Getting a Dose of Reality

The health supplement industry, which made the exotic echinacea plant a modern alternative to chicken soup, is scrambling to find a cure for its sales malaise.

Americans last year reduced purchases of vitamins, herbs and other health supplements for the first time since 1994, a sign that consumers have become skeptical of natural remedies marketed for maladies ranging from sniffles to depression.

The slowdown comes despite continued high prices for prescription drugs and dissatisfaction with managed medical care--factors that drove the self-care market during the last decade. But developments in science and the marketplace, along with recurrent questions about safety, have taken a toll on wellness products.

* Research on top-selling remedies has raised questions about whether they work. In two separate studies published last year, for example, scientists drew opposite conclusions about echinacea’s purported cold-fighting ability. Sales of the strong-selling remedy dropped from 1999. “If experts can’t agree, whom should [consumers] trust?” said nutritional-industry consultant Robert G. Donovan.

* Quality-control issues won’t go away. Watchdog groups and, most recently, online testing service ConsumerLab.com, have found that ingredient levels in supplements frequently fall short of amounts stated on product labels. Of 13 SAM-e products ConsumerLab.com tested last year, for instance, five didn’t contain the amount of S-adenosyl-methionine stated on the label. SAM-e is promoted as an antidepressant.

* Health-conscious consumers have more choices. Vitamin-fortified cereals and drinks, herbal teas and such anti-cholesterol butter substitutes as Benecol offer Americans ever-widening alternatives to pill-popping. “Consumers may be looking to foods first,” said Phillip W. Harvey, an official with the Newport Beach-based National Nutritional Foods Assn., which represents mostly retail stores.

Beyond these issues is “mad-cow” disease, a concern up and down the nation’s food chain. The Food and Drug Administration asked supplement makers on Jan. 29 to identify the source of bovine-derived products, including glandular extracts, collagen, glucosamine and chondroitin, which aren’t covered by regulations that protect Americans from infected beef.

Trade groups representing the industry said they haven’t been able to trace the source of every product and may not be able to do so. Supplement makers aren’t required to maintain records on ingredient sourcing or meet federal manufacturing standards, as drug companies are.

“It is a multinational business,” Harvey said. “It is very difficult to track.”

Mad-cow disease, formally known as bovine spongiform encephalopathy, or BSE, and its human form, new-variant Creutzfeldt-Jakob disease, haven’t been linked to dietary supplements. Industry officials consider the possibility of contracting the disease through supplements remote. But they worry that the faintest mention of the fatal, brain-wasting illness--detected in cattle in nine European countries--might cause consumers to swear off supplements.

“My paramount concern, if consumers freak out and overreact, is that we won’t be able to manage that problem,” said Loren D. Israelsen, executive director of the Utah Natural Products Alliance, whose members market mostly herbal products.

Questions about safety have plagued the supplement business. The FDA has received about 2,900 so-called adverse-event reports about herbal remedies, including ginkgo, ginseng, St. John’s wort and ephedra, a stimulant that also has been linked to 70 deaths. On Wednesday, a jury awarded $13.3 million to an Alaska woman who suffered a stroke after taking a weight-loss product containing ephedra, which is the subject of a lengthy FDA investigation.

The industry consistently has maintained that ephedra, also known as ma huang, and other herbals are generally safe. It argues that the number of people who experience adverse reactions is small compared with the estimated 20% of American adults who regularly use them.

And loyal users of nutritional aids haven’t been scared off. Rose Albano, a Los Angeles secretary, has been taking dietary supplements for close to 30 years and believes she is healthier for it. “I’m a big proponent of supplements because they get to the problem, unlike drugs that mask the problem,” said Albano, 48.

But reports of serious side effects help explain why overall confidence in nutritional supplements is relatively low for substances intended to improve healthfulness. Prevention magazine reports that 14% of consumers consider herbal remedies “very safe.” Only 30% of shoppers think herbal products’ claims are “extremely credible,” according to Natural Marketing Institute, a Philadelphia-based consulting firm.

And the industry’s image hasn’t been helped by online sellers of “body-building” products containing GHB, a depressant that can result in coma and death, or the industrial solvent BD, formally known as 1,4 butanediol. Congress passed a law in April prohibiting sale of the substances as supplements.

A broader problem for supplement makers is product quality, which officials acknowledge is inconsistent. The industry has been routinely embarrassed by results posted by ConsumerLab.com, a testing service founded by a physician and former FDA chemist. The Internet company has found labeling errors in random tests of ginseng, saw palmetto and ginkgo biloba, among other supplement products.

But so far, the industry--represented by five divergent trade organizations, including the American Herbal Products Assn. and the Council for Responsible Nutrition, which represents manufacturers and multilevel marketers, including Herbalife International Inc.--has been unable to adopt its own quality standards.

