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YOUR SOURCE ON FOOD LITIGATION AND REGULATION

On December 1, the US Department of Agriculture's (USDA’s) Food Safety and Inspection Service (FSIS) issued a proposed rule to amend the nutrition labeling regulations for meat and poultry products (Proposed Rule). The revisions in the Proposed Rule are meant to parallel, to the extent possible, the US Food and Drug Administration’s (FDA’s) two similar final rules concerning nutrition fact labels (Nutrition Labeling Rules).1

Some notable similarities between provisions in the Proposed Rule and FDA’s Nutrition Labeling Rules include, but are not limited to, the following:

  • Updating the list of nutrients required or permitted to be declared (e.g., no longer requiring declaration of Vitamins A and C but requiring declarations for Vitamins D and Potassium) and updating Dietary Reference Values (DRVs) and Reference Daily Intakes (RDIs) that are based on current dietary recommendations2
  • Requiring the declaration of trans fat in the Nutrition Facts label
  • Requiring the declaration of added sugars
  • Establishing a new definition of “dietary fiber”
  • Modifying the nutritional labeling format for certain nutrition information (e.g., calories, serving size, and servings per container) prominence, and changing the order of the “Serving Size” and “Servings Per Container” declarations
  • Requiring mandatory dual-column labeling on certain packages of meat and poultry products (i.e., products that contain 200–300% of the applicable reference amounts customarily consumed (RACC))
  • Amending the requirements for foods represented or purported to be specifically for children under the age of four years, and pregnant and lactating women

FSIS is also proposing to change several of the RACCs and product categories, as well as develop some new product categories Additionally, the Proposed Rule would consolidate the nutrition and labeling regulations for meat and poultry products into one new Code of Federal Regulations Part, 9 C.F.R. Part 413.3

Potential Industry Impact

Prior to the issuance of the Proposed Rule, FSIS indicated that it would allow companies to voluntarily implement FDA’s Nutrition Labeling Rules while the FSIS Proposed Rule was being drafted.4 FSIS also indicated that when it ultimately publishes a final rule, companies would have to comply by the relevant effective date and would no longer be able to use the FDA format (assuming that applicable requirements would be different).

Two potential issues arise with this FSIS approach:

  1. Until the FSIS rule is finalized, the precise level of ultimate deviation from the FDA format will remain unclear, as will the degree to which FSIS will ultimately accommodate minor differences in this area.
  2. The Proposed Rule does not provide an expected compliance period. Suggestions for a compliance period range from 12 months to 42 months subsequent to publication of a final rule. This may be particularly problematical for companies that fall within the dual-jurisdiction of FDA and USDA.

Comment Period

Once published in the Federal Register, the Proposed Rule will be available for public comment for 60 days (Docket FSIS-2014-0024).

If you have any questions on the issues discussed in this post or would like assistance preparing comments to FSIS, please contact the authors.

1See 81Fed. Reg. 33742 (May 27, 2016), https://www.gpo.gov/fdsys/pkg/FR-2016-05-27/pdf/2016-11867.pdf and 81 Fed. Reg. 34000 (May 27, 2016), https://www.gpo.gov/fdsys/pkg/FR-2016-05-27/pdf/2016-11865.pdf
2A more extensive discussion of FDA’s list of nutrients and RDIs can be found in the preamble of FDA’s Nutrition Labeling Rules, see supra note 1.
3Currently, the nutrition labeling requirements for meat and meat food products can be found in 9 C.F.R. §§ 317.300-317.400, and the labeling requirements for poultry and poultry products are in 9 C.F.R. §§ 381.400-381.500.
4 FSIS issued a Federal Register Notice stating, among other things, that “[a]s long as the information on the labels is still truthful and not misleading, FSIS will not find noncompliance if companies use the FDA format.” 81 Fed. Reg. 80631 (Nov. 16, 2016) https://www.fsis.usda.gov/wps/wcm/connect/286ab693-1dc8-42ac-b295-1868b1b743a9/2016-0030.pdf?MOD=AJPERES.