Former FDA Commissioner ‘Ordered’ Agency Not to Enforce DSHEA

It turns out that all the critics who have claimed the dietary supplement industry was ‘unregulated’ may have been right but not for the reasons they thought.

In an article written for Natural Products INSIDER, Peter Barton Hutt, Senior Partner at Covington & Burling LLP and former FDA Chief Counsel (1971-75), states that the FDA took virtually no enforcement action under DSHEA for nearly a decade as the result of an order from then-commissioner David Kessler, M.D., to not enforce the new law. Hutt writes: “Kessler was so infuriated by the enactment of DSHEA, however, that he ordered FDA not to enforce the new law.  Initially, this was not widely understood.  As time has gone on, however, former FDA enforcement officials have admitted that, for the first full decade under DSHEA, FDA took virtually no enforcement action because of Kessler’s policy.  Kessler was convinced that, if the law was not enforced and the worst elements of the dietary supplement industry were allowed to run wild, Congress would repeal the law.”

For anyone interested in the back story of how we came to this, read on. The article is part of an ongoing series compiled by Natural Products INSIDER called “DSHEA @ 15″ that includes articles and interviews looking at the 15 years since DSHEA was passed in 1994. To read the complete article by Hutt, click here.

So the industry was unregulated because the FDA chose to not do their mandated job of consumer protection. Instead, the nutritional products industry developed “Good Manufacturing Practices” and policed itself.

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