Supplemental restraint: will the growing popularity of nutraceuticals give rise to tighter regulations?
They're known as dietary supplements or medical foods, but their official title is nutraceuticals, a term coined by physician Stephen DeFelice in 1989. They're a food, or natural supplement, with a purported medical-health benefit, and according to MarketResearch.com, $20 billion dollars' worth are sold every year.
The popularity of nutraceuticals has lead to the side effects of a tumultuous assorted debate: about medical efficacy, marketing methodology, the quality of research and development, the need for industry regulation, and the often-misunderstood side effects caused when the supplements are taken in conjunction with mainstream prescription drugs.
To better track the debate, we need to understand why nutraceuticals have become so popular so quickly. "The movement toward self-medication is driving the industry," says Jeff Hilton, president of Integrated Marketing Group, a Salt Lake-based advertising and marketing firm that specializes in nutraceuticals. "More consumers are taking their health into their own hands."
Pamela Watson, co-owner of Shirlyn's Natural Foods, a supplement distributor in the Salt Lake Valley, points to the Baby-Boomers as one key group driving the industry: "We simply don't want to grow old. We fight the process, and that involves natural supplements. There's also a growing distrust of traditional medicine."
This movement has come about in large part thanks to the Dietary Supplement Health and Education Act (DSHEA) of 1994, which says dietary supplements do not need Food and Drug Administration (FDA) approval. Though manufacturers can't claim that specific health benefits result from the use of their supplements without scientific proof, they can make amorphous health statements, such as "product A aids in relaxation or in the development of strong bones."
Medical experts are often critical of DSHEA and the effect it has had on consumer behavior. "When the general public starts to self-diagnose, you can have serious problems," says Pete Van Aarle, director of pharmacy at Cotton-wood Hospital. "We often see the wrong diagnosis, wrong treatment plan, inadequate treatment, or worse--a serious interaction with a prescription drug. For example, transplant patients can reject their newly donated organs, because of a rapid drug metabolism induced by St. Johns Wort, a popular nutraceutical"
"We feel that nutraceuticals should be regulated, but regulated sensibly," says Loren Israelson, director of the Utah Natural Products Alliance. "Not all herbs are appropriate for self-treatment and self-use. There needs to be a balance between public access and things like proper labeling, good manufacturing processes, and adverse event reporting." Israelson thinks it is critical that DSHEA be fully implemented, and believes the trend toward self-care will continue as people have more access to health information.
In response to DSHEA, Dr. DeFelice proposed in 1999 the Nutraceutical Research and Education Act, which stated that if a company conducted clinical research on a specific product, it would have exclusive rights to make medical claims regarding its efficacy. This incentive could spur companies to invest in more clinical research, but since you can't trademark a natural product the act failed to pass in 1999 and in 2001.
Managing the Hype
Laura Shane-McWhorter, a professor at the University of Utah's College of Pharmacy, routinely sends her students to various distributors of nutraceuticals to ask questions about specific supplements. Her students always return from the project alarmed. "When they find that the people selling these products don't have a clear scientific knowledge of the possible interactions, they're shocked," she says.
"When someone walks into our store asking about natural supplements, we try to educate them with third party literature [such as research] studies, a computer program that catalogs contra-indications, and literature provided by the manufacturer," says Watson. "But it's important for people to have a physician on this journey with them. An accurate diagnosis allows them to make more informed choices."
Hilton agrees this is a tough area to manage. "The nutraceutical industry is regulated by the Federal Trade Commission (FTC), but each distributor has their own standards."
According to Shane-McWhorter, approximately two-thirds of Americans taking nutraceuticals think that the supplements are approved by the FDA. And while Hilton admits the industry is changing, some companies are still giving the industry a black eye.
"We won't take on clients and help market their products if they don't have clear, solid science backing them up," Hilton says. "But not everyone is in it for the long haul. They're happy to throw up a Website, sell a product for a few months, and then walk away and start another one."
Examples of this kind of guerilla marketing can be found millions of times each day as SPAM in e-mail inboxes. Outrageous claims for weight loss and sexual performance enhancement are only two examples of how marketers are trying to outwit the FTC and make a buck on gullible consumers.
In the nutraceutical industry, product labeling is monitored closely by the FTC. "Anything in any literature is considered labeling," says Hilton. "You have to disclose every ingredient in every product. If you make a claim about the ingredient, you have to have the studies to back it up."
Trial or Error
Approximately 17,000 reports of adverse effects, many including death, were attributed to Ephedra before it was removed from shelves this past year. Critics say the lack of clinical research caused the demise of the ingredient also found in over-the-counter products like Sudafed.
Shane-McWhorter contends that not only does the science of the ingredients need to be valid, the ingredients need to be consistent: "A study of Glucosamine and Chondroitin by the National Institutes for Health found anywhere from zero to 115 percent concentration of the drug from batch to batch. The industry is getting better at regulating content and purity, but they do need to look at the consistency of ingredients as well."
Just as consumers fueled the trend toward nutraceuticals, some say the self-care movement will also bring to pass mandatory clinical trials.
Brent Davis, director of technical sales for CornerStone Research & Development, a contract manufacturing company specializing in nutritional and dietary supplements, says the industry better prepare itself for more stringent research regulations.
"The feeling is that the FDA will eventually require the nutraceutical industry to raise its standards to those of other drug industries. And some companies won't be willing to do what it takes to meet those standards," says Davis. "CornerStone already meets or exceeds the criteria for the industry, and we're meeting many of the standards pharmaceutical companies are held to as well."
The consumer demand for nutraceuticals is ahead of regulations and ahead of doctors' awareness of these products. "Doctors will embrace these products if the science is available to back up the claims," says Shane-McWhorter. "But if the industry doesn't offer supporting evidence, it will likely continue to operate under intense scrutiny."
"Doctors are trained to diagnose and there's a reason for that," says Watson. "If people ask their doctor about a product, that requires the physician to find out more."
Opinions may differ as to the validity and effectiveness of nutraceuticals, but both sides agree that if the industry is going to thrive, research must to continue to improve and consumers need to educate themselves and their physicians.
"It all comes right back to the consumer. They drive the industry," says Shane-McWhorter. "The more we encourage the research, the better off the industry will be."
Brooks Stevenson is a Salt Lake City-based freelance writer.
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|Date:||Mar 1, 2005|
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