Tag Archives: FDA

Did you know you can, and should, report a reaction or injury from a packaged food that was inappropriately labeled gluten-free?

Who Determines What Is Gluten-Free?

The organization in the United States that sets the criteria for what gluten-free means in the United States is the Food and Drug Administration.

According to the FDA website, “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”

The FDA defines gluten as any grain or ingredient containing wheat, barley, rye or any crossbreed of these grains.

What Can be Labeled Gluten-Free?

The FDA allows manufacturers to label a product gluten-free if it does not contain any of the following:

• An ingredient that is any type of wheat, barley rye or any crossbreed of these grains.
• An ingredient that has been derived from these grains that has not been processed to remove gluten.
• An ingredient that has been processed from these grains that still contains greater than 20 parts per million (PPM) of gluten.

Foods that are inherently gluten-free can be labeled as such as long as they did not come in contact with foods containing greater than 20PPM of gluten. These foods would include water, fruits, eggs and other whole foods that naturally don’t contain gluten.

We here at Glutenfreeworks.com encourage you to strive for a 100% gluten-free diet where 0PPM is the goal. We also recommend avoiding oats, at least until healing has been determined by your doctor.

What If A Product Says It Is Gluten-Free But It Isn’t?

Any food labeled gluten-free, free of gluten, without gluten, no gluten but fails to meet the FDA’s requirements for use of these terms in considered misbranded and subject to regulatory action by the FDA.

What About Restaurants?

Restaurants gluten-free items on their menus should be consistent with the FDA’s definition.

Reporting Adverse Reactions and Labeling Concerns

If you think you suffered a reaction to gluten, contact your doctor.

Then do the following per the FDA website.

“If a product has unclear labeling or you believe is mislabeled as gluten-free, the FDA would like to know. Keep any food packages because they may contain important information. You may want to contact the manufacturer about the problem. Also, report the problem to the FDA in either of these ways: 

Consumers and manufacturers can submit reports detailing product reactions or labeling concerns to an FDA Consumer Complaint Coordinator for the state where the food was purchased. You can also call FDA at 1-888-SAFEFOOD. 

Consumers can submit a report using FDA’s MedWatch Online reporting form for consumers. Reports submitted to the FDA should include as much information as possible.

For more information, see Gluten-Free Labeling of Foods.”

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.

October 3 is the last chance to have a say on what “GLUTEN-FREE” should mean on food packaging labels.

Don’t miss this opportunity to be heard!

Here is the link to send in your comments on the proposed rule submit comments to the FDA.

Here are the 3 simple steps to get started: Read More »

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 3^rd—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 »