Hard to Swallow: While federal law shut the door on regulation of dietary supplements,marketing hype may be leading the popular aids up courthouse stepsAuthor(s): MICHAEL HIGGINSSource: ABA Journal, Vol. 85, No. 6 (JUNE 1999), pp. 60-63Published by: American Bar AssociationStable URL: http://www.jstor.org/stable/27840828 .

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FOOD AND DRUG LAW

While federal law shut the door on

regulation of dietary supplements, marketing hype may be leading the

popular aids up courthouse steps. BY MICHAEL HIGGINS

f I^he medical establishment la I bored mightily to create the

?L anti-impotence drug Viagra: Three scientists solved a key mys tery about how blood vessels work, winning Nobel Prizes in the pro cess. Drug giant Pfizer Inc. poured $500 million into years of addition al research.

It seems they needn't have bothered, at least according to The Herb Shop, a seller of herbal prod ucts in Woodstock, Ga. The compa ny's Web site touts the dietary sup plement Herbal V as the "natural alternative to Viagra for people looking for the same exciting re sults, with no side effects, and with out a prescription."

Officials at The Herb Shop de clined to discuss Herbal V or their other herbal remedies. But the com pany is hardly alone in making loud medical boasts for herbal and vita min-based dietary supplements. On Internet sites and in fast-talking radio ads, an increasing number of supplement makers claim to have

Michael Higgins, a lawyer, is a reporter for the aba Journal. His ?-mail address is higginsm@staff abanet.org.

the answer to everything from arthritis to depression, high choles terol to herpes, obesity to the com

mon cold. Americans are buying. Sales

of dietary supplements?including many that make more modest claims?topped $12 billion in 1997, according to Nutrition Business Journal. That's up nearly 30 per cent from 1995. Popular products include ginkgo biloba for memory, echinacea for the immune system, St. John's wort for depression, and saw palmetto for prostate problems.

But what many consumers don't realize is that the supplement boom has been fueled less by quan tum leaps in herbal nutrition than by subtle changes in federal law. A 1994 act made it vastly easier to get unproven herb and vitamin-based products to market. And the deluge of products?as many as 28,000 cur rently on the market, according to a government estimate?has made it much harder for the government to police extravagant claims.

Now some consumer advocates say supplement makers are duping vulnerable consumers, especially the elderly, into wasting money on du bious snake-oil products. Groups such as the Arthritis Foundation and the American Heart Association

Selenium (heart)

Androstenedlone (muscle development)

Gingerroot (digestion)

Fo-Ti root (kidneys, liver)

Tribulus terrestr (sexual performanc

MM

Saw palmetto -| (prostate)

M

GRAPHIC BY ROB SCHUSTER 60 ABA JOURNAL/JUNE 1999

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Supplements and claimed physiological or psychological benefits

St. John's wort (mood) Ginkgo biloba, Phosphatidyl serine (alertness)

Echinacea (immune system)

Lobelia (lungs)

Ephedra (weight loss)

worry that some ill people are for going proven treatments in favor of the heavily hyped alternatives.

"Basically, all helPs breaking loose in the marketplace," says Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest, a consumer health organization in Washington, D.C. "Some of these products may be beneficial. But no one knows for sure, because the dietary supple

ment industry has not been re quired to test its products."

But should the government re quire that testing? And can it crack down on misleading claims? Advo cates for the dietary supplement in dustry say there's good reason for the law to treat supplements differ ently from drugs. Millions of their customers?and many key allies in Congress?agree.

'This industry is like any in dustry, composed of the good, the bad and the ugly," says pharmacist Allen Montgomery, ceo of the Amer ican Nutraceutical Association in Birmingham, Ala. "What shouldn't be lost is that there is some good work being done."

Before 1994, the U.S. Food and Drug Administration had wider au thority over dietary supplements. And it treated the products as food additives. That meant that unless a new supplement met the standard "generally recognized as safe/' the fda could hold up the product and demand premarket testing.

But in the early 1990s, the di etary supplement industry and

many of its customers took an in tense dislike to what they saw as regulatory overkill. Their lobbying yielded the Dietary Supplement Health and Education Act of 1994.

Dshea gave supplement mak ers a new way to get their products to store shelves. To avoid most fda interference, the supplement mak ers simply had to refrain from mak ing "health claims" on their product labels. That means not stating out right that a supplement will "cure, prevent, mitigate or treat" a given disease.

A Little Support Supplement labels, however,

may include what the law calls "statements of nutritional support." The result: A supplement maker would need fda approval before it could claim that the supplement saw palmetto, for example, "benefits patients with an enlarged prostate."

