I recently attended a seminar where senior FDA officials were lamenting the dietary supplement industry’s poor compliance with Good Manufacturing Practices (cGMPs). I listened carefully as agency officials offered what they described as serious and widespread manufacturing problems.
 
To make their case, the officials used a myriad of statistics. I captured a few noteworthy stats: More than 400 recalls of spiked products since 2008; 25% of GMP inspections categorized as Official Action Indicated (OAI); and one in four inspections resulted in a warning letter. Needless to say, I’m concerned.
 
Fast forward to a June Chicago Tribune article that purports to sum up FDA’s analysis of the state of dietary supplement GMP compliance. In it there’s a statement from FDA: “At least half of the industry is failing on its face.”
 
Whoa, I say. How did FDA arrive at this statistic? I am not saying the agency got it wrong, but perhaps in an attempt to underscore the importance of the problem, there may be a wee bit, or A LOT of exaggeration. What I know is this: based on the statistics I’ve heard and the publicly available FDA warning letters, I can’t figure out what the basis is for intimating that 50% of the industry is essentially failing to meet GMPs—which, I think, is the only logical interpretation of the quote, and the one intended by the agency.
 
Let’s assume that, as the Tribune article states, there are 1400 dietary supplement firms. If ALL of the “nearly 450” facilities that FDA has inspected to date “failed,” then you would know that only 32% of the industry tripped up. But we know for a fact many inspections have gone smoothly, without any violations being cited. So that can’t be the basis for the statistic, can it?
 
Another attempt to decipher the “at least half” statistic is that if one in four GMP inspections conducted to date (25 percent) resulted in a warning letter and FDA has completed nearly 450 inspections, then there should be about 112 GMP-related warning letters. If hypothetically there are 112 GMP-related warning letters and 1400 firms, then only 8% percent of the industry has received a GMP-related Warning Letter. Moreover, nothing indicates that the nearly 450 inspections to date are representative of the entire industry. Indeed, if FDA is following the risk-based paradigm for enforcement that it espouses, one would expect it to have targeted those firms mostly likely to present a public health risk and therefore more likely to lead to GMP violations. So receiving a GMP Warning Letter couldn’t be the sole determinant of a company as “failing on its face”…right?
 
In an era of FDA transparency, it makes sense that if FDA is going to categorize the state of GMPs as “downright scary,” then it should be forthcoming and accurate with its statistics. We support FDA’s efforts to enforce GMPs, and we appreciate its willingness to work with the industry to help bring all companies up to the high levels required by these regulations.
 
We further sense FDA’s frustration, and we empathize. Like FDA, we would like to see all dietary supplement companies reach 100% compliance. And we understand there may be a need for harsh rhetoric to light a fire under those companies that are lagging behind.
 
However, the responsible dietary supplement industry invests significant resources into GMP compliance and it is unfair to tarnish the entire industry with statistics that are not accurate, or are not easily understood. In addition, there will logically be a period of time during this initial wave of first-time GMP inspections that results in a learning curve for some companies, and other companies may not survive. When the GMP final rule was published, both FDA and industry predicted there would be a winnowing of the industry, so we should not be surprised that some companies are failing. But declaring half the industry to have “failed” is not appropriate—it’s like a professor who fails the entire class after catching a few students cheating.
 
The agency has been quite open as to what it is finding during inspections and the aspects of the regulation in which the industry needs to improve. But to publicly state that half the industry is failing and not to explain how it arrived at this number, FDA is failing to provide the same transparency that it has demanded from industry.