Risk Benefit and DSHEA

Court_front_med_1 The FDA has issued a statement regarding the decision by the Tenth Circuit Court of Appeals reversing a lower court decision on the FDA actions to ban ephedra from sale in the United States.

You will recall that after a series of highly publicized adverse events associated with the use of ephedra in supplement products, and after much prompting by policy makers in Congress, the FDA banned ephedra as a substance in supplements under the authority given it by Congress with the Dietary Supplement Health and Education Act (DSHEA) of 1994.

An interesting point made in the press release was that the court had "found that Congress clearly required FDA to conduct a risk-benefit analysis under DSHEA." 

Unfortunately, the statement does not go on to explain how FDA will employ that right and it leaves many questions unanswered – to name a few:

  • What event or series of events triggers the FDA to conduct a risk-benefit analysis of a supplement?
  • What are the elements of a risk-benefit analysis?
  • How are manufacturers involved in the process?
  • What are the parameters of the risk-benefit analysis?
  • Who decides that such an analysis will take place?

The court decision raises other questions as well.  When the ephedra issue was at the apex of public debate, hearings in Congress suggested not only that the FDA move to ban ephedra, but that DSHEA be amended to provide FDA with specific authority to regulate supplements.  Does the court decision remove some of the motivation for amending DSHEA or not?

As the court decisions make the authority of FDA more clear, it is incumbent on the agency to clarify how it will carry out this authority in the future, for the sake of consumers as well as for manufacturers. 

By the way, if you would like to see the FDA White Paper on ephedra, click here

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