The deadline to comply with the Food and Drug Administration’s (FDA) Nutrition Facts and Supplement Facts label final rules is quickly approaching. Per the new rules, companies with annual sales totaling $10 million or more must be in compliance by January 1, 2020, and companies with annual sales totaling less than $10 million by January 1, 2021. Manufacturers of single-ingredient sugar products, such as honey, maple syrup, and certain cranberry products, must be in compliance by July 1, 2021.
Due to growing concerns of manufacturers regarding their ability to comply by the January 1, 2020 deadline, however, the FDA has recently announced that it plans to exercise enforcement discretion with respect to the new requirements, and intends to work collaboratively with manufacturers during the first six months of 2020 in order to facilitate proper compliance, without placing a heavy emphasis on enforcement.
The purpose of the updated labeling requirements is to make it easier for consumers to make more informed food consumption decisions, and to reflect new scientific information including links between diet and chronic diseases.
Per the final rules, any food products or dietary supplements that are labeled on or after the applicable compliance dates must comply with the new labeling requirements. Products labeled before the applicable compliance dates need not bear the new nutrition label. Required changes to Nutrition Facts labels include:
- Amendments to serving sizes
- Removal of the Calories from Fat line item
- Updates to percent Daily Values for certain nutrients
- Changes to the nutrients required to be listed on the label
- Increases in font size of certain information, most notably Calories
Of particular note is the final rules’ addition of an “Added Sugars” line that expresses the amount in grams and as a percent Daily Value. The FDA has advised that in certain cases, added sugars must be declared even if the sugars are seemingly naturally occurring. For example, when ingredients such as maltodextrins are created through controlled hydrolysis, and are added to food during processing, the mono and disaccharides contributed by the ingredient must be declared as added sugars on the label. Manufacturers expected to be affected by this rule include oat milk manufacturers, whose processes of breaking down oat starch often create added sugars.
The following is an illustrative example of a side by side comparison between the old and new Nutrition Facts label requirements, issued by the FDA.
While not as extensive as changes to the Nutrition Facts label, required changes to Supplement Facts labels include changes to the (b)(2) dietary ingredients that must be listed on the label, including removal of vitamin A, vitamin C, and Calories from Fat, and the addition of vitamin D, and Potassium, as well as the order in which vitamins and minerals are listed. The final rules additionally implement updates to Daily Values and units of measures, and require certain additional information on products intended for use by children ages one through three, including a footnote that Percent Daily Values are based on a 1,000 calorie diet.
The following is an illustrative example of one variation of the Supplement Facts panel under the new rule, issued by the FDA:
As compliance deadlines are quickly approaching, manufacturers of any food, beverage or dietary supplement product should be sure to consult with counsel to ensure timely and proper compliance with the FDA’s new labeling rules.
This alert does not purport to be a substitute for advice of counsel on specific matters.
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