Product Labeling
What Does Gluten-Free Mean?

2013

FDA defines “gluten-free” for food labeling August 2013
New rule provides standard definition to protect the health of Americans with celiac disease.   The U.S. Food and Drug Administration published a new regulation defining the term "gluten-free" for voluntary food labeling. This provides a uniform standard definition to take effect August 2014. continue reading

 

Label Reading2011  

Read the latest on the FDA's proposed standard for gluten-free. 



The Tricia Thompson article with survey results are available

As a result of the early closure of the on-line labeling survey, Tricia Thompson stated, "Thank you, CSA, very much for sending out the link to the survey, February 4th. I apologize if some members were not able to take the survey as there was a 1,000 response limit."

2009
The proposed FDA definition from 2007 remains in draft form. A survey was proposed in the summer of 2009. This has evolved into three, twelve member focus groups in 2009 and 2010 rather than an extensive on-line survey.

The purposes of the survey:
The study will survey a group of 5,000 adults on their perceptions of characteristics related to the claims of “gluten-free” and its allowed variants. The survey will also gauge perceptions of claims such as “made in a gluten-free facility” or “not made in a facility that processes gluten-containing foods”. The study will also assess consumer understanding of “gluten-free” claims on foods that are naturally free of gluten. Finally, the study will gauge consumer reaction to a product carrying a gluten claim along with a statement about the amount of gluten the product contains.
6,000 respondents will be screened. A pretest will be conducted with  140 respondents. 5,000 adults will complete the study. This will include people with celiac disease and people who do not have celiac disease. The data will be collected over the Internet and the FDA estimates that it will take a respondent about 10 minutes to complete the survey.
Comments were solicited on the design of the survey. 

2008
The proposed FDA definition from 2007 remained in draft form.

2007
The United States Food and Drug Administration (FDA) proposed a regulation that defines the term "gluten-free" for voluntary use on product labeling.

In summary - as of April 23, 2007
The proposed FDA definition specifies that a food labeled “gluten-free” does not contain any of the following:

  • An ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as “prohibited grains”)
  • An ingredient that is derived from a prohibited grain and that has NOT been processed to remove gluten (e.g. wheat flour)
  • An ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g. wheat starch) if the use of that ingredient results in the presence of 20 parts per million (ppm or mg/kg) or more gluten in the food
  • 20 ppm or more gluten

A food that bears the claim “gluten-free” in its labeling and does not meet these conditions would be deemed misbranded. Foods that are inherently or naturally free of gluten would also be deemed misbranded if the claim does not refer to all foods of that same type (e.g., “milk, a gluten-free food” or “all milk is gluten-free”) A food made from oats and labeled “gluten-free” must contain less than 20 ppm gluten. According to the FDA, establishing a definition of the term “gluten-free” and uniform conditions for its use in the labeling of foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. The proposed definition is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)


Full Text of FDA Proposed Definition Published January 23, 2007
FDA "Questions and Answers" on the Gluten-Free Labeling Proposed Rule

 


 

Presently, there remains no national standard in the United States for the term “gluten-free”. The United States Food and Drug Administration (FDA) has proposed a definition for voluntary use of the term which was posted in the Federal Register on January 3, 2007.  The final form of the definition was expected to be published in August, 2008. To date, it remains in draft form.  For a summary.

February 2011 As a result of the early closure of the on-line labeling survey, Tricia Thompson stated, "Thank you, CSA, very much for sending out the link to the survey, February 4th. I apologize if some members were not able to take the survey as there was a 1,000 response limit."

The Tricia Thompson article with survey results

 

The proposed FDA definition from 2007 remains in draft form.

Codex Alimentarius Commission Definition for International Trade
European Union (EU) Commission
Regulation concerning the composition and labeling of foodstuffs suitable for people intolerant to gluten—effective as of January 20, 2009

Allergen Labeling

  • Allergen Advisory Labeling
  • Public Hearing on Food Advisory Labeling - 2008
    The U.S. Food and Drug Administration (FDA) held a public hearing on allergen advisory labeling on September 16, 2008, at the FDA Center for Food Safety and Applied Nutrition's Harvey W. Wiley Building in College Park, Maryland. The hearing included presentations by agency officials, invited speakers and members of the public. Formal notice of the Hearing was published in the Federal Register on August 8, 2008.

Federal Register Notice and background information

FDA is developing a long-term strategy to assist manufacturers in using allergen advisory labeling that is truthful and not misleading, conveys a clear and uniform message, and adequately informs food allergic consumers and their caregivers. To that end, FDA is soliciting comments and information to assist the agency in determining how manufacturers currently use advisory labeling, how consumers interpret different advisory labeling statements, and what wording is likely to be most effective in communicating to consumers the likelihood that an allergen may be present in a food. The agency is also interested in receiving comments about whether consumers find advisory labeling helpful for making food purchasing decisions. This public hearing is the first step in closing existing knowledge gaps in developing our long-term strategy.

  • Presentations and Public Comments submitted includes Power points and comments from public and organizations View comments
  • The Food Allergen Labeling and Consumer Protection Act of 2004
    The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) became law on August 2, 2004. Beginning January 1, 2006, FALCPA requires food manufacturers to identify in plain English any ingredient from any of the eight major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans. Such identification must be within ingredient labeling or in a "contains" statement after ingredient labeling. 

Report to The Committee on Health, Education, Labor, and Pensions United States Senate and The Committee on Energy and Commerce United States House of Representatives

Summary Outline

  • The Occurrence of Cross-Contact and Use of CGMP
  • Use of Advisory Labeling by Food Producers
  • Consumer Perferences for Food Allergen Labeling
  • FDA's Allergen-focused Inspections
  • Allergen Recalls
  • Current Efforts to Control Cross-contact  
  • FDA Information for Consumers:
    Food Allergen Labeling And Consumer Protection Act of 2004
    Questions and Answers

CSA efforts for Food Allergen Labeling since 1990

 

 

Self-management is the key to living a full life, gluten-free. Personal application is based on understanding one's own body and experience in light of current research. Knowledge is power.