What the Law Says About Dietary Supplements

October 5, 2020


Many people in the U.S. consume at least one type of dietary supplement. Dietary supplements are products you can use to add more nutrients to your meals or improve your health. You can find them in pharmacies, supermarkets, and boutique nutrition stores.

Food supplements can be vitamins, minerals, amino acids, and fatty acids. You take these products by mouth in pill, capsule, tablet, or liquid form. Dietary supplements are not medicines, nor should they be considered a substitute for food. Your doctor can help you determine if a dietary supplement is necessary.

Who Should take vitamins

The first thing to ask yourself is whether supplements are one of the ways to be healthy. Supplements are never a substitute for a balanced, healthy diet. Research has shown that supplements don’t reduce the risk of heart disease, cancer, cognitive decline, or early death. In fact, too much of some vitamins and minerals can cause health issues. This could make them unsafe in some situations and hurt or complicate your health.

Most people can get all the nutrients they need by eating a healthy, balanced diet. But it sometimes can be hard to eat enough fresh veggies, fruits, and whole grains. As a result, some people may need supplements to correct vitamin or mineral deficiencies.

What the Law Says About Supplements

Dietary Supplement Health and Education Act of 1994 (DSHEA)

The principal legislation regulating supplements is the Dietary Supplement Health and Education Act of 1994 (DSHEA). The act established many great foundations for the supplements market, but its overall impact has been mixed. Since DSHEA became law, even hormones have been labeled as supplements and are being sold openly.

DSHEA regulates supplements in the same way food is regulated, but it stipulates that such products must be labeled “dietary supplements.” This refutes the often cited allegation that the herb and dietary supplement industry are unregulated. However, this regulatory framework for dietary supplements has led to significant misperceptions.

The law provides the FDA with authority to protect consumers while still allowing them access to supplements—but the extent of that oversight remains at the core of controversy with us today. This is because dietary ingredients used in nutritional supplements are not subject to food products’ safety evaluations.

According to the DSHEA, A dietary supplement with established ingredients can be marketed and bought even if they lack evidence of safety. Furthermore, new dietary components must be reviewed (not approved) by the FDA before they are marketed. Instead, dietary supplement manufacturers are responsible for ensuring supplements are safe before they are marketed. When there’s a problem, FDA does take action, and usually, it’s when there is a contaminant.

Since DSHEA became law, the number of available dietary supplements has skyrocketed. At the same time, The FDA’s ability to regulate supplements continues to evolve.

Current Good Manufacturing Practices  Supplements

It took more than ten years after the legislation was passed for the FDA to create dietary supplements manufacturing guidelines. On June 25, 2007, FDA published a final rule that established a regulation entitled Current Good Manufacturing Practice (CGMP). This regulation makes each manufacturer responsible for establishing ingredients and finished goods specifications. The law was implemented in 2008 for big entities and allowed for a three-year phase-in for smaller businesses. Similarly, current Good Manufacturing Practices are not limited to companies located within the U.S.

GMPs have been put in place for each step of the dietary supplement manufacturing process. Each chapter is categorized into several parts according to specific regulatory areas. The final rule establishes the minimum CGMPs necessary for activities related to the handling of a dietary supplement.

The aim is to ensure manufacturers produce unadulterated and adequately labeled dietary supplements.

The label of a Dietary Supplement

FDA labeling is one of the most important regulatory requirements for dietary supplements. The nutrition labeling requirements apply to both conventional foods and dietary supplements. If a label presents an incorrect assertion, the FDA may send warning letters or file a lawsuit.

There’s a lot of details required for dietary supplement labels. Also, the formatting of the Supplement Facts panel is strictly proscribed. The labeling of dietary supplements should also include nutrition information in the form of a “Supplement Facts” label.


For as many as 40 percent of American adults, supplements have become nutritional staples. Supplements can make a dramatic impact on your health and quality of life when done right. As there’s no standard for what constitutes a supplement, their nutrient composition varies by brand. However, supplements don’t necessarily deliver on the promise of better health.

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