The FDA on June 20 issued the first four chapters of a nine-chapter draft guidance titled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA Draft Guidance). The IA Draft Guidance is intended to assist industry in developing and implementing a “food defense plan” (FDP) in accordance with the “Mitigation Strategies to Protect Food Against Intentional Adulteration” Final Rule (IA Rule).
YOUR SOURCE ON FOOD LITIGATION AND REGULATION
Three years after FDA’s final rule on menu labeling was published, the compliance date for the rule finally went into effect on May 7. The federal menu labeling rule requires that calorie information—which is already included on most packaged foods—must be posted on menus and menu boards in chain restaurants.
Since our last post, more than 41 comments have been submitted in response to the US Cattlemen’s Association’s petition (USCA Petition) requesting that the USDA FSIS exclude from the statutory definitions of “meat” and “beef” those products that are not “derived from animals born, raised, and harvested in the traditional manner.” Such excluded products would presumably include plant-based products that resemble the appearance and taste of beef products and cell-cultured meat (CCM).
In a petition (USCA Petition) submitted to the Food Safety and Inspection Service (FSIS) on February 9, the US Cattlemen’s Association requests that FSIS exclude from the statutory definitions of “meat” and “beef” those products that are not “derived from animals born, raised, and harvested in the traditional manner.”
In almost any area where an emerging technology intersects with a highly regulated industry, there is a dynamic of entrepreneurial spirit facing the realities of existing regulatory frameworks. One novel product facing this dilemma is “cell-cultured meat” (CCM)—meat grown in a cell culture instead of culled from an animal.
On February 6, the Agriculture Marketing Service (AMS) posted a notice in the Federal Register announcing it will delay further rulemaking on a Federal Milk Marketing Order (FMMO) in California while it awaits the US Supreme Court’s decision in Lucia v. Securities & Exchange Commission.
An appellate court recently upheld the convictions of former employees of the now defunct Peanut Corporation of America (PCA), affirming what is the longest criminal sentence in a food safety case.
On November 15, the US Food and Drug Administration (FDA) published a draft guidance on best practices to help parties interested in convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS) under the conditions of its intended use.
As referenced earlier in this space, the Food Safety and Inspection Service (FSIS) hosted a public meeting on Whole Genome Sequencing (WGS) issues late in October (see meeting agenda). It provided a range of helpful information on the implications of the rapid and ongoing adoption of such technology by FSIS and other actors in the public health community at both federal and state levels.
The US Food and Drug Administration (FDA) opened a public comment period on November 12, 2015, seeking information and comments on use of the term “natural” on food labeling. The comment period was open until May 10, 2016. FDA received over 7,600 comments but has not yet issued any “natural” definition.