Whether the final destination for a product is on a shelf or online, Amin Talati Upadhye aims to provide legal counsel throughout the lifecycle of that product; from its initial development to its success when it reaches the market to resolving any subsequent issues related to regulation or competition. We begin with the critical first step of classification: cosmetic or drug (or “cosmecutical”)? Personal care or medical device? The answer, which can turn on a single word on a product label, has significant ramifications on how a product can be marketed, how it will be regulated, and how we counsel and move forward with a client.
In the fast moving and highly competitive cosmetic industry – where products move quickly and distinguishing one product from another is extremely challenging – our role is to be proactive in keeping pace with the steps required to remain in compliance while still appealing to consumers and other end-users. Our clients include manufacturers, distributors and retailers of cosmetic products in the United States and abroad. We are intimately familiar with the ever-changing nuances in the regulation of cosmetic labeling and advertising by the Food and Drug Administration and the Federal Trade Commission, proceedings before the National Advertising Division (NAD) and the Electronic Retailing Self Regulation Program, (ERSP) and intellectual property matters (patents and trademarks).
Our services to the cosmetic industry include:
- Reviewing substantiation and advising on proper labeling and advertising strategies
- Designing and overseeing clinical trials and other types of studies to support product claims
- Counseling on compliance issues relating to good manufacturing practices, record keeping, product recalls, FDA inspections
- Representing clients in FTC investigations, responding to Warning Letters and other FDA enforcement actions, and in bringing and defending competitor challenges
- Counseling on permissible product claims with respect to traditional cosmetics, cosmetics containing drugs, and cosmetic devices
- Providing guidance on safety testing
- Assistance in registering products in the Voluntary Cosmetic Registration Program