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FDA Issues Draft Guidance Documents on New Nutrition Facts Label

The Food and Drug Administration (FDA) recently published two food labeling guidance documents on a variety of issues related to the serving-size final rule and the Nutrition Facts label final rule, both published in 2016. These guidances address myriad labeling concerns related to serving sizes and compliance particulars, including calculating the added sugars for certain products such as juice concentrates.

The draft guidance entitled “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics: Guidance for Industry” relates to various serving-size labeling requirements. According to the FDA, the guidance (1) clarifies the conditions under which manufacturers can provide an additional column of nutrition information for single-serving containers that contain more than one unit, like two individually wrapped ice cream bars (2) provides further details on when dual-column labeling may be used for single-serving containers that contain more than 150 percent of the amount customarily consumed, and (3) explains that the FDA intends to exercise enforcement discretion in certain circumstances for certain products containing 200 to 300 percent of the amount customarily consumed when the products could reasonably be consumed by one person in a single eating occasion, among other issues with such labeling.

The final guidance, “Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals: Guidance for Industry,” includes recommendations to help manufacturers calculate “added sugars” in their products. Per the FDA, manufacturers have expressed the need for guidance on the labeling of juice concentrates. The guidance clarifies that the declaration of added sugars should not include fruit or vegetable juice concentrated from 100% fruit juice sold to consumers or used as the fruit component in jellies, jams, or preserves in accordance with the standards of identity for those products. The guidance also clarifies other topics, such as the new requirement to declare quantitative amounts of vitamins and minerals on the Nutrition Facts label.

The FDA is accepting comments on the draft serving-size guidance documents until Jan. 4, 2019.

As always, the FDA’s guidance documents do not establish legally enforceable responsibilities, but rather describe the FDA’s current thinking on a topic.



About this Author

Lynn Tyler Litigation lawyer Barnes Thornburg

Lynn Tyler helps innovative companies secure and preserve their market position and competitive advantage. He advises on FDA compliance, helps protect clients with patent infringement and validity opinions, helps and enforce intellectual property rights — which often must be asserted against imitators who seek to reap where they have not sown.

An accomplished advocate, Lynn litigates and represents clients involved in virtually all stages of the dispute resolution process, including pre-litigation counseling, alternative dispute resolution, formal and informal...