Dietary supplements are regulated differently than conventional foods and drugs. The FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed.
Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet. Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements and include among others
- vitamin and mineral products
- "botanical" or herbal products—These come in many forms and may include plant materials, algae, macroscopic fungi, or a combination of these materials.
- amino acid products—Amino acids are known as the building blocks of proteins and play a role in metabolism.
- enzyme supplements—Enzymes are complex proteins that speed up biochemical reactions.
The FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Manufacturers must make sure that product label information is truthful and not misleading. Under the FDA Final Rule 21 CFR 111, all domestic and foreign companies that manufacture, package, label or hold dietary supplement, including those involved with testing, quality control, and dietary supplement distribution in the U.S., must comply with the Dietary Supplement Current Good Manufacturing Practices for quality control. In addition, the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to FDA all serious adverse event reports associated with use of the dietary supplement in the United States.
The well-publicized cases of contamination involving food and supplements have not only garnered attention from FDA, but have placed greater emphasis on ensuring that quality control procedures are followed through inspections and random testing. The attorneys of Rick Ruz, PLLC provide its clients with advice on all aspects of the regulations pertaining to dietary supplements, particularly under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Our experience in this complex in expanding area of law offers dietary supplement companies the optimal mix of considerable capabilities, efficient resources and cost-effective legal services.