Marian Zboraj12.01.07
Advertising Claims Crackdown
NAD makes its presence known in the dietary supplement market.
By
Marian Zboraj
Associate Editor
In an effort to more closely monitor the dietary supplement industry and its sometimes outlandish and unsupported advertising claims, the National Advertising Division (NAD) of the Council of Better Business Bureaus, New York, NY, recently expanded its review on dietary supplements, pursuant to a series of grants from the Council for Responsible Nutrition (CRN), Washington, D.C.
“By actively participating in the self-regulatory process, the nutraceuticals industry can avoid unnecessary government regulation and/or involvement in its advertising,” said Andrea Levine, director, NAD. “Our program is a totally voluntary system. However, NAD is always disappointed when a company elects not to participate in the process. When that happens—which is not often as 96% of the companies involved participate and comply with NAD’s recommendations—our procedures require that we forward the matter to the appropriate government agency.”
As part of the increased activity in the dietary supplement industry, NAD recently examined advertising from cooperating companies Amerifit Brands, Inc., Cromwell, CT, and Sera-Pharma Labs, Fairfield, NJ. In the case of Sera-Pharma Labs, NAD reviewed claims for Amidren, a dietary supplement aimed at aging men. At the outset, Sera-Pharma Labs explained that its product represents a new category of dietary supplement for andropause, a recently identified natural state of aging males that is marked by a decrease in testosterone and an increase in dihydrotestosterone, which is linked to hair loss and prostate health issues, and a variety of other symptoms.
Following its review, NAD found insufficient evidence in the record to support the advertiser’s claims that Amidren can decrease body fat, help users gain lean muscle, improve mood or energy, prevent thinning hair or increase bone mass. As a result, NAD recommended that those claims be discontinued. NAD noted that the evidence in the record supports a clearly qualified claim that certain ingredients in Amidren may help relieve some symptoms of andropause and that any efficacy claims be limited accordingly.
However, NAD determined that any expressed or implied claims relating to the treatment of benign prostatic hypertrophy, or enlarged prostate, are unsupported and should also be discontinued. In addition, NAD suggested Sera-Pharma Labs modify its advertising to avoid conveying the unsupported implied message that Amidren is effective in increasing male sexual arousal and/or performance or improving physical strength or mental acuity.
In Sera-Pharma Labs’ advertiser’s statement, the company said it “appreciates the NAD’s recommendations in this matter and will remain committed to providing truthful advertising regarding its products to its consumers.”
In the case of Amerifit Brands, NAD examined advertising for the company’s Estroven, Estroven PM and Estroven Vitality dietary supplements. NAD examined evidence that included several studies on ingredients that are found in Estroven, including black cohosh and valerian root. However, NAD determined that in the absence of any testing on the product itself, the advertiser’s “clinically proven” claims for Estroven were unsupported. Although NAD did find that the totality of the research indicated that these ingredients could “help” accomplish the claimed benefits.
In the end, NAD recommended that Amerifit discontinue its “clinically proven” claims and make certain milder ingredient performance claims, i.e., that Estroven contains black cohosh, isoflavones and valerian root—ingredients that may help reduce the symptoms associated with menopause and in the case of valerian root, may help one sleep.
In response, Amerifit Brands did agree that there are changes that need to be made and said it would comply with NAD’s suggestions.
“While we didn’t necessarily agree that the standard they applied was the correct legal standard, i.e., that you can’t support a ‘clinically proven’ claim based on ingredients versus specific clinicals on formulation, we did understand the basis for their concern, and we believe modifying the claims to meet their recommendations offers us an equally compelling basis for consumers to choose our product,” said Craig Larsen, Esq., vice president, Legal & Regulatory Affairs, Amerifit Brands.
Overall, Mr. Larsen feels it’s important for all companies to cooperate with this self-regulatory forum. “While in our case we don’t necessarily agree with their outcomes and suggestions, it has provided us with a greater insight into our products, and how they may be viewed by consumers and other regulatory agencies alike,” he said. “Between our written responses to the NAD and the conversations we had, we gained a new perspective, which ultimately will guide us to better decision making and more effective marketing in the future. We have used our experience with the NAD as a learning tool, and we would encourage others to cooperate and do the same.”
Bioforce USA, Ghent, NY, is another company that applauds CRN and NAD for their efforts at developing a self-regulation initiative, citing public trust as key to the future of the industry and such initiatives—if well-conceived and executed. However, Bioforce says the current manner in which CRN and NAD work together does not meet this standard for several reasons, which is why the company has declined to participate in NAD’s advertising review of Curbita, a German pharmaceutical GMP-certified pumpkin seed oil dietary supplement distributed in the U.S. by Bioforce. Citing concerns over the appearance of impropriety, Bioforce’s reasons for refusal all relate to the fact that the “competitive challenge” had been directly initiated by CRN on behalf of itself and its members.
CRN challenged structure-function claims being made for Curbita, including claims like “helps strengthen bladder muscles” and “helps support normal emptying of the bladder,” which Bioforce says have been confirmed for decades by both science and traditional use. While the manufacturer can cite more than 90 references regarding the safety and efficacy of this ingredient, Bioforce chose not to participate because it believes that it is inappropriate for CRN to file direct complaints with the NAD under a program for which CRN provides direct funding to and then acts as both judge and jury in such matters.
According to Bioforce, since CRN is able to file challenges in its own name and on behalf of its limited membership, the trade association removes the ability for the challenged company to review any advertising claims made by its real challenger—presumably one or more CRN member companies. Allowing CRN to file “competitive advertising” challenges on behalf of its members serves to protect CRN members that may be making identical claims, says Bioforce, and forces non-member companies such as Bioforce to expend significant resources defending their advertising. If a CRN member company wishes to challenge a competitor, Bioforce believes it should do it on its own account.
As a result of Bioforce’s refusal, NAD will refer advertising from Bioforce’s Curbita to the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA).