From ClinicalNeurologyNews.com:
The days when the dietary supplements industry is allowed to regulate itself may be numbered following the release of a new federal report addressing growing concerns about the lack of oversight of the industry.
The report, issued by the Government Accountability Office, calls on the Food and Drug Administration to expand adverse event reporting and increase its efforts to educate the public about the safety, efficacy, and labeling of these products. The Government Accountability Office investigation into supplement safety was made at the request of Congress.
According to the 77-page report, the FDA should be tracking all levels of adverse events related to the use of dietary supplements and herbs, not just severe events. And, the report noted, despite the 2007 requirement for improved manufacturing practices, the FDA still lacks even the most basic ability to track the quality of dietary supplements (www.gao.gov/new.items/d09250.pdf).
Companies that manufacture the products are not required to identify themselves as such, or to provide the FDA with information about the products, including the product name and ingredients, the report said.
If a product is found to be dangerous, the agency is hamstrung—it can only ask for a voluntary recall as it did in December, when Star Caps, a popular weight-loss supplement, was found to contain prescription-strength levels of the diuretic bumetanide.
The FDA lost its authority to regulate the ingredients of dietary supplements prior to marketing with the enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) (www.cfsan.fda.gov/?dms/dietsupp.html). Before passage of the DSHEA, which went a long way toward deregulating the dietary supplement industry, the ingredients of dietary supplements were regulated under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act. Dietary supplements fall within the definition of complementary and alternative medicine. An earlier federal report issued by the Centers for Disease Control and Prevention found that use of complementary and alternative medicine is widespread (“Adults, Children Turn to Alternative Pain Therapies,” February 2009, p. 15).
Some of these products probably do have a beneficial effect in patients with neurologic disorders, said Dr. David Perlmutter, a Naples, Fla., neurologist who incorporates nutritional supplements into his practice.
“One of the key players in neurologic nutrition, for example is docosahexaenoic acid (DHA), an omega-3 fatty acid derived from fish oil or marine algae,” he said in an interview. Deficiencies in the nutrient have been linked to an increased risk of both Alzheimer’s disease and attention-deficit/hyperactivity disorder, he said. “Even now, the National Institute on Aging is conducting a randomized, placebo-controlled trial to determine if DHA supplementation slows the progression of Alzheimer’s.”
Dr. Perlmutter has also used B vitamin therapy to reduce hyperhomocysteinemia—a treatment he feels may reduce the risk of developing Alzheimer’s disease—and the antioxidant coenzyme Q10 to slow the progression of Parkinson’s disease.
“We as neurologists are able to do far more for patients than simply be purveyors of medications,” he said. “When we begin to pay attention to nutrition and supplements, it makes us far more effective.”
However, he acknowledged that quality control—or the lack of it—remains a serious issue. “There certainly are valid concerns, not just about the purity of the supplement, but the overall quality and the risk of contamination. Many supplements that people purchase online or in health food stores are produced in countries where there is little or no [quality control], most often China and India.”
Products imported from those countries have a history of poor quality. In fact, a recent study rather spectacularly showcased the problem. Researchers obtained 190 Ayurvedic medicines from Internet sources and determined their components by x-ray fluorescence spectroscopy. They found that 20% contained some level of toxic metal (lead, mercury, or arsenic). U.S.-manufactured products were just as likely to be contaminated as were those made in India (22% vs. 19%). The FDA’s Good Manufacturing Practices had no impact on the likelihood of contamination. Among companies manufacturing the metal-containing products, 75% claimed that they adhered to the Good Manufacturing Practice regulations (JAMA 2008;300:915–23).
Similar quality control problems led Congress to request the investigation about 18 months ago, said Lisa Shames, the GAO’s director of Food Safety and Agriculture Issues. “There has been a lot of congressional interest into how FDA was implementing the requirements [for oversight of dietary supplements and herbal products], especially the requirement for reporting adverse events,” she said in an interview.
One of the paper’s key findings is that adverse events are probably significantly underreported, she said. In December 2007, the FDA began requiring manufacturers of dietary supplements and herbal preparations to report all serious adverse events related to the use of their products.
“Since then, FDA has had a threefold increase in the number of events reported, but the big question is whether this is all the events that are happening,” Ms. Shames said. From January through October 2008, the FDA received 948 reports of adverse events, compared with 298 over the same time frame in 2007. “FDA recently estimated that the true number of adverse events could be well over 50,000 each year. We recommended that the FDA require reporting of all adverse events, regardless of their severity.”
The report also called on the FDA to require more information from manufacturers about the ingredients in their products. “There is a real lack of information that FDA needs,” Ms. Shames said. “Herbal products are not registered by the companies that produce them, and companies are not required to tell FDA what product they sell.”
Also, under current law, manufacturers are the ones to decide whether an ingredient is “generally recognized as safe,” and thus exempt from the laws that govern pharmaceutical products, she said. The report asks that the FDA take part in this responsibility, by clarifying the evidence needed to document an ingredient’s safety and the methodology necessary to establish that safety.
The agency should also increase its efforts to educate the public about the safety of supplements, the report concluded. “People think all these products are safe and approved by the FDA, and of course, this isn’t the case,” Ms. Shames said.
The report didn’t even touch on manufacturing issues, which are controlled by a set of laws that until recently left manufacturing oversight to the companies, with little government regulation. In 2007, the FDA finalized its Good Manufacturing Practice regulations, which will require quality control measures for all domestic manufacturers and foreign manufacturers that distribute in the United States. But the law is being phased in by company size, with the smallest companies having until June 2010 to come into full compliance.
In an interview, Dr. David Riley, founder of the Integrative Medicine Institute in Santa Fe, N.M., said that in order to reduce the risk of getting a contaminated or placebo product, he currently relies on his own experience and some assumptions about quality practices. “I generally assume that the products made in Europe, especially in Germany, tend to be more reliable and have a higher manufacturing standard, but I don’t really know that’s true.
