FTC News Release
May 11, 2000
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.
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, Efalex&mark; 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.
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.
- Dietary supplements in this country are not held to any set of federal standards for quality or purity.
- Your best advisor is your child’s pediatrician or another health care provider. Be sure to check with them before starting your child on a supplement. And keep them informed of your child’s continuing use of the product.
- Supplements advertised as “natural” are not necessarily safe. In fact, herbs, like other so-called natural products, can have powerful drug-like effects. Some of these effects can be especially risky for people who take other medicines or have certain medical conditions.
- Fraudulent promoters often fall back on the same claims to trick consumers into buying their products. Some tip-offs that they’re trying to fool you are:
- Claims that the product is a “scientific breakthrough,” “miraculous cure,” “exclusive product,” “secret ingredient,” or “ancient remedy.”
- Claims that the product is a quick and effective cure for a wide range of ailments.
- Claims that the government, medical profession and health care industry are in a conspiracy to suppress the advertised product.
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.
- In the Matter of Efamol Nutraceuticals. Docket No. C-3958, FTC File No. 992-3027.
- In the Matter of J & R Research, and Gerald G. McCarthy. FTC File No. 972-3234.
This page was posted on November 28, 2005.