Supplement firms to settle charges on ADHD claims

Two manufacturers of dietary supplement products touted as helping to manage or cure attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) have agreed to settle Federal Trade Commission (FTC) charges that the claims they made for their products lacked adequate scientific substantiation, the FTC said.

The companies, Boston-based Efamol Nutraceuticals and Massena, Iowa-based J&R Research, would be prohibited by the proposed agreements from making certain claims about their products without adequate substantiation.

Efamol markets two supplements containing essential fatty acids, Efalex and Efalex Focus, which the company has promoted in a series of magazine advertisements.

One Efalex ad claims that studies "show that some children with Attention Deficit Hyperactivity Disorder... have problems converting essential fatty acids into the long chain forms the body needs to maintain optimum eye and brain function."

"Only Efalex provides the precise combination of these important fatty acids--G.A., DHA and AA--to properly manage this deficiency," the ad states.

Another ad asserts that "nutritional research conducted at a major American university" has backed up the essential fatty acid deficiency theory for ADHD.

To promote its pycnogenol supplement for ADD/ADHD, J&R Research--a general partner in the Longmont, Colorado-based multi-level distributorship Kaire International--created advertising materials that it sold to Kaire distributors.

Pycnogenol "is becoming a very attractive first-line method of choice by many physicians, in preference to conventional drug administration" for children with attention disorders, the materials state. "Also, in most cases, traditional drug therapy can usually be discontinued--or significantly reduced--provided the patient continues to consume pycnogenol." The FTC noted that the two new agreements represent the agency's third and fourth cases involving products marketed to treat ADHD. Companies advertising unsubstantiated treatments for the condition "prey on a vulnerable population of parents who seek a 'natural' alternative to prescription medications," such as Ritalin, according to a statement released by the agency. "Our fear is that parents who fall for the claims may ignore proven, and perhaps essential, treatments for their child's disorder," FTC Bureau of Consumer Protection Director Jodie Bernstein explained. "That's why parents should exercise caution in giving supplements to their kids."

Along with barring the companies from making unsubstantiated claims, the proposed agreements include other provisions, such as a clause requiring the firms to make copies of advertising and consumer correspondence available to the FTC on request for a period of 5 years.

The commission has voted five to zero to accept the agreements for public comment. The Efamol and J&R Research proposals will be published in the Federal Register and open to comment until June 12 and July 12, respectively. After the comments period closes, the FTC will decide whether to make the agreements final.

The FTC has developed "Promotions for Kids' Dietary Supplements Leave Sour Taste," which offers pointers for parents. It is available on the Internet at http://www.ftc.gov/bcp/conline/features/kidsupp.htm.