On September 7, 2012, the US Food and Drug Administration (FDA) issued a warning letter to cosmetics maker, Greek Island Labs, through its US Agent, Radcliff Consultants LLC, due to product claims on various company websites. The Warning Letter was issued the same day as a similar warning letter to cosmetics maker Lancome USA. In each letter FDA has taken the position that the respective product claims demonstrate the products are “intended to affect the structure and function of the body” rendering them drugs under the Federal Food, Drug, and Cosmetic Act. The Greek Island products cited by FDA include those in the Adonia and Athena lines of products. The specific claims made for the Greek Island products to which FDA objects include, in part, the following:

• “… helps to strengthen hair growth … and combat … hair loss.”
• “Eucalyptus also offers antibacterial, anti-inflammatory benefits and can help to stimulate blood circulation on the scalp, encouraging hair growth…”
• “Human clinical studies have reported that lavender essential oil may be beneficial in … alopecia (hair loss) and as an antibacterial agent.” 
• “Blemish Free Skin in Just 3 Days!”
• “Clinically proven to reduce breakouts and blemishes by 84%”
• “Reduces white heads and black heads by 92%”
• “…has bactericidal…anti-inflammatory…properties.”
• “…protect the skin while helping to prevent blemishes.”
• “…helps in treating a range of skin infections…”
• “…antiseptic properties help to clear…blemishes…”
• “…a potent antimicrobial, antibacterial, and antifungal…recommended for many types of skin disorders.”
• “… effective cell regenerator …”
• “… cell stimulant and tissue regeneration properties …”
• “… anti-infectious botanical, as well as an antifungal … also helps in treating a range of skin infections while offering antiseptic … benefits …”
• “… cell-regenerative for skin, healing for scars (increases production of new cells).”
• “…reactivate your body’s own dormant and weak skin stem cells, pushing them to regenerate.”
• “… acts as an … antiseptic and bactericide … It also improves circulation and removes toxins, ensuring optimum circulation.”
• “… used … to ward off infections …” 
• “ … used … against plague and fevers.”

Though FDA has historically objected to the use of claims related to skin conditions like “acne,” and claims that reference “antimicrobial,” “antiseptic,” “anti-inflammatory,” “antifungal” and similar drug-like therapeutic activity, it is clear that FDA is stepping up enforcement activity against makers of cosmetics and cosmeceuticals that use aggressive marketing claims to promote their products. Such enforcement activity may cause some cosmetic product makers to reassess their marketing strategies, especially if they make marketing claims beyond the age-old traditional moisturizing and beauty claims stemming from the definition of a cosmetic established under the FFDCA. Greek Island Labs has 15 days to respond to FDA’s warning letter. We will continue to follow this and other FDA enforcement actions related to cosmetics. For additional information on this issue, please contact Georgia C. Ravitz or Jim Hartten at Arent Fox LLP. A link to FDA’s warning letter follows. Click here to read the warning letter.