Although the FDA doesn't approve dietary supplements, the agency has a role in regulating them. Because companies often introduce a dietary supplement to the market without notifying the FDA, the agency's role in regulating supplements begins primarily after the product enters the market. Dietary supplements are regulated by the FDA as foods, not as drugs. 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.
Products that contain hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it's important to consult with a health professional before using any dietary supplement. Read these consumer updates for more information. The Food and Drug Administration 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.
The FDA plays an important role in ensuring the safety of the products we use every day, but it doesn't pre-approve all the sectors it oversees. More on that in a minute. According to the FDA, drugs are meant to treat, prevent, mitigate, diagnose, or cure diseases. Human clinical trials must demonstrate that a drug is safe and effective for its intended use.
The drug must then be manufactured under controlled conditions and packaged to meet strict labeling regulations before it is pre-approved by the FDA for consumer use. Unlike drugs, the FDA states that supplements are for nutritional purposes only. Because supplements aren't considered drugs, they aren't controlled the same way. While the FDA has regulations for manufacturing and labeling, dietary supplements have different testing, safety, and efficacy guidelines than pharmaceutical drugs.
Unlike drugs, supplements do not require prior approval from the FDA before being offered for sale to the consumer. 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.
That's why you might see inaccurate wording about what a supplement does: it's made to comply with FDA guidelines on approved dietary supplement claims. 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 you from selling your product. The approval and regulation of dietary supplements is a sensitive issue. No, the FDA doesn't have to approve supplements before they hit the market. However, that doesn't mean that the world of vitamins and supplements is a game of all against all.
Still, it's smart to take precautions when choosing the supplement that's right for you. Office of Dietary Supplement Programs, HFS-810 Food and Drug Administration 5001 Campus Dr. College Park, MD 20740. If there are frequent reports of adverse reactions, the FDA will investigate and, if it finds a defect in the product, it has the power to remove it from the market, impose fines, etc.
So what exactly is the FDA's role in the supplement industry and what do those two little phrases mean? Let's dive in. Information for consumers on the use of dietary supplements includes updates for consumers, information from other agencies, and other educational materials for users of dietary supplements. Nutrition (food) is important because, under the FD&C Act, vitamins and other supplements are treated as a subset of food products and not as pharmaceutical products. However, like the FDA, these organizations do not guarantee that the products are safe or effective, only that they have the ingredients they claim to have and that they do not contain any contaminants.
The FDA does not determine if vitamins and other supplements are truly effective; as the FDA itself points out, it is the manufacturers who must ensure that their products are safe and that the claims they print on their labels are accurate. This agreement was established to resolve the retailer's responsibility for selling supplements produced by an accused company. A dietary supplement is a product that is taken orally and that contains a dietary ingredient intended to supplement the diet. In fact, Harvard Health emphasizes the importance of selecting a dietary supplement that has been approved by one of these three organizations.
For example, you shouldn't take vitamin E when taking blood thinners because this could thin your blood too much and cause internal bleeding. .
