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FDLI Conference on Substantiating Claims for Dietary Supplement Advertising and Labeling, Washington Hilton and Towers Hotel
Washington, D.C.
Jodie Bernstein, Former Director, Bureau of Consumer Protection

Good morning. I'd like to thank FDLI for organizing this conference today. I hope that, with the help of our staff, FDA staff and representatives of the state Attorneys General, we will reach a better understanding of the regulatory framework that governs supplement advertising and labeling, and offer some practical advice as to how to steer clear of law enforcement problems.

In the last few years there has been an explosion in consumer demand for, and marketing of, dietary supplements. A Nutrition Business Journal report estimated that, in 1995, consumers spent 8.9 billion dollars on supplement products and that figure continues to rise dramatically. In record numbers, aging baby boomers are taking supplement products to stave off disease and slow the aging process. Given this tremendous consumer interest and the fact that consumer health and safety is involved, supplement advertising has been, and will continue to be, an important part of the FTC's consumer protection mission.

Two challenges face us in our efforts to ensure that supplement advertising is truthful and not misleading. The first of these challenges is what brings us here today -- the challenge of educating industry about their legal obligations.

With the passage of the Dietary Supplement and Health Education Act (DSHEA) in 1994, the regulatory environment changed dramatically. Combined with the tremendous number of new entrants into the supplement market and you end up with a great deal of confusion and uncertainty in the industry about how to do the right thing.

A few months ago it became apparent to me from discussions with industry members that many companies were genuinely baffled about how to satisfy the FTC's requirement that claims be adequately substantiated. What did that mean? Did they need clinical studies? What kinds of studies? How many? How big? How long? Would something less than human clinical research suffice?

I also heard concerns expressed that our standard was inconsistent with the spirit of DSHEA.

Let me try to clarify one aspect of the FTC's substantiation standard. Although the standard is a rigorous one, often requiring competent and reliable scientific evidence, it is also flexible, because it is dependent on the nature of the claim being advertised. It is by virtue of this flexibility that the standard enables us to both protect consumers and facilitate truthful claims. For this reason, I believe the FTC's substantiation standard is fully consistent with the requirement, embodied in DSHEA, that claims for supplements be truthful, not misleading and substantiated.

Having made that basic point, I recognize that many in the industry are still unfamiliar with the FTC's approach and that it would be helpful to provide the industry with more specific and concrete guidance in this area. You will hear more from our staff later this morning about their efforts over the last few months to identify and respond to industry's concerns and questions about FTC law. Their many meetings with industry groups and others have been very illuminating and I believe that we are now in a position to offer guidance that will have real value to all of us.

What we have in mind is a guidance document to assist supplement marketers in understanding and complying with the substantiation requirement. I anticipate that it will be publicly available in about 4 months, and will describe in some detail our substantiation standard and identify the most frequent shortcomings we see when investigating a company's support for supplement claims. This guidance piece will be part of a larger effort, which will include articles, educational brochures, and training conferences such as this one, to assist industry members.

I must warn you, though, that it is unlikely that our efforts to provide guidance will answer every one of your questions. As I said earlier, our substantiation standard is a flexible one. The level of support required depends on many variables, including the nature of the claim asserted and the manner in which it is presented in a specific ad. To create a complete checklist of do's and don'ts and still maintain the necessary and appropriate flexibility may be difficult, if not impossible. My view, however, is that even if it does not address every conceivable situation, it will be a good start on the basics and can be revised as we work with it.

Often the most valuable guidance we can give is case-specific examples similar to the examples used throughout our Environmental Marketing Guides -- an effort that succeeded in giving industry much greater certainty about how to properly craft claims about the environmental benefits of their products. Although the Environmental Guides were a more formal document than I believe is required here, we can use the same general approach to provide several useful illustrations of how to apply the substantiation standard to supplement claims.

Our effort to provide guidance to the supplement industry is based on a presumption that supplement marketers want to know the rules and plan to abide by them. For those marketers, we have an obligation to make the law and our interpretation of it clear and predictable.

Unfortunately, there appears to be a segment of this industry that has shown no intention to play by the rules, no matter how clearly we articulate them. Just last month the FTC and other federal and state law enforcement officials conducted a "surf" of Internet sites and found hundreds of sites promoting a wide range of products and treatments for heart disease, cancer, AIDS, diabetes, arthritis and multiple sclerosis. Many of these Internet promotions involved dietary supplements and contained outrageous claims about the curative powers of these products. Had the same claims appeared in labeling, there is no question that they would be prohibited by DSHEA, without ever reaching the question of whether they could be substantiated.

Obviously, the FTC must and will continue to maintain an enforcement presence here, giving priority to cases that present serious safety considerations or prey on the very sick and especially vulnerable consumer. But it is quite clear that law enforcement alone will not solve the problem, and it is incumbent upon all of us to develop another means by which to deter, if not stop, the proliferation of irresponsible operators in the dietary supplement industry.

So I would like to conclude this morning with a second challenge, a challenge that will require you to find ways to help police the more unscrupulous members of this industry and encourage them to abide by the rules. I know that many of your trade associations have instituted programs, like NNFA's "ComPLI" program, to ensure quality and consistency in the manufacture and label of supplements, or CRN's dose limits to address safety concerns. I also am aware that the various trade groups, among them CRN, NNFA and AHPA, have codes of ethics which at least touch on the importance of truthful advertising.

But, based on what we've seen so far, the Codes, although valuable, are not enough. Other industries faced with policing themselves have implemented broad-based, highly visible, and rigorous self-regulatory campaigns against false and deceptive advertising. There are effective models already in place that you may want to consider. The National Advertising Division of the Better Business Bureau is a great example. It provides an open and neutral forum for challenging deceptive advertising. Its structure provides for some degree of independence from the industry it polices. And while participation in the process is voluntary, there are concrete consequences. The NAD publishes detailed opinions to explain its decisions and refers matters to government enforcement agencies when voluntary compliance fails.

As government enforcers, we know we can't catch every bad player, even though we will make vigorous efforts. Industry's stake is, in many ways, more critical. Consumers' trust in what they see and hear will determine the ultimate success or failure in the marketplace. My hope is that you will succeed in gaining that trust. And we would be happy to help. If you like, my staff will meet with industry representatives to share our experience with effective self-regulatory models. When the challenge is met, the Commission, the industry, and, most importantly, consumers would all be winners.

And maybe the next time I'm signing on to my computer and I get an e-mail promising that some miracle tonic will make me feel half my age, protect me from cancer, clear my arteries of plaque, eliminate the pain in my aching feet, improve my memory, and even restore my natural hair color, I will know that everyone of those promises is supported by good science, and that my $19.95 for a month's supply will be money well-spent.

Thank you.