Heading into 2022, Nutritional Outlook asked industry leaders and associations to discuss their biggest regulatory concerns for the dietary supplement and natural product industries in the new year—as well as any positive developments to possibly look forward to.
Nutritional Outlook: What are your biggest regulatory concerns for the dietary supplement and natural product industries in 2022?
Christine Burdick-Bell
Executive VP, General Counsel & Board Corporate Secretary, Pharmavite
Steering Committee Chair, Dietary Supplements Quality Collaborative (DSQC)
The dietary supplement market is experiencing significant growth as consumers increasingly prioritize their health and wellbeing, a trend that emerged even before the ongoing COVID-19 pandemic. Today, the dietary supplement market includes over 80,000 products, and experienced record growth in 2020.1 While the majority of the market comprises high-quality products made by reputable companies, as it expands, so too does the risk of potentially dangerous products being sold as dietary supplements by bad actors in the industry. In fact, on December 9, 2021, the FDA reported nine more products marketed as dietary supplements that contained undisclosed active pharmaceutical ingredients.2
One of our greater concerns for the industry in 2022 is the continued existence of a “loophole” in how the FDA considers its legal enforcement abilities, which allows drug products illegally masquerading as dietary supplements to linger on shelves. We are hopeful that Congress will take action to clarify the law for both consumer safety and to level the playing field in the market for responsible manufacturers who prioritize safety and quality. In addition, securing funding for the Office of Dietary Supplement Programs within the FDA is another step that would help cut down on the amount of unsafe products that linger on shelves.
In order to ensure a transparent marketplace where consumers can feel secure in the dietary supplement purchases they make, one of our highest priorities is to see realization in 2022 of a “mandatory product listing.”3 This would include all dietary supplement products on the U.S. market and transparently provide information for use by consumers, the FDA, retailers, and healthcare practitioners alike. Consumers would be able to make informed decisions and have confidence in the quality of the dietary supplements they choose to take, and the FDA would be able to focus its efforts on identifying and removing potentially harmful products from shelves. These measures would make for a safer market filled with quality products.
Daniel Fabricant, PhD
Executive Director & CEO
Natural Products Association (NPA; Washington, DC)
Our biggest concern is the FDA is not using all its regulatory and enforcement authority under the Dietary Supplement Health and Education Act of 1994 (DSHEA). We are especially concerned about the FDA’s failure to take action against adulterated products that violate the New Dietary Ingredient (NDI) notification process, and its reluctance to set a safe level of daily consumption for cannabidiol (CBD).
On the other end of the spectrum, the FDA has overreached on its regulatory determination regarding N-acetyl-L-cysteine (NAC), setting a dangerous precedent that could extend to other products. NPA has pushed back on this forcefully, filing a lawsuit against the FDA to stop its retroactive—and misguided—application of DSHEA.
At the state level, we are watching California, Illinois, Massachusetts, Missouri, New Jersey, and New York, where legislation has been introduced restricting access to supplements.
Until the FDA can demonstrate to the industry and state governments they are capable of fully enforcing DSHEA, the lack of regulatory oversight by the FDA will continue to be the most significant concern for the industry.
Douglas “Duffy” MacKay, ND
Senior VP, Dietary Supplements
Consumer Healthcare Products Association (CHPA; Washington, DC)
The biggest concern for industry remains the impact of the limited number of bad actors manufacturing illegal products. Consumers trust that dietary supplements are manufactured to FDA’s quality and safety standards and make truthful claims. This trust has taken decades to build, but it can be lost in an instant. FDA and industry need to continue to vigorously address the problem of illegal products that slip onto the market, risking consumers’ health and tarnishing the larger supplement community’s reputation.
To address these concerns, FDA needs additional tools and resources. The dietary supplement industry has grown and changed over the past 30 years, and FDA’s supplement regulatory capabilities need to keep pace. Congress must engage with stakeholders to balance consumer safety and consumer access in a way that allows for the industry to meet the growing consumer demand for dietary supplements.
