COSMETICS AND NUTRACEUTICALS

“Cosmeceutical” and “nutraceutical” are industry names for products that present hybrid qualities—for example, a cosmetic or a dietary supplement with therapeutic properties.

However, the FDA does not regulate a product as a cosmeceutical or nutraceutical, per se.

Typically, we counsel clients to distinguish as to whether their product will be regulated as a:

• Cosmetic
• Dietary Supplement
• Drug (prescription (Rx) or OTC)
• Food
• Medical Device
• Medical Food

The FDA notes that if a product makes therapeutic claims (for example, a shampoo whose intended use is to treat psoriasis), then it may fall into multiple regulatory categories and have to meet the requirements of both (for example, cosmetic and drug).