Tag Archives: FDA

FDA Publishes Guidelines for Gluten Free Medication Labeling

Big news today! The Food and Drug Administration of the United States just published it’s draft guidance on Gluten in Drug Products and Associated Labeling Recommendations.

The FDA recommends that the words “Contains no ingredient made from a gluten-containing grain (wheat, barley, rye)” be included when appropriate.

This labeling includes the following types of drugs:

  1. Orally ingested drugs that are absorbed in the intestine.
  2. Topically applied drugs that are placed near the mouth and may be ingested.
  3. Medications that are placed into the mouth.

This labeling does not apply to the following:

  1. Skin products not applied near the mouth.
  2. Costmetics.
  3. Supplements such as vitamins and minerals.

FDA Gluten Free Labeling Update

Cheryl Harris Gluten Free Works

The FDA is finally moving on regulating the claim “gluten-free” on packages, which is fantastic news!  Lots of people have put in countless hours to make this happen.  We’ve got 1 month left to comment—until October 3rd—and YOUR comment is vital to getting the law YOU want.

During the Aug 2nd teleconference, we heard that the comment period was re-opened and we might have a law by late 2012.  Several prominent researchers, including Dr. Alesso Fasano and Dr.Stefano Guandalini, spoke in favor of the new proposed legislation. “This is a standard that has been in use in Europe for almost two decades, & the science supports the U.S. adopting it as well,” commented Dr. Fasano.  I posted highlights of the teleconference, but upon reading the 90+ page safety assessment, I had a lot of questions! http://1.usa.gov/r4NDLA

The safety assessment suggests that for the most sensitive Celiac, Read More »

Gluten Free Certification – What Does It Mean to You?

Currently we have a proposed government definition of the term “gluten-free” for food labeling purposes but no final rule. Under the proposed rule, a labeled gluten-free food has to contain less than 20 parts per million of gluten. When the final rule is released this number could stay the same, go up, or go down—a little or a lot.

The amount of gluten a labeled gluten-free food is allowed to contain is only part of the story. Another part is testing. The FDA stated in its proposed rule that it is tentatively considering using the standard sandwich R5 ELISA and the Morinaga wheat protein ELISA to test food products for gluten when necessary to assess misbranding. In contrast, FDA did not include the omega-gliadin (Skerritt) ELISA among the methods it was considering. One of the limitations discussed in the scientific literature regarding this ELISA is its underestimation of barley protein.

At the present time the R5 ELISA (Ridascreen Gliadin R7001) is widely regarded as the best available validated ELISA for assessing final food product for gluten. In my opinion, all labeled gluten-free foods should be periodically tested using Read More »

Update on FDA’s Gluten-Free Food Labeling Rule

Rhonda Kane, MS, RD, Consumer Safety Officer at the Food and Drug Administration (FDA), provided us with the following status report on FDA’s gluten-free food labeling rulemaking:

The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland.

“FDA published a proposed rule to define the food labeling term “gluten-free” on January 23, 2007, which had a 90-day public comment period that closed on April 23, 2007.  As discussed on page 2803 of the proposed rule (posted under the subheading “Gluten-Free”), FDA committed to conducting a safety assessment on gluten exposure in individuals with celiac disease.  FDA conducted this safety assessment in accordance with the data quality criteria discussed in Read More »

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