Confronting the Myth that Dietary Supplements are ‘Unregulated’ and a ‘Wild West’
By By James Gormley, Gormley NPI Consulting | 03.28.24
In the face of this common refrain, responsible companies in the natural products industry continue to exceed the highest standards.
It seems that we can’t get through a week without the dietary supplement industry being labeled as “unregulated” or dubbed a “Wild West.”
It would also seem that there is a supplements-are-dangerous playbook that “uninformed media, critics, and some healthcare providers” consistently turn to. This script describes the dietary supplement industry as “unregulated,” and its products as unapproved. Oftentimes, the old-fashioned “Wild West” label gets tossed around in reference to the estimated $60+ billion U.S. dietary supplement industry.
A brief search for recent articles and segments using the “Wild West” moniker returned ill-conceived, inaccurate, and anti-supplement statements in National Geographic, The Washington Post, CSPI, Salon, WebMD, Forbes, McGill University, and The Conversation, among many other sources.
A classic example of ill-informed diatribes against supplements came from the American Medical Association in May 2002, in an article titled, “Dietary supplements: Underregulated, unknown and maybe unsafe.”
Numerous FDA commissioners have acknowledged that the agency has ample authority to regulate the dietary supplement industry, but that the agency doesn’t have the resources it needs.
This is why the industry has long, and very loudly, supported legislation to give FDA more resources to crack down on the fringe companies that do not follow the laws regulating the industry and its products.
However, supplements have a proven track record of safety that’s better than pharmaceuticals, over-the-counter (OTC) medicines, and arguably, even common foods.
In addition, industry self-regulation initiatives, such as third-party certification programs and trade association standards contribute to the overall integrity of the dietary supplement market. These voluntary programs set high standards for product quality and transparency, providing consumers with additional assurances of safety and trustworthiness.
Regarding how dietary supplements are regulated compared to conventional foods, Peter Barton Hutt, senior counsel in the Washington, D.C. law firm Covington & Burling LLP, reminded me that a prohibition against products that pose a significant and unreasonable risk applies to dietary supplements but not to conventional foods.
Hutt also noted that if a company wants to introduce a food it only needs to convene an informal Generally Recognized As Safe (GRAS) panel and go to market—without a requirement for the GRAS panel’s report to even be submitted to FDA.
Nevertheless, the industry must not throw up its hands or throw in the towel. The responsible companies in the natural products industry should continue to meet—even surpass—the highest standards for safety, quality, efficacy, responsible sourcing, and transparency.
The only Wild West there is—one which shoots from the hip and which is unpredictable and dangerous—might well be the FDA.
About the Author: James Gormley has been an award-winning natural products industry writer, editor and thought leader since 1995. The head of Gormley NPI Consulting, James can be reached via his website, JamesGormley.com or via email at jamesgormley01@gmail.com.
It would also seem that there is a supplements-are-dangerous playbook that “uninformed media, critics, and some healthcare providers” consistently turn to. This script describes the dietary supplement industry as “unregulated,” and its products as unapproved. Oftentimes, the old-fashioned “Wild West” label gets tossed around in reference to the estimated $60+ billion U.S. dietary supplement industry.
A brief search for recent articles and segments using the “Wild West” moniker returned ill-conceived, inaccurate, and anti-supplement statements in National Geographic, The Washington Post, CSPI, Salon, WebMD, Forbes, McGill University, and The Conversation, among many other sources.
A classic example of ill-informed diatribes against supplements came from the American Medical Association in May 2002, in an article titled, “Dietary supplements: Underregulated, unknown and maybe unsafe.”
On the Books
However, we know that dietary supplements are well-regulated, and the vast majority of products are safe. Companies protect consumers in many ways, in part through provisions mandated by several U.S. laws and rules, including:- The Nutrition Labeling and Education Act of 1990 (NLEA), which provides for mandatory nutrition labeling for most food products intended for human consumption and offered for sale;
- The Dietary Supplement Health and Education Act of 1994 (DSHEA), which defined dietary supplements as a distinct class of foods;
- The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act);
- The Dietary Supplement and Non-Prescription Drug Consumer Protection Act of 2006, which required serious adverse event reporting to FDA;
- The final rule on current Good Manufacturing Practices (cGMPs) of 2007;
- The Food Safety Modernization Act (FSMA) of 2011; and
- Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act on post-market structure/function claim notifications.
Numerous FDA commissioners have acknowledged that the agency has ample authority to regulate the dietary supplement industry, but that the agency doesn’t have the resources it needs.
This is why the industry has long, and very loudly, supported legislation to give FDA more resources to crack down on the fringe companies that do not follow the laws regulating the industry and its products.
“Industry self-regulation initiatives, such as third-party certification programs and trade association standards contribute to the overall integrity of the dietary supplement market. These voluntary programs set high standards for product quality and transparency, providing consumers with additional assurances of safety and trustworthiness.”
A Solid Safety Record
FDA has the legal authority to remove from the marketplace any dietary ingredient that the agency determines to be dangerous.However, supplements have a proven track record of safety that’s better than pharmaceuticals, over-the-counter (OTC) medicines, and arguably, even common foods.
In addition, industry self-regulation initiatives, such as third-party certification programs and trade association standards contribute to the overall integrity of the dietary supplement market. These voluntary programs set high standards for product quality and transparency, providing consumers with additional assurances of safety and trustworthiness.
Regarding how dietary supplements are regulated compared to conventional foods, Peter Barton Hutt, senior counsel in the Washington, D.C. law firm Covington & Burling LLP, reminded me that a prohibition against products that pose a significant and unreasonable risk applies to dietary supplements but not to conventional foods.
Hutt also noted that if a company wants to introduce a food it only needs to convene an informal Generally Recognized As Safe (GRAS) panel and go to market—without a requirement for the GRAS panel’s report to even be submitted to FDA.
Shooting from the Hip
The central problem, such as it is, is not that the supplement industry is unregulated—it is highly regulated—it’s that the FDA does a poor job of enforcement, leaves the industry scratching its head regarding action on dietary ingredients like NAC and NMN, and is often arbitrary and capricious when it does issue regulatory or enforcement decisions.Nevertheless, the industry must not throw up its hands or throw in the towel. The responsible companies in the natural products industry should continue to meet—even surpass—the highest standards for safety, quality, efficacy, responsible sourcing, and transparency.
The only Wild West there is—one which shoots from the hip and which is unpredictable and dangerous—might well be the FDA.
About the Author: James Gormley has been an award-winning natural products industry writer, editor and thought leader since 1995. The head of Gormley NPI Consulting, James can be reached via his website, JamesGormley.com or via email at jamesgormley01@gmail.com.
