Senators Urge FDA Action On Gluten-Free Labeling

Wednesday, July 27, 2011

Two US Senators have sent a letter to the Food and Drug Administration (FDA) urging prompt action on gluten-free labeling laws, after a proposed rule on tolerable gluten thresholds for gluten-free foods has languished for more than four years.

Defining a tolerable threshold level for gluten presence in gluten-free foods was included as part of the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. 

In 2007, the FDA proposed that gluten should be labeled at anything over 20mg per kg (20ppm); foods labeled gluten-free containing more than this amount would be considered misbranded. 

Many companies are already voluntarily using this standard, but the rule has yet to be finalized.
U.S. Senators Ron Wyden (D-OR) and Patrick Leahy (D-VT) sent their letter to FDA Commissioner Dr. Margaret Hamburg asking for an explanation for the delay.
They wrote: “We ask that you provide us with an update on when FDA will promulgate a final rule, why FDA has taken so long to issue this rule, and if there are any legal or regulatory hurdles that have prevented the timely implementation of this legislation.”
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