Court Decision Reverses Ban on Dangerous Ephedra
Statement of CSPI Legal Affairs Director
April 15, 2005
This decision leaves no doubt that the Dietary Supplement Health and Education Act (DSHEA) prevents the Food and Drug Administration (FDA) from taking unsafe products off the market. Congress should swiftly amend DSHEA to clarify and strengthen the FDA's authority to protect the public from dangerous products and mandate that the National Academy of Sciences conduct a comprehensive safety and efficacy review of dietary supplements.
The Federal District Court decision striking down FDA's ban on ephedra states that when the government cannot determine a safe level of a supplement, it must continue to permit the product's sale, even when the product has no health benefits. The Court's decision places the FDA, and consumers, in an untenable position.
Ephedra killed 155 Americans and injured thousands of others, more than that of any other supplement on the market.
We urge the FDA to appeal this decision, but the real solution is for Congress to amend the law and empower the FDA to protect the public from dangerous products.