A dietary supplement claiming to provoke remarkable speech gains in children has removed these claims from its website and is in the process of removing it from product packaging after the National Advertising Division of the Council of Better Business Bureaus recommended that it provide substantiation for a wide range of advertising claims.
In its marketing materials, NourishLife claimed that its patented formula for SpeechNutrients Speak could help children suffering from apraxia and autism who had delayed speech. The ads included claims by users that they saw benefits "as soon as the first week".
In August, NAD requested that NourishLife remove the following claims from all marketing materials:
- “Promotion of healthy inflammatory response;
- “Pharmaceutical Grade”;
- See benefits “as soon as the first week”;
- “Others notice advances in speech and coordination after several weeks”;
- “The combination of omega-3 within vitamin E together had a dramatic impact on these children's symptoms, not only helping with speech, but also improved eye contact and helping to improve pain sensation"; and
- "A patented nutritional therapeutic formulation designed for the treatment of apraxia."
NAD also recommended that the Apraxia Research website that NourishLife directed consumers to as an independent resource for information on childhood speech delays (which was actually created and owned by NourishLife without being disclosed) be inactivated. The company has complied.
In its advertiser’s statement, the company said it “has enlisted the support of numerous scientists and experts in the field in our efforts to have reliable and competent scientific evidence. While NAD asserts that the science behind the Speak product is emerging, NourishLife maintains that the body of science sufficiently supports the claims made. However, with the combined goal of full cooperation with advertising self-regulation, NourishLife has voluntarily discontinued certain claims and agrees to take NAD's recommendations into consideration in future marketing materials and advertising."
'Alternative to FTC enforcement action'
"NAD's advertising review program encourages responsible self-regulation, which increases consumer confidence in dietary supplement industry," Rend Al-Mondhiry, regulatory counsel at the Council for Responsible Nutrition, told NutraIngredients-USA. "It's an independent review process performed by attorneys at NAD whereby companies have the opportunity to modify and self-correct questionable advertising claims. The program is an alternative to FTC enforcement action. We have a high participation rate, roughly 90%."
She added that one of the benefits of the forum is it doesn't involve legalities. "Only a few companies refer to the FTC. Sometimes when a company hears that, they change their mind and participate," she said. "Obviously, NAD will highly scrutinize claims that imply a product is an alternative to conventional medical treatment. Those are a priority."
NAD's recommendations followed a March 2013 letter by consumer advocacy group Truth in Advertising sent complaint letters about NourishLife's marketing of Speak to the company, the Attorney General of Illinois (where NourishLife is based), the Federal Trade Commission and the U.S. Food and Drug Administration (FDA) after a months-long investigation of the company revealed a number of similar deceptive marketing claims.
TINA also found that all but one of the “family” photos associated with the testimonials regarding the effectiveness of Speak were professional photos purchased from iStock.com, and that Speak contains a highly elevated level of vitamin E that exceeds the tolerable upper intake level set by the Food and Nutrition Board. It alerted the FDA and has not withdrawn that portion of its complaint.
In response to the TINA investigation, the company issued a longer response, which is posted in the comments section at the end of this article.
“If the Natural Products Foundation had been exposed to these ads, we certainly would have acted,” said Marc Ullman, a partner at law firm Ullman, Shapiro & Ullman who is active in the NPF's Truth in Advertising campaign. He noted that the NPF sends roughly 100 letters a year identifying noncompliant dietary supplement promotions. “A product claiming to treat apraxia and autism has no business in the dietary supplement category.”
Holes in the research
NourishLife used the results of a 2009 study published in Alternative Therapies in Health and Medicine , as the primary support for its claims that Speak treats apraxia. For the study, doctors Claudia Morris and Marilyn Agin gave daily supplements of omega-3 and vitamin E to a sample of 187 children with verbal apraxia, finding that they were associated with improvements in speech, imitation, eye contact and behavior in 97% of the sample. But the study contained notable limitations.
Among them, the researchers did not use any sort of control group whatsoever to determine whether the perceived improvements were caused by the supplement or by something else; the children in the study were given widely varying doses of the supplements under investigation (vitamin E doses ranged from 400 International Units [IU] to 3,000 IU per day); the results were based on subjective answers; and study does not include the same ingredients that are contained in the Speak supplement (specifically, vitamin K).
When asked how companies get so far in the marketplace using false claims, Ullman replied: “Because there are unscrupulous businesses out there who aren’t really in the supplement business; they’re in the fraud business. They make the calculation that it’s worth the risk to go out to market and make outrageous claims and exit the market before they face serious action.”