Sunday, September 16, 2007

Asking Congress to demand FDA reporting on AER impacts

Copy of a Memorandum sent today to Natural Solutions Foundation

Memorandum Consultancy

Date: 09.15.07
From: Ralph Fucetola JD – NSF Legal Advisory Group
To: Maj. Gen. Albert Stubblebine – President, Natural Solutions Foundation
Re: Reforming FDA Food Authority – Protecting Dietary Supplements

This memorandum is provided for the Natural Solutions Foundation – – to support our efforts to educate Congress and decision makers on the public’s concern for real reform of FDA’s food safety and claims authority. Pending before Congress, in conference committee, is the FDA Revitalization Act (S 1082 and HR 2900).

Here I address publicly expressed concerns regarding the interaction of the AER Act (Dietary Supplement and Nonprescription Drug Consumer Protection Act – P.L. 109–462) and the recent 10th Circuit appeals decision regarding Ephedra, which allowed FDA to use voluntary AERs (Adverse Event Reports) and a drug-like risk analysis to reverse Judge Campbell’s well-considered decision allowing low levels of Ephedra in diet supporting vitamin pills.

The trial judge agreed that federal law restricts the FDA when it tries to ban foods as opposed to drugs; the law requires the FDA to prove that a dietary supplement is harmful, rather than having the manufacturer prove it is safe, as required with drugs. The company president was reported as saying, “The Court made it clear that FDA has authority under DSHEA to remove unsafe dietary ingredients from the market. But the Court also clarified that FDA must follow DSHEA and cannot treat dietary supplements like drugs or medical devices. The Court made other important findings, pointing out that Congress intended that dietary supplements be treated as a subset of foods and, like other foods, are 'presumed to be safe.'"

Among the important explanations of the Dietary Supplement Health and Education Act - DSHEA that the Court offered, was the following, citing the Senate Report on DSHEA: “..the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection to the food adulteration provision…”

While the FDA’s attempt to apply a drug standard “risk – benefit” analysis may yet be held contrary to law, it is our recommendation that Congress address the relationship between this decision and the AER law adopted last year. This can best be accomplished in the Conference Report for the FDA Revitalization Act.

We recommend that any eventual Conference Report for S 1082 / HR 2900 include report language requiring FDA to report to the Senate HELP Committee and the House Energy and Commerce Committee on how implementation of the AER Act impacts the 10th Circuit decision permitting FDA to use a drug-like “risk – benefit” analysis and the intent of Congress expressed in DSHEA that food regulation is the proper model for Dietary Supplement regulation. Then Congress can consider what steps to take to restore the intent of Congress.

This issue is of pressing public concern and was first raised by the National Health Federation which asked all health freedom concerned groups to raise the issue with Congress. Since Natural Solutions Foundation is seeking to educate Congress on public health freedom concerns, it is appropriate for us to second NHF’s call for Congressional action at the FDA Revitalization Act Conference Committee level.

Respectfully submitted
Ralph Fucetola JD

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