FDA and Legal Fun

Sometimes the more you learn about our government agencies, the scarier it gets. It turns out that the FDA Commissioner in 1994, David Kessler, was so unhappy with the Dietary Supplement Health and Education Act (DSHEA) that for 10 years he told his staff not to enforce the laws!

Let’s Back Up - What is DSHEA?

In 1994 Congress passed the Dietary Supplements Health and Education Act (DSHEA). You can read all about DSHEA in our post here. Basically DSHEA was an act passed by congress that allowed dietary supplements to remain on the market, at a time when FDA Commissioner Kessler wanted to ban basically all dietary supplements.

Due to a very strong grassroots movement and the climate of a political election in 1994, DSHEA was passed and supplements were allowed to be sold, under the guidelines of DSHEA.

Don’t Like A Law? Close Your Eyes and Wish it Away

Commissioner Kessler thought that DSHEA was a terrible law and figured if his agency did not enforce it, the rest of the world would also see what a terrible law it was. So, for almost a full decade, the FDA did not enforce DSHEA, in hopes that Congress would enact new legislation when they saw that DSHEA was not “working”.

“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 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. Of course, that did not occur. For a full decade, however, Kessler sacrificed protection of the public health to his own personal animosity toward DSHEA.”

- The History and Future of DSHEA - 9/21/09, Natural Produts Insider

Is it Just Us or Is This Just Flat Out Appalling ??

If Peter Barton Hutt, the author of the above article, got this all right - it is appalling. Imagine the uproar if a cop on the street decided he did not believe in Miranda rights, so he did not read anyone their rights. Now imagine it was not just a cop on the street, but the Police Commissioner who decided no one should be read their Miranda rights because he disagreed with the law. This would be completely unacceptable.

I think our nation works best when we enforce all the laws equally, not just the ones we like. Kessler’s plan almost worked - for years after DSHEA people said the supplement industry was unregulated and unsafe. There were calls for new laws and new regulations. In the end, DSHEA provided the regulations and laws - little did we know that the problem was just that the FDA had decided not to enforce the laws for personal reasons.

Additional Resources:

The History and Future of DSHEA - 9/21/09, Natural Produts Insider

What is A Dietary Supplement Anyway?

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