The Food and Drug Administration (FDA) is a federal agency responsible for regulating products that affect public health, such as food products, pharmaceutical drugs, medical devices, cosmetics, and even tobacco products. Unlike drugs, which must be proven to be safe and effective for their intended use before they are marketed, the law does not require the FDA to approve the safety of dietary supplements before they reach the consumer. Dietary supplements are regulated by the FDA as foods, not as drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) defined the role of supplements and outlined what dietary supplement companies can legally say about their products. The law states that, since supplements are not drugs, supplement companies cannot imply, insinuate, or claim that their products diagnose, treat, cure, or prevent diseases of any kind.
The FDA has also interpreted some normal conditions as precursors or markers of diseases. The FDA doesn't “approve” dietary supplements because it doesn't approve foods. The FDA only approves pharmaceutical drugs. The FDA monitors the manufacture and labeling of supplements, and regularly inspects companies to ensure that they comply with all regulations. If a supplement company doesn't comply with FDA regulations, the FDA may prohibit them from selling their product. To ensure public safety, the FDA has defined good manufacturing practices (GMP) that it applies through inspections and has the authority to process seize and recall dangerous products from the market.
Since 2004 the FDA has taken more than two dozen of these products off the shelves with names such as Stiff Nights and True Man because they contained sildenafil (the active ingredient in Viagra) or a chemical cousin of Viagra. It's important to consult with a health professional before using any dietary supplement. Products that contain hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it's essential to be aware of the regulations surrounding dietary supplements and to understand how they differ from pharmaceutical drugs. Introduced in 1958 before food technology raised many of the questions it poses today the GRAS loophole allows food product producers to bring new ingredients to the market without informing the FDA. Jane Henney commissioner from 1998 to 2001 recalled that the DSHEA law was actually passed as a result of the FDA “really trying to achieve stronger regulatory authority with dietary supplements”.
Hamburg also recognized the “widespread concern” about the origin and content of these products noting that the FDA “has some manufacturing authority” but limited resources make it difficult for the FDA to take advantage of the few authorities it has. So what exactly is the FDA's role in the supplement industry? To ensure public safety, the FDA has defined good manufacturing practices (GMP) that it applies through inspections and has the authority to process seize and recall dangerous products from the market. The FDA also monitors supplement companies to ensure they comply with all regulations. It's important to remember that unlike drugs, supplements do not require prior approval from the FDA before being offered for sale to consumers. However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or with a medical condition you may have. That's why it's essential to consult with a health professional before using any dietary supplement.