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FDA: Cosmetic Regulation

The U.S. Food and Drug Administration (FDA) regulates cosmetics under authority granted to the agency by the Federal Food, Drug and Cosmetic Act (FDCA). The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is responsible for day-to-day regulation, and assuring cosmetics are safe and properly labeled.

Cosmetics are defined by their intended use: “articles 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” (FDCA Sec. 201). While this definition seems quite straightforward, the FDA is charged with inspecting, detaining, and refusing those articles with intended use claims that push boundaries and turn what would be a simple cosmetic into an unapproved new drug or medical device. FDA also spends significant resources inspecting cosmetics for adulteration (i.e. microbiological) contaminations.

Our goal is to provide experience and counsel as it relates to cosmetic labeling and regulations – keeping our clients competitive in the market while lowering regulatory risk. We help clients manage and create marketing claims that are compliant and competitive, but do not touch on therapeutic uses, such as affecting the structure or function of the body, or treating/preventing diseases (despite recent language – there is no such thing as a “cosmeceutical”). For example, the claim “reduces the appearance of fine lines and wrinkles” makes an article a cosmetic, but the claim “reduces fines lines and wrinkles” would make a product an unapproved new drug. The FDA regulations impact the label, ingredients, and marketing – and they all work together in determining how the FDA regulates an article.

Our cosmetic advisors assist with:

  • Label and labeling reviews, advertisements, Internet marketing and social media networks for your cosmetic
  • Cosmetic claim substantiation
  • Product ingredient reviews, including color additives and restrictions based on use and area of the body
  • Voluntary Registration of Cosmetic Product (VRCP) Establishments
  • Purity and safety testing coordination
  • Cosmetic product warning statement requirements
  • Bulk ingredient safety compliance
  • Audits of your operations and risk assessment related to non-compliance
  • Inspection of cosmetic manufacturers
  • Cosmetic Standard Operating Procedures (SOPs)
  • Compliance with cosmetic current Good Manufacturing Practices (cGMPs) and best practices
  • Defense against FDA and FTC enforcement actions such as product recalls, FDA detentions and refusals, warning letters, 483s, adulteration and misbranding charges, import alerts, or claims brought by state and federal prosecutors for violation of safety regulations, and false labeling and advertising
  • U.S. Customs matters such as Form 28s, liquidated damages, criminal investigations, seizures, HTS classifications, free trade agreements, country of origin issues, and import/export guidance
  • Analysis and advocacy with respect to relevant legislation and regulatory matters
  • Obtaining patents and trademarks and gray market protection strategies