United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-09-28 article Rules and Regulations D09002ee1c7f3811f D09002ee1c7f381ad United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry." The guidance advises manufacturers who wish to use the implied nutrient content claim "healthy" to label their food products as provided by our regulations. More specifically, the guidance advises food manufacturers of our intent to exercise enforcement discretion with respect to the implied nutrient content claim "healthy" on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of "low fat", or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D. 81 FR 66527 https://www.govinfo.gov/app/details/FR-2016-09-28/2016-23367 2016-23367 fr28se16-10 4164-01-P Docket No. FDA-2016-D-2335 https://www.govinfo.gov/app/details/FR-2016-09-28/2016-23367 https://www.govinfo.gov/content/pkg/FR-2016-09-28/html/2016-23367.htm https://www.govinfo.gov/content/pkg/FR-2016-09-28/pdf/2016-23367.pdf 3 p. 66527 66529 81 FR 66527 Title 21 Part 101 21 CFR Part 101 Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry; Availability; Federal Register Vol. 81, Issue RULE 2016-23367 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2016-D-2335 4164-01-P 2016-23367 Notification of availability.

The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry." The guidance advises manufacturers who wish to use the implied nutrient content claim "healthy" to label their food products as provided by our regulations. More specifically, the guidance advises food manufacturers of our intent to exercise enforcement discretion with respect to the implied nutrient content claim "healthy" on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of "low fat", or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

Submit either electronic or written comments on FDA guidances at any time. Vincent de Jesus, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450. Guidance for Industry: Use of the Term Healthy in the Labeling of Human Food Products , http://www.fda.gov/FoodGuidances http://www.fda.gov/regulatoryinformation/dockets/default.htm http://www.regulations.gov Vol. 81, no. 188 Office of the Federal Register, National Archives and Records Administration 2016-09-28 continuing daily deposited born digital 315 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-09-28 P0b002ee1916fea8c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28se16 https://www.govinfo.gov/app/details/FR-2016-09-28 https://www.govinfo.gov/content/pkg/FR-2016-09-28/pdf/FR-2016-09-28.pdf https://www.govinfo.gov/content/pkg/FR-2016-09-28/xml/FR-2016-09-28.xml fdlp 66487 66790 DGPO 2016-09-28 2024-06-01 FR-2016-09-28 machine generated eng FR FR-2016-09-28 81 188