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 A.D.D -- 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 A.D.D. 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 A.D.D. 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 A.D.D., as well as several hundred other dietary supplement products. The company sold Pedi-Active A.D.D. 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 A.D.D. 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 A.D.D., 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 "A.D.D." or any other name that represents that Pedi-Active A.D.D. 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. A summary of the proposed consent agreement will be published in the Federal Register shortly. The agreement will be subject to public comment for 30 days, until August 30, 2001, after which the Commission will decide whether to make it final. Comments should be addressed to the FTC, Office of the Secretary, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580.
NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.
Copies of the complaint, the proposed consent agreement and an analysis to aid public comment are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC works for the consumer to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop and avoid them. To file a complaint, or to get free information on any of 150 consumer topics, call toll-free, 1-877-FTC-HELP (1-877-382-4357), or use the complaint form at https://www.ftc.gov/ftc/complaint.htm. The FTC enters Internet, telemarketing, identity theft and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.
(FTC Matter No. D-9294)
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