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:

Carmit Targets Global Gluten-Free Market with Luscious Chocolate Clusters

Carmit Candy Industries launches a new line of gluten-free chocolate clusters for healthy indulgence at Natural Products Expo West, Anaheim, March 7-9, booth #571. The new line will be available in multiple international markets.

“Our new line of gluten-free clusters targets both the mainstream market and the specific niches of people suffering from Celiac Disease/Gluten Intolerance and those following a gluten-free lifestyle,” explains Steve Grun, CEO of Carmit. “This has been a strong focus for Carmit over the past decade.”

Global confectionery launches with a “gluten-free” positioning increased by 46% in 2013 from 2012, according to Innova Database. While this indicates significant growth in gluten-free claims, gluten-free product-launch activity is still relatively niche for confectionery. Only 7% of confectionery product launches tracked in 2013 filled such positioning.

A cluster is a snack, based on a blend of ingredients that does not have a structured or consistent shape. The gluten-free clusters line includes a wide range of combinations of gluten-free cereals and dried fruits or nuts, and is covered in either chocolate or yogurt. The clusters can be custom packed in different sizes and shapes as private-label for marketers, restaurant chains and retailers, and for on-the-go packages or a multi-pack. All are designed to address a healthy, gluten-free lifestyle.

“We launched the line regionally and gained rapid success in food chains and health-food stores, culminating in our winning the prestigious ‘Product of the Year Award’ this week,” enthuses Adrian Sagman, VP of Export Marketing and Sales for Carmit.

A significant industry challenge is in how to blend cereals such as cornflakes and rice puffs with nuts and/or dry fruits, and bind them with 70% chocolate in a way that the inclusions are not dominated by the chocolate and maintain overall great taste and texture. To achieve this, Carmit conducted a number of trials to hit the perfect balance in percentage of each ingredient and viscosity of the chocolate. The final product is a remarkably rich, bite-sized cluster of crispy cereals and chewy dried fruits, covered in milk or dark chocolate.