A consumer walking down the aisle of a local drugstore can choose from a wide variety of supplements, vitamins and nutrients for his or her particular needs. Whether it’s a pill to treat a specific ailment, nutrients and minerals to supplement a deficient diet or vitamins tailored to age and gender to promote long-term health, supplements provide significant benefits to the consumers who rely on them. Yet if Sen. Richard J. Durbin, Illinois Democrat, and the Food and Drug Administration have their way, many of these products will disappear.
Earlier this month, Mr. Durbin and the FDA released proposals for a time-consuming and costly approval process for vitamins and nutritional supplements. The proposals would force companies to pull these products off the shelves for months, if not for good, and significantly raise prices, making the remaining supplements expensive and harder to find. While it isn’t a direct ban, regulatory hurdles such as these are a means by which government bureaucrats get in the way of individuals’ ability to make their own decisions about their health care.
Mr. Durbin claims his bill, the Dietary Supplement Labeling Act of 2011 (S. 1310) is needed to regulate supplements that masquerade as foods. For example, Mr. Durbin has oft-cited Lazy Cakes as an example. Lazy Cakes, which are melatonin-laced brownies, are reportedly being sold in convenience stores and clubs and purport to help users relax and sleep better. Mr. Durbin’s bill would give the FDA power to compile a list of all dietary ingredients believed to have the potential for adverse health effects and require manufacturers to add warning labels to any supplements containing those ingredients. That may not sound too bad, but combined with new FDA guidelines released on the same day, Mr. Durbin’s bill would prove devastating.
Since passage of the 1994 Dietary Supplement Health and Education Act, supplements have been exempted from the time-consuming and expensive drug approval process that pharmaceutical drugs undergo. This exemption was deemed necessary to preserve the vibrancy and variety of the market for supplements. Because supplements generally cannot be patented, manufacturers would never see a return on the investment of proving scientifically what is already known about their safety and effectiveness. Yet, these new guidelines seek to find a way around that exemption by giving the FDA power to pull all dietary supplements created after 1994 off the market and require them to submit all of their ingredients to an assessment process thatcould keep products off the shelves for months or longer.
Additionally, if products created before 1994 have changed their ingredients or manufacturing process in any way, the FDA would have the power to force them through the re-evaluation process, too. This means that virtually all supplements will need to submit to the approval process. Together, these proposals could decimate the vitamin market as we know it.
To make matters worse, the FDA is known for dragging out its reviews - sometimes for years - even after multiyear extensive drug trials, causing needless suffering and death for patients waiting desperately for new treatment options. Yet with this latest proposal, the FDA would face a flood of new paperwork on top of its already considerable backlog. Supplement manufacturers would have to submit an application, consisting of evidence to support supposed safety, for every ingredient in each supplement they sell.
It isn’t just the effects of the proposal that are bad, but also the justification on which it is based. The FDA already has the power to take Lazy Cakes off the market, yet has not done so. This means that either the FDA recognizes that the product is safe and is using it as a smoke screen or it is taking a dangerous risk by allowing a potentially hazardous product to remain on the market in order to bolster its case for more power.
Many of the nutrients and minerals in supplements have been part of the human diet since the dawn of history and were used by doctors and in folk remedies for centuries. The supplements industry has a good record of safety, especially when compared with the FDA-regulated drug market. While there are some supplements with questionable benefits, the decision about which supplements are right for whom ought to be left to consumers and their medical care providers to determine.
The Durbin and FDA proposals do nothing to improve the safety of the supplement marketplace and likely will eliminate many of the available products. If the proposals are implemented, the increased cost and decreased variety will mean that many consumers, especially low-income ones, will be forced to stop taking the vitamins and nutrients that can benefit their long-term well-being. This unnecessary power grab would benefit FDA regulators and pharmaceutical companies by taking their competitors off the market, but it would harm the American public.