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A Flurry of End-of-Year Activity from FDA on Food

In what seemed like a bit of end-of-year housekeeping, FDA issued a series of minor guidance documents, notices, and other regulatory paraphernalia related to food.  Coming in under the wire in 2014 were:

  • A notice requesting nominations for non-voting industry representatives to the Food Advisory Committee. Nominations are due by January 7, 2015.  FDA is also requesting that industry organizations interested in participating in the selection of non-voting industry representatives to the Food Advisory Committee should notify FDA in writing of their interest by January 7, 2015.
  • A notice requesting nominations for voting members to FDA’s Food Advisory Committee. Nominations are due by January 30, 2015.
  • A final rule establishing January 1, 2018 as the uniform compliance date for food labeling regulations issued between January 1, 2015 and December 31, 2016.
  • A response to objections to FDA’s final rule approving advantame as a non-nutritive sweetener and flavor enhancer for use in foods generally, except for meat and poultry products. FDA determined that the final rule approving advantame should not be modified and confirmed the final rule’s May 21, 2014 effective date.
  • A final guidance document on labeling of certain beers subject to FDA labeling jurisdiction – Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration. Under the guidance, beers that are not made from both malted barley and hops but instead made from substitutes for malted barley, such as sorghum, rice, or wheat, or are made without hops (other than sake, which is classified as a wine), are not “malt beverages” under the Federal Alcohol Administration Act.  Such beers must comply with FDA labeling requirements, but are also subject to certain Alcohol and Tobacco Tax and Trade Bureau (TTB) labeling requirements (g., the Government Health Warning Statement about consumption of alcoholic beverages).
  • A final guidance document on labeling of processed and blended seafood products made primarily with fish protein – Compliance Policy Guide Sec. 540.700 (Labeling of Processed and Blended Seafood Products Made Primarily with Fish Protein).
  • A notice announcing the availability of a revised draft guidance document on the level of coli in crabmeat at which the agency will consider crabmeat products to be adulterated (i.e., 3.6 Most Probable Number per gram (MPN/g) of E. coli) – Compliance Policy Guide Sec. 540.275 (Crabmeat – Fresh and Frozen – Adulteration with Filth, Involving the Presence of the Organism Escherichia coli). To be considered before FDA begins work on a final guidance, comments must be received by February 17, 2015.
  • An update on other pending food labeling matters – Update for Industry on Certain Proposed Rules, Draft Guidance and Petitions Related to Food Product Labeling.  This update includes some interesting tidbits about the current status of matters FDA did not complete in 2014.  For example, FDA completed data collection for a consumer study on “whole grain” label statements, and is now considering comments received on FDA’s 2006 draft guidance and developing a final guidance document on this subject.  Missing is any mention of the status of a final guidance document on “non-GMO” label statements, which FDA had promised to issue in 2014.

Some notable end-of-year announcements related to food made by other federal agencies include:

  • An announcement of a public workshop on “Options for Consideration of Chronic Disease Endpoints for Dietary Reference Intakes” to be held on March 10 and 11, 2015 by the Dietary Reference Intakes (DRI) Committees of the U.S. and Canada. The workshop will evaluate the scientific issues involved in using chronic disease endpoints to set DRIs.  The DRI Committees are also requesting public comments on the specific questions posed in the workshop announcement.  Comments are due January 30, 2015.
  • Recommendations of the Presidential Task Force on Combating Illegal, Unreported and Unregulated Fishing and Seafood Fraud.  The recommendations submitted to President Obama by the Task Force include: work with Congress to pass legislation implementing the 2009 Agreement on Port State Measures to Prevent, Deter, and Eliminate Illegal, Unreported and Unregulated (IUU) Fishing; direct the Secretaries of Agriculture, Commerce, Health and Human Services (HHS), Homeland Security, and Interior and the Attorney General to develop a strategy to collect, share, and analyze information and resources to prevent IUU and fraudulently labeled seafood from entering U.S. commerce; direct the Secretaries of Agriculture, Commerce, HHS, and Homeland Security to standardize and clarify rules on identifying the species, common name, and origin of seafood; direct the Task Force to establish a regular forum with harvesters, importers, dealers, retailers, processors, and non-governmental organizations to improve collaboration in combating IUU fishing and seafood fraud; direct the Task Force to develop a list of the types of information and operational standards needed for an effective seafood traceability program; and direct the Task Force to establish the first phase of risk-based traceability program to track seafood from point of harvest to entry into U.S. commerce.  Comments on the recommendations are due by January 20, 2015.

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