January 5, 2017, Covington Alert

Yesterday, FDA issued a long-anticipated draft guidance intended to help industry comply with the agency’s May 2016 final rules modernizing nutrition labeling. Presented in a question-and-answer format, the draft guidance (Q&A Draft Guidance) provides information related to the compliance date, labeling of added sugars, rounding of the declaration of quantitative amounts of vitamins and minerals, and label format. Notably, it does not address the issue of dietary fiber, which FDA defined for the first time in the new nutrition labeling regulations. Nor does it extend the current earliest compliance deadline of July 26, 2018.

November 2, 2016, Covington Alert

Last week, FDA released a draft guidance1 clarifying requirements for the “disclosure statement” provisions of its four major Food Safety Modernization Act (FSMA) rules. Entities subject to these provisions must disclose, in documents accompanying the food, that certain hazards have not been controlled. The draft guidance provides insight into the circumstances in which FDA would expect covered entities to utilize the “disclosure statement” provisions, explains how the covered entity should describe the identified hazard, and discusses what type of documents may be used for the disclosure statement. Additionally, FDA reminds industry stakeholders that the entity receiving such a disclosure statement is responsible for taking appropriate steps to ensure that the identified hazards are controlled before the food reaches the consumer.

August 25, 2016

Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act (FSMA). The PC rule generally requires all FDA-registered domestic and foreign food facilities to establish and implement a food safety system, documented in a written food safety plan that is prepared by a preventive controls qualified individual (PCQI) and includes an analysis of hazards and implementation of risk-based preventive controls (PCs).

July 18, 2016, Covington Alert

On July 14, 2016, FDA published its amended final regulations for registration of domestic and foreign food facilities under the Food Safety Modernization Act (FSMA). Registration is required for such facilities that manufacture/process, pack, or hold food for human or animal consumption. The final rule codifies a number of provisions that were mandated by FSMA and already in effect under that law, and adds some new requirements.

July 15, 2016, Covington Alert

Yesterday, the United States House of Representatives passed Bill S.764 (“Joint Bill”), which will amend the Agricultural Marketing Act of 1946 to add Subtitle E: “National Bioengineered Food Disclosure Standard,” and Subtitle F: “Labeling of Certain Food.” The United States Senate passed the same bill last week on July 7, 2016. The Joint Bill, if signed into law by President Obama,3 will immediately preempt most provisions of Vermont’s Act 120, “An Act Relating to the Labeling of Food Produced with Genetic Engineering” (Vermont Law), which requires that certain foods offered for retail sale in Vermont be labeled, “produced with genetic engineering” or with similar alternative statements depending on the specific circumstances.4 The Vermont Law went into effect on July 1, 2016.

May 31, 2016, Covington Alert

On May 27, 2016, FDA finalized its seventh and final food safety rule under the Food Safety Modernization Act (FSMA), which will become new 21 C.F.R. Part 121. The Intentional Adulteration rule establishes requirements to help protect food against adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism. For the first time, domestic and foreign food facilities will be required to complete and maintain written food defense plans assessing their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm.

May 23, 2016, Covington Alert

On Friday, May 20, 2016, FDA issued two final rules to revise the nutrition labeling requirements for conventional foods and dietary supplements—the first major revisions to the nutrition labels since they were originally required over 20 years ago. Recognizing a shift in the average American’s consumption habits and understanding of the Nutrition Facts label, the two rules include changes to the content and format of the Nutrition Facts label, as well as to the reference amounts that determine the serving sizes of conventional foods. FDA also finalized conforming changes to the Supplement Facts label.

October 2014, Mass Torts Litigation Newsletter of ABA Section of Litigation

January/February 2014, Update