The NAD recently reviewed claims for an omega-3 supplement. See Prevention Pharmaceuticals, Inc., NAD Case No. 5966 (July 2016). The NAD found that the advertiser had solid data for a variety of content and purity claims. The NAD, however, concluded that some claims overstated the underlying evidence. The case provides a reminder of several positions that NAD routinely takes on certain types of claims:
- Claims, like, “Free of heavy metals.” “In determining when the presence of trace levels of a substance [will] prevent an advertiser from claiming its product is free of that substance, NAD considers (1) the reasonable expectations of the consumer, and (2) the applicability of the regulatory framework and/or industry standards.”
- Unqualified Superiority Claims (e.g., “Helps manage the body’s inflammatory response more than any other omega-3 supplement”). The NAD takes the position that “[i]n order to make a market wide superiority claim, an advertiser should identify the dietary supplement products that comprise a majority of the current marketplace (usually 70-80%, based on sales data).”
- Health Benefit Claims. In the NAD’s view, health benefit claims “should be supported by competent and reliable scientific evidence, generally defined as methodologically sound and statistically significant (p≤.05) human clinical trials with consumer relevant results.” The NAD will generally reject in vitro testing as sufficient evidence for a health benefit claim unless that there is evidence that the in vitro results “could reasonably be extrapolated to humans.”
- Claims Based on Ingredient Studies. According to the NAD, “While advertisers may make properly qualified claims based on ingredients in their supplements, those ingredients must be present in [the] products in the same amount, formulation, and route of administration as the underlying ingredient studies.”
The third bullet reflects that the NAD, like the FTC, continues to expect human clinical studies for an extremely wide variety of health-related claims. In general, for any disease claim or cause-and-effect claims (e.g., lose weight, improve memory), the NAD and FTC demand at least one clinical study. Relying on lesser evidence requires careful execution and careful compilation of the relevant support in order to decrease risk and maximize a company’s chances to win a challenge.