Pull back the mask on illegal products masquerading as dietary supplements

This op ed commentary represents the views from the authors and/or the organizations they represent. 

The challenge

Let’s face it. A significant obstacle to advancing dietary supplements in health care and health care policy is the availability of illegal products with hidden drug ingredients that masquerade as dietary supplements.

It is not uncommon to read an FDA announcement or news article about products marketed for “male sexual enhancement” with unbelievable names like “Stiff Rox” and “Mojo Nights” that FDA has determined contain hidden drug ingredients, yet they are marketed as dietary supplements. It’s not just embarrassing—it’s dangerous, and industry and FDA must do more to eradicate this illegal activity.

For anyone new to this topic, you would expect FDA could simply arrest individuals responsible for the production and distribution of dangerous and illegal products, and that the solution is increased enforcement. However, for over a decade, FDA has noted its narrow authority and limited resources to remove illegal products from the market make it difficult to hold violators accountable. Instead, FDA sends “buyer beware” messages through its website and educational materials to consumers and health care providers about “tainted” dietary supplements, and often refers to its limited ability to enforce compliance with the law.

Health care providers and policymakers are influenced by this environment, making it harder to build trust in the supplement category. In fact, while the industry advocates for expanded access to dietary supplements through tax-deferred accounts like HSAs (health savings accounts) and FSAs (flexible spending accounts), state legislators are increasing efforts to limit access to certain types of supplements through age restrictions.

The opportunity

Tremendous opportunity exists for dietary supplements to be used by health care providers—and embraced by policymakers—as a cost-effective and safe way to improve health and fill existing nutrient gaps that impact 13.5 million people in the U.S. (about twice the population of Arizona). Dietary supplements should be embraced in nutrition policy, not to replace healthy eating, but to augment it.

Health policy programs should focus on efforts to provide access to fresh and healthful food. However, supplementation provides an opportunity to fill documented nutrient gaps quickly and efficiently, ensuring no American experiences an adverse health effect that results from missing nutrients like folic acid, iron, vitamin B12, iodine, vitamin D and fiber.

Even when healthy food is available, making and sustaining diet changes can be difficult and takes time. Diet changes require learning new ways to cook, store and shop for healthy food. Health care providers, community workers and others who work on the front lines of improving nutrition for Americans have an opportunity to use critical, evidence-based dietary supplements to fill nutrient gaps while other dietary changes are made over time.

In some instances, even a healthful diet does not provide adequate nutrient intake, and supplementation is recommended. For example, vitamin B12 insufficiency is a risk in older adults because of decreased ability to absorb B12 as people age. Therefore, the past few iterations of the Dietary Guidelines for Americans (DGAs) recommended B12 supplementation for older adults. Low B12 has been linked to mental problems like depression, memory loss and behavioral changes that are significant issues as people age (Cureus. 2020;12[10]:e11169). Furthermore, it’s not just older adults who are vulnerable to having a deficit of B12—getting enough of the vitamin can be difficult for vegetarians and individuals who have had gastrointestinal surgery, too.

Over 50% of American households already use dietary supplements, and this number increases to more than 70% of adults over the age of 65, according to a National Center for Health Statistics (NCHS) Data Brief. There is a missed opportunity to link consumer use of supplements with health care and health policy in America.

The millions of Americans at risk for vitamin B12 deficiency should have access to high-quality and safe B12 within the health care system, if desired. This is one reason why the Consumer Healthcare Products Association (CHPA) supports legislation like H.R. 5214, which would expand HSA/FSA eligibility for dietary supplements, so, for example, those in need of B12 can use their tax-deferred dollars to get it.

The path forward

The best way to protect dietary supplement consumers and advance the industry is to support regulatory modernization. For instance, mandatory product listing (MPL) would benefit consumers, regulators, health professionals and retailers by providing an authoritative repository of dietary supplement labels. While the merits of MPL are being debated, companies with products like Mojo Nights and Stiff Rox that make claims like “works in 30 minutes” and “lasts all night” are not going to want to add their labels to this list. This will help consumers and retailers to avoid these products, marking an improvement from the status quo.

While dietary supplement MPL is important, it alone is not enough to clean up illegal products masquerading as supplements. The law that governs FDA regulation of supplements (Dietary Supplement Health and Education Act of 1994, or DSHEA) is over 27 years old, and it is time for new and efficient regulatory tools to help FDA close the gap in the manufacturing facilities that it does not inspect annually.

One way to do this is by FDA authorizing third parties to issue a cGMP (current good manufacturing practice) audit certification, similar to how it is done for food imports through the FDA Voluntary Qualified Importer Program (VQIP). More audits of dietary supplement facilities through such authorization by FDA will allow the agency to be efficient with its resources and target higher-risk facilities for inspection.

Protecting the market from illegal products is not only FDA's responsibility. The industry can increase self-regulatory efforts. Programs like the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP) and University of Mississippi’s National Center for Natural Products Research (NCNPR) Botanical Adulterants Prevention Program (BAPP) have developed extensive laboratory tools and methods to help industry identify and remove fraudulent raw material from the supply chain. Retailers like Amazon have initiated testing requirements that screen for hidden drug ingredients for male enhancement and other high-risk product categories. These efforts will create barriers to illegal behavior.

We will be in a stronger position to advance trust in the dietary supplement category if industry, retailers and regulators continue to identify and execute ways to isolate and eradicate from the market illegal products tainted with hidden ingredients. And building trust will accelerate the universal acceptance of supplements as a credible part of health by consumers, health care providers and policymakers.

Naturopathic doctor Duffy MacKay is the senior vice president of dietary supplements at the Consumer Healthcare Products Association (CHPA), where he leads the association’s dietary supplement scientific, policy and legislative initiatives. His career in supplements spans over 25 years and includes serving as a senior executive and scientist at leading dietary supplement companies, including CV Sciences, Nordic Naturals and Thorne Research.