Description
In theFederal Registerof May 27, 2016 (81 FR 34000), we published a final rule pertaining to serving sizes for food. The final rule amends the definition of a single-serving container, requires dual-column labeling for certain containers, updates the tables of Reference Amounts Customarily Consumed (reference amounts, or RACCs), and amends the serving size for breath mints. The rule became effective on July 26, 2016. We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document restates in plain language the legal requirements set forth in the rule, and is intended to help small entities comply with the rule established in 21 CFR 101.9 and 101.12.
Scope & Applicability
Product Classes
10Defined as a product packaged and sold individually containing less than 200 percent of the RACC; Implicitly referenced through serving size logic for discrete units
Category including dried, fresh, canned, and pickled vegetables
Category including candies, confectioneries, and breath mints
Category including all varieties and dry soup mixes
Category for chips, pretzels, and fruit leather-type products; chips, pretzels, popcorn, extruded snacks
Product category for various liquid and semi-solid food accompaniments
Product category including gelatin, pasta, potato, and vegetable salads
Category including carbonated drinks, wine coolers, and water.
Category including cheese, milk, and yogurt.
General food supply category including bagels, muffins, and breads; Category containing croutons
Stakeholders
3Target audience for enforcement discretion
Entity responsible for submitting NDINs
Responsible for declaring acceptable market names on labels.
Regulatory Context
Attributes
5The amount of product in a final consumable serving.
The required text format for the Nutrition Facts label
The unit (e.g., cup, piece, tbsp) used to express serving size.; Units like tbsp, cup, and tsp used in label statements; Common units like cups, tablespoons, or teaspoons used for labeling
The serving size declared on the food label based on the RACC.; The serving size information required on the Nutrition Facts label
percentage used to define nutrient limits (e.g., 10% DV); Used to quantify the amount of Added Sugars per serving (20% Daily Value).
Related CFR Sections (3)
- 21CFR101.9§ 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section.Read full regulation →
- 21CFR101.12§ 101.12 Reference amounts customarily consumed per eating occasion.
(a) The general principles and factors that the Food and Drug Administration (FDA) considered in arriving at the reference amounts customarily consumed per eating occasion (reference amounts) which are set forth in paragraph (b) of this section, are that:Read full regulation →
- 21CFR101.13§ 101.13 Nutrient content claims—general principles.
(a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements.Read full regulation →
Related Warning Letters (5)
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2022-08-30
Food Labeling/Misbranded
National Food Industries LLC
- 2022-02-01
Food Labeling/Misbranded
Picket Fence Creamery LLC
- 2021-12-07
New Drug/Misbranded
Synaptent, LLC
- 2021-07-28
Unapproved New Drugs/Misbranded
Nutrishus Brands, Inc.
See Also (8)
- Guidance for Industry: FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels (Status: Final)
- Small Entity Compliance Guide: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements (Status: Final)
- Small Entity Compliance Guide: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims (Status: Final)
- Small Entity Compliance Guide: Nutrient Content Claims Definition for “High Potency” and Definition for “Antioxidant” for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods (Status: Final)
- Small Entity Compliance Guide: Health Claims on Calcium and Osteoporosis; and Calcium, Vitamin D, and Osteoporosis (Status: Final)
- Guidance for Industry: Food Labeling Guide (Status: Final)
- Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages (Status: Final)
- Small Entity Compliance Guide: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Status: Final)