DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994

Known as DSHEA (dah-shay), the Dietary Supplement Health and Education Act of 1994 ended years of wrangling over how dietary supplements would be regulated. Up until passage of the bill, these products, such as vitamin, mineral and other nutritional supplements, including herbs, were considered "unapproved drugs". Since they were considered low priority in the list of "drugs" needing scientific study for safety, Americans had enjoyed over-the-counter access for decades. Then, in 1992, the FDA proposed rules to remove dietary supplements from the market as they represented a "disincentive" for patentable drug research. At the same time, a gunpoint FDA raid into a patient-filled doctor's office to confiscate records and confiscate supplements roused the American public to action and in short order, outraged citizens wrote 2.5 million heartfelt letters to Congress, among the most ever received on a single issue. As a result, Congress unanimously passed DSHEA.

Key provisions of DSHEA include:

1. The establishing of dietary supplements as food NOT drugs.

2. Supplements are considered safe unless one of its ingredients presents a "significant or unreasonable risk of illness or injury" when used as described on the label or under conditions if no directions are on the label.

3. It is up to the government to provide evidence of "unreasonable risk of illness or injury".

4. Manufacturers are responsible to ensure the product is safe and properly labeled.

5. Third party information about the healthful benefits of the supplement can be made so long as it is truthful and not misleading.

6. Manufacturers are not allowed to make claims that the product can diagnose, treat, cure or prevent any disease. (only manufacturers of drugs can make such a claim.) Claims about well-being are allowed.

The Inside Story of DSHEA and Its Success
DSHEA has been a great success. Under clear regulations, the dietary supplement industry has expanded year after year and now 88% of the population use supplements. The safety of these products are obvious. Supplements cause fewer adverse reactions than ordinary food and 800 times fewer reactions than drugs.

DSHEA’s Past, Present and Future
http://www.naturalfoodsmerchandiser.com/ASP/1158/Display-Article

Americans Consume More Dietary Supplements Than Ever Before
http://www.imakenews.com/eletra/mod_print_view.cfm?this_id=92528&u=bioanalogics&issue_id=
000020014&show=F,T,T,T,F,Article,F,F,F,F,T,T,F,F,T,T

Dietary Supplement Health and Education Act of 1994 - Public Law 103-417 - 103rd Congress
http://www.fda.gov/opacom/laws/dshea.html

DSHEA IS UNDER ATTACK

Even with, and perhaps because of, the success of DSHEA, and the eagerness with which hundreds of millions of Americans now use supplements, there are people who think DSHEA was a mistake. They think these products should be regulated strictly like drugs and there now seems to be a steady stream of bills in Congress trying to gut the strengths of DSHEA.

It doesn't take much imagination to understand the real reason easy access to supplements is under attack. When we take supplements we are less likely to become ill and need the services of the allopathic medical industry and we are less likely to take prescription drugs.

In addition, with the coming of Codex regulations, large manufacturers of supplements, such as pharmaceutical companies, whose products tend to be low dose, sometimes synthetic products, are more than happy to promote more regulations. The cost of keeping up with complex regulations is no burden to them. In addition, selling millions of low dose, basic supplements is highly-profitable to them so they don't have a need to protect the availability of specialty products. Conversely, the small or medium-sized manufacturers, who are the ones who develop the leading edge products of today, are at risk should DSHEA be gutted.

In the end, the big losers will be the public.

For this reason, we ask you to please sign up for our action alerts and check our Action Alert page often to stay on top of what YOU can do to protect YOUR access to supplements.