Recall of 2 Products Points Up Risks of Using Supplements

Americans have grown increasingly fond of vitamin and herb supplements, with about half saying they now take the products to promote good health. But the $13-billion industry is not as tightly regulated as the pharmaceutical industry, so consumers often can’t be sure precisely what they’re getting. The recent government-ordered withdrawal of two popular herbal products for contamination highlighted the problems in the industry and may have unsettled many who put their faith in the supplements.

Question: Why were PC SPES and SPES pulled from the market?

Answer: PC SPES, sold as a treatment for prostate cancer, and SPES, touted as a general immune system enhancer, were withdrawn from the market by the California Department of Health Services on Feb. 8. State investigators had determined that the products were contaminated with the prescription drugs Xanax, an anti-anxiety medication, and Coumadin, a blood-thinner. Both products are made by Bot- anicLab of Brea.

The popular PC SPES, which studies have shown could help men with a particular type of treatment-resistant prostate cancer, is a blend of eight herbs including saw palmetto and Baikal skullcap. The prescription drugs found in the product could cause severe side effects, such as bleeding and allergic reaction.

Q: Could other products be contaminated?

A: Dietary supplements are rarely removed from the market due to contamination, but no one knows how often products might be impure. The government doesn’t regulate dietary supplements like it does food and prescription drugs, and routine quality-assurance testing of products would not necessarily reveal the presence of contaminants.

There have been some high-profile cases of supplement contamination, including the 1989 deaths of 37 people who took L-tryptophan as a treatment for insomnia, depression and other ailments. More recently, authorities have withdrawn some calcium supplements made from natural sources, which may contain lead, and some supplements possibly tainted with salmonella.

Q: How do products become contaminated?

A: Contamination problems most likely occur when raw materials for supplements are processed at factories with poor quality-control practices. Many supplement manufacturers have quality-control programs but would not be able to identify contaminants unless they were actually looking for specific substances, says Forouz Ertl, of U.S. Pharmacopeia, a nongovernmental agency that sets quality standards for medicines. For example, health authorities would not have detected Coumadin in the PC SPES product without testing it for the presence of Coumadin. State officials began investigating the product after learning of consumer complaints of adverse effects.

Q: Is the government doing anything to protect consumers from contaminated supplements?

A: The U.S. Food and Drug Administration monitors dietary supplements for reports of adverse effects and has the authority to remove unsafe products, which it has done in rare instances. The government depends on manufacturers of dietary supplements to self-police their industry to ensure product quality.

Federal law does allow the FDA to establish mandatory good manufacturing practices--or GMPs--for dietary supplements, but so far it has not done so. In 1997, the FDA issued a proposal for the standards and asked for public comment. The FDA is currently reviewing comments to that notice. The rules are supposed to help ensure the quality of raw materials used to make supplements, the cleanliness and safety of manufacturing facilities and proper testing, production and distribution practices.

Q: Why has it taken so long for the federal government to enact protections?

A: Enacting new rules is a complicated process that has been prolonged by the change of administrations in Washington, says Christine Lewis Taylor, director of the office of nutritional products, labeling and dietary supplements for the FDA. “We’re hoping to have the rules sooner rather than later,” she says.

Opponents of mandatory government manufacturing practices charge that the standards may impose an unnecessary and costly burden on supplement manufacturers, particularly smaller companies. They say the rules could force manufacturers to make their products a certain way when there are better ways than those dictated by law. Standards, opponents say, may make it hard for manufacturers to change their products as new scientific knowledge or marketplace demands arise.

Q: In the meantime, how can consumers protect themselves?

A: There are no assurances for consumers, says Mark Kantor, an associate professor of nutrition and food science at the University of Maryland. “Consumers need to accept the risk [of contamination] given the past history of supplements and the fact that there are so many manufacturers now,” he says.

Consumers might be safer buying products made by large, established companies. “The larger the company and the greater its reputation, the more it has to lose,” says Kantor. “Large companies have the resources and wherewithal to do testing.”

Consumers can also look for quality approval seals from various independent testing programs, such as ConsumerLab and Good Housekeeping. However, the most extensive independent testing is being offered by U.S. Pharmacopeia. Under a voluntary program, U.S. Pharmacopeia will test dietary supplements for quality and safety. Products that earn the “USP-verified” seal must contain ingredients in the designated amounts, meet acceptable limits for undesired materials and be manufactured properly.

According to Ertl, USP also offers a “vendor specification program” to supplement manufacturers. The program examines the company’s entire setup--from a review of its raw materials’ vendors to its own manufacturing facilities--to verify safety and quality. “You have to start with a quality system in place to safeguard against this situation” of product contamination, she says.

Q: Are there other concerns about dietary supplements besides the risk of contamination?

A: Federal manufacturing guidelines would be “a major step forward” in bringing credibility to the industry, Ertl says. But many health experts doubt that supplements work--after all, few products undergo rigorous scientific testing for efficacy. Others have expressed fears that consumers will take supplements that interfere with prescription drugs or will opt for supplements in place of prescription drugs that have proven effective. Still others are concerned about side effects of various herbs.

“In my opinion, the most important issue is that dietary supplements contain bioactive ingredients that have not been adequately tested for safety and effectiveness,” says Kantor.

“Companies say these products have been used a long time and that there is no reason to think they are unsafe. But there could be a portion of the population who, because of their genetic variation, may react in a way that we just don’t know about.

“How dietary supplements interact with food and drugs is another issue,” Kantor says. “You are just kind of out there with a lot of unknowns.”