NAD has recommended that Pharmavite discontinue the claim "Nearly 4X Better Absorption* *than standard fish oil concentrate, following a challenge by RB, LLC, the maker of MegaRed Omega-3 dietary supplement. At issue was whether the advertiser could support its claim with testing that used a higher dose of the active ingredient than what is contained in the actual product and extrapolate the absorption differential for its claim.
NAD agreed with the advertiser that a human absorption study conducted with 500 mg of EPA/DHA is not the sole means by which it could support the challenged claim. However, because "nearly 4X better absorption" is a health-related advertising claim, NAD determined that the advertiser must demonstrate that its basis for extrapolating the absorption differential was grounded in competent and reliable scientific evidence. Following its review, NAD found that the evidence in the record was insufficient for the advertiser's absorption claim. Accordingly, NAD recommended the claim be discontinued.
Notwithstanding the fact that the advertiser agreed to conduct a further clinical trial to provide additional evidence of the absorption benefit of its product, because it did not agree to comply with NAD's recommendations, NAD referred the matter to the FTC.
NAD looks for a "good fit" between an advertiser's substantiation and its claim. Testing a formulation that differs in any material way from the product itself will always be difficult for an advertiser to defend, particularly if health claims are involved.
* * *
Central to evaluating the truthfulness of the "nearly 4X better" claim is whether a study that compared the absorption of two doses of EPA/DHA can reliably support a quantified absorption claim for a dose lower than the dose tested in the study.
This alert provides general coverage of its subject area. We provide it with the understanding that Frankfurt Kurnit Klein & Selz is not engaged herein in rendering legal advice, and shall not be liable for any damages resulting from any error, inaccuracy, or omission. Our attorneys practice law only in jurisdictions in which they are properly authorized to do so. We do not seek to represent clients in other jurisdictions.