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Cosmetic Labeling & Label Claims

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Cosmetic Labeling & Label Claims

Proper labeling is an important aspect of putting a cosmetic product on the market. FDA regulates cosmetic labeling under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws and their related regulations are intended to protect consumers from health hazards and deceptive practices, and to help consumers make informed decisions regarding product purchase.

The two most significant laws governing cosmetics marketed in the United States are the Food Drug and Cosmetic Act (FDCA) and the Fair Packaging and Labeling Act (FPLA).  The FDCA prohibits both the marketing of adulterated or misbranded cosmetics and the marketing of cosmetics that are improperly labeled in the United States.  Under the authority of the FPLA, FDA requires an ingredient declaration on all cosmetics and specific warnings on certain cosmetic products.  C. Humphrey & Associates,

P.A. FDA attorneys and FDA consultants are well-versed and knowledgeable in all areas of cosmetic regulation including:

  • Current Good Manufacturing Practices (cGMPs)

  • Voluntary Cosmetic Registration Program (VCRP)

  • Product label reviews, including labeling claims and substantiation

  • Ingredient reviews including reviews of color additives

  • Importation and exportation

  • Import Alerts

  • Shipment detentions

  • Consumer complaints

  • FDA recalls and FDA Warning Letters

Claims made about a product, whether in advertising or labeling, can be the difference between whether the product is regulated by FDA as a drug, a cosmetic, or both.  The compliance team at C. Humphrey & Associates, P.A. assists clients with formulating claims for products that are permissible and appropriate for cosmetic marketing.  We are equipped to assist clients in ensuring there is adequate data and information to substantiate product claims and the safety of product ingredients.  The food and drug attorneys at C. Humphrey & Associates, P.A. are experienced conducting reviews of product labels and labeling materials to ensure all labeling and declarations meet the requirements established by the FPLA and FDCA.  We also assist clients in crafting advertising campaigns that are compliant under FTC and FDA regulations.

Our FDA Attorneys and FDA Consultants are experienced handling issues involving Customs and Border Patrol (CBP) and assisting clients in the importation of cosmetic products into the United States.  We help importers ensure imported products are in compliance with all state, federal, and international labeling regulations.  Our team is familiar with FDA Import Alerts and regulatory works with CBP and FDA personnel on shipment detentions and exporting cosmetic products internationally.  We are experienced with working and communicating with FDA and CBP personnel regarding detentions of cosmetic shipments and FDA inspections.  We have experience negotiating with FDA on behalf of our clients regarding shipment detentions and Import Alerts and we have represented clients in litigation involving both FDA and private parties.

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