Institute of Medicine Report Urges FDA to Reduce Sodium Levels Across the Food Supply
April 22, 2010

The Institute of Medicine (IOM) released its 434-page report entitled, “Strategies to Reduce Sodium Intake,” which calls on the Food and Drug Administration (FDA) to take swift and sweeping regulatory action to reduce sodium levels in the U.S. food supply through a series of phased-in reductions over the next several years. The effort is intended to aid consumers eating an ordinary diet to limit their sodium intake to levels recommended in the U.S. Dietary Guidelines for Americans. In 2008, Congress directed the IOM to recommend strategies for reducing sodium intake to levels consistent with the Dietary Guidelines, which currently recommend that Americans 2 years of age and older consume no more than 2,300 mg of sodium per day. In response, IOM’s Food and Nutrition Board convened the Committee on Strategies to Reduce Sodium Intake (the Committee), which developed the sodium reduction strategy and policy recommendations laid out in the ambitious report issued on April 20, 2010.

Policy Recommendations

  • As a primary strategy for reducing sodium in the U.S. food supply, the IOM report recommends that FDA “expeditiously initiate a process to set mandatory national standards for the sodium content of foods,” and should rely on its authority under the Federal Food, Drug & Cosmetic Act (FDCA) to determine the conditions of use for salt that are “generally recognized as safe” (GRAS) under FDCA section 201(s) to do so. Specifically, the IOM report recommends that FDA establish conditions of use for salt in processed food that are consistent with the Dietary Guidelines by modifying the GRAS status of salt. The report states that such a modification is justified in view of the body of evidence that has developed concerning the health effects of salt since it was first recognized as GRAS in 1959.
  • Under the strategy the IOM report recommends, salt would be GRAS when added to various categories of food in amounts that FDA determines to be consistent with the Dietary Guidelines, but would be subject to regulation as a “food additive” when added to food in greater amounts, requiring FDA to authorize any use of salt that exceeds the GRAS levels by promulgating a food additive regulation.
  • Under the FDCA, the GRAS policy recommended by the IOM report would limit the use of salt in all foods intended for human consumption, including foods regulated by USDA’s Food Safety and Inspection Service (i.e., meat, poultry, processed egg products), and foods served in restaurants and food service operations.
  • The IOM report recommends that FDA take swift action to develop the new GRAS policy for salt through notice and comment rulemaking, and implement the new restrictions on added salt in food in a phased, step-wise manner to achieve gradual reductions in sodium in the food supply, allow adequate time for consumer taste preferences to adjust to reduced sodium levels, and ensure the sodium reduction program is adequately monitored and evaluated.
  • During the development and implementation of the new GRAS policy and mandatory sodium standards, the IOM report recommends that the food manufacturers and restaurant/foodservice operators “accelerate and broaden” programs to reduce sodium in processed foods and menu items on a voluntary basis, and that the food industry work together with government, professional, and public health organizations “to promote voluntary collaborations to reduce sodium in foods.”
  • To augment and support the primary sodium reduction strategy restricting the GRAS status of salt, the IOM report recommends a number of “supporting strategies,” that would modify current FDA and USDA food labeling regulations. The IOM report recommends that the Daily Value (DV) for sodium be based on the Adequate Intake (AI) that IOM previously reported, and that other sodium-related standards established for purposes of nutrition labeling, nutrient content claims, and health claims be reviewed and updated (e.g., disclosure/disqualifying levels). In addition, the IOM report recommends that federal standards governing nutrient content claims and health claims for packaged food products be extended and applied to restaurant/foodservice menu items, and that nutrition labeling exemptions for restaurant/foodservice foods be eliminated.
  • The IOM report recommends that food retailers and governmental organizations that purchase or distribute food products on a large-scale, establish sodium specifications for such foods to strengthen the economic incentives available for reduced sodium food products. The report recommends that sodium specifications be established for foods purchased or served through federal programs including through the federal school lunch and breakfast programs, and military programs. The report further suggests that sodium specifications may be appropriate for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and the Supplemental Nutrition Assistance Program (SNAP). The IOM report also recommends that state and local governments establish sodium specifications for food procurement programs.
  • The IOM report recommends that a number of initiatives be launched by governmental and private organizations to help educate the public concerning the health benefits associated with sodium reduction, and support consumers in making behavior changes to reduce sodium intake in a manner that is consistent with the Dietary Guidelines. The report specifically encourages the food manufacturers, retailers, and restaurant/foodservice operators to support and distribute consumer educational materials about sodium intake and selecting diets lower in sodium. In addition, the report encourages restaurant/foodservice operators to improve the availability of sodium content information to consumers at the point of purchase, or prior to consumption. The IOM report also recommends that federal public health agencies launch a public education campaign concerning sodium reduction to healthy dietary practices.
  • The IOM report makes a number of recommendations aimed at expanding and enhancing federal dietary and nutrition monitoring programs relating to sodium, including the National Health and Nutrition Examination Survey (NHANES).


Implications for Manufacturers and Retailers

These recommendations have a myriad consequences for food manufacturers and retailers. Specifically, adjustments to the GRAS status for sodium could significantly affect the marketing and sale of processed foods. As noted above, FDA currently regulates sodium as a GRAS ingredient with no limits on the amount of sodium that can be used in particular foods. The IOM report — proposing a multi-year approach involving setting a safe level of sodium for the food supply in general based upon a review of approximately 11 different categories of foods. Once these levels are established, food manufacturers would be required to achieve a certain level of sodium reduction within a specific time frame followed by an additional reduction within another timeframe until consumption levels reach the current USDA Dietary Guideline of 2300 mg per day.

