Tuesday, January 20, 2009

Second Opinion on Herbs

Second Opinion on Herbs In a recent opinion, physician Henry I. Miller advocates a new way to regulate dietary supplements (DS), arguing that they are currently unregulated. Although a onetime FDA official and longtime industry critic, Dr. Miller seems out of touch with the current state of DS regulation, including recent major advances in quality assurance by manufacturers. His bias against natural products is made evident by his use of the slur “snake-oil” to dismiss herbal products as simultaneously ineffective and “dangerous”. Many observers, including FDA commissioners during congressional testimony, have testified that the agency has all of the authority it needs to regulate DS. Recent advances include the FDA’s current imposition of mandatory Good Manufacturing Practices (GMP), which was authorized by a 1994 law (DSHEA) that Dr. Miller inexplicitly claims exempted DS from government oversight. That same law stipulates that supplements must not be mislabeled or adulterated and the FDA has repeatedly taken action against such products, again proving Dr. Miller wrong. Manufacturers are now required to have procedures in place to assure product identity, potency and safety, as authorized by a law that Dr. Miller misrepresents. DS manufacturers supported a serious adverse event reporting (AER) law to track patterns of serious side effects. In the first year, the number of DS reports was significantly less than the FDA had predicted. An AER is casually linked to, but not proven to be caused by, a product. Dr. Miller’s assertion that foods and DS like herbs interfere with drugs (Miller’s ‘“real” medicines’) is telling. Is it professional bias to claim that foods, herbs and vitamins are unnecessary nuisances that are interfering with all-important medical treatment? In fact, these legendary interactions appear to be a minor issue. When the Mayo Clinic did a large patient survey to scientifically assess the risk, it reported that there were few such interactions, none serious, limited to only a handful of drug types and a few supplements such as garlic. Dr. Miller’s proposal for a new voluntary oversight entity for herbal products to correct a supposed lack of regulation is illogical; such entities already exist, and how could a voluntary program replace adequate regulation? His seeming ignorance of the current regulatory status of herbs is troubling, undercutting his rationale for such tinkering. Statistically, dietary supplements are safer than drugs and even safer than eating a meal, as recent AER reports prove. DS labeling and manufacturing are currently well-regulated. I suggest that studying drug-nutrient-herb interactions and addressing these on drug labels – where they belong - is a far wiser strategy than creating a “voluntary oversight” entity for dietary supplements, especially as there are already voluntarily GMP-certified brands available.

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