Michael McGuffin
President
American Herbal Products Association (AHPA; Silver Spring, MD)
At a time when we cannot stop talking about supply chain disruptions, we must be alert to regulatory concerns that might develop from this reality. The increase in demand for botanical ingredients during the pandemic has raised concern about misidentification or intentional adulteration of botanicals. Thankfully, the regulatory system governing botanical product manufacturing here in the U.S. protects against the risks associated with inauthentic ingredients. Manufacturers are required and have a responsibility to confirm the identity of any botanical raw material they import. Still, in order to ensure these regulations are effective, FDA must be consistent in their regulatory enforcement.
On another topic, take a look at the thousands of CBD products on the market today. FDA has taken the position that CBD is not lawful as a dietary ingredient, so CBD products are effectively unregulated. For example, manufacturers of these products are not being inspected to ensure compliance with FDA’s current Good Manufacturing Practices (cGMP) rules or submission to FDA of serious adverse event reports. The lack of regulatory clarity for CBD and subsequent lack of enforcement is a disservice to Americans who expect to be—and should be—protected from unregulated, untested, and potentially unsafe products. In carrying out enforcement, FDA must also treat all players the same, no matter how big or small a company is or where it is located.
Steve Mister
President & CEO
Council for Responsible Nutrition (CRN; Washington, DC)
We believe the general uncertainty at FDA on a variety of matters—specifically the Commissioner and Director of FDA’s Office of Dietary Supplement Programs (ODSP) positions that currently remain vacant; the outstanding legal issues involving NDI guidance; the continuing uncertainty around NAC; and the lack of a clear legal path forward for CBD—are our most pressing concerns.
These are challenging problems when taken as singular matters. The fact these are happening concurrently creates a negative regulatory environment that stunts our industry’s growth and innovation for at least the immediate future.
Harry B. Rice, PhD
VP, Regulatory & Scientific Affairs
Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City, UT)
Should the pandemic continue to drag on with no improvement in the supply chain for raw materials, we could see an increase in economically motivated adulteration. This brings with it a whole host of issues, not the least of which includes erosion of consumer confidence. With the exception of sporadic adulteration of krill oil with vegetable oil, adulteration of omega-3–rich oils is rare.
Over the last eight months, at least four class action lawsuits have been filed concerning the labeling of omega-3 ethyl esters as fish oil. In November, the first of the four cases was sent to arbitration. In time, GOED anticipates the remaining three will be dismissed in deference to the FDA who has primary jurisdiction over the labeling of dietary supplements.
Nutritional Outlook: What positive regulatory developments do you think the dietary supplement and natural product industries could see in 2022?
Daniel Fabricant, PhD
Natural Products Association
Over the past two years, demand for natural products skyrocketed as more and more Americans looked for ways to improve underlying health conditions, support their immune systems, and live an overall healthier lifestyle.
Congress is taking note of this increased demand for natural products, and momentum is building to pass legislation that would expand access to supplements through pre-taxed savings accounts. Last year, Senator Kevin Cramer (R-ND) introduced S.4463, expanding reimbursement eligibility to dietary supplements.
This year, Sens. Mike Lee (R-UT), Tim Scott (R-SC), and Kyrsten Sinema (D-AZ) proposed a provision in the American Rescue Plan Act of 2021 and the National Defense Authorization Act (NDAA) to expand health savings account (HSA) reimbursement eligibility to dietary supplements. Joining them are five members of the House—Reps. Darin LaHood (R-IL), Brendan Boyle (D-PA), John Curtis (R-UT), Josh Gottheimer (D-NJ), and Peter Meijer (R-MI)—who have cosponsored legislation to put dietary supplements on a level tax playing field, with growing support in both chambers. We believe we have an excellent opportunity in the year ahead to build on this momentum and finally provide consumers with the option for pre-tax natural products.
Additionally, the Senate will consider the nomination of Robert Califf, MD, to lead the FDA. NPA will be engaging with Dr. Califf and Senate staff during the confirmation process on our priorities for the next commissioner. Our priorities for the next commissioner include: 1) Establishing a regulatory pathway for CBD, 2) Ensuring that FDA uses its enforcement capabilities to protect American consumers and intellectual property, and 3) Supporting the agency providing Congress and the public an annual report of their activities related to cGMP inspections, structure-function claim notifications, and New Dietary Ingredient notifications.
