Duffy MacKay, ND, Vice President, Scientific and Regulatory Affairs, Council for Responsible Nutrition09.15.12
It is clearly time for the responsible industry to get its house in order. If the existence of tainted dietary supplements does not end, those responsible for protecting public health are going to be compelled to do something drastic. The recently passed Food Safety Modernization Act (FSMA) may give FDA the authority to do it.
The issue is ugly and awful. Criminals are spiking products with drugs—and calling them supplements. That’s illegal. Period.
The availability of adulterated products creates a public health risk for the unknowing consumer and according to FDA is particularly problematic for those who seek a quick fix to lose weight, bulk-up, or improve performance in the bedroom. In a perfect world, consumers would understand that dietary supplements can be part of an integrated approach to tackling issues like weight loss, but that there is NO PRODUCT—dietary supplement, body cream, shoe, or magic belt (with the exception of drugs, some legal, some not) that provides a quick fix for these outcomes. If any product claims to be a supplement and claims to provide instant and unrealistic results, that is a screaming red flag to consumers to avoid the product.
Is FDA concerned? Absolutely! I think anyone tasked with keeping the public safe from harmful products would be. I recently attended a seminar on adulterated products where FDA presented a couple of slides that summed up the state of the dietary supplement industry from their perspective. The first slide titled “general regulatory paradigm” was followed by the bullets: limited premarket review; no premarket approval; no formulation standards; no approval of structure function claims; manufacturer responsible for ensuring safety. Luckily I wasn’t holding my breath for the next slide to explain how this paradigm is appropriate and intentionally structured for supplements to balance consumer access to supplements with consumer safety. And it was a good thing because I would have passed out!
Next, I learned that as the dietary supplement industry approaches the third decade of DSHEA, FDA has shifted to an era of preventive controls, as evidenced by the passage of FSMA. As my FDA colleague pointed out from the podium, the focus on prevention has resulted in over 400 recalls of spiked products since 2008. In the same breath, FDA pointed out 25% Official Action Indicated on cGMP inspections; approximately 1,200 Adverse Events reported annually; that 51,000 dietary supplements have entered the market with only 50 New Dietary Ingredient Notifications annually; and here is the kicker – at the bottom of the slide sits the words “Low-Risk?”
One may ask why I might think a single bullet on a slide that reads “Low Risk?” is important. Note the question mark. FDA is pondering the question: are dietary supplements a low risk category of food? Unfortunately the problem of adulterated products makes it difficult to answer no. And this is important because if FDA classifies dietary supplements as a “high-risk” category of food then there are several provisions of FSMA that will become relevant to manufacturers of dietary supplements. These include enhanced record keeping requirements, increased inspections frequencies and/or new regulations specific to preventing intentional adulteration.
Responsible companies sell responsible products in a responsible manner. The majority of companies in our industry sell healthful products to consumers who want to live a healthier life. But we run the risk of illegitimate companies swiping our reputation and burning down our house. The challenge is that those responsible for adulterating dietary supplements are not from our house or even our community—they are intruders trying to break in and destroy it. How can we protect our house and our supplement industry neighborhoods? FDA is asking responsible companies to fully qualify your suppliers, to report (rather than just send back) ingredients that test as adulterated, and to educate consumers about the potential risks of adulterated products. Some would say it’s unfair to ask responsible companies to bear the burden of criminals thumbing their nose at the law; others would recognize the need to not only protect consumers, but to help solve this problem to avoid drastic measures down the road.
The issue is ugly and awful. Criminals are spiking products with drugs—and calling them supplements. That’s illegal. Period.
The availability of adulterated products creates a public health risk for the unknowing consumer and according to FDA is particularly problematic for those who seek a quick fix to lose weight, bulk-up, or improve performance in the bedroom. In a perfect world, consumers would understand that dietary supplements can be part of an integrated approach to tackling issues like weight loss, but that there is NO PRODUCT—dietary supplement, body cream, shoe, or magic belt (with the exception of drugs, some legal, some not) that provides a quick fix for these outcomes. If any product claims to be a supplement and claims to provide instant and unrealistic results, that is a screaming red flag to consumers to avoid the product.
Is FDA concerned? Absolutely! I think anyone tasked with keeping the public safe from harmful products would be. I recently attended a seminar on adulterated products where FDA presented a couple of slides that summed up the state of the dietary supplement industry from their perspective. The first slide titled “general regulatory paradigm” was followed by the bullets: limited premarket review; no premarket approval; no formulation standards; no approval of structure function claims; manufacturer responsible for ensuring safety. Luckily I wasn’t holding my breath for the next slide to explain how this paradigm is appropriate and intentionally structured for supplements to balance consumer access to supplements with consumer safety. And it was a good thing because I would have passed out!
Next, I learned that as the dietary supplement industry approaches the third decade of DSHEA, FDA has shifted to an era of preventive controls, as evidenced by the passage of FSMA. As my FDA colleague pointed out from the podium, the focus on prevention has resulted in over 400 recalls of spiked products since 2008. In the same breath, FDA pointed out 25% Official Action Indicated on cGMP inspections; approximately 1,200 Adverse Events reported annually; that 51,000 dietary supplements have entered the market with only 50 New Dietary Ingredient Notifications annually; and here is the kicker – at the bottom of the slide sits the words “Low-Risk?”
One may ask why I might think a single bullet on a slide that reads “Low Risk?” is important. Note the question mark. FDA is pondering the question: are dietary supplements a low risk category of food? Unfortunately the problem of adulterated products makes it difficult to answer no. And this is important because if FDA classifies dietary supplements as a “high-risk” category of food then there are several provisions of FSMA that will become relevant to manufacturers of dietary supplements. These include enhanced record keeping requirements, increased inspections frequencies and/or new regulations specific to preventing intentional adulteration.
Responsible companies sell responsible products in a responsible manner. The majority of companies in our industry sell healthful products to consumers who want to live a healthier life. But we run the risk of illegitimate companies swiping our reputation and burning down our house. The challenge is that those responsible for adulterating dietary supplements are not from our house or even our community—they are intruders trying to break in and destroy it. How can we protect our house and our supplement industry neighborhoods? FDA is asking responsible companies to fully qualify your suppliers, to report (rather than just send back) ingredients that test as adulterated, and to educate consumers about the potential risks of adulterated products. Some would say it’s unfair to ask responsible companies to bear the burden of criminals thumbing their nose at the law; others would recognize the need to not only protect consumers, but to help solve this problem to avoid drastic measures down the road.
