I have written previously about the woefully inadequate regulation of dietary supplements in the U.S. under the Dietary Supplement Health an Education Act (DSHEA). Much has previously been written at the Science-Based Medicine Blog on the subject of the Dietary Supplement and Health Education Act of 1994 (DSHEA) (e.g. 1, 2, 3, 4). Essentially, the supplement industry and sympathetic lawmakers created this law to pretend to regulate herbal remedies and other dietary supplements while effectively stripping the FDA of the ability to control the sale of these products for the prevention or treatment of disease. This was accomplished by classifying all such products as foods and codifying the principle that they must be assumed to be safe unless the government can generate substantial evidence to the contrary. There are some restrictions on the medical claims manufacturers can make on the labels of these remedies, but they are routinely ignored and the resources and will behind enforcement of them are manifestly inadequate.
Proponents of supplements claim they are inherently safe because they are “natural,” but this is patent nonsense. There is ample evidence of the harm such unregulated products can cause. While it is likely some of these products will have real benefits (as has been shown for fish oils and probiotics, for example), there is no reason not to require the same standards of evidence for safety and effectiveness applied to any other medical therapy.
Attempts to require some reasonable evidence of safety and efficacy before marketing supplements as medical therapies have been made, and these have consistently been defeated by the supplement industry and lawmakers influenced by their campaign donations. This year, another bill has been introduced to require just a little bit of oversight to these potentially dangerous products. It doesn’t, in my opinion, go far enough, but it is absolutely a step in the right direction. I urge everyone to call and write your U.S. Senators and urge them to support S. 1425: Dietary Supplement Labeling Act of 2013.
Here are some of the provisions of this law:
1. Manufacturers of dietary supplements will be required to list their facilities in a public registry so we can know who is producing supplements and what they are making.
2. Within one year of passage, the government will compile a list of supplement ingredients and mixtures that could potentially cause serious adverse effects, interfere with prescription medications, or harm vulnerable groups such as children or pregnant women.
3. Within 18 months after passage, the independent, non-artisan, non-profit Institute of Medicine will produce an evidence-based report evaluating the risks of potentially dangerous supplement ingredients or blends.
4. Within 2 years of passage, the Institute of Medicine will establish mandatory warning labels for potentially dangerous supplements.