On August 12, 2020, the United States Food and Drug Administration (USFDA) released a final rule for the labeling of food products falling under the category of fermented and hydrolyzed food. The rule is also applicable to food products containing fermented or hydrolyzed ingredients, which claim to be “gluten-free”, along with other foods like yogurt, sauerkraut, pickles, cheese, green olives, distilled food and beverages, and processed foods such as soups, sauces, and seasonings, which contain hydrolyzed plant proteins.

As per the final rule, there is no scientifically valid analytical method that can detect and quantify the content of gluten protein or equivalent amount of intact gluten proteins in any fermented or hydrolyzed food product. Therefore, the Agency evaluates the compliance of such “gluten-free” products based on the records maintained by the manufacturers to justify their claims, before fermentation or hydrolysis of products. This final rule also throws light on the compliance process for distilled foods, such as vinegar. However, the rule does not change the FDA’s definition of “gluten-free” products established in 2013.

In this context, the FDA seeks manufacturers of fermented and hydrolyzed foods to maintain the following information to provide adequate assurance about their food claims:

  • The food must comply with the definition of “gluten-free” before being fermented or hydrolyzed
  • Manufacturers must thoroughly examine the product for any cross-contact with gluten during the manufacturing process

With the above-mentioned amendments in the final rule, FDA intends to ensure that common products labeled as “gluten-free” are in fact gluten free. This will not only boost the quality of the products, but also help the consumers make an informed buying decision. The rule is set to come into effect from October 13, 2020. Hence, manufacturers entering the U.S. market are advised to align the labels of gluten-free products with the new labeling rule of the FDA. For more information on food supplements labeling, Consult a Regulatory expert.


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