Dietary Supplement Claims: The Emperor's NewClothes?

Dietary Supplement Claims: The Emperor's NewClothes?
The need for self-regulation in the dietary supplement industry

by Marc Ullman, Esq.

As my colleagues in New York battled through one of the coldestJanuaries in recent memory, I had the pleasure of spending five days in balmyScottsdale, Ariz., attending Virgo Publishing's Focus on the Future conference.Overall, it was an extremely pleasant experience. Who could help but enjoy80-degree weather, a corporate tent at the Phoenix Open, a Super Bowl party andan informative, provocative seminar schedule?

One part of the program, however, was not particularlyenjoyable. In fact, it was downright unpleasant. The final seminar featured JaneBrody, health columnist for The New York Times and a frequent critic ofour industry. True to form, Brody, who holds a bachelor's degree inbiochemistry, devoted her talk to a devastating review of the supplementindustry's shortcomings. Her subjects included outrageous claims to curelife-threatening diseases and the inability of supplement manufacturers to meetlabel claims for their ingredients. She also touched upon the industry's failureto develop uniform standards for the identification of active constituents, aswell as the marketing of products such as ephedra that, she opined, pose a fargreater health risk than justified by any beneficial properties the products maypossess.

As she recited this lengthy list of shortcomings, many membersof the audience became quite agitated, apparently feeling her attacks were adistortion and not representative of the "responsible" marketingpractices of their companies. At the first opportunity, I took Brody to task forher failure to acknowledge that most of the supplement industry (certainly thosecompanies of the caliber that attended this conference) worked very hard tomarket products with legal claims, containing exactly what they represent theycontain. I also challenged her for her failure to recognize that many of theoutrageous claims she had recited were made by "outliers," operatingprimarily on the Internet, and suggested that the right target for her attackson this subject was the Food and Drug Administration (FDA) for its failure toadopt good manufacturing practices (GMPs) in a timely manner or to enforce thelaws against the sale of misbranded or adulterated products. When our discoursewas terminated by Brody's announcement that FDA could be excused because it wasunderfunded and that she refused to engage in a debate with a lawyer, I was leftfeeling pretty good. I had made my point and she had retreated.

However, only weeks later I found myself no longer feeling sogood about our industry or myself. In fact, after thumbing through the mostrecent copies of several industry trade magazines that I trust and a packagefrom a client containing his competitor's product labeling, I felt like theemperor must have felt when he realized he was not wearing a stitch of clothing.

The package from the client featured a variety of outrageous,flagrantly illegal claims. For example, one company issued a variety ofmaterials relating to the "Cancer Risk Management and SupportProgram." The product catalog for this line noted, "The treatment ofcancer continues to be one of the most disappointing areas of modern medicine.... With this in mind [we] have developed a line of products designed to ...inhibit the growth and proliferation of new cells." The catalog presented avariety of products targeted to the prevention of specific types of cancers(colon, breast and prostate), as well general cancer prevention. Claims forthese products suggested that they contain ingredients that have been"shown to reduce breast cancer occurrence in animal studies" and to"protect against adenoma (polyp) formation."

What I saw in the trade magazines was equally disturbing. Therewere a number of products claiming to be effective in individuals with diabetesor as treatments for impotence. Companies touted herbal pain creams (any topicalproduct with this type of claim cannot be a dietary supplement and isautomatically a drug) and Viagra "knock-off" supplements. One producteven claimed to be an effective treatment for eczema and herpes.

I then turned to a magazine targeting consumers of dietarysupplements and other natural products. Here, one product claimed to reducecholesterol levels, despite FDA's repeated statements that such claims areillegal. A variety of products offered consumers access to "homeopathic HGH,"an ingredient that does not appear in the Homeopathic Pharmacopeia of the UnitedStates and potentially runs afoul of a prohibition on the possession of HGHwithout an approved new drug application (NDA) for a specifically indicated use.In addition, a number of transdermal progesterone creams made claims far beyondthose appropriate for a cosmetic without any appearance of having undergone thedrug approval process.

