August 15, 2019
The U.S. Food and Drug Administration today released a guidance for industry providing step-by-step instructions on how to convert the previous units of measure for folate, niacin, vitamin A, vitamin D, and vitamin E to the new units required on the updated Nutrition Facts and Supplement Facts labels. The guidance includes conversion factors to be used for each of these nutrients and sample calculations for converting new units of measure.
For folate, the unit of measurement was changed from micrograms to micrograms dietary folate equivalents (mcg DFE). For vitamins A and D, labels must declare units of measure using micrograms (mcg) rather than international units (IU). The unit of measurement for niacin has changed from milligrams (mg) to milligrams Niacin Equivalents (mg NE) but will still be labeled as mg. For vitamin E the unit of measurement was changed from IUs to mg alpha (α) tocopherol but can be labeled as mg.
In 2016, the FDA amended the regulations for the nutrition labeling of conventional foods and dietary supplements to update the Nutrition Facts and Supplement Facts labels. The regulations include updated Daily Values for folate, niacin, vitamin A, vitamin D, and vitamin E, in addition to other nutrients, based on newer scientific evidence. Daily Values are used to calculate the percent Daily Value that consumers see on the label. The % Daily Value helps consumers understand the information in the context of a total daily diet. In addition, units of measurement were updated to reflect those used in the National Academy of Medicine’s recently updated Recommended Dietary Allowances (RDAs). Units of measurement changed only for folate, niacin, vitamin A, vitamin D, and vitamin E. Consumers will see units of measurement on the new Nutrition Facts label because the 2016 regulations require that manufacturers list the actual amounts of vitamins and minerals on the label. They will also appear on dietary supplements.
The compliance date for these and other changes related to the Nutrition Facts and Supplement Facts labels is January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will receive an extra year to comply. FDA intends to exercise enforcement discretion to give manufacturers of single-ingredient sugars such as honey and maple syrup, and certain cranberry products, until July 1, 2021, to comply.
For conversion factors and detailed examples and explanations of conversions, please consult Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels: Guidance for Industry.
FDA has also updated its Questions and Answers to include two new questions--- one on how sugars and syrups that contain two or more ingredients must be labeled and one on the use of the linear display for a package of a single-ingredient sugar or syrup.