Dietary supplement advertising in the United States has come under increased scrutiny due to an initiative between the Council for Responsible Nutrition (CRN) and the National Advertising Division (NAD), a department of the Council for Better Business Bureaus. A series of grants supplied by CRN has enabled NAD to increase its staff and devote a significant amount of energy into reviewing and settling challenges of dietary supplement ads. In 2007, NAD reviewed a total of 25 dietary supplement advertising challenges, more than tripling the organization’s previous annual average of 8 (L. Bean, e-mail, January 11, 2008).
CRN, a leading trade association of the dietary supplement industry, announced in 2006 that it had allocated a series of grants totaling nearly $500,000 to NAD over a 3-year period.1 These grants enabled NAD to hire an attorney devoted specifically to monitoring dietary supplement advertising and resolving challenges brought against such ads.
According to CRN President and CEO Steve Mister, CRN primarily chose to fund the initiative with NAD because advertisements can impact the way the entire American public perceives the dietary supplement industry. “The advertising is seen by everybody, not just the people who use the product,” said Mister (oral communication, November 13, 2007). Mister argued that this program should help to quietly and effectively rectify or remove incorrect and misleading advertisements, while also sending a message to the entire industry that such ads are now the subject of increased monitoring.
“The vast majority of supplement advertisers are walking the straight and narrow,” he said, noting that most advertisers are familiar with Federal Trade Commission (FTC) guidelines and are producing accurate ads. “There’s only a small minority of ads that are really causing us heartburn.”
The initiative with NAD officially went into effect in November of 2006, and the NAD handed down its first decision regarding a dietary supplement advertising challenge under the new program in January of 2007 (L. Bean, e-mail, November 28, 2007). The NAD gave its attorney Mark Levine the job of exclusively reviewing dietary supplement advertising and hired a new attorney to replace Levine as a general attorney. In addition to Levine, all other NAD attorneys may be assigned dietary supplement advertising challenges as part of their regular case loads.
An NAD review is initiated when a company or organization submits a challenge to NAD regarding the claims made by a particular advertiser. Such challenges are typically submitted by a competing company or an industry organization, although NAD also occasionally raises its own challenges based on its monitoring of national advertising and its investigations of consumer complaints or referrals. The NAD informs the challenged advertiser about the inquiry and gives the advertiser 15 business days to provide substantiation for the advertising claims at issue. NAD later forwards the advertiser’s submission to the challenger (with any proprietary or confidential information redacted), giving the challenger 10 business days to file its response. That response is then sent to the advertiser for additional comments. Following the conclusion of this communication process, the NAD produces a final decision, of which the advertiser may submit a statement. Copies of NAD’s final decision are ultimately posted on the agency’s Web site and summarized in a press release.
“It is a user-friendly process to encourage participation,” explained Andrea Levine, director of the NAD (e-mail, November 28, 2007). “Advertisers who decline to participate, or who decline to modify or discontinue advertising as recommended by NAD, may be referred to the appropriate federal agency for law enforcement action.”
According to Mister, CRN imposed certain goals on NAD when funding the initiative. Chief among these objectives is for NAD to try to review 30 or more dietary supplement advertising challenges each year. Although NAD has stated that 25 cases were reviewed in 2007, Mister added that additional cases were also filed that year. “CRN is very pleased with the quantity and the quality of the decisions by NAD during the first year of this program,” said Mister (e-mail, February 8, 2008).
In April of 2007, CRN launched an advertising campaign in support of its initiative with NAD, encouraging companies to assist in the industry’s self-regulation efforts by filing challenges with NAD over false or misleading ads of competitors.2 According to Mister, CRN immediately recognized that one of the program’s biggest hurdles would be to convince the dietary supplement industry that the NAD process is a safe and effective forum for challenging one another’s advertising (oral communication, November 13, 2007).
“If you look back at NAD’s history, many companies [outside the dietary supplement industry] have been very comfortable using the NAD,” Mister explained. “We haven’t had that kind of history with NAD as an industry. There’s been some reluctance among companies to call each other out.”
Andrea Levine commented that NAD did witness some increased activity from dietary supplement companies following CRN’s advertising campaign. “We are seeing increased interest, and we are always pleased to see company challenges,” said Levine.
According to Mister, some legislators in Washington have commended the initiative for contributing to the industry’s efforts at self-regulation. “This program has been very well received by both industry and some of our critics,” he said.