These are but a few examples. Others that I've seen recentlyinclude products that purport they "may" be effective for individualswith migraines, AIDS, hypertension and even radiation poisoning. None of theseclaims are even arguably defensible. All of the products described would beconsidered unapproved new drugs based upon the claims they make and/or themethod of systemic delivery they use. In addition, it is hard to believe thatmost of the companies that would make such claims are concerned with matterssuch as adequate substantiation for the claimed benefits of their products, orproducing the products in facilities with adequate processes and controlsdesigned to guarantee that all label claims for ingredient content are met.

All of the claims and products referenced above are quite real.All of the publications in which they appeared are current. So long as materialof this nature flourishes in our industry, it will be open season for criticslike Brody.

FDA has not offered much help, taking almost a decade to evenissue proposed GMP guidelines. Indeed, a cynic would suggest FDA has decided notto take any enforcement action in the hope that outrageous claims and sub-potentproducts will lead to wide support for calls for reform of the DietarySupplement Health and Education Act (DSHEA) by people like Brody or Sen. RichardDurbin (D-Ill.). While the Federal Trade Commission (FTC) has been far moreactive in the field of supplement regulation, it is clear that FTCcannot--especially in this era of laissez-faire regulation--police the entiremarketplace by itself. Companies following recent enforcement actions may evenconclude it is a viable business plan to simply make whatever claims arenecessary to sell a product and set aside a small percentage of profits to payoff the government.

One avenue of potential relief would be an industry"self-regulatory" body similar to the National Advertising Division (NAD)of the Better Business Bureaus (BBB). The problem with this is that NAD hasrepeatedly demonstrated it is either overtly hostile to dietary supplements orsimply does not understand the legal framework under which they are marketed.Recent NAD decisions have suggested there is a need for "goldstandard" clinical trials on any product making specific performance claimsin advertising. These decisions have rejected claims that rely on studies ofindividual ingredients, even in the absence of evidence of potential confoundingfactors. Moreover, in any matter in which the average supplement marketerattempted to challenge the propriety of a claim such as Wyeth's incrediblemarketing campaign for the use of its calcium product in the prevention of coloncancer, past history suggests NAD would have little interest in taking on apharmaceutical giant.

Rather than turning to these unreliable sources, it appears thetime has come for the supplement industry to support a move towardself-regulation. One approach that deserves serious consideration is anindustry-wide effort to form an independent advertising/claim review board,similar in format to NAD. Such a body could be available to review challenges byindustry members to supplement advertising that appears illegal, unsupportableand without substantiation. FTC Chairman Timothy J. Muris and other FTCofficials have made comments suggesting the industry adopt some type ofself-policing standards for advertising and suggested collaboration betweenindustry and FTC is plausible.

This effort would not be easy. Cooperation among the majorindustry trade associations, a commitment to support the program from industrytrade publications and, most importantly, support from leading companies wouldall be required. Complicated issues such as developing the structure of thereview board, the identity of any pool of arbitrators and securing adequatefunding would also pose significant challenges.

However, the potential rewards could be well worth it. Imaginehaving the ability to tell critics such as Brody, "We've cleaned up ourhouse." The re-establishment of our credibility and renewed consumerconfidence would also follow.

The time has long since passed for hoping regulators will solveour problems. If anyone is going to do it, the effort must come from theindustry itself. Maybe then, the emperor will have something real to wear.

Marc Ullman is a partner in New York City's Ullman, Shapiro& Ullman LLP. His practice includes the counseling of clients in all areasrelating to the marketing of natural products. He can be reached at [email protected]or (212) 571-0068.

Editor's Note: INSIDER welcomes industry commentary andletters to the editor. Direct your comments to Heather Granato, group editor,3300 N. Central Ave., Ste. 2500, Phoenix, AZ 85012, FAX (480) 990-0819, [email protected].Letters may be edited for content or clarity and do not necessarily representthe views of Virgo Publishing or INSIDER.