Cosmetics

From inception to market success and beyond, we offer comprehensive legal counsel tailored to the unique needs of each cosmetic product. Beginning with product classification—Is it a cosmetic, drug, or medical device?—we understand the profound implications of these distinctions on marketing, regulation, and our strategic guidance to clients.

In the dynamic and fiercely competitive cosmetic industry, where product differentiation is paramount and trends evolve rapidly, our proactive approach ensures compliance without compromising consumer appeal.

Our comprehensive services to the cosmetic industry encompass:

  • Compliance with The Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. 
  • Counseling on safety testing and clinical studies.
  • Reviewing substantiation and advising on product claims.
  • Helping with product recalls, FDA inspections.
  • Responding to Warning Letters and FDA enforcement actions.
  • Reviewing website and social media pages for compliance.
  • Counseling on Import issues including detention and refusals, Import Alert removal and product reconditioning.
At Talati, our expert counsel and proactive strategies are tailored to empower clients to thrive in this dynamic industry landscape.