Dietary Supplement Safety
Under the Dietary Supplement Health And Education Act of 1994 (DSHEA), the U.S. Food and Drug Administration (FDA) was given several post-marketing responsibilities to ensure the safety of dietary supplements. If a dietary supplement presents “a significant or unreasonable risk of illness or injury” or contains “a poisonous or deleterious substance which may render it injurious to health,” FDA has the authority to remove the product from the market. Effective December 22, 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act mandates that manufacturers, packers, and distributors of dietary supplements in the U.S. report information about serious adverse events associated with the use of these supplements to FDA.
A “serious” adverse event is defined as one that results in:
- A life-threatening experience;
- Inpatient hospitalization;
- Persistent or significant disability of incapacity;
- A congenital anomaly or birth defect; or
- Requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.
Tainted Dietary Supplements
Consumers should feel confident that the supplements they purchase from known and trusted retailers are safe and contain the ingredients provided in the labeling for the product. Unfortunately, there are unscrupulous manufacturers who market dietary supplements containing hidden drugs and/or chemicals. These tainted dietary supplements, which are typically promoted for weight loss, bodybuilding, or sexual enhancement, can subject consumers to unforeseen risks.
In December 2010, the U.S. Food and Drug Administration (FDA) addressed the potentially significant health problems associated with these products and called on dietary supplement manufacturing firms to investigate their supply chain and review manufacturing activities in order to ensure the quality and safety of their products. The dietary supplement trade associations’ support heightened efforts to remove these products from the marketplace. CHPA, in collaboration with the Council for Responsible Nutrition, also called attention to retailer efforts to stop this illegal marketing of tainted products and fully support FDA’s efforts (see articles in Convenience Store Decisions and Convenience Store Petroleum).
- Ensuring the Safety of the Supplements on Your Shelves, Convenience Store Decisions
- FDA letter to industry on significant public health problems posed by products marketed as dietary supplements that do not qualify as dietary ingredients (Dec. 15, 2010)
- Hatch/Heinrich letter to US Attorney General urging aggressive action against companies marketing illegal products masquerading as supplements (May 19, 2015)