Natural Organics Settles FTC Charges That
They Made Unsubstantiated ADHD Treatment Claims

FTC News Release
July 31, 2001

Natural Organics, Inc., based in Melville, New York, and its president, Gerald Kessler, have agreed to settle Federal Trade Commission charges that they made unsubstantiated claims that their dietary supplement product — Pedi-Active ADD — would mitigate or effectively treat Attention Deficit/Hyperactivity Disorder (ADHD) or its symptoms. The FTC also had alleged that the respondents, in their advertisements, made claims that Pedi-Active ADD would improve the attention span and scholastic performance of children who have difficulty focusing on school work. The proposed consent agreement to settle the charges would prohibit the respondents from making claims about the ability of Pedi-Active ADD or any other food, drug or dietary supplement to treat not only ADHD in children, but also any childhood disease or mental disorder, unless they possess competent and reliable scientific evidence to support such claims.

ADHD is a behavioral disorder which affects up to 2.5 million school-aged children in the United States. ADHD's symptoms — inattention and/or impulsiveness and hyperactivity — are common in nearly all children at various times. However, in children with ADHD, the symptoms are chronic and age inappropriate. The disorder can severely affect a child's school performance, family relationships and social interactions.

In August 2000, the FTC issued an administrative complaint against Natural Organics, which does business as "Nature's Plus." Natural Organics markets Pedi-Active ADD, as well as several hundred other dietary supplement products. The company sold Pedi-Active ADD through independent retail stores for approximately $14.00 for 60 tablets. The FTC's complaint alleged that Natural Organics represented through print ads, a brochure, an informational letter and on its website that Pedi-Active ADD would treat or mitigate ADHD or its symptoms, including inattention and poor scholastic performance, without having a reasonable basis to substantiate those claims.

The proposed consent agreement announced today would prohibit the respondents from claiming that Pedi-Active ADD, or any food, drug or dietary supplement, would improve the attention span of children, would improve the scholastic performance of children, or can treat or mitigate ADHD in children, unless they have reliable scientific evidence to substantiate those claims. In addition, the proposed settlement would require the respondents to possess and rely upon competent and reliable scientific evidence before claiming that any food, drug or dietary supplement marketed for children can treat or cure any disease or mental disorder.

The proposed agreement would also prohibit Natural Organics from using "ADD" or any other name that represents that Pedi-Active ADD or any substantially similar product marketed to children can treat or mitigate ADHD, unless they have competent and reliable scientific evidence that the product is effective in treating or mitigating ADHD.

The consent agreement would allow the respondents to make representations for drugs or dietary supplements that are specifically permitted by the Food and Drug Administration.

The Commission vote to accept the proposed consent agreement and place it on the public record was 5-0.

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This page was posted on November 20, 2005.

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