What is substantiation?  It’s not what we do the day after we have ice cream sundaes for dinner (that’s rationalization). It’s what advertisers should do every time they make a claim about a product or service. Whether you are advertising its effectiveness, purpose, price, or any other attribute – if you claim it, you need data to back it up

Take the recent letters the Federal Trade Commission (“FTC) and Federal Drug Administration (“FDA”) sent to three dietary supplement companies warning them about making claims that their products would treat, fix, or otherwise address various diseases and health conditions.

Gold Crown Natural Products, TEK Naturals and Pure Nootropics, LLC all received letters stating that the FTC and FDA believed the companies’ ads could be seen as making unsubstantiated claims regarding their ability to treat or cure serious diseases such as Alzheimer’s and Parkinson’s, among others.

The companies’ advertising made claims as to the medical effectiveness of their products. Some examples included: “Responsible for lowered LDL cholesterol”, “The treatment of ear infections . . . and even some forms of cancer”, “Possible treatment for Alzheimer’s patients” and even, “Helps prevent cancer”. Pretty bold claims.

The FTC letters stated that the claims, which were used on websites, blogs, posts, and across social media platforms, established that the supplements were “drugs” under the Federal Drug and Cosmetic Act (“FDCA), by purporting to tell consumers that the supplements had disease curing attributes. (Dietary supplements are not the same as FDA approved drugs, and are not allowed to make the same kinds of claims as an FDA approved drug.)

Further, according to the FTC, the dietary supplements were not “generally recognized as safe and effective for the uses for which they were advertised” and were considered “new drugs” (because of their claims) under the FDCA.  Under the statute, a new drug must go through the FDA approval process prior to being released. These were not.

The FTC also informed the companies that any claims as to the effectiveness of the products must be substantiated and backed up by hard data, tests, trials, or other reliable scientific evidence. If not, they may face further penalty for violating the FTC’ substantiation requirement.

Remember, advertisers need evidence and science to back up any health claims.  In the FTC’s 1983 Advertising Substantiation Policy Statement, it states that “when the substantiation claim is express (e.g., “tests prove,” “doctors recommend,” and “studies show”)” the expectation is that the advertiser has “at least the advertised level of substantiation.” And while lots of things from the 80s aren’t around today (scrunch socks anyone?), substantiation in advertising claims will never go out of style.

If you represent expressly or by implication that your product can prevent or treat diseases or serious medical conditions, back up those claims with measurable scientific evidence.