Claim Study Series 2: Clinical Tests Must Show Statistically Significant Results Compared To Control

It's not new news that to support weight loss or other health claims the FTC is requiring substantiation in the form of at least one (sometimes two) RTCs or randomized, controlled human clinical trials. The NAD recently clarified that not only must your clinical test show results but the results must differ from the control group by a statistically significant (to the 95% confidence level) amount. While sometimes clinicians will find results of a study to be clinically relevant, for legal substantiation, a marketer is going to have to show not only that its product works but that it works better than a meaningful control. For weight loss with a supplement, this likely means a control group given direction of "usual care" or basic instruction in limiting caloric intake along with a placebo weight loss supplement and a test group given similar instructions but also given the real supplement. Even if both groups show weight loss, the supplement manufacturer needs to show