By D. John Hendrickson
The NAD found that Great Health Works, LLC had a reasonable basis to make several establishment and performance claims regarding the efficacy of the Omega-XL supplement in reducing joint inflammation and pain.
In reaching its decision, the NAD noted that eight clinical studies have been conducted on the Omega-XL preparation over a period of thirty years, with the last trial being published in 2013, and in the arena of dietary supplements, such evidence that utilizes the product itself, as opposed to simply the ingredients in a compound, is the “gold standard” of clinical trial testing on a dietary supplement. Further, the NAD found that at least one of the advertiser’s “gold standard” studies constituted competent and reliable scientific evidence because it was randomized, placebo-controlled, conducted on eighty subjects over a six month period, utilized a validated pain assessment scale and obtained statistically significant and clinically relevant results against a placebo group.
The balance of the challenge, however, which was brought by the Council for Responsible Nutrition, a dietary supplement industry trade association, was a mixed bag for the advertiser. To illustrate that point, when considering the claim that “Omega-XL is a breakthrough secret supported by over 30 years of clinical research,” the NAD found that the advertiser had a reasonable basis to state that Omega-XL is supported by over thirty years of research…but a thirty-year old product, by definition, cannot be a “breakthrough secret.”
Similarly, the NAD determined that the advertiser had provided a basis for its claims that “Omega XL is so potent it requires only a very small dose to be effective,” and “Omega XL, smaller, yet MORE POTENT than regular fish oil,” but because these are such powerful superiority claims, they would only be reasonable if the advertiser modifies the claims to clearly and conspicuously disclose the basis of the comparison (i.e., a standard 18% EPA and 12% DHA omega-3 fatty acid blend).
On the other side of the spectrum, the NAD recommended the discontinuance of a claim that Omega-XL “makes it easy for you,” because it conveys to consumers that they will experience pain relief quickly, but the advertiser’s clinical studies only began to demonstrate pain reduction results at four weeks. In addition, NAD recommended the discontinuance of its unqualified claims that there is “no known drug interactions” and “does not interfere with other medications,” because although they may be literally true, the product studies did find side effects, which may or may not have been a result of interactions with the participants’ other medications.
Takeaway: To stand up to scrutiny, particularly when dealing with a dietary supplement product, the advertiser will want clinical testing on the product itself, which is conducted in an independent setting with a well-designed competent and reliable scientific protocol.
Legal disclaimer: This article is not intended to constitute legal advice or to create an attorney-client relationship. We trust you knew this anyway.