FDA Press Release on Updated Nutrition Facts, Added Sugars, Fiber, Serving Sizes and Honey

Today FDA published a press release and statement from Commissioner Scott Gottlieb on efforts to advance implementation of the new nutrition (and supplement) facts regulations. The Commissioner noted that FDA needs to help industry implement and consumers understand the changes, which became effective in July 2016 but will not be enforced until January 2020.  The FDA will undertake a consumer education program once the new rules are implemented but today the agency published several updated guidance documents intended to help industry make the required changes to the nutrition facts box by the implementation dates.

I had hoped that FDA would someday rescind the requirement to list added sugars in the nutrition facts since it is confusing and since there are no test methods that would enable FDA to determine whether the amount of added sugars is properly stated on a label.  I had also hoped that FDA would continue to allow pre-2016 isolated and manufactured fibers to be declared as dietary fibers for 3 to 5 years while testing could be done to demonstrate effectiveness per the 2016 regulations.  While my hopes seem to have no chance of coming true, FDA did provide a couple of helpful clarifications in the guidance documents issued today:

March 1, 2018 Guidance Documents

  • The most helpful new guidance for food labelers is the Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products This guidance allows the use of a symbol after added sugar declarations in the nutrition facts box for pure honey, pure maple syrup and certain cranberry products.  The symbol is used to guide the consumer to text outside the facts box explaining, in the case of pure honey and pure maple syrup, that no sugar was added to the product.  FDA’s sample explanatory text is, “All these sugars are naturally occurring in honey.” In the case of cranberry juice and dried cranberries, FDA will allow use of a symbol leading consumers an explanation that cranberry products are minimally sweetened when those products “have been sweetened with added sugars and that provide total sugars at a level no greater than the amount of total sugars in comparable products with endogenous sugars and no added sugars.”  FDA’s sample language for this is, “Sugars added to improve the palatability of naturally tart cranberries. The 2015-2020 Dietary Guidelines for Americans state that that there is room for limited amounts of Added Sugars in the diet, especially from nutrient dense food like naturally tart cranberries.”
  • FDA also issued a clearer Guidance for Industry: Proper Labeling of Honey and Honey Products.  The format and citations used in this updated guidance are more typical of FDA documents than the 2014 draft guidance.
  • The March 1st flurry of guidance documents included two on Reference Amounts Customarily Consumed (RACC) serving sizes; one is the final guidance and the other is the small entity compliance guide, which provides detailed examples of foods in each category.  The only revised RACC I spotted was the addition of serving sizes for dietary supplements,
    • “The maximum amount recommended, as appropriate, on the label for consumption per eating occasion or, in the absence of recommendations, 1 unit, e.g., tablet, capsule, packet, teaspoonful, etc.”
    • This has always been the requirement for dietary supplement serving sizes but is now part of the RACC table in the regulations.
  • Finally, March 1st saw the publication of a Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-Digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30) .  This is a final version of a draft guidance issued in November 2016.  There are some clarifications made to the language but the requirements for the studies required to document the physiological effects of fiber have changed very little.  However, the final guidance includes a helpful appendix that discusses some types of studies that may be used to support a fiber as having a physiological effect.  The most interesting addition, which upturns a portion of the draft guidance,  allows the use of studies on diseased populations.  The final guidance states, “We have reconsidered this approach [prohibiting the use of studies on diseased populations] and determined that, for certain endpoints, studies conducted on individuals diagnosed with a specific disease can be considered as part of our evaluation of the totality of the evidence when deciding whether an NDC [non-digestible carbohydrate] meets our definition of dietary fiber.”

Today’s press release reiterated FDA’s proposal to extend compliance dates for the 2016 food labeling regulations from July 2018 to Jan. 1, 2020, for manufacturers with $10 million or more in annual food sales and to Jan. 1, 2021, for smaller manufacturers.  It further stated that they plan to issue a final rule on the extended compliance dates this spring.  I do not expect the dates to be pushed further back, but if they change, we’ll keep you updated.  As always, contact us with any questions!

 

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