The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), and veterinary products.4 The intent of this analysis will focus the FDA’s regulation of dietary supplements, specifically the ‘Dietary Supplement Health and Education Act (DSHEA).’
The FDA’s regulation of dietary supplements is to protect and warn consumers of potential side effects. Dietary supplements are manufacture to allow individuals to ingest shortfalls in their diets (vitamins), speed up muscle recovery (whey protein and creatine), improve memory (herbs), and etc. The FDA needs to regulate what is going to market to ensure bottles are packaged with proper nutrition facts, accurate ingredients, and producer’s claims are not misleading to the consumer. The supplement industry is not subject to massive testing as the pharmaceutical industry, so its product goes to market quicker to begin capturing profits. Given this process when claims are filed by consumers it is necessary for the FDA to expeditiously intervene.
DSHEA defined "dietary supplements" as a separate regulatory category and would not be approved by the FDA. Manufacturers of dietary supplements can simply take their product to market. However the FDA was directive in their approach by which all manufacturers of dietary supplements and nonprescription drugs were mandated to notify the FDA about serious adverse events related to their products. Manufacturers must report deaths; life-threatening experiences; inpatient hospitalizations; persistent or significant disability or incapacity; birth defects; or the need for medical intervention to prevent any such problems.5 The FDA’s response to new ingredients is reactive but it’s assumed once incidents have been reported and trended, it will enable the FDA to quickly remove products/ingredients from the market that have negative effects to consumers. The idea this will work because manufacturers will want to put out a product that does not have them participating in the mandated activities listed above.
The regulation has performed poorly as it does not protect consumers and it has made it easier for dietary supplements to come to market. Without scrutinizing supplements before they go to the marketplace is putting consumers at risk. Also by manufacturers simply stating ‘Statements have not been reviewed by the FDA’ lessens the liability of the FDA, while enabling businesses to stretch the truth of their product. However the regulation is effective; given the example of ephedra in the mid-2000s when numerous reports were filed because the ephedra ingredient was linked to causing heart attacks. The burden of proof resided with the FDA and they were able to provide enough linkage between the ingredient and side effects to have it banned for sale in the US.
Within the past year the US Senate has submitted the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” in effort to modify the regulation. The draft suggest any New Dietary Ingredient (NDI) introduced starting in 1994 be reviewed and tested. While I agree the regulation needs to be changed I believe the current proposal is an