Why Dietary Supplements are Not Regulated by the FDA: An Expert's Perspective

The Food and Drug Administration (FDA) does not require approval for dietary supplements before they reach consumers. Learn why it is important to consult with a health professional before using any dietary supplement.

Why Dietary Supplements are Not Regulated by the FDA: An Expert's Perspective

The Food and Drug Administration (FDA) is responsible for enforcing the law after marketing, but unlike drugs, it does not require the FDA to approve the safety of dietary supplements before they reach consumers. Dietary supplements are regulated by the FDA as foods, not 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 is important to consult with a health professional before using any dietary supplement.

Unlike drugs, the FDA states that supplements are for nutritional purposes only. Since supplements are not considered drugs, they are not controlled in the same way. While the FDA has regulations for manufacturing and labeling, dietary supplements have different guidelines for testing, safety, and efficacy than pharmaceutical drugs.Unlike drugs, supplements do not require prior approval from the FDA before being offered for sale to the consumer. If a supplement company does not comply with FDA regulations, the FDA may prohibit them from selling their product.

The supplement industry is not declining in terms of products or sales, which worries consumers and athletes.Supplements are often marketed now without being proven to work as claimed, causing the FDA or FTC to update them once they have been distributed. The dietary supplement industry remains stable and its revenues continue to increase every year, largely as a result of the fact that almost any product can be released on the market without having been verified or tested for purity, safety and quality.Dietary supplements that include not only vitamin and mineral formulas, but also any derivative of herbs, amino acids, glands and enzymes and which are then distributed in the form of tablets, capsules, liquids or powders, have taken over the market. For example, “a supplement isn't supposed to be able to be advertised as if it would help treat a disease or ailment”.A dietary supplement is a product that is taken orally and that contains a dietary ingredient intended to supplement the diet. It's important to note that the FDA continues to oversee some of the manufacturing processes and that it tries to control misleading claims, but sadly, it simply doesn't have the necessary reach to ensure that all manufacturers of dietary supplements comply with the regulations.Whatever their form, the Dietary Supplement Health and Education Act (DSHEA) classifies dietary supplements (DS) into a special category within the general scope of food and therefore, the FDA remains responsible for helping to regulate the industry, albeit playing a minor role.

Two members of the American Medical Association (AMA) spent time discussing what doctors would like patients to know about vitamins and nutritional supplements.That's why “I strongly recommend that people talk to their doctors about supplements” since “inappropriate use of supplements can cause several problems”. That's why you might see vague wording about what a supplement does in order to comply with FDA guidelines on approved dietary supplement claims. And some of them have had dramatic effects on the sale of supplements and the use of supplements according to Dr.