According to Marc Ullman, lawyer with New York-based firm Ullman, Shaprio & Ullman, the distinction between cosmetics and pharmaceutical products is of utmost importance when devising product literature and marketing material.
“The way the FDA looks at things, cosmetics don’t do anything, they only appear to do something,” he told CosmeticsDesign.com USA.
Under the FDA’s definition, cosmetics are for cleansing, beautifying, promoting attractiveness or altering the appearance; but, if a product is intended to affect the structure or any function of the body then it becomes a drug.
“If you are making a claim that says increased collagen production, this is a structure and function claim,” he said.
Warning letter
Early last week, CosmeticsDesign.com USA reported on a warning letter sent by the FDA to cosmetics company Jaba Labs for pharmaceutical-like product claims.
Some of the claims highlighted by the letter included:
- “Lose your wrinkles! without painful injections”
- “Hyaluronic acid [an ingredient of Faitoz-25] helps reduce spider veins….”
- “Argireline mimics the actions of Botulinum by … relaxing muscle contractions....”
- “This incredible PhytoCellTec apple stem cell cream emulsion is the first product to harness the regenerative potential of your own facial stem cells to renew skin …. It will actually ‘rejuvenate’ your skin by ‘awakening’ your body’s own reservoir of undifferentiated stem-cells.”
Ullman noted that claims of this kind are not unheard of in the industry; but, he said something had obviously caused the company’s websites to be brought to the attention of the regulatory body.
Potential action after receiving such a letter could include altering the contested passages, he explained, and added that it looked like changes had been made to Jaba Labs websites.
Ullman warned that the consequences of making statements that go against the current regulatory position could be more serious than a warning letter. Companies that receive warning letters could then be subject to lawsuits brought by consumers, or could experience problems moving products across international borders, he said.
Testimonials
Ullman also warned that under the US regulatory scheme for any kind of consumer product, testimonials are claims and will be judged accordingly.