FDA regulations currently allow relative claims and a health claim relating to a low sodium diet and reduced risk of high blood pressure pursuant to 21 C.F.R. §§ 101.61 and 101.74 respectively. Changes to the GRAS status of sodium and to the nutrition labeling of sodium based upon adequate intake, as recommended by the report, could affect the nutritional labeling of a significant percentage of food products and could alter the landscape of those foods currently labeled as “reduced sodium.” That is, if FDA implements a “safe” level of sodium per the GRAS process, many “regular” foods may have to reduce their current levels of sodium. Those products that have less sodium, e.g., the “reduced sodium” versions, may also have to further reduce sodium content.

The reformulation and relabeling of these products to meet consumer tastes and yet still comply with the GRAS standards would have significant costs for food manufacturers and retailers and require them to balance the challenges of the new restrictions with consumers’ taste preferences. The stepwise approach to sodium reduction is not new. In early 2003, the FDA proposed an amendment to the then-current regulation for sodium levels on foods bearing a “healthy” claim. Essentially, a first-tier sodium level existed for meal and main dish foods bearing the nutrient content claim “healthy.” FDA had established but not yet implemented a second-tier level for individual foods bearing the “healthy” claim. The agency believed that “the proposed sodium levels will help consumers achieve a total diet that is consistent with current dietary recommendations, as the proposed levels will give consumers a reasonable number of "healthy" products from which to choose.” [1]

Just two years later, in 2005, FDA again amended its regulations pertaining to the sodium content of foods bearing a “healthy” claim. The agency retained the currently effective, less restrictive, "first-tier" sodium level requirements for all food categories, including individual foods (480 milligrams (mg)) and meals and main dishes (600 mg), and dropped the "second-tier" (more restrictive) sodium level requirements for all food categories. [2] The rationale for the change included technological barriers to reducing sodium in processed foods and poor sales of products that met the second-tier, more restrictive, sodium level. The agency thus determined that requiring the more restrictive sodium levels would likely inhibit the development of new "healthy" food products and risk substantially eliminating existing "healthy" products from the marketplace. [3]

The IOM report does not address the technological barriers to reformulating products with less sodium or the previous stepwise approach. The report does note that many food manufacturers have already made significant sodium reductions in their food products.

The report also recommends extending the GRAS modification to food served in restaurants and food service outlets as well as removal of the nutrition labeling exemption for these entities. This could mean multiple reformulations for chain restaurants and single location establishments and development of nutrition information for consumers.

Moreover, we previously wrote about new calorie disclosure requirements facing food retailers with 20 or more locations. If the report’s recommendations are adopted, restaurants of all sizes would be required to provide the nutritional information on their products, a significant expansion of the calorie disclosure requirement now facing only larger food retail operations. Under the recent FDCA amendments, FDA has authority to require the disclosure of nutrients, in addition to calories. [4] Given the attention that governmental and health professional leaders are giving to sodium reduction, the FDA could implement the new restaurant food labeling requirements in a manner that would require sodium to be disclosed along with calorie information.

Processing and packaging techniques may also have to be evaluated to meet lower sodium criteria. Foods that rely on sodium as a preservative, including certain meat products, as added during processing, may have a different shelf life, texture or taste if processed using a sodium substitute or alternative process. The shelf life changes could necessitate packaging changes for certain products if less sodium is used to preserve them.

Industry Response and Comment

The FDA, a sponsor of the IOM review of sodium reduction strategies, announced on Tuesday that it would review the IOM recommendations but that it had not already begun the process of regulating the amount of sodium in foods. Shortly after the official release of the Report, House Agriculture Appropriations Chairwoman Rosa DeLauro, D-Conn., and Senate Health, Education, Labor and Pensions Chairman Tom Harkin, D-Iowa, called for aggressive action in response and suggested they would “push” the FDA to act quickly in implementing recommendations to sharply reduce the amount of salt in processed foods.

Food manufacturers and retailers should prepare to comment on proposed regulations regarding safety and allowable levels of sodium. Given this year’s emphasis on health care reform and obesity, Congress clearly believes that decreasing the sodium content of the food supply will reduce medical costs and save lives. In addition, food manufacturers and retailers should evaluate the sodium content of their products and determine the impact of reduced sodium on their products, e.g., taste, shelf life, etc. They should also determine if reformulation is warranted and whether the technology required to successfully do so is available. The IOM was not tasked with determining the feasibility and impact that these recommendations would have on those who produce and sell the nation’s food. It will be necessary for the food manufacturing and retailing community to help determine acceptable levels of sodium and the implementation of these across the nation’s food supply based, in part, on what their businesses can support.

Kelley Drye & Warren LLP

Kelley Drye's team of Food and Drug lawyers strives to integrate our clients' business strategies with FDA compliance and to help resolve regulatory enforcement matters when they arise. Working side-by-side with business development and marketing professionals, we provide comprehensive regulatory counseling and assist in developing products, labels, and promotional materials that achieve our clients' goals without running afoul of regulatory requirements. With close knowledge of FDA's enforcement priorities and deep experience with the FTC's regulation of advertising, our team can provide comprehensive legal advice with an eye towards giving clients a competitive edge.

For more information about this Client Advisory, please contact:

Sarah Roller
(202) 342-8582
sroller@kelleydrye.com

Kristi L. Wolff

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kwolff@kelleydrye.com



[1]See 58 Fed. Reg. 2413.

[2]See58 Fed. Red. 24131.

[3]Seeid.

[4]See § 4205(b)(H)(vi).