From the Editor's Desk

FDA’s inspection hiatus provides opportunity for industry to prove self regulation is real

By Hank Schultz contact

- Last updated on GMT

Getty Images
Getty Images

Related tags: coronavirus, COVID-19, Dietary supplement industry, Gmps, Gmp compliance

With FDA receding into the inspection background, now is the time for the dietary supplement industry to step up and show if there are any real teeth in the notion of self regulation.

The agency put out a statement earlier this week saying that it is suspending on site GMP inspections of dietary supplement firms​ in the face of the worsening COVID-19 crisis.  Some players in the industry have opined that this will open wide the door to adulteration and fraud.

That might be an overreaction in the short term.  In the statement that announced the inspection hiatus, FDA Commission Dr Stephen Hahn, MD, noted that in the best of times FDA inspects only about 5% of the registered food facilities in the US in any one year.  So few companies would have been inspected during this period in any case.

Inspections are like speeding tickets

That rate of inspections, like the rate at which speeding tickets are issued, could only ever serve as something of a moral deterrent. Companies are required to register their facilities with FDA prior to manufacturing dietary supplements or holding them for distribution.  But after that they are subject to only the periodic on site inspection or website review.  The chance of that happening at any one time has always been low, unless a company has put out a contaminated product that is causing an immediate public health concern or has made a disease treatment claim.

Hahn sounded a hopeful note in his statement, saying he believes dietary supplement companies by and large understand their responsibilities. That’s a departure from other recent statements by the agency, which have been along the lines of a general disappointment in the industry’s perceived lack of progress on the rate of GMP compliance.

“From our experience across the agency, we also believe FDA-regulated firms understand and appreciate their shared responsibility to ensure the integrity of the supply chain and we will continue to communicate with them during this time to underscore this partnership,”​ Hahn said.

Time for best players to shine

So it’s up to the responsible portion of industry to step forward to make Hahn’s belief a fact. The aforementioned low barriers to entry mean the dietary supplement industry has always included a fringe, less engaged element.  How can high quality, above-board companies differentiate themselves from the fly-by-nighters, especially in this time when a bevy of new, frightened and perhaps desperate consumers are seeking these products out?

Highlighting trade organization membership might be one avenue.  What if point of sale placards or some other such form of communication could proclaim that these are the companies working together to make high quality, safe products to meet consumers needs during this crisis?

 It seems companies in this industry are sometimes reluctant to mention that it is possible to buy low quality, ineffective products that look just like other dietary supplements.  And they’d rather not admit that consumers might be hard pressed to distinguish the worst products from the best ones.  The less said about it the better, or so the thinking seemed to go.  If some consumers are misled into buying that junk well, then, too bad. We’ll move on, and try to catch the eye of the next consumer who comes down the aisle.

How to shine spotlight on quality

Maybe it's time to rethink that laissez faire attitude.  Thought leaders are starting to look forward to what the world will look like after this crisis passes and, while no one knows for sure, the consensus seems to be that many things will not be as they were before.  Are we looking at changes in social networks, in corporate governance, in public policy priorities?

Should we assume, then, that the dietary supplement industry will go through this fire and come out operating just as it had before?  Perhaps this crisis will provide an opportunity to find a way to finally draw that sharp line in the sand.  To find a way to tell consumers:  Buy on this side of the line if you want a product backed by the best science, made with the highest quality ingredients and manufactured in accredited facilities.  Buy on that side if all you’re concerned about is price.

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