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. Fuerst Ittleman attorneys are well-versed and knowledgeable in all areas of cosmetic regulation including:
- Good Manufacturing Practices (GMPs)
- 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 warning letters
Claims, Advertising, and Labeling
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 Fuerst Ittleman helps clients formulate 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 Fuerst Ittleman 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.
Import and Export
Fuerst Ittleman attorneys 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.
Ingredients and Color Additives
FDA regulations prohibit or restrict the use of certain ingredients and color additives in cosmetic products. Fuerst Ittleman helps clients ensure that only legal ingredients and color additives are present in their cosmetic products through formulation and label reviews.
FDA Enforcement Action
Fuerst Ittleman is experienced 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.
Voluntary Cosmetic Registration Program
The VCRP is an FDA post-market reporting system for cosmetic product manufacturers, packers, and distributors that are in commercial distribution in the United States. The program allows for communication between FDA and cosmetic product firms in order to ensure only safe ingredients are used and that there is an open dialogue between the Agency and the product manufacturers and distributors. Fuerst Ittleman is very familiar with the program and is able to assist clients in initial registration for the program as well as formulation submission.