However, there has been some criticism leveled against the program. The herbal supplement company Bioforce USA (Ghent, NY) issued a letter in October of 2007 initially refusing to participate in an NAD review regarding the company’s advertising of Sanhelios® Curbita Bladder Caps because the challenge was filed by CRN.3 The company primarily noted that it was concerned about what it termed a “lack of transparency” regarding CRN’s selection process for initiating the advertising challenge. Bioforce ultimately agreed to participate in the NAD review, which began in January of 2008 and was concluded in June 2008.4
Sanhelios Curbita Bladder Caps contain pumpkinseed oil from the European-grown pumpkin (Cucurbita pepo, Cucurbitaceae). The NAD review of the Bioforce advertising covered 3 different areas of product claims: that Curbita Bladder Caps can “support the entire system of bladder muscles and normal emptying of the bladder,” “enhance bladder function,” and “strengthen” the bladder and/or urinary tract. While NAD found that the evidence and testing on the benefits of pumpkinseed oil support the advertiser’s claims that the product can support and enhance bladder function, NAD asked that some advertising claims associated with “strengthening” of the bladder or urinary tract be discontinued and asked that others be further qualified and limited in language. In particular, the company was asked to include the word “may” before some claims relating to strengthening of the bladder.
According to Pierce Sioussat, president of Bioforce USA, the company was happy with both the NAD’s decision and the process that the NAD used when conducting its review. “We were very impressed with how thorough NAD was in their review process, and if you were to examine their report in its entirety, you would see they put a great deal of effort into understanding the science we provided and making a determination regarding our claims, all of which were deemed to be substantiated with the caveat that we qualify the claim regarding strengthening of the bladder,” said Sioussat (e-mail, June 13, 2008).
Sioussat noted that Bioforce strongly supports efforts to enhance self-regulation of the dietary supplement industry and is glad that CRN has developed an initiative to help strengthen self-regulation. However, he added that Bioforce still has some concerns regarding the process by which CRN initiates challenges.
“We believe there is quite a bit CRN could do to improve their process, primarily with regard to the criteria used for bringing a challenge and the amount of due diligence they do before burdening companies with full participation in an NAD review,” he said.
Sioussat explained that there should be greater transparency as to how or why a company’s advertising has been selected for an NAD challenge and if there is a reasonable basis for such a challenge. Further, there should be some evidence that the individuals initiating the challenge are qualified to assess the advertising claims of a product and that those individuals have done some extent of research into publicly available information that might support the product’s claims before initiating the challenge.
According to Sioussat, these measures are particularly warranted in light of the fees a company can incur when participating in an NAD review and because a company cannot submit a counter challenge to a trade organization such as CRN, as it would be able to do to a competing company that issues a challenge.
Press statements issued following the conclusion of NAD reviews indicate that many companies have expressed appreciation of the NAD review process and that many have altered their advertising when recommended to do so by NAD5,6,7,8—although some companies have noted their disagreement with NAD decisions.6,7,8
“We are pleased to hear that Bioforce, as well as other companies, are appreciative of the NAD review process,” said CRN’s Mister. “The entire process by which ads are challenged has been very clear and transparent from the beginning.”
Mister added that a person or company may initiate an NAD advertising challenge not only through directly filing complaints or competitive challenges to the NAD, but also by submitting questionable ads to CRN. CRN’s advertising review task force prioritizes ads based on their claims in an effort to submit the highest priority ads for NAD review.
“Generally speaking, the NAD process is a good one,” said Marc Ullman, an attorney specializing in the natural products and dietary supplement industry (oral communication, December 17, 2007). “It’s very fair and very impartial. Supplement companies, however, have been somewhat reluctant to participate because there have been some questions raised as to whether they set standards more appropriate for pharmaceuticals.” Ullman initially represented Bioforce in the CRN-NAD challenge. He noted that there appears to be some reluctance within the NAD to accept ingredient-based substantiation for claims, which is often the standard in the dietary supplement industry. (An ingredient-based substantiation of a claim stems from research concerning a product’s ingredient(s), as opposed to a product-based substantiation of a claim, which involves clinical testing of a particular finished product.)
Although CRN has committed to only 3 years of funding for the program, the association’s board may choose to provide additional grants after that time, pending an evaluation of the success of the initiative. “In addition, we hope that after the initial 3 years, dietary supplement companies would see the benefits of self-regulating the industry and would continue to submit challenges to the NAD on their own that will help to fund the program,” said Mister. “This program can only be successful if companies are willing to participate in the process, and we hope that it will be able to continue long after the initial grants have run out.”