Sunday, October 21, 2012

FDA Delays

Here's the timeline --

2004 -- Food Allergen Labeling and Consumer Protection Act passes, requiring FDA to propose within 2 years regulations defining "gluten-free" for purposes of food labeling and finalize those regulations within 4 years.  (In case you hate math, that's 2006 for the proposal and 2008 for the final rule).

2007 -- FDA published a proposed rule to permit food manufacturers to label a food as "gluten-free" if, generally, it does not contain more than 20 ppm of gluten.  The rule was published on Jan. 23, 2007, with a comment period ending April 23, 2007.  (If you're not close to the regulatory process, a four month comment period is LONG).

2011 -- May.  FDA publishes a study entitled Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease.

2011 -- August.  FDA reopens the comment period on its previous rule proposal.  In the accompanying press release, the FDA states that it wants up to date information prior to finalizing the rule.  And cites to 2008 data.  This time, the comment period stayed open for 60 days.

2012 -- October.  Over a year later, no final rule has been adopted.

What we need here is a petition for rulemaking.


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