The Food and Drug Administration is constitutionally required to treat foods and
dietary supplements equally when it comes to rules governing qualified disease
prevention claims, the Grocery Manufacturers of America said today.
GMA said that conventional foods should not be restricted from making qualified
claims that can be made for dietary supplements because consumers can benefit
from increased information about the link between food and health.
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In a petition filed this week, GMA told the FDA to prepare for a court challenge
if it does not reverse its stance on how it implements the Pearson v. Shalala
decision. In Pearson, the U.S. Court of Appeals of the District of Columbia
ruled that the FDA’s restrictive policy on food disease prevention claims was
a violation of the First Amendment.
Although that particular decision involved four disease claims for dietary
supplements, James Skiles, GMA vice president and general counsel, said the
decision applies to all food.
"FDA’s continued preference to read the First Amendment protections narrowly
to the facts of the Pearson case is a misreading of the case law," said
Skiles. "Nothing in the Pearson decision limits the impact of the court’s
analysis to dietary supplements."
"If FDA refuses to recognize the interpretation of the Pearson v. Shalala
decision, GMA is fully prepared to move forward with a court challenge to protect
the industry’s First Amendment rights," concluded Skiles.
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By GlobalDataThe four qualified disease prevention claims approved for dietary supplements
involve the following relationships; folate and neural tube defects; omega-3
fatty acids and cardiovascular disease; and folate, vitamin B6, and vitamin
B12, and vascular disease.
A copy of the petition is available at www.gmabrands.com
