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Tuesday, February 21, 2012

Guest Blogger James T. O'Reilly: Changing The Culture of Those Who Market Probotic Cultures

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Fecal transplants, anyone? Yes, if you have a clostridium difficile infection, the best medicine may be to have a gastroenterologist implant a piece of non-infected fecal matter into your rectum and allow it to dissolve. No, please, no rush of donors to volunteer.  Before health law profs choke, gag, or put this into an exam question, the science of the lower bowels is becoming a major area for study. You’ll have a gut feeling that there will be a lot coming out on this topic, most of it banned from polite tableside conversation….

The National Institutes of Health study of probiotics regulatory options has wrapped up its third and final two-day session on Feb. 17 at the University of Maryland, with a report to follow this spring. Probiotics, including pills, yogurts, and liquids, are a potential billion-dollar market opportunity for bowel problems. If you’re just a regular guy like me, you can leave the marketing to Jamie Lee Curtis and other Activia activists. But for many, the bloating and gas and sometimes serious infections pose an opportunity for the preventive consumption of millions of special bacilli which re-populate the intestinal flora and are hoped to reduce the problems in the humane microbiome.

As a member of the study dialogue, I recommended that the probiotics marketers who now have an “anything goes” approach should be constrained to tell the whole relevant truth. If they label their product with probiotic claims, there must (at the end of the marked shelf life) be enough active biologic entity in the consumer’s dose of that product, such that the probiotic will actually deliver the promised benefit. A yogurt whose Cosmo ad promised faster “transit time” in the gut (and we’re not talking speedier subway cars) must actually deliver. To get to the enforcement of this ideal state the FDA and FTC must have clear guidance, hence the NIH’s efforts.

I recommended to NIH and FDA the use of the OTC Monographs (21 CFR Parts 330 et seq.) as the readily available, Supreme Court-blessed, no statute needed, mechanism for the characterization of biologic contents, effectiveness studies, supporting documentation and actually defensible marketing claims. To say that industry threw a lot of anal output my way is to say it mildly. The probiotic toothbrush makers, the probiotic lipstick makers and the goddess of yogurt-borne regularity will  not embrace FDA review and FTC norms. They prefer to be vendors of pricier versions of old, normal, little-regulated foods or cosmetics or within that magical, regulation-eluding mélange cloaked as “dietary supplements”.  We’ll watch for the final report and will cover it in this blog, but for now, probiotic fans must caveat their emptor, each time they empty their wallets. Wishing you all faster transit time and fewer consumer frauds…..

- Jim O’Reilly

http://lawprofessors.typepad.com/healthlawprof_blog/2012/02/guest-blogger-james-t-oreilly-yes-it-walks-like-a-duck.html

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