ABA JOURNAL / JUNE 1999 61

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But it would not need fda approval to claim that the same product "supports healthy prostate func tion."

In theory, dshea was only a moderate reform. The fda is still supposed to get notice before a new supplement ingredient hits the_

market. And it is supposed to get notice of label claims with in 30 days after a supplement goes on the market. The fda can demand substantiation of those claims. And supplements that make statements of nutri tional support must carry a disclaimer: "This statement has not been evaluated by the fda. This product is not intend ed to diagnose, treat, cure, or prevent any disease."

But in practice, dshea's impact has been enormous, critics of the law say. James O'Reilly, health law professor at the University of Cincinnati and a former chair of the aba Administrative Law and Regu latory Practice Section, calls it "the greatest removal of fda ju risdiction in the 90-some-year history of the fda."

Why? Clever marketers can get a lot of mileage out of the statements of nutritional support, suggesting miracle health benefits without quite promising them. Some manu facturers don't comply with the various notice requirements. And the law doesn't define what kind of substantiation the fda has a right to demand.

Meanwhile, once supple ment makers get their products on store shelves, the balance of power shifts dramatically. It becomes the fda's burden to prove that a giv en product presents a "significant or unreasonable risk" or makes an unsubstantiated claim.

So far, the fda has focused its limited resources on products that cause direct harm?for example, the bodybuilding supplement gbl, which has been linked to seizures and at least one death. Products that are simply ineffective have been a much smaller priority.

The agency is re-evaluating its policies and hopes to have a new framework in place by the end of the year, says Robert Moore, a se nior regulatory scientist at the fda's Office of Special Nutritionals.

"We can always challenge sub stantiation" of claims, Moore says.

"It's simply a matter of where it fits in the priorities scheme."

It All Ads Up But even if supplement mak

ers follow DSHEA closely when putting information on product la

II I I Mil MI i MwWr1111 1I I 1 1111 I lilil??

BRUCE SILVERGLADE basically, all hell's breaking loose in the marketplace" without testing.

bels, that doesn't mean unsubstan tiated health claims don't find their way to the public.

It's often supplement sellers who handle product advertising. And they're not bound by the fda's rules.

Take The Health Source, a Connecticut-based company that sells nutrition products through its Web site Musclesoft.com. Owner Charles Moser says that when drawing up his online sales pitch, he starts by looking at the promo tion material he gets from supple

ment manufacturers. But that isn't necessarily where he stops.

The manufacturer's material can be a bit bland and lawyerly,

Moser says. "Sometimes we will jazz it up a bit and actually say what the product is supposed to do," he says. "We go out on the limb."

For example, some products with the supposed aphrodisiac trib ulus terrestris come to him with tepid statements about nutritional support, Moser says. On the Inter net, he favors statements such as: "Excellent Viagra Alternative! In

crease Sex Drive! Build Muscle Faster! Feel Younger!"

Is Moser concerned about the government coming after him? "I don't think anybody's really going to spend the money to do that, just because we write what we think the product is going to do," he says.

Others in the supplement industry are more concerned about government watchdogs, but they feel the tug of com merce as well.

Larreacorp Ltd., based in Chandler, Ariz., makes and sells numerous supplements based on larrea, a shrub native to the Southwestern desert that the company says has powerful anti viral effects.

Biochemist Robert Sinnot, Larreacorp's ceo, says he takes his responsibilities under dshea seriously. "We do not specifical ly put disease claims on our products."

Perhaps not on the prod uct labels. But on its Web site. Larreacorp bills a product

? called Simpl-X Extra Strength S Arthritis Formula as "designed

for patients suffering from 51 rheumatoid arthritis." And it

touts its Larreastat Capsules as "designed for patients suffer ing from frequent herpes symp

toms."

The Web site claims were "pushed by our marketing people," Sinnot explains. "Not everyone at the company is entirely comfort able with doing that, but it's one of those business decisions. We're fol lowing the trends in the industry."

Sinnot's right about the trend in the industry. The Federal Trade Commission has jurisdiction over product advertising. And it has taken an interest in dietary supple

ments and their online claims. Late last year, the ftc and var

ious consumer groups held a "surf day" in which they searched the Internet for dietary supplement sellers who were making specific health and disease-related claims for their products. They found 1,200 sites.

The large number of adver

62 ABA JOURNAL / JUNE 1999 ABAJ/ROB CRANDALL

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tised treatments raised red flags with ftc investigators, says Mi chelle Rusk, an attorney at the agency's Division of Advertising Practices. The agency sent e-mail to the sites, warning them the ftc could demand documentation of their claims.

