FDA Reopens Comment Period on Proposed Gluten-Free Food Labeling Rule

FDA NEWS RELEASE

For Immediate Release: Aug. 2, 2011

Media Inquiries: Siobhan DeLancey, 202-510-4177, siobhan.delancey@fda.hhs.gov

Trade Inquiries: Stephen King, 240-402-1407, stephen.king@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

 

FDA reopens comment period on proposed ‘gluten-free’ food labeling rule

Rule would help by creating a uniform and enforceable definition

 

The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.

 

One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more gluten. The agency based the proposal, in part, on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20 ppm. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries.

 

People who have celiac disease cannot tolerate gluten, a protein in wheat, rye, and barley. Celiac disease damages the small intestine and interferes with absorption of nutrients from food. About 1 percent of the United States population is estimated to have the disease.

 

“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”

 

The proposed rule conforms to the standard set by the Codex Alimentarius Commission in 2008, which requires that foods labeled as “gluten-free” not contain more than 20 ppm gluten. This standard has been adopted in regulations by the 27 countries composing the Commission of European Communities.

 

The FDA encourages members of the food industry, state and local governments, consumers, and other interested parties to offer comments and suggestions about gluten-free labeling in docket number FDA-2005-N-0404 at www.regulations.gov. The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days.

Senators seek FDA's explanation on delay in gluten- free-labeling laws

Sens. Ron Wyden, D-Ore., and Patrick Leahy, D-Vt., asked the FDA for updates on when it will implement gluten-free-labeling regulations and demanded an explanation for the delay in enforcing such rules. "The regulatory uncertainty surrounding FDA's inaction has led to a proliferation of 'gluten free' standards and labels provided by 3rd party groups. This creates confusion for consumers, and hesitancy amongst producers on what their requirements will be," they wrote in a letter to FDA Commissioner Dr. Margaret Hamburg.

See full story here - http://mobile.foodnavigator-usa.com//Regulation/Senators-urge-FDA-action-on-gluten-free-labeling

FDA to Study Gluten Free Food Labeling - Summer 2009

I've been pretty critical of the FDA on this blog over the last few months. Being critical or negative is not something I like to do normally, but I personally think they could be doing a lot more for Gluten Free consumers and manufacturers. However, I do understand how the federal government "works" - slowly.

I received notice a few days ago about a new study the FDA will be doing this summer about Gluten Free food labeling - it is called Gluten-Free Labeling of Food Products Experimental Study. They published a notice about the study and under federal law must allow for 60 days of comments before the study can begin. You may comment on the study notice until May 5, 2009. My comment would be something like "Hurry the heck up already!".

The purpose of the study is to gauge perceptions of characteristics related to claims of ‘‘gluten-free’’ and allowed variants (e.g.,‘‘free of gluten,’’ ‘‘without gluten,’’ ‘‘no gluten’’), in addition to other types of statements (e.g., ‘‘made in a gluten-free facility’’ or ‘‘not made in a facility that processes gluten-containing foods’’) on the food label. The study will also assess consumer understanding of ‘‘gluten-free’’ claims on foods that are naturally free of gluten, and gauge consumer reaction to a product carrying a gluten claim concurrently with a statement about the amount of gluten the product contains. The data will be collected over the Internet from samples derived from two sources: (1) A membership list from a celiac disease special interest organization and (2) an online consumer panel. Participation in the study is voluntary.

We all know that the FDA missed the August 2008 deadline to finalize the FALCPA law proposed in 2004 and passed in 2006. The law states the following for Gluten labeling...

Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with appropriate experts and stakeholders, shall issue a proposed rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods. Not later than 4 years after the date of enactment of this Act, the Secretary shall issue a final rule to define, and permit use of, the term ``gluten-free'' on the labeling of foods.

Two years was August 2008 - but I guess they technically have until 2010 to make the proposed rule final. Hopefully the FDA will get their act in gear and the study this summer will finalize labeling of Gluten Free products. More to come on this topic - stay tuned!

Petition to the FDA about Gluten Free Drugs

We are all pretty aware of the fact that drug manufacturers in the USA frequently use gluten in their products. We also know that the FDA, who regulates the industry, allows for these companies to add gluten to their products even though it is toxic to approximately 1% of the US population. Thanks again FDA!

Luckily for us, a man named Michael Weber of NY has officially petitioned the FDA to ban gluten from all medications regulated by the FDA in the US.

Want to sign the petition? Below is an snippet of an article written by Michael and published on celiac.com.

Time to Take Action!
There is, however, something you can do. I petitioned the FDA to get gluten gone for good. I asked my congresswoman to write a letter to the FDA highlighting her concern about my petition. And any citizen can comment to the FDA about my petition, for or against. You can ask your congressman to pay attention to the decision, which the FDA is about to make.

Now that I’ve wound you all up, here is how to contact the FDA. Go on the internet and surf to www.regulations.gov and enter the Docket number of my petition, 2008-P-0333, which you might enjoy reading. My petition is called Michael Weber of New York State. Highlight the line for comments of submissions, and then tell them what you think and who you are. Tell the FDA why you think there shouldn’t be any gluten in your medicine—please do it now!

Please help take action today!