BBB National Programs Archive

NAD Refers Advertising Claims for Pharmavite’s NatureMade Omega-3 Xtra Blend Dietary Supplement After Advertiser Declines to Comply with Recommendation

New York, NY – Feb. 5, 2018 – The National Advertising Division has referred an absorption claim made by Pharmavite, LLC for its NatureMade Omega-3 Xtra Blend Dietary Supplement to the Federal Trade Commission (FTC) for further review, after the advertiser said it would not comply with NAD recommendations.

NAD is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus.

NAD 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.

The recommended daily intake of Nature Made Omega-3 with Xtra Absorb Technology is one capsule, which contains 500 mg of EPA/DHA omega-3 fatty acids.  Omega-3 fatty acids are poorly absorbed by the body unless taken with a high fat meal.  An omega-3 supplement that could be absorbed more easily without requiring a high fat meal may have a significant competitive advantage.  The advertiser claims that Nature Made supplements, manufactured with self-microemulsifying drug delivery system, or SMEDS, technology are absorbed “nearly 4x better” than standard fish oil.

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.

NAD noted in its decision that the parties agreed that SMEDS technology enhances absorption of DHA and EPA even in the absence of a high fat meal and that the study in question, the Qin study, was reliable and well-conducted. The main disagreement between the parties was whether the absorption differential of Nature Made could be reliably extrapolated from the Qin study, which examined the absorption of higher amounts of EPA and DHA.

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 not a good fit for the advertiser’s absorption claim. NAD recommended the claim be discontinued.

Pharmavite, in its advertiser’s statement, took issue with NAD’s findings and said the company “has determined not to comply with NAD’s recommendation.”

“Pharmavite strongly disagrees with the NAD decision and the NAD’s characterization of Pharmavite’s position and the evidence in the case. Pharmavite has great confidence in the opinions of its four highly qualified experts, who each determined that the disputed claim is supported by competent and reliable scientific evidence.  However, out of respect for the self-regulatory process, and in consideration of NAD recommendation, Pharmavite is undertaking an additional adequate and well-controlled clinical trial to provide additional evidence of the absorption benefit of its product, against the same comparator at the same dosage as used in the lower dose … study,” the company said.

Pursuant to its procedures, NAD has referred this case to the attention of the appropriate government agency for possible enforcement action.

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.