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September 25, 2017
In 2015, FDA’s Office of Dietary Supplement Programs (ODSP) was formed with the recognition that “elevating the program’s position will raise the profile of dietary supplements within the agency and will enhance the effectiveness of dietary supplements regulation."
Since that time, core questions have come to the fore: has the office met its mission? Does it have ample funding and manpower to fulfill its charge? Would an infusion of new money be a smart use of taxpayer dollars? Or, in this age of belt-tightening, is this an office that isn’t living up to its billing, and therefore should be left on the cutting room floor of the budget process?
Analyzing these questions requires us to refocus on the office’s core priorities: namely, removing unsafe products from the marketplace; combating consumer deception in the industry; improving compliance with GMPs (good manufacturing practices); and enhancing the review structure of NDIs (new dietary ingredients).
Each of these functions is central to ODSP’s mandate; performing them is essential to its future success.
Let’s start with job number one: ensuring safety. ODSP works with FDA’s Center for Drug Evaluation and Research, and its regional field offices, to remove falsely labeled products that contain harmful and illegal agents. The office also can identify dangerous items through evaluating mandatory reports of serious adverse effects (SAERs), which can offer early signals that a dietary supplement may present a public risk.
On this front, the past three fiscal years have seen a steady decline in the number of warning letters sent out to manufacturers of illegal goods. At the same time, very few products have been eliminated based on SAERs. On the surface, these data points indicate improved industry compliance; however, the far more likely explanation is that this is a result of dwindling oversight resources at ODSP. If that’s the case—if the American people face uncertainty about the safety of dietary supplement products—FDA needs to vie for additional funding focused on this vital task.
Next, FDA works to ensure consumers are never deceived. Yet shortchanged funding has hamstrung the agency’s ability to scale up its reviews of label claims cases. As a result, many in-depth examinations are passed on to the FTC or are conducted by the industry’s self-monitoring programs.
This area should not be left up to companies’ own goodwill. But if large budget cuts hit FDA and FTC, then, at a bare minimum, government leaders should work with their industry counterparts to bolster funding for self-policing initiatives, like the Council for Responsible Nutrition’s (CRN) partnership with the National Advertising Division of the Council of Better Business Bureaus, which can boost consumer confidence and reduce regulators’ workloads.
Third on the list are steps to confirm ingredients claimed on a label are actually in the product. Upholding this responsibility requires an effective regime of GMP inspections of dietary supplement manufacturers.
The biggest challenge in this regard is to fix the poor quality of ingredients brought to market by some suppliers; expand FDA oversight of the ingredient supply chain; and end the mistaken decision to exempt certain suppliers from the inspection process.
One way FDA can improve GMP compliance is through expanded education and training for dietary supplement manufacturers. With limited resources, ODSP won’t have the requisite bandwidth to conduct this kind of outreach, but it is a central part of the agency’s duties that deserves every penny available. Meanwhile, customers should be encouraged by the actions of reputable companies to allow for more transparency about what goes into their products, including the establishment of the Supplement Online Wellness Library (OWL), a new product registry. An increase in these types of activities is a welcome way to reassure consumers that every dietary supplement product sold in the U.S. contains the components stated on the label.
Finally, there are NDI safety reviews, the final activity allowing ODSP to keep unsafe products from store shelves. Current resources seem adequate to maintain the 40 to 50 NDI notifications received by FDA each year. Instead, the real problem occurs when ODSP has to publish the final NDI notification guidance document. Often, this process can lead to a flood of NDI notices for a wide array of products already in the market, and without additional resources, ODSP will be hard-pressed to handle the influx of work.
One way to tackle this challenge would be to establish an old dietary ingredient (ODI) list in cooperation with industry. Such a joint database will help companies and FDA determine whether an NDI notification would still be needed. What’s more, developing this list could happen without extra regulations, meaning it could be devised and implemented without jumping through too many bureaucratic hoops.
Other options exist to make NDI reviews more efficient and less time-consuming. But what’s clear is that innovative solutions are absolutely critical to avoid overwhelming the ODSP staff with a massive increase in the number of NDI notifications.
To sum up, ODSP could clearly do far more than its current capacity permits, if more funding were available. That seems unlikely now, so FDA will have to prioritize how it expends existing resources while fighting for more in the future—all in pursuit of the agency’s ultimate objective: to provide America’s customers with safe products that enhance their health and well-being.
Interested in learning more about what’s happening at FDA around dietary supplements? Join FDA’s Steven Tave, director of FDA’s Office of Dietary Supplement Programs, in the SupplySide West Featured Speaker session on Wednesday, Sept. 27, at SupplySide West 2017.
Vasilios “Bill" Frankos, Ph.D., M.S., is senior corporate advisor of product science, safety and compliance with Herbalife Nutrition. He previously served as the director of FDA’s Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition (CFSAN). Frankos was FDA’s lead scientist for dietary supplements and was responsible for the full implementation of the Dietary Supplement Health and Education Act of 1994 to ensure the safety and accurate labeling of dietary supplements and supported legislative compliance, enforcement and public affairs initiatives. Frankos holds a doctorate in pharmacology and toxicology from University of Maryland Pharmacy School; a master’s in molecular biology and a bachelor’s in biology from University of Maryland.
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