FDA guidance summarizes 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. The nutrition labeling requirements apply to both conventional foods under 21 CFR 101.9(a) and dietary supplements under 21 CFR 101.9(j)(6).
Does the Rule Cover Dietary Supplements?
Yes. Nutrition labeling information for food must be provided for all products intended for human consumption and offered for sale, unless an exemption is provided (21 CFR 101.9(a)). As dietary supplements fall under the definition of “food,” they are therefore subject to nutrition labeling. Specific nutrition labeling requirements and guidelines for dietary supplements can be found in 21 CFR 101.36.
Records are needed to verify the declaration of the following:
- The amount of added sugars added to the food during processing, when both naturally occurring and added sugars are present in a food
- The amount of added sugars, if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient) when both naturally occurring and added sugars are present in a food
- The amount of added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber when the dietary fiber present in a food is a mixture of non-digestible carbohydrates that do and that do not meet the definition of dietary fiber
- The amount of added soluble non-digestible carbohydrate(s) that does not meet the definition of dietary fiber when the soluble dietary fiber present in a food is mixture of soluble non-digestible carbohydrates that do and that do not meet the definition of dietary fiber
- The amount of added insoluble non-digestible carbohydrate(s) that does not meet the definition of dietary fiber when the insoluble dietary fiber present in a food is a mixture of insoluble non-digestible carbohydrates that do and that do not meet the definition of dietary fiber
- The amount of all rac-α-tocopherol added to the food and RRR-α-tocopherol in the finished food when a mixture of both forms of vitamin E are present in a food and
- The amount of synthetic folate and/or folic acid added to the food and the amount of naturally-occurring folate in the finished food when a mixture of both forms is present in a food.
How Long Must Records be Kept?
Records must be kept for a period of two years after introduction or delivery for introduction of the food into interstate commerce.
These recordkeeping requirements are the same for foreign and domestic firms.
Records must be provided to FDA upon request during an inspection for official review and copying (or other means of reproduction) (21 CFR 101.9(g)(11)) . Records need to be reasonably accessible to FDA during an inspection at each manufacturing facility, even if not stored onsite, to determine compliance with labeling requirements (81 FR 33742 at 33963).
Which Units of Measure Have Changed?
The units of measure have changed for vitamin A, vitamin D, vitamin E, folate, and niacin.
Previously, “international units,” or “IU,” were used for vitamin A, vitamin D, and vitamin E, now the FDA requires the use of a metric unit of measure.
Vitamin A, D and E
- mcg RAE for vitamin A
- mcg for vitamin D
- mg α-tocopherol for vitamin E
Folate is to be declared in mcg Dietary Folate Equivalents (DFE). The terms folic acid or folacin are no longer allowed to be used as synonyms for folate. They cannot be listed without parentheses in place of folate, and they cannot be added in parentheses immediately following folate, unless synthetic folic acid is added as a nutrient supplement to a product or a claim is made about it.
The unit of measure has changed for niacin, from “mg” to “milligrams NE,” where “NE” stands for “niacin equivalents”
Is the Declaration of Vitamins and Minerals Mandatory or Voluntary?
Declaration is mandatory for the vitamins and minerals of public health significance, which have been updated and now are vitamin D, calcium, iron, and potassium.
They must be listed in that order, and their declaration is mandatory on foods for adults and children 4 years of age and older, as well as on foods represented or purported to be specifically for infants through 12 months, children 1 through 3 years of age, or pregnant women and lactating women (21 CFR 101.9(c)(8)(ii)).
Voluntary declaration is allowed for any other essential nutrient presented in Figure 2. However, if any of these nutrients is added to food as a nutrient supplement or if a claim is made about it on the label or in the labeling of foods, then mandatory declaration is required (21 CFR 101.9(c)(8)(ii)).
Rule compliance Timelines:
- If the entity has $10 million or more in annual food sales, compliance date is January 1, 2020.
- If the entity has less than $10 million in annual food sales, your compliance date is January 1, 2021.