Since its loss in the Lane Labs case (see here for prior blog on the case), FTC Staff has been clear it intends to modify its traditional requirement of “competent and reliable scientific evidence.” The Bureau Director has indicated that under his watch the BCP will include more precise language in orders as to the amount and type of scientific evidence necessary to support health claims, as well as an effort to harmonize with FDA requirements. He indicated that an “outlier study” even if well conducted should not be sufficient basis for a health claim. New language being proposed by Staff, but not to our knowledge accepted by the Commission and made available for public comment, includes a definition of competent and reliable scientific evidence consisting of:
- at least two adequate and well-controlled human clinical studies,
- of the product at issue or substantially similar product,
- conducted by different experts independently of each other,
- that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate the health claim.
Time will tell if this proposal with considerably heightened standards for substantiating health claims will become the new norm. In the meantime the FTC continues to bind respondents to the old standard. This past week, the FTC accepted a proposed agreement containing a consent order from the Indoor Tanning Association in relation to the promotion of indoor tanning products and facilities.
In March of 2008, the Indoor Tanning Association launched the “Get the Facts About Tanning” campaign purported to dispel various myths created and disseminated by sun-hating dermatologists and the nefarious sunscreen industry. The Indoor Tanning Association allegedly claimed:
- No compelling scientific evidence exists that tanning causes melanoma
- The rewards of “soaking up the sun” outweigh the risks of overexposure
- Indoor tanning is considered by many to be a safer alternative to tanning outdoors
- A study by the National Academy of Sciences determined that the risks of not getting enough UV light far outweigh the hypothetically minute risk of skin cancer
- And last but not least, indoor tanning is a government-approved, controlled environment designed to give you a tan without ever burning.
The FTC’s complaint alleged that these claims were false and unsubstantiated because tanning does in fact increase the risk of skin cancer, including squamous cell and melanoma skin cancers and the National Academy of Sciences study never determined that the risks of not getting enough ultraviolet light far outweigh the risk of skin cancer. The Complaint alleges that while the ITA promoted the benefits of causing the skin to generate Vitamin D, it did not disclose that consumers can increase their Vitamin D levels through exposure to ultraviolet levels lower than that needed to tan.
The proposed consent order contains provisions prohibiting respondent from making any future representations about the health related risks or benefits of tanning and Vitamin D in connection with the advertising or sale of tanning, unless they possess competent and reliable scientific evidence sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields to substantiate that the representations are true. Representations in non-commercial settings, including ITA lobbying efforts, are carved out of the consent. The order further requires that ads making claims about the safety or health benefits of indoor tanning are required to make this disclosure: “NOTICE: Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury.”