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Appendix Q
Regulations Related to the Sodium Content of Foods Labeled “Healthy”

MAY 1994

  • FDA published a final rule (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

    • Defined criteria for use of the implied nutrient content claim “healthy” and its derivatives (e.g., “health” and “healthful”) on individual foods (including raw, single-ingredient seafood, and game meat) and on meal and main dish products.

    • Established two separate time frames in which different criteria for sodium content would be effective for foods that could bear the term “healthy” of a related claim.



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OCR for page 379
Appendix Q Regulations Related to the Sodium Content of Foods Labeled “Healthy” MAY 1994 • FDA published a final rule (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 • Defined criteria for use of the implied nutrient content claim “healthy” and its derivatives (e.g., “health” and “healthful”) on indi- vidual foods (including raw, single-ingredient seafood, and game meat) and on meal and main dish products. • Established two separate time frames in which different criteria for sodium content would be effective for foods that could bear the term “healthy” of a related claim. 

OCR for page 379
0 SCHOOL MEALS 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) Sodium Criterion (in mg) Before January 1, 1998 After January 1, 1998 (first tier) (second tier) ≤ 480 ≤ 360 Individual Foods ≤ 600 ≤ 480* Meal and Main Dish Products 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 consum- ers 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. SEPTEMBER 2005 • This final rule (FDA, 2005) eliminates the second-tier, more restric- tive 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 stakehold- ers 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