The National Advertising Division, referred Pharmavite, LLC to the Federal Trade Commission after the company refused to comply with NAD’s recommendations that it discontinue its claim that its NatureMade Omega 3 Xtra Blend dietary supplement has “Nearly 4X Better Absorption* *than standard fish oil concentrate.”
To substantiate its “Nearly 4X Better Absorption” claim, Pharmavite relied on a study that compared the absorption of 630 mg and 1680 mg doses of EPA/DHA omega 3 fatty acids manufactured with and without a self-microemulsifying drug delivery system (SMEDS). The study determined that the absorption of EPA/DHA manufactured with SMEDS was better than the absorption rate of standard fish oil (manufactured without SMEDS) for the two doses of EPA/DHA. The study concluded that there was a 6.2 differential for a 630 mg dose and a 9.6 differential for a 1680 mg dose.
NAD found that Pharmavite’s basis for extrapolating the absorption differential was not grounded in competent and reliable scientific evidence. The recommended dosage of the NatureMade Omega 3 XtraBlend supplement was only 500 mg – 20% below the dosage range in the study. Specifically, NAD was concerned that the study only had two empirically derived data points of 630 mg and 1680 mg and NatureMade was “not entitled to the same assumption of predictable linearity” as dosages within the study range. Especially since, the study report expressly limited its conclusions to dosages between 630 and 1680 mg.
Pharmavite has stated that it “has determined not to comply” with NAD’s recommendations because it submitted opinions from “four highly qualified experts, who each determined that the disputed claim is supported with competent and reliable evidence.” Despite its stated confidence in its substantiation, Pharmavite also stated that it “is undertaking an additional adequate and well-controlled clinical trial to provide additional evidence of the absorption benefit of its product…”
The FTC is not bound to NAD’s decisions and will review the evidence de novo. The FTC will apply the five Pfizer factors in its review of the claims and substantiation:
- the type and specificity of the claim made—e.g., safety, efficacy, dietary, health, medical;
- the type of product—e.g., food, drug, potentially hazardous consumer product, other consumer product;
- the possible consequences of a false claim—e.g., personal injury, property damage;
- the degree of reliance by consumers on the claims; and
- the type, and accessibility, of evidence adequate to form a reasonable basis for making the particular claims. (Pfizer, Inc., 81 F.T.C. 23, 64 (1972))
The FTC’s findings will likely hinge on whether experts in the field would agree that Pharmavite’s extrapolation of the results of the absorption study to its 500 mg dosage was reasonable and whether Pharmavite’s new study confirms that that extrapolation was reasonable.