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FDA Cosmetic Compliance

FDA Compliance & Registration for Cosmetic Products

Ms. Capote is an FDA Lawyer helping businesses register their cosmetic products with the FDA as well as providing help with FDA issues related to cosmetic compliance with the FDA

The United States Food and Drug Administration (FDA) monitors cosmetic corporations who must comply with the Food and Drug and Cosmetic Act (FDCA) while selling cosmetic products in the United States. The FDCA prohibits marketing of cosmetics to the public within the United States that are adulterated, misbranded, or mislabeled. All cosmetics sold in the U.S. must be clearly labeled with accurate ingredients used to make the cosmetic and any warnings to the consumer.

How to register cosmetics with the FDAAccording to federal law, a ‘cosmetic’ is defined 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 appearance.” A few examples of cosmetics are hand lotions, moisturizers, make-up, shampoos, conditioners, perfumes, deodorants, body powders, toothpastes, and nail polishes. Federal law requires all cosmetic companies to label their products with accurate ingredient lists and warning labels.

Capote Law Firm has experience working with corporations in the cosmetic industry. Our cosmetic attorneys are dedicated to ensuring your company is in compliance with FDA rules. The FDA has cosmetic regulations which differ from other products regulated by the FDA, such as drugs, biologics, and medical devices which there is no review process prior to marketing. Cosmetic distributors, importers and manufacturers interested in selling cosmetics to the general public must ensure they stay within legal compliance with FDA’s rules and regulations.

Capote Law Firm cosmetic attorneys are dedicated to working with cosmetic firms worldwide ensuring FDA regulatory obligations are met prior to marketing cosmetic products in the U.S. market. The following are only a few ways our cosmetic lawyers can assist your company with FDA compliance:

  • Ensuring the cosmetic is marketable and safe for humans to use;
  • Verifying ingredient list and warning labels are accurate and FDA compliant;
  • Verification of additives listed within the cosmetic;
  • Verify batch certification requirements are met;
  • Good Manufacturing Practices (GMP) compliance;
  • Labeling cosmetic product in accordance with FDA’s requirements;

Our FDA attorneys provide legal advice and representation for not only U.S. cosmetic industry compliance, but for most other FDA related issues such as: FDA Notice of Action; FDA Enforcement Action Notice; understanding FDA rules and regulations imposed by the Federal Trade Commission (FTC) regarding advertising and marketing of cosmetics; Customs and Border Protection (CBP) as it relates to the Import and Export of Cosmetics; Cosmetics Safety; Cosmetics Labeling; Cosmetics Guidance; Cosmetics Regulation; Cosmetics Compliance; and Cosmetics Enforcement.

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