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FDA working on the updating “Healthy” Claim

Posted by Lisa Capote | Nov 09, 2016 | 0 Comments

The FDA is planning to update the regulations regarding nutrient content and health claims to conform to the updated nutrition labeling regulations published in May, 2016.

FDA's Guidance announces that it intends to exercise enforcement discretion for products labeled as “healthy” that are not low in total fat, if the fat predominantly consists of unsaturated fats, and if the nutrition facts box declares the amounts of the poly and mono unsaturated fats. In addition, FDA intends to exercise enforcement discretion when the food contains less than ten percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of vitamin A, vitamin C, calcium, iron, protein, and fiber, but the food contains at least 10% of the DV per RACC of vitamin D or potassium. For labels that do not use the updated nutrition facts panel, the manufacturer may use the old DVs. If a manufacturer uses the updated nutrition facts panel, the updated DVs for potassium and vitamin D must be used. In addition, the relevant nutrient(s) must be declared in the nutrition facts box.  FDA stated, “it that it may take some time, but we want to get it right”

About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.

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