Finding your way through the educational maze
In recent months, the dietary supplements industry has seen a spate of new actions by the Federal Trade Commission against companies using false or misleading advertising to sell their products. These actions extend beyond the always-contentious arena of weight loss products to newly touted "cure-alls" such as coral calcium. In the FTC's most recent action, the manufacturers of Coral Calcium Supreme were cited on June 10 for claiming their product could cure cancer and other diseases.
"There has been a definite increase in actions against false and misleading claims and disease claims," says Don McLemore, vice president of standards for New Hope Natural Media, based in Boulder, Colo. "I've seen more actions in the last six months than in the previous two years." New Hope publishes The Natural Foods Merchandiser.
FTC actions are likely to continue to increase in number. Richard Cleland, of the Bureau of Consumer Protection at the FTC, says, "I would say that the increase in actions is intentional. What you are seeing is a long-term law enforcement effort that has been building for some years now. It's likely to increase further, because both FTC and [the Food and Drug Administration] have announced new efforts in the dietary supplements area."
This view is echoed by FTC Commissioner Sheila Anthony in remarks to the Food and Drug Law Institute in April: "Misleading or unsubstantiated claims in dietary supplement advertising constitute a large and growing part of the FTC's enforcement agenda."
This policy has repercussions for both manufacturers and retailers. Many retailers are familiar with some provisions of the Dietary Supplements Health and Education Act, such as those regulating allowable structure/function claims on product labels. Labeling issues fall under the purview of the FDA, while advertising issues are addressed by the FTC. Often companies that abide by the rules for structure/function label claims will push the boundaries in their product advertising, perhaps because in the past FTC actions against advertisers were relatively rare.
But in light of recent enforcement efforts, the need for retailer and manufacturer education on allowable advertising claims is clear. But where should industry members turn for this information? "I think any company trying to market a good product within legal boundaries should first get good legal advice from a regulatory consultant," McLemore says. The FTC itself can serve as a resource too: "If [a company] were to call the FTC with questions about a particular ad, they would get an answer on whether it's in compliance."
Retailers should be aware that, while manufacturers are responsible for the content of their advertising, retailers who use promotional materials provided by manufacturers can also be liable. "Certainly retailers are liable in creating their own promotion material, even if it features another company's products," FTC's Cleland says. "And when the retailer is using manufacturer-provided promotional material, they're potentially liable if the material is misleading or deceptive."
The FTC would prefer to deal directly with the source of the information rather than individual stores, Cleland says. But, given the often negative press coverage afforded the dietary supplements industry—often because of Internet marketers who make unscrupulous claims—retailers can help protect the integrity of the industry and their individual stores by carefully screening products for label and advertising compliance before deciding to stock them.
But manufacturers should also focus on self-regulation. "In 1994, DSHEA charged the industry with the responsibility of self-regulation," McLemore says. "The more the industry associations take initiative to honor that responsibility, the better off we all will be. I don't think that FTC and FDA would be doing what they're doing if there were already some efficient self-regulatory policy in place."
Cleland says, "I'm a strong believer in self-regulation, and I think the commission over the years has supported self-regulation, not as a substitute for law enforcement but as a complement to law enforcement." Self-regulation has two positive effects, says Cleland. It takes away the argument that companies don't know they're breaking the law, and it frees enforcement resources to go after the worst offenders.
It may also help change public perception of the industry, drawing a line between reputable companies and companies that promise cures for SARS, AIDS, cancer and a host of other illnesses, in clear violation of the law.
One such industry initiative for self-regulation was recently released: a set of guidelines for marketers of dietary supplements for weight loss, drafted by the American Herbal Products Association of Bethesda, Md.
AHPA President Michael McGuffin says, "The industry should work together. We need to stand together as a community and work with FTC to figure out what the rules are." McGuffin believes that the cases brought by the FTC in recent years clearly show its expectations regarding proper dietary supplements advertising. "I find it laudable that FTC is leaving clear signals, saying, 'Here's what we're doing, and here's how we'll make our enforcement decisions.'"
McGuffin believes that conscientious companies have two responsibilities in regard to advertising. "First, they need to continue to ensure that their own advertising is in conformity with regulatory guidelines. Any substantiation [for product efficacy] has to be believable, credible and properly defensible."
The second issue facing companies in the dietary supplements industry is what to do about unscrupulous marketers, which are often lumped together with reputable companies in the eyes of consumers and the media. "What are we going to do about the fly-by-nights, the companies making egregious claims? I'm intrigued by the idea of setting up a mechanism whereby companies can get the FTC's attention if they see an ad that they consider inappropriate or unlawful," McGuffin says.
One such mechanism already in existence is the National Advertising Division of the Better Business Bureau, which is set up specifically to review national advertising for truthfulness and accuracy. Cleland welcomes this approach because, often, NAD can work directly with advertisers to correct misleading advertising. "If advertising issues can be resolved without [commitment of] taxpayer money and scarce enforcement resources, everybody benefits," he says.
The final shape of industry self-regulation efforts may not yet be clear; what is clear, however, is that the status quo is not acceptable to either government agencies or industry trade groups. "The bottom line is that many marketers of dietary supplements have not taken the responsibility of self-regulation seriously," says McLemore. "They are blatantly making false and misleading claims and disease claims on their products, and damaging the credibility of the whole industry."
Mitchell Clute is a poet, musician and freelance writer based in Paonia, Colo.