FDA – Gluten Free Labelling Compliance Requirements Proposed Rule

The U.S. Food and Drug Administration released a proposed rule to establish requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, and bear the “gluten-free” claim. The proposed rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods”, pertains to foods such as yogurt, sauerkraut, pickles, cheese, green olives, vinegar, and FDA regulated beers.

In 2013, the FDA issued the gluten-free final rule, which addressed the uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods in terms of intact gluten.  Due to this uncertainty, the FDA has issued this proposed rule to provide alternative means for the agency to verify compliance for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer.

The proposed rule, when finalized, would require these manufacturers to make and keep records demonstrating assurance that:

  • The food meets the requirements of the gluten-free food labeling final rule prior to fermentation or hydrolysis
  • The manufacturer has adequately evaluated its process for any potential gluten cross-contact
  • Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process

Distilled foods such as distilled vinegars are also included in the proposed rule. Distillation is a purification process that separates volatile components from non-volatile components such as proteins.  Thus, when properly done, gluten should not be present in distilled foods. The proposed rule states that FDA would evaluate compliance of distilled foods by verifying the absence of protein (including gluten) using scientifically valid analytical methods that can detect the presence of protein or protein fragments in the distilled food.

The FDA is accepting public comments beginning Wednesday, November 18 (closing date February 2nd, 2016). To electronically submit comments to the docket, visit www.regulations.gov and type docket number “FDA-2014-N-1021” in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number “FDA-2014-N-1021” on each page of your written comments.

Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

For more information:

FDA revises proposed Nutrition Facts label rule to include a daily value for added sugars

The U.S. Food and Drug Administration today proposed including the percent daily value (%DV) for added sugars on the Nutrition Facts label of packaged foods, giving consumers additional information for added sugars similar to information they have seen for decades with respect to nutrients such as sodium and certain fats. The percent daily value indicates how much a nutrient in a serving of food contributes to a daily diet and would help consumers make informed choices for themselves and their families. The percent daily value would be based on the recommendation that the daily intake of calories from added sugars not exceed 10 percent of total calories.

The proposed rule is a supplement to the March 3, 2014 proposed rule on updating the Nutrition Facts label, under which the FDA proposed that food companies include added sugars on the Nutrition Facts label. The proposed rule did not include the declaration of the percent daily value for added sugars.

The 2015 Dietary Guidelines Advisory Committee (DGAC) recently summarized scientific data related to added sugars. The FDA considered the scientific evidence that the DGAC used, which showed that it is difficult to meet nutrient needs while staying within calorie requirements if one exceeds 10 percent of total calories from added sugar, and has determined that this information supports this daily value for added sugars. The DGAC also recommended that Americans limit their added sugars intake to less than 10 percent of total calories; this and other recommendations from the DGAC, which is an independent advisory committee, will be considered in the development of the final 2015 Dietary Guidelines.

The FDA’s initial proposal to include the amount of added sugars on the Nutrition Facts label is now further supported by newly reviewed studies suggesting healthy dietary patterns, including lower amounts of sugar-sweetened foods and beverages, are strongly associated with a reduced risk of cardiovascular disease. When sugars are added to foods and beverages to sweeten them, they add calories without providing additional nutrients.

“The FDA has a responsibility to give consumers the information they need to make informed dietary decisions for themselves and their families,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “For the past decade, consumers have been advised to reduce their intake of added sugars, and the proposed percent daily value for added sugars on the Nutrition Facts label is intended to help consumers follow that advice.”

The current label requires the percent daily value be listed for total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, calcium and iron.

The FDA is also proposing to change the current footnote on the Nutrition Facts label to help consumers understand the percent daily value concept. The proposed statement on the label would be shorter than the current footnote to allow for more space on the label, stating:

*The percent daily value (%DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

The FDA is seeking public comment on the proposal for 75 days. The agency continues to review comments received on the 2014 proposed rule and is reopening the comment period on its March 2014 proposal for 60 days to invite public comment on two consumer studies related to label formats. The agency will consider comments on the original and this supplemental proposed rule before issuing a final rule. The proposed rule on serving size requirements, also issued in March 2014, is not affected by the supplemental proposed rule on the Nutrition Facts label released today.

In addition, the FDA is also releasing results of its consumer studies on the declaration of added sugars and the footnote and on the label format. As part of the March 3, 2014 proposed rule, FDA proposed updating the format of the Nutrition Facts panel and continues to consider the comments received on this proposal as it develops the final rule. Based on comments received to the proposed rule and the consumer studies’ results, the FDA does not intend to pursue the alternative graphic format for the Nutrition Facts label at this time.