Regulation

UNPA's Israelsen proposes new carrot to go with FDA's GMP stick

29-Apr-2013
Last updated on 29-Apr-2013 at 20:06 GMT - By Hank Schultz
UNPA's Israelsen proposes new carrot to go with FDA's GMP stick
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The dietary supplement industry is falling behind on GMP compliance, says Loren Israelsen, executive director of the United Natural Products Alliance.  Fixing that is a matter of coming up with a new carrot to go with the stick wielded by the Food and Drug Administration.

“We recognize the problem. We believe the next set of answers to change the situation, to improve compliance, has got to be more than FDA stepping up enforcement.  Market forces have got to be part of the answer—a self-understood self interest to improve quality,” Israelsen told NutraIngredients-USA.

Israelsen delivered his thesis during a talk at the recent 12th annual International Conference on the Science of Botanicals held at the University of Mississippi in Oxford.  One of the key tenets of his presentation was that market forces are not being harnessed to help drive GMP compliance. On the contrary, under the current situation, companies that invest a lot of time and money in GMP compliance often find themselves at a competitive disadvantage with regard to companies that take a more lackadaisical view toward meeting the requirements. And that has to change, Israelsen said.

Blizzard of (mostly) worthless logos

To illustrate his point, Israelsen presented a number of slides filled with 500 or more  logos he and his staff have found on product labels that pertain to GMP compliance (and that's just the tip of the iceberg, he said).  A number of these included verbiage such as “FDA approved manufacturer” and all of them implied official government approval. But none of these logos are an official FDA imprimatur, Israelsen said, and some of them, those that reference FDA directly, are actually technically illegal. Third party GMP certifiers such as NSF, NPA or USP, will issue logos that can be used, but that message of having cleared at least some bar of quality is getting lost in the noise, Israelsen said.

“We believe there is a growing problem in lack of confidence in third-party certifying logos and symbology because it is being choked over by a lot of things that have no merit, no substance,” Israelsen said.

But companies resort to the use of these logos either as a shorcut to actual compliance or in absence of something better if they are in fact doing what they are supposed to do. What do you get from FDA to use on your label if you “pass” inspection, i.e. your inspection does not result in the issuance of a 483?  Nothing. Nada. Zip.

Restaurant ratings as an example

Israelsen said that while FDA has long taken the position of not wanting to be seen as endorsing certain companies, other governmental agencies that regulate consumer food products have not shown a similar squeamishness. County and state health departments across the country, for example, routinely inspect restaurants and assign letter grades that are in most cases displayed on the premises and can form part of the restaurant’s cache, creating a situation in which a company would actively seek the highest level of compliance.

“If you go to California, at every burger stand you’ll have a big bright “A” saying to the consumer, come and have a sandwich here. We’re a clean operation recognized by the state of California,” Israelsen said. “So what is the problem? Why cannot FDA come up with a mechanism to do something similar to give some guidance to the consumer?

“We’ve seen FDA’s rhetoric, and that is a consistent theme of undercompliance with DSHEA on the part of our industry. We don’t disagree.  There is a compliance gap.

“But the good have gotten better. Just recently three of our members had three- to five-day inspections with no 483s. They are letting me know so I can tell our members that they did a fantastic job. Why can’t that become a public fact? Why can’t these companies be rewarded for doing an outstanding job? If I’m a consumer, I’d like to know that. If I’m a retailer doing private label branding for my store, I’d like to know that,” Israelsen said.

Joint trainings could help

In addition to advocating for some sort of official affirmation of GMP quality, Israelsen said additional joint training sessions with FDA and industry could help boost compliance.  The agency now has more than five years’ worth of data on what companies are doing right and where they are failing, and unlocking some of that could help improve future compliance.

“We’d like to do some additional joint education with FDA.  We believe that the GMP training sessions we’ve done have borne some fruit. We need FDA as a working partner to help improve compliance,” Israelsen said.

“FDA is saying, ‘We are doing all we can as a regulator and we don’t feel as if as if our inspections and our warnings are having an effect.  We are getting really frustrated and we are going to become tougher and less patient. You have all been warned.’  But apparently just getting tough with companies that don't get it isn't working. Let’s use market forces to encourage the change of the industry’s compliance posture.  We need that carrot,” Israelsen said.

Related topics: GMPs, QA & QC, Regulation, Botanicals & Herbals