Instead, supplement makers have been lobbying the FDA to promulgate so-called good manufacturing practices, which would, among other things, regulate cleanliness of supplement factories and the potency and stability of ingredients. The FDA has called adoption of such standards a priority, one that is likely to draw heightened attention because of mad-cow concerns. In a videotaped address to a Consumer Health Products Assn. convention in Anaheim on Jan. 31, Joseph A. Levitt, director of the FDA unit that regulates supplements, said he is “very concerned there are no regulations at FDA” on BSE. “The industry needs regulations,” he said. The FDA planned to move the issue “quickly to the front burner.”

The FDA has been urging manufacturers and importers of dietary supplements to avoid products from countries where BSE has been detected. On Nov. 14, it sent a letter to the industry listing 21 bovine tissues suspected of harboring the disease. Of highest concern are supplements made from the brain and spinal cord. The industry believes many of the so-called glandular products, which account for about 1% of supplement sales, are made from domestic cattle or animals from Argentina and China.

However, Western Europe is a primary source of chondroitin, a strong-selling arthritis remedy made from cattle trachea.

Trade group representatives said the existence of manufacturing standards would have allowed them to trace the source of supplements. The National Nutritional Foods Assn., which has a voluntary quality-assurance program, said the handful of firms that participate have been able to demonstrate their products are from non-BSE countries.

Dietary supplement sales peaked in 1999, capping five years of steady growth fueled by the Dietary Supplement Health Education Act. The 1994 law partially deregulated the supplement business, allowing firms to market age-old remedies without first proving their safety and effectiveness. The FDA retained authority to yank products that turned out to be unsafe and to oversee product claims. Mass-market sales swelled 80% to $1.26 billion in 1999 from $699.5 million in 1997, according to the sales-tracking firm Information Resources Inc. Growth hit the skids in 2000 as sales slipped 1.2%.

Some in the industry said the slowdown shows the business is settling into a more sustainable growth pattern. Revenue spikes in earlier years were driven by consumer experimentation with alternative remedies that no longer seem novel.

Jeff Shillingstad of Los Angeles says he has slashed his yearly spending on dietary pills and formulas to $50 from $200. “For a while, I did chase some fads,” said Shillingstad, 30. “I’ve settled for a few things that worked for me.”

By some estimates, the industry continues to mushroom. Nutrition Business Journal reports sales rose to about $16 billion in 2000 from $15.4 billion in 1999, figures that include a broad range of products, including weight-loss formulations, sleep aids and sports supplements. The General Accounting Office, an arm of Congress, estimates that in 1999 consumers spent $31 billion on supplements and related products, such as herbal teas, snacks and other so-called functional foods.

But Donovan, the industry consultant, and others see signs of weakness below the surface. Mass-market sales of herbals fell 14% in 2000, as each of the top five herbs--echinacea, garlic, ginkgo biloba, ginseng and St. John’s wort--posted double-digit sales declines. The slide is troubling because herbals had been the industry’s star performers.

Besides quality issues, herbals have other challenges. Piecemeal research into their effects has led to product warnings and recommendations, sometimes within a matter of months. Take the case of St. John’s wort. Last February, the FDA issued a public health alert about taking it with other medications. That came on top of evidence that it can cause temporary nerve damage when users are exposed to bright sunlight.

But a study in the September issue of the British Medical Journal found the herb was as effective as and had fewer side effects than the commonly prescribed antidepressant imipramine, and concluded St. John’s wort was a better choice for treatment of mild depression. Still, mass-market sales of St. John’s wort skidded 45% last year.

Claims of other herbal products haven’t held up to scrutiny. Various studies have found little evidence to support ginseng’s purported benefits as a performance enhancer, an anti-cancer agent or an aphrodisiac.

Herbals aside, there are bright spots. Sales of glucosamine and chondroitin, touted for relief of arthritis pain, grew 25% from 1999. A study published in the medical journal Lancet last month found glucosamine may help stop progression of osteoarthritis, an inflammatory disease that attacks the joints.

Sports performance supplements are also strong sellers, though the FDA recently told the industry of its concerns about androstenedione, an alternative to anabolic steroids once used by home-run slugger Mark McGwire. A 1999 study on the effects of “andro” found that it increased levels of the female hormone estrogen rather than boosting testosterone and strength as promised.

An economic downturn could hurt products that are doing well. A 20-day supply of glucosamine and chondroitin can cost as much as $40, more than three times the price of a similar supply of ibuprofen. Supplements aren’t immune to economics. Unit sales fell 6.6% last year, a sign that some mass-market shoppers weren’t willing to pay higher prices.

Said the National Nutritional Foods Assn.’s Harvey: “We’re kind of going through growing pains. Maybe we’ll see a resurgence. Or maybe we won’t.”

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Supplement Slowdown

Through the late 1990s, consumers snapped up dietary supplements purported to improve conditions ranging from sniffles to depression. But doubts about their safety and effectiveness have stymied growth. *

Source: Information Resources Inc. *

Times staff writer Hang Nguyen contributed to this report.