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Guidance for Industry: Policy Related to Cranberry Products with Added Flavorings

FinalHuman Foods Program08/30/2019

Description

The purpose of this guidance is to advise manufacturers of certain dried cranberry products  with added flavorings of our intent to exercise enforcement discretion until July 1, 2020, for their compliance with the updated labeling requirements set forth in two final rules published in the Federal Register of May 27, 2016 entitled, “Food Labeling:  Revision of the Nutrition and Supplement Facts Labels” (hereafter referred to as “Nutrition Facts label final rule” (81 FR 33742)) (see 21 CFR 101) and “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion;  Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (hereafter referred to as the “Serving Size final rule” (81 FR 34000)) (see 21 CFR 101).

Scope & Applicability

Product Classes

5
dried cranberries with added flavorings

FDA extending enforcement discretion until July 1, 2020 for these products

dried cranberry and cranberry beverage products

products sweetened with added sugars containing total sugars at levels no greater than comparable products

pure maple syrup

intent to exercise enforcement discretion with respect to the use of a † symbol

single-ingredient packages and/or containers of pure honey

intent to exercise enforcement discretion with respect to the use of a † symbol

dried cranberry products

manufacturers of certain dried cranberry products with added flavorings

Stakeholders

1
manufacturers

manufacturers are responsible for ensuring that their labels conform to all applicable FDA labeling laws

Regulatory Context

Attributes

5
July 1, 2020

compliance date for dried cranberries with added flavorings

July 1, 2021

compliance date for pure honey and maple syrup

Reference Amounts Customarily Consumed

Standardized serving size metric (RACC)

Daily Values

Nutrition Facts label final rule changes some Daily Values

added sugars

sugars that are either added during the processing of foods or are packaged as such; percent DV representing the contribution of added sugars to the diet

Related CFR Sections (1)

Related Warning Letters (2)

  • CGMP/Finished Pharmaceuticals/Adulterated

    BioLyte Laboratories, LLC

    2021-03-22
  • CGMP/Dietary Supplement/Adulterated/Misbranded

    Davis Ventures, Inc dba The Green Herb and New Genesis Health

    2020-08-11

See Also (6)

Guidance for Industry: Policy Related to Cranberry Products with Added Flavorings | Guideline Explorer | BioRegHub