Douglas “Duffy” MacKay, ND
Consumer Healthcare Products Association
At the end of 2021, the Department of Justice prosecuted bad actors who knowingly sold dangerous, illegal products while misrepresenting that they were safe and legal dietary supplements. This is a good example of how targeted enforcement can be used to address a public health threat. FDA enforced its regulations, and then the Department of Justice held the responsible parties accountable for disregarding the law and public health. Punishing bad actors by sending them to jail sends a strong message to other bad actors and is a positive development for all supplement stakeholders. CHPA is hopeful this trend will continue in 2022 and beyond.
A strong FDA is important, because industry is also accountable for raising the bar. Industry continues to expand self-regulatory programs aimed to improve the safety, quality, and science behind supplements. There has been significant progress in harmonizing third-party quality and product testing standards to ensure all programs are using an appropriate, transparent level of rigor. In addition, the National Institutes of Health made significant improvements to its Dietary Supplement Label Database, which now has nearly 130,000 labels and several user-friendly features. This is important because it helps to inform future conversations about the pros and cons of a federal mandatory product listing requirement for dietary supplements.
Self-regulation plays a crucial role in maintaining the safety and integrity of our products, and we will continue to work with our members and partner organizations to ensure we grow in this area throughout 2022.
Michael McGuffin
American Herbal Products Association
AHPA has been actively encouraging FDA to complete the process of updating regulations for use of the term healthy in food labeling. In comments submitted to FDA, we stated that criteria for a “healthy” claim should not be limited to food’s nutrient content. If regulations allowed for claims such as “spices are a healthy alternative to salt” or “unsweetened tea is part of a healthy diet,” companies would be motivated to provide healthier options and educate consumers about healthy substitutes. These recommendations from AHPA align with the 2015-2020 Dietary Guidelines for Americans, which call for healthy dietary patterns that are “low in saturated fat, added sugars, and sodium.” In 2021, FDA announced that it has begun consumer research to develop a symbol that could be voluntarily used to label food that meets the updated definition of healthy—which indicates that the process is moving along.
On the hemp and CBD front, we are long overdue for regulatory certainty. FDA has not used its authority to issue regulations to establish a lawful route to market for allowing CBD to be added to food or used as dietary ingredients, despite thousands of hemp and CBD products currently on the market. Should FDA inaction continue, Congress could create a federal pathway for the sale and marketing of these products through legislation instead.
At AHPA, we are intrigued about how FDA might apply some of the lessons learned in the last two years to create more efficient processes for regulatory inspection for cGMP compliance. We have discussed this matter with our members and have initiated conversations with FDA about applying tools like its newly implemented remote regulatory assessments in the development of a more efficient approach to cGMP oversight.
Steve Mister
Council for Responsible Nutrition
We remain hopeful the FDA will resolve the cloud over NAC, along with Congress enacting a legal pathway forward for CBD. Additionally, CRN looks forward to the introduction and passage of legislation establishing a mandatory product registry for supplements that balances the demands for transparency with the potential burdens such a program would create to assure compliance. We also remain hopeful we will welcome a new confirmed commissioner and permanent director of ODSP, who will address the issues facing the agency, most notably, enforcing inspections and enforcement actions.
Harry B. Rice, PhD
Global Organization for EPA and DHA Omega-3s
Legislation proposing mandatory product listing for dietary supplements is the first thing that comes to mind. Mandatory product listing would not only increase FDA’s visibility into the dietary supplement market, but it would increase consumer trust.
By the time this goes to print, Robert Califf, MD, may have been confirmed as the new FDA commissioner. While many in the industry are enthusiastic about his confirmation, it has yet to be determined what impact he will have on the dietary supplement industry.
Last month, the first meeting of the Committee on Dietary Reference Intakes (DRIs) for Energy was held. While it remains unknown how the federal DRI steering committee plans to proceed with reviewing the macronutrients, which would include fat and thus omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), GOED remains hopeful that we will have a clear line of sight in the coming months.
References
- Congressional Research Service report. “Regulation of Dietary Supplements: Background and Issues for Congress.” Updated September 20, 2021.
- FDA Medication Health Fraud webpage. “Tainted Sexual Enhancement Products.” Updated December 8, 2021.
- Dietary Supplements Quality Collaborative. “Modernizing and Strengthening Policies to Advance the Safety and Quality of Products Marketed as Dietary Supplements.” Posted 2020.
