Cosmetic Compliance — FDA

Under federal law, “cosmetic” refers to an article “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” — such as moisturizers, make-up, shampoos, toothpaste, deodorant, nail polish and the like.  More importantly, all cosmetics marketed in the United States must comply with the Food Drug and Cosmetic Act (FDCA), which prohibits the marketing of adulterated, misbranded, or mislabeled cosmetics; and the Fair Packaging and Labeling Act (FPLA), which requires that all cosmetics be labeled with an ingredient declaration and certain cosmetics bear specific warnings.  At Gaitan Law Group, our FDA cosmetic attorneys are well-versed in these laws and their application in the global marketplace.

FDA’s regulation of cosmetics is different from other products regulated by the agency, in that unlike drugs, biologics, and medical devices there is no pre-market review process.  Thus, cosmetic manufacturers, importers and distributors must take the necessary steps to ensure that their cosmetic products are in compliance with FDA’s rules and regulations.  The FDA cosmetic compliance attorneys at Gaitan Law Group counsel cosmetic firms on the myriad of requirement applicable to cosmetic products, affecting the formulation and ingredients, labeling, safety, manufacturing, and importation of cosmetic products.

Our FDA cosmetic attorneys work with cosmetic firms to make sure they meet their regulatory obligations when placing a cosmetic product in the US market, such as:

  • Labeling cosmetic product in accordance with FDA’s requirements for format and constant
  • Obtaining adequate substantiation for all cosmetic claims
  • Ensuring that cosmetic product is formulated with allowable ingredients
  • Verifying that color additives are properly identified and have batch certification when needed.
  • Ensuring that product is safe for human health
  • Manufacturing the product in accordance with Good Manufacturing Practices (GMP)

Aside from the above key obligations, our FDA attorneys assist cosmetic firms with other related issues such as petitioning for removal from Import Alert, responding to an FDA Notice of Action or other enforcement action, as well as complying with the rules and regulations imposed by the Federal Trade Commission (FTC) regarding advertising and marketing of cosmetics, as well as Customs and Border Protection (CBP) as it relates to the import and export of cosmetics.

Whether you are looking to open a new cosmetic business, expand an existing cosmetic brand, begin importing a new cosmetic product to the U.S. or otherwise, our FDA compliance attorneys are here to help.

To speak with an established FDA attorney, e-mail Gaitan Law Group at [email protected] or call us at 786.440.8115. We offer flexible fee arrangements.

If you are establishing a cosmetic manufacturing or repackaging establishment in the State of Florida, our attorney can assist you with DBPR’s permitting requirements.

Hablamos español.