Millions of Americans turn to dietary supplements each day without any guarantees that the herbs, vitamins and minerals they take are uncontaminated, manufactured properly and contain exactly what's on the label.
That could change under proposed Food and Drug Administration rules -- stalled for years -- that would assure purity and consistent dosing with every batch and bottle made by a particular manufacturer. The draft regulations, released earlier this month and expected to be finalized next year, are the first attempt to more tightly regulate the $19-billion supplement industry, which is not currently held to the same standards as the pharmaceutical industry.
Although they're not completely satisfied, consumer activists and doctors have reacted favorably to the move, especially because consumers so often take product quality and reliability for granted.
"We've come out over and over showing problems with products," said Dr. Tod Cooperman, president of ConsumerLab.com, an independent testing company. Up to 40% of herbal products don't contain precisely the active ingredients listed, the company's tests have shown. Some contain less or more of plant chemicals than what's stated on the label; others contain the wrong part of an herb, such as the root instead of the leaf. Cooperman said that in two weeks ConsumerLab.com will release a new review of ginkgo products that uncovered even more problems than a similar analysis of ginkgo biloba three years ago.
Some dietary supplements have been found to contain pesticides and heavy metals such as lead, and, in rare cases, prescription ingredients. Regulators last year pulled from the market a promising treatment for prostate cancer called PC SPES after finding it contained a prescription blood thinner and an anti-anxiety drug.
"If they are enforced, which they may or may not be ... when someone picks up a package that says this has 40 milligrams of dietary supplement X, it is more likely to have 40 milligrams," said Dr. Sidney M. Wolfe, executive director of Public Citizen Health Research Group in Washington, D.C., a consumer advocacy organization. But Wolfe also took issue with what many consumer activists and health experts see as a shortcoming in the regulation of dietary supplements -- safety and effectiveness still are not addressed. The proposed rules are part of a 1994 law that allows for only minimal regulation of vitamins, minerals and herbs.
"Even if it's 100% enforced, the law is deadly silent on how what you're getting may be extremely dangerous, may cause death and may not work," Wolfe said. In addition, it doesn't require supplement makers to report side effects or register their products so the FDA can track what's being sold.
Cooperman said it's possible for a manufacturer to meet the proposed standards but still turn out a poor-quality product.
He also questioned how tightly new regulations would be enforced, given that the 1994 law already says products must contain 100% of what they claim and that they should be free of impurities and contaminants.
Both the industry and its critics acknowledge that the FDA doesn't have the staffing to monitor dietary supplements more closely.
To date, the FDA has only taken action against supplement makers for "outrageous health claims or safety issues that just can't be ignored anymore, as in the case of ephedra," Cooperman said. Two weeks ago, responding to an outcry about ephedra use in athletes after the Feb. 17 death of Baltimore Orioles pitcher Steve Bechler, Health and Human Services Secretary Tommy Thompson announced a proposed label warning telling consumers that ephedra products may contribute to heart attack, stroke and death.
Manufacturers back change
Given the crisis in consumer confidence, large supplement manufacturers and ingredient suppliers are backing the proposed manufacturing rules. The 1994 Dietary Supplement Health and Education Act, which placed supplements in a virtually unregulated category closer to foods than drugs, authorized the FDA to begin setting good manufacturing practices for the industry. Although the FDA in 1997 proposed good manufacturing practices based on industry recommendations, they were stalled until the March 7 announcement and last Thursday's formal release. The rules are subject to a 90-day comment period and subsequent modifications.
In the absence of such standards, several large manufacturers, many of which are subject to FDA inspections for pharmaceuticals they produce, voluntarily sought good manufacturing practice certification to enhance their credibility with consumers. These are offered by the National Nutritional Foods Assn. in Newport Beach; the nonprofit, non-governmental NSF International in Ann Arbor, Mich., and the U.S. Pharmacopeia in Rockville, Md.
Although the voluntary certifications address quality control, cleanliness, potency and purity of ingredients, equipment maintenance and record-keeping, the proposed FDA regulations would go further -- requiring testing of finished products.
Annette Dickinson, the president of the Council for Responsible Nutrition, a Washington, D.C.-based trade association, predicted that the proposed regulations, which are likely to cost large companies millions of dollars, would improve the quality of what's on the market.
And while some of the estimated 1,000 dietary supplement makers in the U.S. market have followed stringent manufacturing practices and quality assurance programs, only a few sought outside certification, making it hard for consumers to tell which were doing things right.
Dickinson said many problems have come from newer entrants into the dietary supplement industry that "may not have the experience in quality assurance that they really ought to have. Everybody in the industry knows we are facing an issue with consumer confidence that has to be dealt with by having some good, sound rules."
More stringent rules
The new regulations are a step forward for the practice of herbal medicine, said Dr. Mary Hardy, director of integrative medicine at Cedars-Sinai Medical Center in Los Angeles. She said the proposed rules would "bring a degree of rigor that has been lacking."
Many supplements and herbs don't need to be held to pharmaceutical standards, she said, noting: "if you're making a cup of peppermint tea from mint in your garden, you don't need that level of assurance."
But even as supplement makers are prohibited from making disease or treatment claims, the reality is that many supplements are used in place of prescription drugs.
When a patient takes something such as St. John's wort rather than a prescription medication for mild depression, Hardy said, "you need it to be consistent so you get the same kind of effect from one dose to the next. There ought to be enough reliable information on the label that you can take a specific dose with a degree of comfort."