Page "Dietary supplement" Paragraph 20

The DSHEA, passed in 1994, was the subject of lobbying efforts by the manufacturers of dietary supplements and restricted the ability of the FDA to exert authority over supplements as long as manufacturers made no claims about their products treating, preventing, or curing diseases.

According to Consumer Reports, " The law has left consumers without the protections surrounding the manufacture and marketing of over-the-counter or prescription medications " and it became the FDA's responsibility to prove that a supplement is not safe.

While pharmaceutical manufacturers must demonstrate their products are effective as well as being safe, supplement manufacturers are not required to demonstrate efficacy.

The FDA has ever found only one dietary supplement to be unsafe, the weight loss / energy supplement ephedra.

Discussing the legislation, Time referred to the DSHEA as " ill-conceived and reprehensible ", that " gives the industry virtually to market products defined as dietary supplements, while severely limiting the FDA's ability to regulate them ".

The DSHEA was heavily lobbied for by the supplement industry, and was criticized for exposing the public to worthless compounds that bilked consumers out of money to no benefit.

Because of the requirements put into place by the DSHEA, the FDA must demonstrate that individual supplements are unsafe using their adverse events reporting system, which is estimated to capture only 1 to 10 percent of all adverse events linked to supplements.

The FDA has also lacked the funding to undertake the rigorous tests to meet the standards for a supplement to be considered " hazardous " and, thus, removed from the market ; in the one situation where this standard was reached ( ephedra ), the agency faced significant opposition from the supplement industry and the United States Congress, instead limiting themselves to making announcements about problematic supplement safety records on their website.