• As our readers may recall, FDA held a public meeting on September 27, 2019, to discuss FDA’s efforts to modernize food Standards of Identity (SOI) and to provide information about changes the FDA could make to existing SOIs. Section 401 of the Federal Food, Drug, & Cosmetic Act gives FDA authority, whenever in its judgment it “will promote honesty and fair dealing in the interest of consumers, to promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a definition and standard of identity.” There are literally hundreds of food products for which standards of identity have been promulgated. These standards are set forth by product category in 21 C.F.R. Parts 131 through 169. The procedures for setting standards of identity, many of which were initiated by the food industry, are set forth at 21 C.F.R. Part 130.

• On January 6, the Center for Science in the Public Interest (CSPI) sent Dr. Susan Mayne, the Director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) a letter urging the Agency not to make broadly conceived horizontal changes to SOIs, which as CSPI states, “could introduce unintended negative consequences and/or confuse consumers about the quality or nutritional value of foods.” Although CSPI supports the FDA’s efforts to re-examine the SOIs, CSPI urged the FDA to proceed with caution and ensure that any amendments to the SOIs are “targeted, clearly defined, and fully considered to support specific public health priorities.”

• Overall, CSPI recommended the Agency review proposed amendments to SOIs in light of potential public health benefits and drawbacks, and also outlined 5 changes that the Agency should prioritize should the Agency wish to consider broad horizontal changes that cut across food categories:

  1. Issue regulations requiring the amount of key healthful ingredients to be declared

  2. Allow salt substitutes to be used in standardized foods where necessary to achieve sodium reduction targets.

  3. Maintain and expand key standards for enriched cereals.

  4. Require dairy substitutes to disclose when the product contains less of a key nutrient than the reference dairy food.

  5. Develop a streamlined process for reviewing other changes to standardized foods on a case-by-case basis.

We will continue to monitor updates on the FDA’s efforts to modernize SOIs.