On the regulation, testing of probiotics

I am a clinical nutritionist, and I enjoyed the Children’s Health article in the June 23 Daily Herald, but take issue with a couple of concerns. First, the opinion that probiotic supplements are not regulated by the U.S. Food and Drug Administration. Though shared by medical authorities for many years, that opinion is simply wrong. All dietary supplements, including probiotics, are regulated by the FDA under the Code of Federal Regulations (21 CFR), authorized by the Dietary Supplement Health and Education Act of 1994.

The agency’s website reports: “FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products.”

A lot of medical professionals who are used to drug products/claims being narrowly approved by the FDA think that products regulated under different rules are unregulated. But dietary supplements are regulated as a special food category, with far more governing rules than conventional foods, but fewer than drugs. It’s only logical, since dietary supplements are degrees of magnitude safer than drugs, which need to be more highly regulated due to their inherent toxicity.

The other concern is a broad recommendation for probiotics to be tested by a third party. While this sounds reasonable, large companies with third-party certified ISO-compliant laboratories that have invested in RiboPrinters or other instruments to assay their probiotics and can identify the genus, species and strain (all three should be on the product label) typically do not outsource their testing. Outsourcing is needed by small brands that haven’t invested in the microbiologists and advanced instrumentation required to do their own ISO-accredited testing.

The same would apply to analytical testing; independently certified labs are not always “third-party” facilities.

Neil E. Levin

Bloomingdale