Efamol Nutraceuticals, Inc., and J & R Research, Inc., two companies that market and sell dietary supplements that claim to mitigate or cure the effects of Attention Deficit Disorder or Attention Deficit Hyperactivity Disorder (ADHD), have agreed to settle Federal Trade Commission charges that the claims for their products were unsubstantiated. The products are: Efalex and Efalex Focus, marketed by Efamol, and Pycnogenol, sold by J & R. In separate agreements, each company would be prohibited from making certain efficacy claims about their products unless they have scientific evidence to support those claims.
These are the FTC's third and fourth cases involving products marketed to treat ADHD, a behaviorial 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 commonly prescribed medications for treatment of ADHD are stimulants, such as Ritalin. The advertisements at issue prey on a vulnerable population of parents who seek a "natural" alternative to prescription medications.
"We're very concerned about how some dietary supplements for kids are being portrayed in ads," said Jodie Bernstein, director of the FTC's Bureau of Consumer Protection. "Many of the products have not been proven to provide the benefits they claim. Our fear is that parents who fall for the claims may ignore proven, and perhaps essential, treatments for their child's disorder. That's why parents should exercise caution in giving supplements to their kids."
Efamol Nutraceuticals, Inc., based in Boston, Massachusetts, markets and sells "Efalex" and "Efalex Focus," dietary supplement products that contain essential fatty acids. The FTC's complaint alleges that Efamol did not have substantiation for claims that Efalex and Efalex Focus can mitigate or cure the effects of ADHD, and are effective in reducing attention and behavioral problems. One of the ads at issue features a photograph of a young boy and includes the following statements: "FREAK Why would anyone say such a thing? He's a beautiful kid. But sometimes beautiful kids suffer from really ugly attention and behavior problems. Luckily, EfalexTM is here." Another ad touting Efalex is titled: "Long-term Side Effects May Include: Hugging Your Mom." The ad also states: "When your child is bouncing off the walls, hyper and aggressive, do you go crazy wishing he'd just let you love him?"
The proposed consent agreement with Efamol would prohibit the company from making claims that any food, drug or dietary supplement can cure, prevent, treat or mitigate ADHD or its symptoms; or that such product is effective in reducing attention and behavioral problems, unless it has competent and reliable scientific evidence to substantiate the claims. The proposed settlement would further prohibit Efamol from making any claim about the health benefits, efficacy or safety of any food, drug or dietary supplement that contains essential fatty acids, unless it has scientific evidence to support the claim. The proposed settlement would allow Efamol to make representations specifically permitted by the Food and Drug Administration.
J & R Research, Inc., based in Massena, Iowa, and its owner Gerald McCarthy, were general partners in a distributorship of Kaire International, Inc., a multi-level marketing company that was headquartered in Longmont, Colorado. J & R created and marketed audio tapes and other promotional materials to Kaire distributors that promoted a product containing pycnogenol. J & R made the claims at issue while acting as distributors for Kaire. The respondents touted pycnogenol as effective in treating ADHD as well as cancer, heart disease, arthritis, diabetes, and multiple sclerosis.
The FTC's complaint alleges that J & R did not have competent and reliable scientific evidence to support the claims that Kaire's pycnogenol products would treat or improve numerous health disorders and that consumer testimonials included in the advertising did not reflect the typical experience of those using the products. The complaint also alleges that the respondents falsely represented that scientific research established that the pycnogenol products are effective at treating or curing numerous diseases and disorders.
The consent agreement with J & R would prohibit the respondents from making the alleged claims when advertising pycnogenol or any other food, drug, or dietary supplement, without competent and reliable scientific evidence to substantiate the claims. In addition, they would be required to have competent and reliable scientific evidence before making any claim regarding the benefits, performance or efficacy of any food, drug, or dietary supplement. The settlement would also prohibit the respondents from misrepresenting the existence, contents, validity, results, conclusions or interpretations of any test, study or research in an advertisement for any product. The settlement would further prohibit J & R from deceptively representing that any user testimonial or endorsement of a product represents the typical or ordinary experience of members of the public who use the product. The settlement would allow the respondents to make representations specifically permitted by the Food and Drug Administration.
Finally, both settlements contain standard record keeping provisions designed to assist the FTC in monitoring the respondents' compliance.
The FTC's Consumer Education Office has developed an FTC Consumer Feature titled: "Promotions for Kids' Dietary Supplements Leave Sour Taste," which offers, among others, the following "Pointers for Parents":
Before giving your child a dietary supplement, be aware that many dietary supplements, especially herbal products, have not been tested in kids to determine their safety or effectiveness.
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 accept the two consent agreements for public comment was 5-0. The FTC's Western Region handled the investigations.
Announcements regarding the two proposed consent agreements will be published in the Federal Register shortly. The agreement with Efamol Nutraceuticals will be subject to public comment until June 12, 2000, and the agreement with J & R Research will be subject to public comment until July 12, 2000, after which the Commission will decide whether to make them final. Comments should be addressed to the FTC, Office of the Secretary, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580.
NOTE: Consent agreements are for settlement purposes only and do 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 complaints, consent agreements and analyses of the agreements to assist the public in the Efamol Nutraceuticals and J & R Research matters 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.
(FTC File No. 992 3027 - Efamol Nutraceuticals)
(FTC File No. 972 3234 - J & R Research)