What is a Dietary Supplement?
According to the Federal Food and Drug Administration (FDA) a dietary supplement is more closely related to a food than a drug. Supplements are meant to add or enhance nutrition an individual is receiving from their food intake. It is important to note however, that dietary supplements contain ingredients that can have strong biological effects on the body.
What is the role of the manufacturer in dietary supplement regulation?
When it comes to regulation of dietary supplements the FDA has little control over what becomes available on the market. Responsibility for the safety and effectiveness of a dietary supplement is largely placed on the manufacturer.
- Manufacturers must notify FDA of New Dietary Ingredients (NDIs), submit them for review, and ensure that they meet the definition of a dietary ingredient—“…a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.”
- If a new dietary supplement does not include a NDI, the manufacturer has full responsibility for the product’s safety and efficacy. The FDA does not approve or review the supplement to ensure regulations for current good manufacturing practices of dietary supplements are complied with before their release on the market.
- The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006—an amendment to the Food, Drug, and Cosmetic Act (FD&C Act)—made it a requirement for manufacturers to report to the FDA any serious adverse events brought to their attention regarding their product in terms of safety or effectiveness.
What is the FDA’s role in dietary supplement regulation?
There have been various pieces of legislation in the past few decades giving The Center for Food Safety and Applied Nutrition (CFSAN)—A subsidiary of the FDA—a particular amount of control in enforcing regulations concerning dietary supplements.
- The Dietary Supplement Health and Education Act (DSHEA) of 1994 gives the FDA power to pull a supplement from the market if it finds substantial evidence that it is unsafe. The FDA also has this power if they are able to prove manufacturers are making false and misleading claims about the effectiveness of a dietary supplement or any of its ingredients. This includes claiming that the supplement will treat, diagnose, prevent, or cure diseases—which by definition a supplement, or any of its singular ingredients, cannot do.
- The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA power to review the safety of New Dietary Ingredients—a dietary ingredient that was not marketed in the United States in a dietary supplement before October 15, 1994.
- A 2006 amendment to the FD&C Act also gives the FDA power to make public any adverse events regarding a supplement that is brought to its attention by the manufacturer.
Dietary Supplements and Consumer Safety
Millions of Americans use dietary supplements to meet their health needs, achieve weight loss goals, and enhance athletic performance on a daily basis. No matter what your intention behind supplement use may be, it is important to get all the facts before taking anything that could potentially affect your health and wellbeing.
Although the FDA does not approve or regulate dietary supplements based on their safety and efficacy, they take care to warn consumers of actions involving dietary supplements that could be injurious, or even life-threatening, such as combining supplements with medications and other supplements, or using supplements as a substitute for prescription medication.
If you or someone you know has taken a dietary supplement that may have caused severe injury, sickness, or death please call the Minneapolis personal injury attorneys at 1-612-436-5026 for a free consultation.