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The Journal of the American Medical Association has published a study on products marked as supplements containing drugs or drug-analogs but the study actually shows how well the system works
October 22, 2014
The study hasn’t even hit the mainstream press and I can already hear the chorus from some in the natural products industry. It goes something like this: the Journal of the American Medical Association is the mouthpiece of the medical establishment and big pharma, and both of them want to bring down the supplement industry.
That’s the chorus only because they weren’t listening to the actual song. On Tuesday, JAMA released a study calling out the supplement products containing drugs or drug-analogues and decrying the enforcement environment that allowed them to slither onto shelves and websites. What people in the chorus need to be singing is that the system worked. These are not supplements. They are drugs and they got pulled from the shelves just as they should have been. The system didn’t just work. It worked well. Of the 274 recalled products cited in the study, only 18 remained on the market past the recalls with active pharmaceutical ingredients.
The study may taint the industry in the media but the media attention span is finite. The truth is a 93 percent success ratio on recalls could mean fewer negative headlines going forward. These are administrative actions, not enforcement actions, and yet the compliance rate shines even in the darker corners of the industry. The industry may not want to applaud JAMA but everybody in the supplement company might take a moment to applaud the Food and Drug Administration (FDA).
It’s not the industry’s job to enforce regulations—you don’t protect good people from bad people with good people—and yet the industry is already helping the FDA with adverse event reports. That generally falls to the practitioner and finished product companies that already know what to look for. With tainted products all should be on the lookout. The Food Safety Modernization Act (FSMA) is going to bring raw ingredient companies into the reporting system too on some level. This is not just an idea. This is an obligation.
So the system is already working. It can work better. The industry needs to use some of its political juice to help make that happen. The right calls could get the right enforcement and some of that enforcement could be targeted at quicker results—more misdemeanor charges and administrative actions. Felony charges have impact but lesser charges could have more immediate, and wider, effect.
The call for more laws in the JAMA article just doesn’t fit. The companies producing the products in the study are not making supplements. They are making drugs. They can be held accountable. What they are doing is already criminal. Are we going to make it super criminal?
The industry certainly doesn’t need to sing the chorus of persecution. The refrain the media needs to hear is that the industry and the FDA are singing in the same key. The industry and the Natural Products Association want enforcement and the mission is clear— call it out. Call it for what it is. While it’s probably everyone’s least favorite part of the government, at least while in airports, we can borrow the line from the Department of Homeland Security: when you see something, say something.
CEO, Natural Products Association
Daniel Fabricant, PhD, is executive director and CEO of the Natural Products Association (NPA), the nation’s largest and oldest trade organization representing the natural products industry, including dietary supplements, foods, personal care products and more. He is responsible for implementing board policy for the advancement and protection of the natural products industry, while overseeing every aspect of the association’s programs and activities.
Most recently, Dr. Fabricant served as the Director of the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA), where he directed agency policy, public affairs and regulatory action regarding regulation of the dietary supplement industry for more than three years. While with the agency, he successfully navigated the large, heavily matrixed governmental organizational structure to bring life to a regulatory function that was non-existent for almost 20 years.
Prior to the FDA, Dr. Fabricant was vice president, global government and scientific affairs, for NPA, responsible for establishing and leading industry coalitions dealing with a range of legislative, regulatory and scientific matters. Dr. Fabricant carried his interest in natural products into the classroom, earning a Ph.D. in Pharmacognosy from the University of Illinois at Chicago, where he has served as an adjunct professor in the Department of Medicinal Chemistry and Pharmacognosy since 2009. Pharmacognosy is the study of drugs derived from natural sources (plants and animals). He has also published extensively and is internationally recognized for his regulatory and governmental public health expertise and natural products research.
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