Cosmetic Product Causes Permanent Skin Damage


Regulatory ExpertThis is a product liability case involving a group of plaintiffs who suffered allergic reactions to a cosmetic powder foundation. The allergic reactions caused many of the plaintiffs to contract rashes which caused permanent skin damage. It was alleged that the product was not in compliance with FDA and that the cosmetic manufacturer had known about the dangers of using the product and failed to warn the public. An expert in FDA regulations and particular familiarity with cosmetics regulatory good practices and industry influence on decision-making was sought to review the case.

Question(s) For Expert Witness

  • 1. Please describe your background with FDA regulations and best practices.
  • 2. Please describe your experience with cosmetic regulations.

Expert Witness Response E-065690

Expert-ID: E-065690

I spent 28 years in regulatory roles with the FDA. Much of my focus was on pharmaceuticals and medical devices because these areas are extremely regulated. I also have some toxicology experience and I am familiar with cosmetic regulations. There isn’t a tremendous amount of regulatory history because the FDA is hands off when it comes to cosmetics. The FDA typically will not intervene unless a clear problem is presented, generally allowing the cosmetics industry to regulate itself. Only within the last 15 years has the FDA become involved in regulating cosmetics, and so far they have only intervened when imports were involved. That being said, potential issues with cosmetics have been known for decades. The FDA did some studies by collecting retail samples, but participation was voluntary and they have not issued any warnings.

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