ARTICLE
20 February 2017

FDA Issues Two Draft Guidance Documents On Nutrition Facts Label And Serving Sizes

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Last month, FDA issued a draft guidance in the form of questions and answers that addresses questions related to the compliance date, added sugars, and declaration of quantitative amounts of vitamins...
United States Food, Drugs, Healthcare, Life Sciences
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Last month, FDA issued a draft guidance in the form of questions and answers that addresses questions related to the compliance date, added sugars, and declaration of quantitative amounts of vitamins and minerals set forth in the 2016 final rule, "Food Labeling: Revision of the Nutrition and Supplement Facts Labels."

The draft guidance discusses the available methods to calculate the amount of added sugars in a fruit juice blend that has not been reconstituted to 100 percent, or to calculate the added sugars when a non-enzymatic browning or fermentation process is added to the product or when a concentration process is added during the processing of the product. The guidance also includes a chart with recommendations for declaration of quantitative amounts of vitamins and minerals on the Nutrition and Supplement Facts labels using RDIs for adults and children four years of age or older. FDA confirms it will refrain from taking regulatory action or compliance actions with respect to mandatory and dual column nutrition labeling for "bottled water products and coffee beans (whole or ground), tea leaves, plain unsweetened coffee and tea, condiment-type dehydrated vegetables, flavor extracts, and food colors that would have been exempt under §101.9(j)(4)."

FDA issued a second draft guidance to provide examples of products that belong in each of the product categories included in the tables of Reference Amounts Customarily Consumed ("RACCs") per Eating Occasion established in 21 CFR §101.12(b). The RACCs were updated or modified by the 2016 final rule "Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments."

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