Late last week, the FTC Business Center Blog posted a short but important entry on health-related advertising representations entitled 5 principles to help keep your health claims healthy. This friendly reminder highlights lessons from a few of the FTC’s recent enforcement actions, including the $1.35 million settlement with Tommie Copper, Inc. The settlement was entered into as a result of deceptive advertising claims made by Tommie Copper that its copper-infused compression clothing was effective in relieving severe and chronic pain and inflammation caused by arthritis and other diseases. (The Tommie Copper stipulated judgment was actually in the amount of $86.82 million (!), but the remaining $85.47 million of the judgment was suspended subject to the defendants’ financial representations). The FTC has also recently scrutinized claims involving dietary supplements, health-related mobile apps and weight loss products.

The bottom line:  “Before promising a health benefit, have appropriate proof in hand.”

While many advertisers may think otherwise, this general rule squarely applies to consumer and celebrity testimonials published or sponsored by an advertiser.  The FTC knows you can’t always control what others say and do, but that doesn’t get you off the hook.  Advertisers are responsible for the implied claims conveyed by consumer endorsements that they print, publish or even re-post. In the FTC’s words: “If you don’t have that evidence, don’t attempt the end-around of conveying the claim through a testimonial.”  Further, prudent advertisers confirm that their endorsements comply with the FTC’s Endorsement Guides. This means disclosing material connections and confirming that endorsers are bona fide users of the product being advertised, among other things.

A recent NAD inquiry into claims made by New Nordic U.S.A., Inc. for its Skin Care Collagen Filler dietary supplement also serves as a reminder of these important principles. When NAD initiated its inquiry, it requested substantiation for various express claims, including “Reduces formation of wrinkles,” and “Collagen Filler with Proven Ingredients,” as well as the implied claims arising from a consumer testimonial that noted “I have used the tablets for six months and they really work for me. . . . I feel my skin looks better, tighter, and healthier.” The advertiser indicated it was in the midst of conducting clinical testing, so in the meantime, it submitted 23 ingredient studies, some conducted in vitro, some conducted on animals and a few conducted on humans.  NAD reprimanded the advertiser for lacking appropriate substantiation before disseminating the claims, as FTC policy requires.  NAD also indicated that, as a general rule, ingredient studies are not sufficient to substantiate product performance claims.  It also cautioned the advertiser that “as a general rule, animal studies and in vitro studies can provide useful background information on an ingredient’s biological effect, [but] they have limited, if any, probative value on the impact of a substance (or a product) which is consumed by humans.”  Given the absence of any competent and reliable scientific evidence, NAD recommended that the claims be discontinued.

These recent FTC and NAD cases show that while the type of the proof necessary to substantiate therapeutic health claims can vary, the gold standard in claim substantiation is human clinical studies that are randomized, double-blind, placebo-controlled and conducted by qualified researchers.