FDA Looking to Regulate Vitamins and Herbs
By Paul Yeager
Americans spent $6.5 billion on dietary supplements in 1996, nearly doubling the 1990 total of $3.2 billion and the most recent figures reveal that sales have reached over $26 billion. This booming mega-money industry, which consists largely of natural health products, is currently being sharply challenged by both the Food and Drug Administration (FDA) and the medical community; and with such large sums of money at stake, it naturally raises questions about motive.
Is this a legitimate effort by the FDA and the medical community to protect the health and safety of the public? Hopefully, since that fits the job description. Or is this a concerted effort by the FDA and medical community to protect the financial interests of pharmaceutical drug industry and the medical community? Thats possible, since some of the billions of dollars spent on supplements would otherwise be spent on drugs and doctors.
The FDA is now considering changes to dietary supplement labeling for the purpose of "clarifying for manufacturers what types of claims they may--and may not--use on labels of dietary supplements under the Dietary Supplement Health and Education Act (DHSEA) of 1994," according to the FDA (April 27, 1998 fact sheet). The DHSEA established the framework for FDA regulation of supplements, and it gave dietary supplement manufacturers more freedom to market products and provide information to consumers than they had previously. This freedom, in large part, is the reason that supplement sales have increased dramatically in the past few years.
"An FDA Guide to Dietary Supplements," which can be found on the FDA website (www.fda.gov), documents the role of the FDA as it relates to supplements, and it expresses the agencys concerns. "In choosing whether to use dietary supplements, FDA answers consumers questions by noting that under DHSEA, FDAs requirements for pre-market review of dietary supplements is less than that of other products it regulates, such as drugs...." In addition, the FDA "has the responsibility for showing that a dietary supplement is unsafe before it can take action to restrict the products use." Drugs, on the other hand, must be deemed to be safe before the FDA allows them to be used.
Since the DHSEA was passed by Congress, the FDA must stay within its guidelines; it cannot randomly change the way supplements are regulated. One clause of DHSEA states that supplements cannot claim to treat a specific disease. This allows a loophole for the FDA to assume more control, since the agency can define the term "disease" as it relates to supplements. Call "headache" a disease, and then the FDA can regulate supplements that claim to relieve headaches. That is what the FDA is proposing to do, and it has some people upset.
The consumer group Citizens for Health, on its website (www.citizens.org), says that new FDA regulations would not only define headache as a disease but also conditions such as menopause, aging, premenstrual syndrome, and pregnancy. The result, according to the group, would be that "producers of dietary supplements will not be able to tell you how new scientific research has been linked to supplements that address these and other conditionsor how their products can be used to help you address them."
Andrew Weil, medical doctor and best-selling author, is one of the leading proponents of "integrative medicine," which combines effective alternative therapies with mainstream medicine. On his website (DrWeil.com), he says that he agrees that the dietary supplement industry needs regulation and that perhaps it should come from "an independent unit of the FDA that is free of the influence of the pharmaceutical lobby or from a non-governmental agency...."
In addition to concerns about regulation, scientific proof of the effectiveness of alternative treatments has been the basis of recent attacks by the medical community. Herbal medicine, which constitutes a large part of the supplement industry, is considered to be the most popular form of alternative therapy.
An editorial in The New England Journal of Medicine (Sept. 17, 1998) is representative of the attacks. "What most sets alternative medicine apart [from ordinary medicine], in our view, is that it has not been scientifically tested and its advocates largely deny the need for such testing." Dr. Weil strongly disagrees: "The Journals assertion that advocates of alternative medicine dont want their methods to be researched is absurd. We do." He goes on to say that more research needs to be done on alternative therapies and that other countries are far ahead of the United States in that regard.
The safety, efficacy, and proper use of dietary supplements, and alternative therapies in general, is critically important, since more and more Americans are turning to them every year. It is also critically important that government decision makers, doctors, and supplement manufacturers remember that the best interest of the public is more important than the size of their piece of this multi-billion-dollar pie.
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