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.
Wow, it’s about time. The timelines sound pretty aggressive to me, at least for government work. What else would you have liked to see in such a bill?
I would love to see supplement manufacturers required to provide pre-market evidence of safety and efficacy, to have openly accessible clinical trial data on their products, and to be required to have a system in place for monitoring and reporting adverse events. There are some differences between many supplements and pharmaceuticals, but far fewer than most people believe, and the basic principles of establishing safety and efficacy and monitoring for unexpected harm is the same for both kinds of intervention.
I can imagine this will also put an added burden on the FDA, and wonder just how helpful it may be in that regard. Yes, it’s a step in the right direction!
So does this mean Bill Nelson supports the bill or likes DSHEA? DSHEA should be toast.
Dear Dr. Malernee:
Thank you for contacting me regarding the health benefits and regulation of dietary supplements. The most important aspect of dietary supplements is not only having access to the information about the potential benefits of the supplements, but also ensuring that these dietary supplements are safe and produce the results that they claim to achieve.
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA) to meet the concerns of consumers and manufacturers and help ensure that safe and appropriately labeled products remain accessible. The provisions of DSHEA include defining dietary supplements and ingredients, establishing a new framework for assuring safety, requiring ingredient and nutrition labeling, and authorizing the Food and Drug Administration (FDA) to establish good manufacturing practice regulations.
The FDA, through implementation of DSHEA should be funded and allowed to do the work of ensuring the safety of supplements and the truthfulness of manufacturers and suppliers. It is important for the FDA to ensure the safety of dietary supplements so that the people who use them are able to get the most out of them.
On August 1, 2013, Senator Durbin introduced S. 1425, a bill that would require manufacturers of dietary supplements to register their products with the FDA. Please be assured that I will keep your views in mind when the Senate considers issues affecting dietary supplements. If you have any further concerns please do not hesitate to contact my office.
Sincerely,
Bill Nelson
P.S. From time to time, I compile electronic news briefs highlighting key issues and hot topics of particular importance to Floridians. If you’d like to receive these e-briefs, visit my Web site and sign up for them at http://billnelson.senate.gov/news/ebriefs.cfm
All ingredients should always be labeled and clear! What are they hiding if they can’t publish what is in the products!