Description
In theFederal Registerof May 27, 2016 (81 FR 33742), FDA (we) published a final rule entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (“the final rule”). The final rule amends the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices and set a compliance date of July 26, 2018, for manufacturers with $10 million or more in annual food sales, and July 26, 2019, for manufacturers with less than $10 million in annual food sales. We subsequently extended the compliance dates to January 1, 2020, and January 1, 2021, respectively (83 FR 19619). 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 revisions made in the final rule and is intended to help small entities comply with the requirements established in 21 CFR 101.9, 101.30, and 101.36.
Scope & Applicability
Product Classes
4Category of products covered in the table of contents; Covered by allergen labeling requirements; Guidance on declaring major food allergens for dietary supplements.
Standard food products subject to nutrition labeling; General food labeling context; Standard food products requiring Nutrition Facts.
Exempt from nutrition labeling requirements
Includes honey and maple syrup
Stakeholders
5Entity responsible for submitting NDINs
Population group for specific labeling rules.
Population group with specific RDI requirements
Population group through 12 months of age; Population group for specific labeling rules (through 12 months).
Target audience for the compliance guide
Regulatory Context
Attributes
8Updated values used for calculating percent Daily Values; Updated values used to calculate Percent DV
Standardized serving size metric (RACC)
Percentage of nutrient contribution to a daily diet.
Font size requirements for various label elements.; Specific point size requirements for label text.
percentage used to define nutrient limits (e.g., 10% DV); Used to quantify the amount of Added Sugars per serving (20% Daily Value).
Updated values used for calculating percent Daily Values; RDIs used in the declaration of the percent DV of nutrients; nutrition information for two different RDI groups
Percent Daily Value contribution
Reference Daily Intake
Related CFR Sections (11)
- 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 →
- 21CFR101.8§ 101.8 Vending machines.
(a) Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this section. In addition, for the purposes of this section:Read full regulation →
- 21CFR101.36§ 101.36 Nutrition labeling of dietary supplements.
(a) The label of a dietary supplement that is offered for sale shall bear nutrition labeling in accordance with this regulation unless an exemption is provided for the product in paragraph (h) of this section.Read full regulation →
- 21CFR101.30§ 101.30 Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.
(a) This section applies to any food that purports to be a beverage that contains any fruit or vegetable juice (i.e., the product's advertising, label, or labeling bears the name of, or variation on the name of, or makes any other direct or indirect representation with respect to, any fruit or vegetRead full regulation →
- 21CFR150.140§ 150.140 Fruit jelly.
(a) The jellies for which definitions and standards of identity are prescribed by this section are the jelled foods each of which is made from a mixture of one or a permitted combination of the fruit juice ingredients specified in paragraph (b) of this section and one or any combination of the optioRead full regulation →
- 21CFR150.160§ 150.160 Fruit preserves and jams.
(a) The preserves or jams for which definitions and standards of identity are prescribed by this section are the viscous or semi-solid foods, each of which is made from a mixture composed of one or a permitted combination of the fruit ingredients specified in paragraph (b) of this section and one orRead full regulation →
- 21CFR102.33§ 102.33 Beverages that contain fruit or vegetable juice.
(a) For a carbonated or noncarbonated beverage that contains less than 100 percent and more than 0 percent fruit or vegetable juice, the common or usual name shall be a descriptive name that meets the requirements of § 102.5(a) and, if the common or usual name uses the word “juice,” shall include a Read full regulation →
- 21CFR168.122§ 168.122 Lactose.
(a) Lactose is the carbohydrate normally obtained from whey. It may be anhydrous or contain one molecule of water of crystallization or be a mixture of both forms.Read full regulation →
- 21CFR101.4§ 101.4 Food; designation of ingredients.
- 21CFR101.81§ 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD).
(a) Relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods and the risk of CHD.Read full regulation →
- 21CFR10.30§ 10.30 Citizen petition.
(a) This section applies to any petition submitted by a person (including a person who is not a citizen of the United States) except to the extent that other sections of this chapter apply different requirements to a particular matter.Read full regulation →
Related Warning Letters (10)
- 2025-09-30
CGMP/Dietary Supplement/Adulterated/Misbranded
Valentine Enterprises, Inc.
- 2024-11-26
Food Labeling/Misbranded
Stew Leonard’s Holdings LLC
- 2024-11-05
CGMP/Dietary Supplement/Adulterated
Top Health Manufacturing, LLC
- 2024-07-23
New Drugs/Dietary Supplements/Food Labeling/Misbranded
Formulation Technology, Inc.
- 2024-06-25
Food Labeling/Misbranded/False and Misleading
Bimbo Bakeries USA, Inc.
- 2023-09-05
Unapproved New Drugs/Misbranded
Osmosis, LLC
- 2023-08-29
CGMP/Dietary Supplement/Adulterated/Misbranded
Cosmax NBT USA
- 2023-02-07
CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Quality Supplement Manufacturing, Inc.
- 2023-01-31
CGMP/Dietary Supplement/Misbranded
Adept Life Science, LLC
- 2023-01-24
Dietary Supplement/Misbranded
Evimeria El Aztecano, 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)