The Push to Get Americans to Eat Healthier Continues – FDA Issues Voluntary Draft Guidance for Sodium Reduction in Processed and Restaurant Foods

The Food and Drug Administration (FDA or agency) and the Obama administration continue on their shared goal to get Americans to eat healthier by issuing a draft guidance outlining voluntary targets for sodium reduction for both processed and commercially prepared foods.  Americans currently consume an average of 3,400 milligrams (mg) of sodium per day – which is 1,100 mg more sodium than the recommended 2,300 mg per day – mostly from processed and prepared foods (i.e., restaurant foods).[1]  According to the 2010 Institute of Medicine (IOM) report, attempts to reduce sodium consumption through education initiatives over the last 40 years have been unsuccessful.[2]  Thus, “without an overall reduction on the levels of sodium in the food supply, consumers will not be able to reach [the sodium level intakes] recommended by Dietary Guidelines.”[3]  Reduced sodium levels are expected to decrease the rate of hypertension, a major risk factor for heart disease and stroke, which are the first and fifth leading causes of death in the United States.[4]

untitledThe draft guidance is intended to reach all members of the food industry. However, the agency recognizes that a “great majority of food consumption in the U.S. comes from a fairly small number of products and menu items and that many of these products are produced by a limited number of companies.”[5]  Thus, FDA believes that reformulation by these companies “could lead to increased demand for lower-sodium versions of ingredients used to produce packaged and prepared foods.”[6]  To that end, in order to achieve the most “public health impact,” FDA is specifically encouraging that the following food industries to pay attention to the voluntary guidelines:

  • Food manufacturers whose products make up a significant proportion of national sales in one or more food categories, and

  • Restaurants and similar retail food chains that are national or regional in scope.

While FDA is encouraging the food industry to reduce sodium levels, the agency is promoting a “gradual, efficient voluntary reduction . . . using effective and sustainable strategies that maintain other measures of nutritional quality.[7]”  With that goal in mind, the agency’s preferred approach is intended to “avoid large, abrupt changes to individual products that might result in noticeably altered taste, generally reduced shelf life, or other undesirable product outcomes.”[8]

Voluntary Approach to Sodium Reduction

salt+sodiumWhile the agency recognizes that sodium in foods has multiple uses (microbial safety, stability, and other functions), the agency is seeking to provide “measurable” voluntary goals for sodium content in commercially prepared, packaged, and prepared foods to gradually reduce excess sodium consumption.[9]  To that end, FDA developed both short-term (2 years) and long-term (10 years) targets for sodium reduction for various food products.

FDA’s proposed voluntary guidelines are based on 4[10] key elements:

  • Food categories

  • Baseline sodium concentrations

  • Target mean sodium concentrations, and

  • Upper bound sodium concentrations

FDA proposed targets (See Draft Guidance Appendix, Table 1) for many food categories (e.g., bakery products, meats cheeses).  The agency did not, however, suggest targets for categories of foods that do not contribute meaningfully to overall sodium intake (e.g., salted dried fish and organ meat), either because these foods are not frequently consumed or because they provided little contribution to sodium intake in comparison with other food groups.  FDA is seeking comments on the proposed food categorizations and targets (see below).  The agency is also seeking comments on the method for determining and the suggested baseline sodium concentrations for each of the identified food categories.[11]

While the agency is providing sodium targets for foods, FDA is not providing detailed guidance on the “technical details” of reducing sodium in those foods leaving it up to the “experts” to come up with ways to achieve the desired goals.  However, the agency specifically states that in developing sodium reduction or reformulation strategies, the food industry should keep in mind the importance of the “broader public health goals and [the] maintenance of nutritional quality.”  For example, sodium reduction that relies on increases in added sugars would not be consistent with the public health goals of the draft guidance.[12]

Finally, the guidance does not prescribe how much of a sodium-containing ingredient, such as salt or sodium nitrite, should be used in a formulation.  FDA is focused on the total amount of sodium in a given food.

Request for Comments

 In the Federal Register Notice announcing the availability of the draft guidance, FDA requested comments on the following 8 issues.  The agency is encouraging interested parties to provide comments on Issues 1 through 4 by August 31, 2016 and on Issues 5 through 8 by October 31, 2016.

In particular, the agency is interested in comments on “collecting and organizing these data into food categories, our methods for quantifying sodium content, refinements to the specific mean and upper bound targets based on adjustments of our category structures and data, and any challenges of implementing the voluntary goals.[13]”

  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) timeframes for these goals achievable? If the timeframes are not achievable, what timeframes 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) timeframes for these goals achievable? If the timeframes are not achievable, what timeframes 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.

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[1] See Sodium Reduction, available at http://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/ucm253316.htm#FAQs.  FDA is also focusing on restaurant foods because Americans eat approximately a third of their food calories and spend about half their food dollars eating out.

[2] Draft Guidance at 5.

[3] Id.

[4] Id. at 4.

[5] Id. at 6.

[6] Id.

[7] Id. at 7.

[8] Id.

[9] Id. at 4.

[10] See FDA Food Categories and Voluntary Targets, available at http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM504014.pdf.

[11] Draft Guidance at 12.

[12] Id. at 14.

[13] See 81 Fed. Reg. 35,363, 35,366 (June 2, 2016).

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