Rusk acknowledges, however, that a big ftc crackdown is unlike ly. "It really wouldn't be feasible to bring 1,200 investigations," she says. "We can't get every deceptive ad that's out there."

Ripple Effect Marketing hype, of course, is

as old as marketing. If some sup plement makers slip ineffective products past the fda, and dubious ads past the ftc, is that _ really cause for concern?

Brian Butcher thinks so. A doctor and vice pres ident with the Arthritis Foundation in Atlanta, he worries that the ads ex ploit people with arthritis and may drag them from treatments that do help.

Butcher says he gets regular offers to endorse one herbal arthritis prod uct or another. "I usually say to these people, 'Send

me the data.' And at best, they'll send you these an ecdotal stories that are re ally no good."

Yet many arthritis sufferers have spent mon ey on unproven remedies, Butcher says. "As with all chronic diseases, people just really get fed up with it and they get desperate."

At the American Heart Associ ation in Dallas, Dr. Terry Bazzarre, a staff scientist, has similar wor ries. Some supplement makers like to suggest that taking the right supplement might prevent heart disease or stroke. But there's no ad equate evidence right now to sug gest that any supplement makes a difference, Bazzarre says.

Neither Butcher nor Bazzarre completely dismisses research in to dietary supplements, but they urge skepticism. Some supplement studies rely on sparse anecdotes and ignore contrary information. Others don't account for placebo ef fects. Still others leap to unwarrant ed conclusions based on animal studies, or from human studies that involved very few people.

"Marketing is a very interest ing process," Bazzarre says. "Some times it's what they don't say that ends up making what they do say

misleading." Advocates for the supplement

industry say that when it comes to vitamin-based and herbal products, consumers ought to be free to read, learn and make their own decisions.

For starters, supplements are generally safer than drugs, says Bill Soller, a senior vice president at the Consumer Health Care Products Association, a trade group for mak ers of supplements and nonpre scription drugs. 'They're basically foods. They've basically been used for hundreds of years."

And most people who take

HEALTH FOOD STORES push herbal and vitamin-based supplements, which totaled $12 billion in sales in 1997.

them don't forsake other medical treatment. The name "supplement" itself should signal that the products are an addition to a normal health regimen?not a substitute, they say.

High Cost of Testing On a more practical note, sup

plement makers argue that they simply can't afford to conduct the kind of extensive clinical testing common in the pharmaceutical in dustry. Large drug companies can spend hundreds of thousands of dol lars on premarket testing because they can patent the resulting prod uct. And even if a company spent $2 million and managed to prove that, say, crushed acorns cure the com

mon cold, it couldn't get a patent on the oak tree.

Supplement makers are doing more and more research, says Mont

gomery of the American Nutraceu tical Association, a group of about 5,000 doctors and pharmacists in terested in supplements. And dshea "allows companies that have done good studies to share that with the consumer."

As for the sometimes shoddy advertising, Montgomery says that as large companies enter the sup plement business, they will raise standards industry-wide.

Some companies have already begun calling the ftc to report com petitors' dubious advertising, Mont gomery says. "That's self-policing, and that's going to be helpful."

Self-policing isn't enough, say critics. They would like to see the fda regain its power to demand pre

^^^^ market testing across the

^^^H There appears little ^B^l chance that will happen. If Qgfy^ffM officials even suggested it,

Montgomery jokes, "You'd

?ai?? i ProDably blow out the ?SPQ phone system in Washing Fli^^ ton, D.C., with the con ???|Mh sumers going to the mem *38IIB bers of Congress."

If the government is

^^^H not about to rein in dietary

J*^j supplement marketing, consumer advocates say, it

nrj^J can at least promote good

B&Sy science about them. There are some signs of progress.

Sfl^H The National Center JSBj for Complementary and l h f? Alternative Medicine at

the National Institutes of Health now has a $50 million annual budget to

study supplements and other non traditional medical practices. Nih's Office of Dietary Supplements has a $2 million budget to study sup plements.

Silverglade says a better solu tion would be to force supplement

makers to contribute to an indus try-wide fund, with payments made according to market share. The fund would then provide for the clinical trials that no one company wants to pay for on its own.

Soller says members of his group have talked about some kind of research fund, "but nothing has gotten off the ground yet."

If companies balk at research, Silverglade argues, it shows how much they count on folk wisdom and placebo effect to drive sales. They may not want to find out which ones work and which ones don't."

ABAJ/ROBERT A. DAVIS ABA JOURNAL / JUNE 1999 63

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