Cosmetics That ‘Do Something’ A Regulatory Compliance Challenge
This article was originally published in The Rose Sheet
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.
You may also be interested in...
Statements about collagen production, maintaining cellular integrity, addressing age spots, even shrinking wrinkles and treating noncystic acne – all are viable structure/function claims for nutricosmetics, assuming there's evidence to back them up. The Rose Sheet discusses the growing opportunity with regulatory and legal experts and provides an overview of the market at present.
Regulatory and legal challenges have not held back J&J/Neutrogena’s Rapid Wrinkle Repair business, which has been joined by a Rapid Tone Repair line and Rapid Clear acne treatments. Meanwhile, new Aveeno Absolutely Ageless products similarly provide results in just one week, the company says.
A key component of FDA’s enforcement strategy in the cosmetics space is monitoring companies’ websites for overreaching product claims and issuing warning letters accordingly. Examination of past offenders’ current sites and updated claims offers potential visibility into language the agency will and will not tolerate when it comes to promoting skin-care benefits.