Congress enacts a law directing the FDA to issue a guidance document to regulated industry within 270 days after the law passes, and the Agency fails to do so. A well know company promotes its new product with the outrageous claim “Eat all you want and still lose weight . . . “ and the FTC fails to act. The Council for Responsible Nutrition issues a press release announcing a self regulatory initiative in conjunction with the National Advertising Division (“NAD”) of the Better Business Bureau and vows that it will not have any role in what claims the NAD will review (CRN also repeats this claims in numerous advertisements touting the NAD initiative). Despite this, CRN files claims in its own name as well as on behalf of all of its members against non-CRN member advertisers.
It is no secret that one of the ongoing issues that has been plaguing the dietary supplement industry since its infancy is the seeming inability of mainstream members to bring advertising by “outliers” into compliance with FDA and FTC laws and regulations. Outrageous claims of the ability to cure disease or promote instant or effortless weight loss (to name just two examples) continue to appear on the Internet, television, radio and in print with alarming frequency. While there are certainly a plethora of reasons for this, it has occurred to me that some of the very authorities that should be delivering the compliance message with absolute certainty and leading by example are, in fact, delivering mixed messages that may lead some to conclude that not playing by the rules is OK after all. Three examples come to mind. First, on December 22, 2006, the Dietary Supplement and Nonprescription Drug Consumer Protection Act, more commonly referred to as the Adverse Event Reporting Bill was signed into law. That legislation required the FDA to “issue guidance on the minimum data elements that should be included in a serious adverse event report as described under the amendments made by this Act” within 270 days of the bill’s enactment into law. As recently noted in an October 3, 2007 letter sent by the American Herbal Products Association to the Secretary of Health and Human Services and the responsible FDA officials, this guidance was due on September 18, 2007, yet no such guidance has appeared. FDA has not even deigned to advise industry when it might expect the guidance to appear! What kind of message does it send to regulated industry if FDA feels free to ignore the law?
Second, anyone attempting to watch late night television is certain to have been bombarded by advertising touting a recent “European weight loss breakthrough” that allows the use to “eat all you want and still loose weight (And we couldn’t say it in print/ on TV if it wasn’t true)”. This advertising has seemingly run nonstop for the past month, even though it appears to make numerous “red flag” claims that the FTC has publicly stated would warrant close scrutiny and likely enforcement action by the agency. When such apparently non-compliant advertising runs on a consistent basis for weeks on national media and the FTC fails to take action, what kind of message does that send to companies that expend significant recourses (and potentially loose significant sales to companies making fantastic promises) attempting to utilize compliant advertising?
Third, in response to some of the problems caused by inconsistent enforcement efforts by industry regulators, on September 16, 2006 the CRN and the NAD launched self-regulatory program designed to encourage companies advertising dietary supplements to ensure that their advertising was truthful and nonmisleading. This program is funded by a series of grants from CRN to NAD “that allow NAD to expand its existing review of dietary supplement advertising”. As part of the adverting campaign to promote this program, CRN and NAD have attempted to reassure industry that all members of the supplement industry will be treated equally by expressly promising that “CRN will have no role in determining which advertisements NAD chooses to review or whether claims are determined to be truthful and accurate”. Nevertheless, CRN has taken it upon itself to file complaints with the NAD against non-CRN members (one such complaint was filed against one of my firm's clients). These complaints further state that they are also being brought on behalf of CRN’s members. (One such complaint which was recently made public was filed against the makers of “Lipodrene” for making claims that their product delivered a reduction of “40-70% overall fat under the skin” and “loss of 20-35% abdominal fat”.) No matter how odious the nature of the claims that CRN might chose to challenge in this matter, such an action by a trade association that has paid to sponsor the NAD’s supplement review program is disconcerting. It seems that there are obvious questions concerning the potential ant-competitive effects of such a filing in addition to an appearance of impropriety in having NAD rule on a complaint by CRN under a program funded by CRN. It also would certainly appear that CRN is attempting to exert influence on the NAD’s decision to review advertising; something it expressly promised not to do. What kind of message does it send to an industry that has had the concept of “self-regulation” preached to it when the sponsor of a major “self-regulation” program ignores the rules that it has established for that program?
Mixed messages like these are clearly counterproductive in the effort to ensure that dietary supplement marketers comply with the law and deliver only truthful and nonmisleading messages to consumers. Until we find a way to ensure that the message to advertisers/marketers is consistent, the type of advertising that has helped tarnish the supplement industry’s image will probably be with us for a long time.