Cosmetics That ‘Do Something’ A Regulatory Compliance Challenge

Food and drug attorney Katherine Giannamore speaks to the challenges cosmetic firms face in marketing their offerings competitively – as products that “do something” – without violating FDA’s definition of a cosmetic. While companies may instinctively want to push the envelope, the repercussions of a warning letter should not be taken lightly, she said, emphasizing the importance of regulatory risk assessment.

Competitive players in today’s cosmetics market are under pressure to claim that their products ‘do something’ in a structure/function sense, but that something is often what triggers an FDA warning letter, food and drug attorney Katherine Giannamore observed in a March 30 interview.

Giannamore, who heads her own law firm in Coral Gables, Fla., routinely works with cosmetics firms to assess risk associated...

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