On December 2, a coalition of 207 organizations representing a broad segment of the United States economy, including farm, ranch, consumer, and manufacturing interests, delivered a letter to the Senate, urging Senate leaders to continue supporting the United States
FSMA update: Revised proposed rules receive mixed reviews as comment period closes
The Food Safety Modernization Act (“FSMA”) grants the FDA broad powers to make and enforce regulations aimed at preventing microbial contamination of produce and other food products at all points in the chain of distribution, from “farm to fork.” The
FDA announces that BPA in food is safe; concern over the additive remains
Last week the Food and Drug Administration (“FDA”) announced the conclusions of its four-year review of the safety of the synthetic compound bisphenol A (commonly known as “BPA”). BPA is a component in certain beverage bottles, as well as metal
FDA Warning Letter update
It is FDA’s practice to issue Warning Letters in order to provide individuals and companies an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The agency’s position is that it issues Warning Letters only
FDA shuts down fish processing plant because of unsanitary conditions
The Food and Drug Administration (“FDA”) has shut down the Los Angeles based Neptune Manufacturing Inc. (“Neptune”) because of longstanding unsanitary conditions, according to a consent decree of permanent injunction entered in a California federal court. Neptune is a fish
FDA issues new menu labeling rules
Last month, the Food and Drug Administration (“FDA”) issued final rules that require restaurants, grocery stores, and other types of food businesses to list information regarding the caloric intake of food on their menus. The purpose of the final rules
Legal battles over GMO laws in Hawaii and in Oregon continue
The use of Genetically Modified Organisms (“GMOs”) in food continues to be a heavily litigated issue, as seen by recent developments in Hawaii and in Oregon. Several other lawsuits over GMO-labeling laws are pending in various courts across the country.
Top things you should know about the Sunshine Act database
The shifting guidance on whether the industry should report mere funding of educational events, the likely enforcement ahead by federal and state agencies, and maps showing the “hotspots” of consulting, food and beverage, and travel and lodging payments: here’s what
FDA proposes move to electronic labeling
On December 18, the FDA announced a long-anticipated proposed amendment to the prescription drug and biological product labeling regulations requiring electronic distribution of prescribing information intended for healthcare professionals. 79 Fed. Reg. 75506 (Dec. 18, 2014). Currently, this prescribing information
FDA finalizes guidance on patient Counseling information for physician labeling rule
On December 10, 2014, the FDA published industry guidance (Guidance) targeting the Patient Counseling Information (PCI) section of the Physician Labeling Rule (PLR) regulations. 79 FR 73322; FDA-2013-D-1067-0004, available at www.regulations.gov (The FDA’s December 10, 2014 guidance finalizes the draft