Dietary supplement

Lore & Background

Dietary supplements are defined under U.S. They cannot be approved as a new drug unless previously marketed as food or supplement. Products include vitamins, minerals, amino acids, essential fatty acids, non-nutrient substances from plants, animals, fungi, or bacteria, and live microorganisms like probiotics. Synthetic copies of naturally occurring substances, such as melatonin, are also permitted. Unlike drugs, no government approval is required before marketing; manufacturers themselves confirm safety, and the FDA can only remove unsafe products after assessment.

Reader's Guide

About 60% of American adults consume them, with higher usage among those over 60. Multivitamins are the most common type. The U.S. National Institutes of Health notes that some supplements may help provide essential nutrients or support health for those with limited dietary variety. However, federal regulations prohibit claims that supplements prevent or treat disease; only structure/function claims are allowed with a disclaimer that the FDA has not evaluated the claim. The FDA enforces safety and good manufacturing practices. In the European Union, harmonized rules ensure safety and appropriate labeling. The definition under DSHEA distinguishes supplements from conventional foods, medical foods, and drugs, emphasizing that they are deemed food except for drug purposes. This regulatory framework shapes how supplements are marketed and consumed, balancing consumer access with safety oversight.

Did You Know?

• Dietary supplements may contain substances not confirmed as essential to life, such as plant pigments or polyphenols.
• Animals can be a source of supplement ingredients; for example, collagen may be extracted from chickens or fish.
• In the United States, it is against federal regulations for supplement manufacturers to claim their products prevent or treat any disease.
• The U.S. Institute of Medicine sets tolerable upper intake levels for some vitamins, but companies can sell products with content per serving higher than those levels.