Did you know the supplement industry is government regulated?

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

Coastal Pharmacy & Wellness Staff

Over the past 30 plus years, Greg has worked in various pharmacy settings at a handful of southern Maine locations. The settings ranged from: independent & chain, to supermarket & traditional, to voluntary free-clinic services, to the current hybrid model. In 2008, Greg was one of the founding partners of Apothecary by Design. To responsibly provide the most accurate and up to date information, Greg has read many books and articles, and has attended numerous seminars featuring key luminaries in the field of holistic medicine. A self-proclaimed lifelong student, he continues to stay informed by studying current and relevant material on the subject. Presently, as pharmacist and nutritional/supplement consultant at Coastal Pharmacy & Wellness, Greg is positioned to address patients’ prescriptive and nutritive needs in this dynamic new pharmacy setting.

Disclaimer

This site provides general information and discussion about medicine, health and related subjects. The words and other content provided in the site and any linked materials are not intended and should not be construed as medical advice. Information provided here is not meant to be a substitute for professional medical advice, diagnosis, or treatment. If the reader or any other person has a medical concern, he or she should consult with an appropriately-licensed physician or other health care worker.

Where health claims of dietary supplements are referenced, the statements have not been evaluated by the Food and Drug Administration. The products are not meant to diagnose, treat, cure or prevent any disease.