Health Law Daily FDA provides food labeling rule guidance for small entities
Tuesday, February 4, 2020

FDA provides food labeling rule guidance for small entities

By Cathleen Calhoun, J.D.

What are the 2020 (and beyond) food labeling requirements and how do small entities comply?

The FDA has announced the availability of industry guidance on food labeling changes—the Small Entity Compliance Guide (SECG). The FDA stated that, through the SECG, it intends to help small entities comply with the final rule issued in May 2016 entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labeling.” The guide covers who is subject to the rule, what foods are covered by the rule, and what foods are not, changes to required nutrient listings, and record-keeping compliance (Notice, 85 FR 6045, February 4, 2020).

Manufacturing companies. Only those entities that manufacture food that is subject to FDA nutrition labeling requirements must comply. The nutrition labeling requirements are applicable to both conventional foods and dietary supplements.

Food. The rule covers food in the general food supply, eaten by persons four years and older, as well as food for infants through 12 months (excluding infant formula) and for young children age one to three. Dietary supplements are also included.

The rule does NOT cover:

  • foods offered for sale by a retailer who has annual gross sales made or business done in sales to consumers that is no more than $500,000;
  • foods offered for sale by a retailer who has annual gross sales made or business done in sales of food to consumers of not more than $50,000;
  • medical foods; and
  • foods that contain insignificant amounts of all nutrients, such as coffee beans or tea leaves

New requirements. "Added sugars" must be added to labels. They are defined as sugars that are "either added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), sugars from syrups and honey, and sugars from concentrated fruit or vegetable juices that are in excess of what would be expected from the same volume of 100 percent fruit or vegetable juice of the same type" (21 CFR 101.9(c)(6)(iii)). Exclusions include certain sugars in juice, jams, and alcohol, among other exceptions.Sugar calculation requirements and certain vitamin listings are also outlined.

Records. Records must be kept on the stated amount of added sugars added to the food during processing, when both naturally occurring and added sugars are present in a food. Other records on the carbohydrate levels of the foods must also be made, among other record-keeping requirements.

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