The fact is, multiple government agencies hold broad authority to regulate dietary supplements. Yet reporting by the mainstream media continues to misrepresent this fact, perpetuating the “myth” that supplements are unregulated. This myth is so ingrained into the average consumer, that when I recently asked family members gathered for Christmas dinner, “Is the dietary supplement industry regulated by the government?” Only one of the eight correctly responded “yes”.
Granted, this was a small informal survey of college-educated, (with the exception of one) adults, yet is representative of the misconception that exists surrounding this issue. The balance of this article is to provide context, examples, and more important, peace of mind to both supplement and potential supplement consumers considering the purchase of products from a reputable retail establishment.
Granted, this was a small informal survey of college-educated, (with the exception of one) adults, yet is representative of the misconception that exists surrounding this issue. The balance of this article is to provide context, examples, and more important, peace of mind to both supplement and potential supplement consumers considering the purchase of products from a reputable retail establishment.
A common misunderstanding as to why many consider dietary supplements “unregulated” is because they are not regulated the same as prescription or over-the-counter medications. The distinction is that dietary supplements have always been regulated as a category of food, not drugs. Nonetheless, virtually all facets of dietary supplement manufacturing, labeling and marketing are covered by regulations issued and enforced by the Food & Drug Administration (FDA) and the Federal Trade Commission (FTC).
The FDA is charged with inspecting manufacturing facilities, reviewing labeling and monitoring products for safety. The FTC pursues deceptive, false and misleading advertising. Although categorized as food, more rigorous good manufacturing practice (GMPs) standards are imposed upon dietary supplements than are required for conventional foods. (read more 1)
Currently, there is a coordinated set of enforcement activities taking place by the FDA, the FTC, the US Department of Justice, the Department of Defense, the United States Postal Service as well as other federal agencies. These activities have the full support of the supplement industry. (read more2) It seems contradictory that a supposedly unregulated industry is getting so much attention from the Feds. It also bears mentioning that multiple State Attorneys General are also exercising their regulatory authority. (read more 3)
At the urging of the major supplement trade associations and under-reported in mainstream media outlets, in December of 2015, the FDA created the Office of Dietary Supplement Programs (ODSP). Though this may seem like the addition of yet another box to the government’s already bloated organization chart, this action will actually enhance the effectiveness of dietary supplement regulation. (read more 4) The industry views this event as a demonstration of the government’s commitment to leveling the playing field for the responsible companies already following the law. It is also an important step for increasing consumer safety by taking stronger enforcement action against rogue manufacturers who sell illegal products, particularly via the internet. (read more 5)
Our hope is that the paradoxical situations detailed above, in which actual events counter a commonly held, long term belief or “myth”, will dispel the notion you were misinformed into believing about the dietary supplement industry not being regulated by the government. We encourage your feedback to this piece as well as future articles that may be of interest to you.
REFERENCES
1- www.crnusa.org Fact Sheets accessed 12/27/2015
2- https://www.holisticprimarycare.net/news/1751-coordinated-fed-enforcement-action-has-supplement-industry-playing-defense.html accessed 12/27/2015
3- http://holisticprimarycare.net/topics/topics-h-n/news-policy-a-economics/1708-ag-action-triggers-new-wave-of-supplement-scrutiny.html accessed 12/27/2015
4- http://www.nutraingredients-usa.com/Regulation/It-s-here!-FDA-creates-Office-of-Dietary-Supplement-Programs accessed 12/27/2015
5- Download Supplement Sweep Chart to release_2015-11-12_updated accessed 12/27/2015
About the Author
Greg Boucouvalas, RPh, MS
