Are Dietary Supplements "Unregulated?"
Are Dietary Supplements “Unregulated.”
The media continues to make statements that imply there is a lack of regulation of nutritional supplements. This is incorrect. We have provided information that refutes this claim many times in the past.
While it is true that dietary supplements are not regulated the same way drugs are regulated, it is also true that nutritional supplements are not drugs, and are not allowed to make drug-like claims, etc. If they did, then drug regulations would apply.
Drug products are allowed to make claims that they effectively treat and cure various diseases. They are required to submit proof to the FDA that they do indeed do so (New Drug Application, etc). Dietary supplements cannot, by law, make such claims. So, obviously, they cannot be required to provide proof of efficacy. How can you be expected to proove something that you cannot claim happens?
Does this mean that dietary supplements are “not regulated?” Of course not.
There are some who blame the most recent law, DSHEA, for allowing problems to go unresolved relative to dietary supplements. They want to change the law. To provide some insight into what DSHEA actually entails, and to show how wrong the “unregulated” charges are, a summary of the regulations, as provided by The Council for Responsible Nutrition (www.crnusa.org/leg.html) is presented below.
DSHEA Summary & Analysis
When it enacted the Dietary Supplement Health and Education Act of 1994, Congress recognized the role supplements can play in health promotion and in the prevention of chronic diseases such as cancer, heart disease, and osteoporosis. This comprehensive piece of legislation established a new regulatory framework for supplements, ensuring continued access to safe products, made to quality standards. It also allowed for increased dissemination of information about the health benefits of these products.
In signing the Act in 1994, President Clinton stated that "After several years of intense efforts, manufacturers, experts in nutrition, and legislators-- acting in a conscientious alliance with consumers at the grassroots level-- have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law." The White House press release concluded by saying "in an era of greater consciousness among people about the impact of what they eat on how they live and how long they live, it is appropriate that we have finally reformed the way Government treats consumers and supplements in a way that encourages good health."
The legislation defined dietary supplements, created a mechanism for dealing with safety issues, regulated health claims and labeling of dietary supplements, provided for good manufacturing practices, and established new government entities to review regulations and encourage research on dietary supplements. The provisions which will aid the millions who re