Natural Organics, Inc., of Melville New York, and its owner, Gerald A. Kessler, have been charged by the Federal Trade Commission in an administrative complaint with making unsubstantiated claims that its dietary supplement tablets, "Pedi-Active A.D.D.," treat or mitigate Attention Deficit Hyperactivity Disorder (ADHD). In its advertisements, the company also claims that Pedi-Active A.D.D. improves the attention span and scholastic performance of children who have difficulty focusing on their schoolwork.
This is the FTC's fifth action involving products marketed to treat ADHD, a behavioral disorder which affects up to 2.5 million school-aged children in the United States. ADHD's symptoms include inattention, impulsiveness and hyperactivity. Although these behaviors are common in nearly all children at some time, in children with ADHD, the behaviors are chronic and age inappropriate. The most common treatment for ADHD is a combination of physician-prescribed stimulants and behavior therapy. The ads at issue prey on a vulnerable population of parents seeking alternative treatments for their children.
"Consumers should be able to rely on advertising for solid information when they're making purchasing decisions," said Jodie Bernstein, director of the FTC's Bureau of Consumer Protection. "If they can't trust the claims in the ads, they're in a tough spot, particularly parents who are trying to do the best for their kids. ADHD is a serious condition, and parents who are concerned about it should talk to their children's doctors about appropriate treatment."
Natural Organics, which does business as "Nature's Plus," markets and sells Pedi-Active A.D.D., and a variety of dietary supplements through independent retail stores. Sixty tablets sell for approximately $12.56. In its print ads, a brochure, an informational letter, and its Web site, Natural Organics represents that Pedi-Active A.D.D. will treat or mitigate ADHD or its symptoms, including inattention and poor scholastic performance. The ads appear in numerous magazines.
The FTC's administrative complaint detailing the charges alleges that Natural Organics did not have a reasonable basis to substantiate the claims that Pedi-Active A .D.D.:
The notice order, attached to the administrative complaint, would prohibit Natural Organics from claiming that any food, drug or dietary supplement will improve the attention span of children; will improve the scholastic performance of children; or can treat or mitigate ADHD or its symptons, unless the claims are substantiated by competent and reliable scientific evidence.
The notice order also would prohibit Natural Organics from using the name "A.D.D." or any other name that represents that the product can treat or mitigate ADHD, in connection with the sale of Pedi-Active A.D.D. or any other substantially similar product, unless Natural Organics could substantiate that the product can treat or mitigate ADHD or its symptoms.
In addition, if the notice order is adopted, the respondents would be prohibited from making any claims about the health benefits, performance, or efficacy of any food, drug or dietary supplement, unless the claims are substantiated by competent and reliable scientific evidence. The notice order would allow the respondents to make representations specifically permitted by the Food and Drug Administration.
Finally, the notice order includes various reporting requirements to assist the FTC in monitoring the respondents' compliance with its provisions.
The FTC's Consumer Education Office has developed an FTC Consumer Feature titled: "Promotions for Kids' Dietary Supplements Leave Sour Taste," which offer valuable "Pointers for Parents." The full text of the consumer education feature can be found on the web at: www.ftc.gov.bcp/conline/features/kidsupp.htm
The Commission vote to issue the administrative complaint and notice order was 5-0.
NOTE: The Commission issues a complaint when it has "reason to believe" that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the defendant has actually violated the law. Such action marks the beginning of a proceeding in which the allegations will be ruled upon after a formal hearing.
Copies of the complaint and the notice order 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; 877-FTC-HELP (877-382-4357); TDD for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
Office of Public Affairs
Matthew Gold or Kerry O'Brien
Western Region - San Francisco
415-356-5276 or 415-356-5289
(FTC File No. 972 3175)