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FDA New-trition Rules

Last month, the FDA finalized amendments to the Nutrition Facts labeling rules for packaged foods and dietary supplements to reflect developments in nutrition science, including new scientific information regarding the link between diet and chronic diseases such as obesity and heart disease. Here are the highlights:

  • Nutrition Facts labels will no longer declare the “Calories from fat” because current science supports a view that, with respect to increased risk of chronic diseases, the type of fat is more relevant than overall total fat intake.

  • In addition to declaring “Total Sugars,” the labels must declare the gram amount of “Added Sugars” in a serving of a product directly below the “Total Sugars” on the label. The new regulations establish a Daily Reference Value and also require labels to declare the percent Daily Value for Added Sugars in the product serving. This amendment reflects scientific data showing that it is difficult to meet nutrient needs while staying within calorie limits if you consume more than 10% of your total daily calories from added sugar, and is consistent with the 2015–2020 Dietary Guidelines for Americans.

  • There are updates to the required listing of vitamins and minerals of public health significance. For instance, the final amendments require the declaration of vitamin D (which helps prevent osteoporosis, a highly prevalent disease in America) and potassium (which helps lower blood pressure and, like vitamin D, has low intake among some population groups). In contrast, the amendments permit, rather than require, the declaration of vitamins A and C because data indicate that those vitamin deficiencies are not common.

  • There are also updates to certain reference values used in the declaration of percent Daily Values of nutrients such as sodium, dietary fiber and vitamin D. The updates are based on scientific evidence from the Institute of Medicine and other reports such as the 2015 Dietary Guidelines Advisory Committee Report, which was used in developing the 2015–2020 Dietary Guidelines for Americans.

  • “Calories” must be formatted in larger typeface.

  • A footnote table listing reference values for certain nutrients for 2,000 and 2,500 calorie diets is no longer required because of evidence that it was confusing to consumers. The footnote will now be used to explain the meaning of “% Daily Value” in reference to a 2,000 calories-per-day diet.

  • The amendments require manufacturers to maintain records to support declarations of certain nutrients in specified circumstances where there are no analytical methods to verify the declared nutritional content. For example, manufacturers must maintain records to distinguish between dietary fiber and non-digestible carbohydrates, added and naturally occurring sugars, various forms of vitamin E, and folate and folic acid.

Additionally, in light of new research on consumption and consumer understanding of the Nutrition Facts label, the FDA also promulgated final amendments that redefine the size of a “single-serving” container, modify several “reference amounts customarily consumed” that are used to determine serving sizes, and require a dual-column labeling layout with “per serving” and “per package” Nutrition Facts for certain food packaging containing multiple servings.

The amendments are effective July 26, 2016. Manufacturers will be required to implement the new labels by July 26, 2018, although food makers with less than $10 million in annual sales will have an additional year to comply.

© 2020 Proskauer Rose LLP. National Law Review, Volume VI, Number 169


About this Author

Daniel Werb, Proskauer Rose, litigation attorney

Daniel Werb is an associate in the Litigation Department.

Prior to joining Proskauer, Dan was a judicial intern for the Honorable Eric N. Vitaliano of the U.S. District Court for the Eastern District of New York. At Columbia Law School, he served as an Articles Editor of the Columbia Journal of Law & the Arts and was an extern at Volunteer Lawyers for the Arts.