New York, NY – May 9, 2014 – The National Advertising Division has recommended that Akeso, LLC, the maker of “MigreLief Original Formula” for adults and “Children’s Migrelief” dietary supplements, discontinue a wide range of claims for the products, which are marketed as providing relief from migraine headaches.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus. The claims at issue in this case were challenged by the Council for Responsible Nutrition.

Key to NAD’s decision was an examination of the advertiser’s evidence regarding Puracol, Akeso’s proprietary feverfew formulation, and ingredients magnesium and riboflavin.

Following its review of the evidence in the record, NAD recommended Akeso discontinue the following claims:

• “Children’s MigreLief offers the parents of children who suffer from migraines a safe nutritional option, with none of the potentially disruptive side-effects of prescription drugs, to maintain normal cerebrovascular tone and function in their children”‘ and “MigreLief contains a patented ‘Triple Therapy’ approach to reestablishing normal cerebrovascular tone and function which is disrupted in children who have migraines,” 
•  “MigreLief can safely be used with migraine prescription medications or by itself.”
•  “Randomized clinical trials have shown that both high dose Riboflavin and oral Magnesium function prophylactically in children to both reduce migraine frequency and intensity” 
•  “MigreLief can safely be used with migraine prescription medications or by itself

NAD recommended that the advertiser discontinue its “doctor-recommended” claim that “all 3 ingredients have been recommended for years by many doctors and top headache specialists based on the clinical studies behind them,” because the advertiser did not provide any evidence that demonstrated that doctors recommend riboflavin, magnesium or feverfew migraine prevention.

The advertiser submitted no evidence on the efficacy or safety of its proprietary blend of Puracol or magnesium. Given the absence of such evidence, NAD recommended that the advertiser discontinue the following claims:

•  “Puracol, MigreLief’s proprietary blend of two unique feverfew sources, magnesium from two sources and high dose, highly absorbable riboflavin (Vitamin B-2) have all independently been shown to be of significant therapeutic benefit to chronic migraine sufferers;”
•  “Plus, MigreLief’s Puracol Feverfew contains high levels of parthenolides and other active components, which other feverfew products can not guarantee;” and
•  Puracol Feverfew is just one of the reasons for the superior efficacy of MigreLief.”
•  “In addition to high dose riboflavin, a specific combination of two forms of magnesium which maximize absorption and efficacy are used in MigreLief.”

NAD further recommended the advertiser discontinue the following testimonials: NAD

•  “MIGRELIEF has done a wonderful job for my patients who have migraine headaches. I have found on several patients who use this product that the incidence of their migraine headaches has diminished by 75 percent in addition to taking less in the way of prescription drugs.” —-Jack J. M.D”
•  “MIGRELIEF has kept me nearly migraine free for the past 12 months,” — Bruce
•  “I simply cannot believe the difference after about 3 weeks of taking the tablets. Amazing product. I take very very few Imitrex and Maxalt now and am off of the Topomax entirely. Thanks for making this so well…” -Bryan L
•  “This product has taken me from daily headaches to nearly no headaches

NAD determined that the advertiser had a reasonable basis for its claim “so, with MigreLief, you need only one product (instead of separate feverfew, magnesium and riboflavin products),” but recommended it discontinue the claim “you take only two tablets per day, versus 4 to 10 tablets per day if taken separately,” because no evidence was provided comparing the dosages of other single ingredient supplements.

NAD determined that the advertiser had provided a reasonable basis for its claim that it contains magnesium in a quantity “far above what’s found in most multi-vitamins,” but recommended that the advertiser modify its claim “recommended daily dosages of magnesium typically range from 200 to 600 mg to compensate for this deficiency, far above what’s found in most multi-vitamins” to reflect the fact that the recommended daily allowance for magnesium in dietary supplement form is 240 to 350 mg.

Akeso, in its advertiser’s statement, took issue with NAD’s findings but agreed to take NAD’s recommendations into account in future advertising.

“MigreLief Original Formula and Children’s MigreLief are both efficacious products that are highly valued by consumers,” the company said. “Akeso will redouble its efforts to communicate the benefits of both products in a truthful and accurate manner.”