The administration reviewed a variety of products on the company's website, including a ‘Copper Sun Tanning & Firming Body Lotion,’ ‘BioHeal Cream,’ ‘Squalane,’ and a ‘CP Serum’, on which it ruled that the marketing of the products alongside their claims violated it's regulation laws.
“The claims on your website indicate that these products are intended for use in the cure, mitigation, treatment or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act.”
The FDA also pinpoints one testimonial in particular on the company's 'BioHeal Cream' whereby a 'consumer' declared that; "I had two cysts on my face that would not heal. I finally ordered BioHeal and within a week, they were healed even though a crater type scar remained."
"These products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)]."
In this instance, the administration is advising Skin Biology “to review all of your websites, product labels, and other labeling and promotional materials for all your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.”
And to include any documentation necessary to show that correction has been achieved - "If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration."
FDA crack down on cosmetic companies
The FDA regularly raps cosmetics companies over marketing claims associated with cosmetic and personal care products, and is particularly vigilant over anti-aging claims.
Only last month, it sent a warning letter to L’Oreal over marketing terms relating to skin care products sold under its Lancôme brand in the United States.
In this complaint the organization cited concerns of 11 different skin care products marketed under the Génifique, Absolue and Rénergie brand names on the company’s US-dedicated website portal.