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FDA Extends Comment Periods on “Voluntary” Sodium Reduction Goals for Foods

FDA has published Federal Register notice of an extension of the comment periods for issues pertaining to its draft guidance, entitled “Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.”  The agency is taking this action in response to requests to extend the two comment periods to allow interested persons additional time to submit comments.  See our original article on this matter here.

In its original June 2, 2016, Federal Register notice, FDA posed eight (8) specific questions/topics for comment:

  1. Are there categories where foods have been grouped together that should be separated on the basis of different manufacturing methods or technical effects relating to the potential for sodium reduction? Conversely, are there categories which could be merged due to similar sodium functionality and potential  for reduction?  Are there foods that contribute to sodium intake that we have not effectively captured?   Are the categories amenable for use by restaurant chains and if not, how should they be modified to make them amenable for use by restaurant chains?
  2. Are the baseline sodium concentration values reasonably representative of the state of the food supply in 2010? For categories that do not appear representative, what food products are not adequately represented?  Are there situations in which our method of quantification could lead to unrepresentative baseline values?
  3. Are there categories for which the 2-year target concentration goals are infeasible? If so, why are these targets not feasible, e.g., for technical reasons?  What goals would be feasible in the short-term (2-year), and why?  For reference, a supplementary memorandum to the docket is provided to further describe the type of information needed, “Target Development Example: Supplementary Memorandum to the Draft Guidance” (Ref. 7).
  4. Are the short-term (2-year) time frames for these goals achievable?  If the time frames are not achievable, what time frames would be challenging, but still achievable?
  5. Are there categories for which the 10-year target concentration goals are infeasible? If so, why are these targets not feasible, e.g. for technical reasons?  What goals would be feasible in the long-term (10-year), and why?  For reference, a supplementary memorandum to the docket is provided to further describe the type of information needed, “Target Development Example: Supplementary Memorandum to the Draft Guidance” (Ref. 7).
  6. Are the long-term (10-year) time frames for these goals achievable? If the time frames are not achievable, what time frames would be challenging, but still achievable?
  7. What specific research needs or technological advances (if any) could enhance the food industry’s ability to meet these goals? What are possible innovations in the area of sodium reduction and are there any unintended consequences associated with their use?
  8. What amendments to FDA’s standard of identity regulations in 21 CFR parts 130-169 are needed to facilitate sodium reduction by permitting alternative ingredients to be used in standardized foods? For example, amendments could include revisions to specific standards (e.g., cheese or cheese products) and to the general requirements for foods named by use of a nutrient content claim (e.g., “reduced  sodium”) and a standardized term under 21 CFR 130.10.

The comment period on questions/topics 1-4 has been extended to October 17, 2016, while the  comment period on questions/topics 5-8 has been extended to December 2, 2016.

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