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NourishLife revokes Speak claims to follow National Advertising Division recommendations

1 commentBy Maggie Hennessy , 15-Oct-2013
Last updated on 08-Nov-2013 at 22:49 GMT2013-11-08T22:49:44Z

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.”

1 comment (Comments are now closed)

SpeechNutrients Refutes Disparaging Representations Made by Truth In Advertising Organization

November 8, 2013 NourishLife, the makers of the SpeechNutrients speak™ omega-3 + vitamin E dietary supplement, dispute the allegations made by Truth in Advertising (TINA), an organization claiming to be a consumer watchdog group and cautions other companies against TINA’s questionable tactics.

In March of 2013, NourishLife was contacted by TINA who had subjectively decided that NourishLife’s marketing needed to be altered. TINA’s allegations focused on standard industry practices used by Nourishlife including the use of the term “pharmaceutical grade”, a phrase to indicate purity and high standards, use of stock photo images of consumers on the SpeechNutrients website (provided by NourishLife to protect individuals’ privacy), and a link to an informational website which follows the “2 click rule” of separation, a common industry practice.

TINA also dictated that NourishLife needed to change “patented” to “patent-pending.” Furthermore, TINA took it upon themselves to question the doses and level of nutrients in speak’s™ licensed-formulation despite the product’s 5 year track record of safety, with nutrient levels in complete compliance with FDA DSHEA (Dietary Supplement Health and Education Act of 1994, the federal statute governing dietary supplements.)

TINA further demanded sweeping changes to the marketing of the speak™ product and threatened to contact Federal and State agencies unless their demands were met within a week. To address their questions, NourishLife provided 723 pages of substantiation to TINA, verified by signature as received on March 27, 2013 at 11:41 am. Approximately 29 minutes later, at 12:10 pm, TINA emailed NourishLife announcing that they had reviewed NourishLife’s materials and proceeded in their threat of filing complaints with the FDA, FTC, NAD, Children’s Hospital and Research Center Oakland (CHRCO) and other organizations.

According to Mark Nottoli, President of NourishLife, “We were disappointed to say the least that TINA attacked speak™ in such an aggressive and non-judicial manner. We question how 723 pages of scientific documentation could be read and evaluated in less than 30 minutes from receipt. For the TINA organization to condemn our product which has provided benefits to thousands of children without thoroughly reviewing the science provided is reprehensible, irresponsible, and outrageous.”

Nottoli continues, “Due to TINA’s bullying tactics and in an effort to cooperate and avoid time-consuming engagement, we elected to remove “pharmaceutical grade” from our packaging and revise “patented” to “patent-pending” to reflect our 2 patent applications. In addition, we inactivated our DSHEA compliant third party website because to list NourishLife as the author as TINA demanded could be seen as the promotion of a particular manufacturer, in violation of DSHEA.” Ultimately, in response to these changes, TINA withdrew their complaints to Federal and State agencies.

Robert Armstrong, an attorney specializing in FDA/FTC compliance and NourishLife’s legal counsel states, “In over 35 years in the nutrition industry, I’ve never seen such aggressive tactics and demands placed on a company without due process, especially one who has been previously reviewed by regulatory agencies and found to be in compliance. Speak™ is a perfectly legal and safe dietary supplement, marketed in concordance with DSHEA. I caution other supplement companies operating within the law to be vigilant to TINA’s tactics as there are no regulatory organizations watching what TINA is doing.”

The National Advertising Division (NAD) of the Better Business Bureau was one of the organizations contacted by TINA. Unlike TINA, the NAD undertook a fair and thorough evaluation of NourishLife’s marketing and recommended modifications to some of NourishLife’s claims due to the emerging nature of the science on children with certain nutritional requirements.

In their decision regarding the matter, the NAD noted with appreciation NourishLife’s offer to voluntarily revise certain items. In addition, NAD stated, “NAD is mindful that the advertiser’s product provides supplementation for a population struggling to find alternative therapies to aid in the development of healthy speech.” (NAD decision 2013) In regards to the remaining claims, NAD determined that the science was emerging, and claims should reflect that level of substantiation. NourishLife agreed to take the NAD’s recommendations into consideration in future marketing and have modified claims to reflect NAD’s recommendations.

GOED, the Global Organization for EPA and DHA of which NourishLife is a founding member, has also cautioned their members against attacks from the media and misinformed sources. In a recent letter, Adam Ismail, the Executive Director of GOED cautioned, “I firmly believe that the increased frequency of attacks on omega-3s is going to continue and is going to require a new approach as an industry.”

The SpeechNutrients speak™ product is a proprietary, patent-pending formulation developed by a pediatrician for children with special nutritional requirements. Thousands of children have used the speak product, and the company has received numerous anecdotal reports from parents and physicians describing the benefits observed in children. For the past four years, NourishLife has been the recipient of the Complaint Free Award from the Better Business Bureau, and in 2012 NourishLife was awarded the Outstanding Application in Health Management award at the Nutraceutical Business & Technology Awards in Geneva, Switzerland.

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Posted by SpeechNutrients
08 November 2013 | 22h262013-11-08T22:26:49Z

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