers and importers face many unique challenges distributing their product in the United States. Ingredient safety is a top concern for FDA officials and the American public. In recent years lead contamination and illegal ingredients have created cause for alarm in the American media, catching the attention of U.S. lawmakers and the FDA. Cosmetic manufacturers and distributors (especially international ones) have shown a lack of control in the use of colorants, banned ingredients, lack of uniformity in labeling standards in different countries and marketing claims. They also face new challenges such as FDA’s increased focus on cosmetics and forth-coming legislative changes. The next few years will bring both new challenges and opportunities to the international cosmetic industry.

Labeling Requirements

Cosmetic products in the United States are regulated under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. According to the applicable laws governing cosmetics, a cosmetic product can be considered “mislabeled” for any of the following reasons:

  • The product’s intended use is to affect the structure of the body
  • The product is also considered a “drug”
  • The product is inaccurately named
  • The product lists the ingredients in the wrong order
  • The product uses the wrong names for allowable ingredients
  • The product incorrectly declares its Net Quantity
  • The product incorrectly lists its manufacturer’s address
  • And countless other regulations covering quantity, warnings, uses, claims, fonts, images, colorants and more.

One unique area of concern for cosmetic manufacturers and distributors relates to the use of additives. Certain colorants are allowed for food but not for cosmetics (and vice versa). Did you know that some colorants must be declared using one name for cosmetics and another name for foods? This is one area where cosmetic manufacturers often get it wrong and where FDA knows what to look for almost immediately.

Other Facts About Cosmetic Imports

  • Trade secrets and formulations can be protected in regard to labeling requirements but only after approval by FDA. Cosmetics in general do not need FDA approval.
  • Your product can be considered a “drug” depending on the claims you make about it.
  • Calling a color additive by the wrong name, even if approved and safe for use, will cause your product to be misbranded.
  • There are specific regulations concerning multiunit packages and assortments of a variety of cosmetic products.
  • There are different labeling regulations for the same product but in different sized packages.
  • One claim on your product’s packaging that implies a physiological change can cause FDA to stop your product from coming to market.
  • Warnings and disclaimers are expected on your packaging no matter what size.
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