For many of the estimated 57 million Americans with moderately high cholesterol (200-239mg/dL), the supplement Cholestin is a natural treatment for heart health. The formula derives its benefits from red yeast rice, a traditional Chinese food whose virtues as a circulation tonic were extolled by the Tang Dynasty in 800 A.D. Since then, more than 30 clinical trials in China and the U.S. have documented the positive effects of the supplement, including a most recent study conducted at the UCLA School of Medicine. As reported in The American Journal of Clinical Nutrition in February 1999, the double-blind, randomized trial of 83 subjects showed Cholestin to significantly reduce total cholesterol levels. With heart disease the number one killer in America today, thousands are turning to this product to keep their cholesterol levels down.
Unfortunately for Pharmanex, the maker of Cholestin, the FDA has not been willing to jump on the bandwagon. In the spring of 1998, the federal agency informed the company that their product was a drug, not a supplement, and an unregulated one at that. One of the constituents in Cholestin is chemically identical to a synthetic ingredient in the prescription drug Mevacor, and this, said the FDA, put the product on par with other prescription drugs.
The FDA banned the company from importing the fermented rice and told them they would have to apply for drug status if they wanted to continue selling it. Pharmanex's subsequent appeal of the decision has become the landmark test case of the Dietary Supplement Health and Education Act (DSHEA). In 1994, thousands of health consumers and natural products companies fought for passage of this law to guarantee consumer access to dietary supplements without lengthy and costly FDA approval. Groups on both sides of the issue have monitored the Pharmanex case closely, knowing that the final verdict would have far-reaching ramifications for those who use herbal products.
"The implications of this case were enormous," recalls Pharmanex President Bill McGlashan. "Cholestin contains all naturally occurring ingredients. Mevacor is a synthetically isolated, purified, and crystallized drug product. The FDA was basically saying that we needed to spend the $75 to $300 million it takes to get a drug approved. Taking it a step further, plants with active beneficial ingredients like green tea would have to be marketed as drugs too."
Millions of dollars in legal fees later, says McGlashan, the case was before the Utah U.S. District Court, which had to decide whether or not to overturn the FDA's decision. In February of 1999, much to the relief of natural products companies throughout the country, the court ruled that the natural cholesterol-lowering formula was indeed a supplement. The judge pointed to the fact that the DSHEA law allows supplement makers to sell products without the approval of the FDA, unless a safety issue is involved. Since the agency never questioned the safety of Cholestin, Pharmanex was off the hook.
Many viewed the ruling as an important affirmation of the DSHEA law. Susan Haeger, president and CEO of Citizens for Health, a nonprofit consumer advocacy group in Boulder, Colorado, explains, "This is the first time that DSHEA—an intent of Congress to make supplements accessible to consumers—has been tested in court. Pharmanex has done so much research to be able to communicate the benefits of red yeast rice clearly to their consumers, and had the FDA won this case, it would have discouraged other companies from investing in science. For the FDA to classify this product as a drug was extremely disturbing. I'll be very interested to see if the FDA appeals the case."
The Pharmanex case is just a first chapter in what is likely to be a long tale of strained relations between the rapidly growing natural products industry and the FDA.