Do Vitamins Need FDA Approval?

Vitamins and nutritional or dietary supplements can be beneficial to health, but they can also pose health risks. The Food and Drug Administration (FDA) does not have the authority to review the safety and effectiveness of dietary supplements before they are marketed. The 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. It plays an important role in ensuring the safety of the products we use every day, but it doesn't give prior approval to every industry it oversees. Drugs are used 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 standards before the FDA pre-approves it for consumer use. On the other hand, supplements are for nutritional purposes only and don't require prior approval by the FDA before they go on sale to the consumer. The Dietary Supplements Health and Education Act of 1994 (DSHEA) defined the role of supplements and described what dietary supplement companies can legally say about their products. The law states that, since supplements are not drugs, supplement companies cannot imply, imply, or declare 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 vague wording about what a supplement does to comply with FDA guidelines for approved dietary supplement statements. The FDA doesn't “approve” dietary supplements because it doesn't approve foods. The FDA only approves pharmaceutical products. The FDA monitors the manufacturing 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 it from selling its product. Ascorbic acid, or vitamin C, is not produced endogenously and human exposure depends on external dietary sources, such as fruits and vegetables.

In addition

to vitamins, dietary supplements may contain minerals, herbs or other botanicals, amino acids, enzymes, and many other ingredients. Multivitamins, vitamin D, echinacea, and fish oil are among the many dietary supplements that are available in stores or available online. Supplement companies are responsible for having proof that their products are safe, and the label's claims are true and not misleading. However, as long as the product does not contain a “new dietary ingredient” (one introduced since October 15, 1999), the company does not have to provide this safety evidence to the FDA before marketing the product. These statements should be followed by the words: “This statement has not been evaluated by the Food and Drug Administration”.

Manufacturers can add vitamins, minerals and other supplement ingredients to the foods you eat, especially cereals and breakfast drinks. For example, too much vitamin A can cause headaches and liver damage, reduce bone strength, and cause birth defects. The FDA evaluates reports of adverse events reported by healthcare providers or consumers to identify early signs that a product may pose safety risks to consumers. Popular supplements include vitamins D and B12; minerals such as calcium and iron; herbs such as echinacea and garlic; and products such as glucosamine, probiotics and fish oils. For example, calcium and vitamin D can help strengthen bones, and fiber can help maintain bowel regularity. The term dietary ingredient includes vitamins and minerals; herbs and other botanical products; amino acids; dietary substances that are part of the food supply, such as enzymes and living microbes (commonly referred to as probiotics); and concentrates, metabolites, constituents, extracts or combinations of any dietary ingredient from the above categories. The summary basis of approval is not yet available for vitamins but it is reasonable to assume that literature was heavily relied upon for their approval due to their historical use in treating scurvy.

These three types of claims are not approved by the FDA and do not require evaluation by the FDA before they are used in the labeling of dietary supplements. Scurvy is an orphan disease in the United States which most commonly affects malnourished people such as homeless or refugees (and in 15th-16th centuries sailors due to food rich in vitamin C spoiling during long sea trips). Accordingly DSHEA requires that when a label includes such a statement it must be accompanied by a disclaimer informing consumers that the FDA has not evaluated the claim.

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