Dykema Food & Beverage Industry Group Newsletter

It was a busy couple weeks in Washington, D.C., for food regulation. This newsletter discusses recent reports impacting food regulation in the near and long term:

• The Office of Inspector General (“OIG”) published a report entitled “Challenges remain in FDA’s Inspections of Domestic Food Facilities Report”
• FDA proposed to extend compliance dates for Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to January 1, 2020
• USDA transferred the U.S. Codex Office from food safety at FSIS to the Trade and Foreign Affairs Office

OIG FDA Inspection Report

OIG’s report on FDA’s domestic inspection performance and future progress emphasizes four main findings:

• Although FDA is meeting its FSMA inspection requirements, it has not inspected a greater number of facilities
• FDA does not always take action to ensure that facilities corrected significant inspection violations
• FDA mostly relied on facilities to voluntarily correct significant inspection violations, which were not always timely or resulted in corrective actions occurring
• FDA did consistently conduct timely follow up inspections to ensure that facilities had corrected significant inspection violations

Those findings may put more pressure on FDA to issue ID 483 violations and ensure, through its own actions, that manufacturer continue actions. FDA may be less inclined to resolve issues identified during inspections.

Label Rule Compliance Extension

The U.S. Food and Drug Administration proposed to extend the compliance date for the Nutrition Facts and Supplemental Facts Label final rule and the Serving Size final rule from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual sales. Companies with sales less than $10 million have until January 1, 2021.

FDA stated that it has extended the compliance dates “in response to the continued concern that companies and trade associations have shared with us regarding the time needed for implementation” to update all of their products. FDA also extended enforcement discrimination related to these labeling rules from July 26, 2018, to July 26, 2019, subject to the completion of the rule making.

U.S. Codex Office Transfer

Agriculture Secretary, Sonny Perdue, transferred the U.S. Codex Office, responsible for the U.S.’s work with the international food safety governing body of the Codex Alimentarius, from the USDA’s food safety office at FSIS to the Office of Trade and Foreign Affairs Agricultural Affairs (“TFAA”). Many food and agriculture organizations support the move in hopes that the trade office will be more forceful in promoting science-based standards in the Codex. Consumer Food Safety groups, on the other hand, oppose the decision because the individuals who work full-time on Codex issues are in the FSIS office. Some fear the U.S. will lose credibility in dealing with Codex matters.

For more information about the information in this alert, please contact David P. Graham (612-486-1521 or dgraham@dykema.com) or your Dykema relationship attorney.