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TABLE Q-1 Sodium Criteria in the Final Rule (September 29, 2005; 59 FR 24232) to Define the Term “Healthy” as an Implied Nutrient Content Claim Under Section 403(r) of the Federal Food, Drug, and Cosmetic Act, 1944


Sodium Criterion (in mg) Before January 1, 1998 (first tier)

Sodium Criterion (in mg) After January 1, 1998 (second tier)

Individual Foods

≤ 480

≤ 360

Meal and Main Dish Products

≤ 600

≤ 480*

NOTE: Sodium content is per reference amount customarily consumed (RACC or reference amount), per labeled serving (serving size listed in the nutrition information panel of the packaged product), and if the reference amount was small (i.e., 30 grams (g) or less or 2 tablespoons or less), per 50 g.

*The agency selected the 480 mg sodium level because it was low enough to assist consumers in meeting dietary goals, while simultaneously giving consumers who eat such foods the flexibility to consume other foods whose sodium content is not restricted because there were many individual foods and meal-type products on the market that contained less than 600 mg of sodium: and because comments suggesting other levels did not provide supporting data.


  • This final rule (FDA, 2005) eliminates the second-tier, more restrictive sodium requirement (480 mg) for meal and main dish products, which had been stayed until January 1, 2006, and also eliminates the second-tier sodium requirement for individual foods (360 mg) instead of allowing it to go into effect on January 1, 2006, as proposed.

  • This action is being taken as a result of comments from stakeholders urging FDA to eliminate the more restrictive sodium requirements.

    • The comments documented substantial technical difficulties in finding suitable alternatives for sodium and demonstrated the lack of consumer acceptance of certain “healthy” products made with salt substitutes and/or lower sodium.

    • Comments from both industry and consumer advocates support the conclusion that implementing the second-tier sodium requirements would risk substantially eliminating existing “healthy” products from the marketplace because of unattainable nutrient requirements or undesirable and, thus, unmarketable flavor profiles.

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