In the settlement, NourishLife LLC and its owner, Mark Nottoli, have agreed to stop making non-compliant claims on the Speak softgels and capsules and Speak Smooth liquid supplements that were sold online and through distributors for about $70 a bottle. The company has also agreed to a $200,000 fine, which is part of a $3.68 million suspended settlement. The supplements, which contain Omega-3 and Omega-6 fatty acids and Vitamins E and K, were advertised via the Internet, including search engine ads such as Google sponsored links and on websites, and at conferences on autism spectrum disorders.
“Parents of children with speech disorders need accurate information about products that may be able to help,” said Jessica Rich, director of FTC’s Bureau of Consumer Protection. “This company took advantage of parents’ trust.”
“If you are going to make claims regarding children’s products that’s an invitation for scrutiny from the FTC,” Marc Ullman, a principal in the law firm Ullman, Shapiro & Ullman told NutraIngredients-USA. “The commission is making no secret that those kinds of claims are a priority.”
The FTC’s complaint alleged that NourishLife failed to disclose the fact that parent and practitioner endorsers of the products were compensated by receiving substantial amounts of the products for free. The complaint also said the company fraudulently maintained that the site apraxiaresearch.com, to which visitors the company’s website were directed, was an independent research organization.
NourishLife’s outsized claims on the effect its products allegedly had on children suffering from apraxia and autism who had delayed speech first came to light almost two years ago in the form of a March 2013 letter by consumer advocacy group Truth in Advertising (TINA) sent about NourishLife's marketing of Speak to the company, the Attorney General of Illinois (where NourishLife is based), the Federal Trade Commission and the US Food and Drug Administration (FDA) after a months-long investigation of the company revealed a number of allegedly deceptive marketing claims, such as claims that the product showed results in “as little as one week.”
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. The ads included claims by users that they saw benefits "as soon as the first week". NourishLife received a recommendation from the National Advertising Division of the Council of Better Business Bureaus to remove the noncompliant claims from its website and to shut down the apraxiaresearch.com website. At that time, the company said it was complying with the recommendations.
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).
Long road to settlement
In the FTC complaint, the noncompliant ad language and undisclosed material connections it cited were from 2013. The apraxiaresearch.com website is now inactive, but it is unclear when the site was taken down.
“We don’t know when exactly the FTC picked this up and what actually triggered this action and whether NourishLife did what they told the NAD they would do back in 2013,” Ullman said.
But Ullman said it was not uncommon for the resolution of FTC actions to drag on for what to outsiders seems an inordinately long time.
“You have to keep in mind that at FDA all they have to do is say you are making a drug claim and they can shut you down. FTC has to go out and affirmatively demonstrate the absence of substantiation. It’s a lot more involved for the FTC,” Ullman said.