Food, Drug & Agriculture

FDA’s New Safety and Performance Based Pathway for Medical Devices Reflects a More Modern Approach to Finding Substantial Equivalence

By Allison Fulton on September 20, 2019

On September 19, 2019, FDA issued a guidance document, “Safety and Performance Based Pathway,” describing an optional pathway for medical devices with well-understood safety and performance profiles. The guidance signals FDA’s willingness to implement a more modern approach under the arcane 510(k) premarket pathway.…

Food & Ag Law Insights

The Buzz Around Vaping Illnesses: FDA Launches Criminal Probe

By Seth Mailhot on September 20, 2019

There have been numerous stories in the media about the heartbreaking illnesses associated with vaping. In this post on Husch Blackwell’s Cannabis Law Now blog, Seth Mailhot (with the help of Fall Clark Julia Banegas) explains the launch of a criminal probe by the FDA, the parallel investigation by the CDC and details how companies can appropriately prepare for an FDA inspection.…

The Daily Intake

USDA Publishes Final Rule to “Modernize” Pork Inspection

By Samuel Jockel on September 20, 2019

As we have previously covered on this blog, on February 1, 2018, FSIS put forward a proposed rule to establish a voluntary, opt-in inspection system for market hog slaughter establishments, called the New Swine Slaughter Inspection System (NSIS). The proposal had received pushback from consumer groups and several media outlets, with FSIS defending its proposal in a direct response to a Washington Post article earlier this year. On September 17, 2019, FSIS released the final rule…

A Seat at the Table

FSMA Implementation: FDA Launches Food Defense Plan Builder 2.0

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Christine Forgues on September 20, 2019

The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB) to help companies meet the requirements of the final rule “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA Rule) under the FDA Food Safety Modernization Act (FSMA). The FDPB is a voluntary tool intended to aid entities subject to the IA Rule in preparing customized food defense plans. FDA is hosting…

Canna Law Blog™

Major Changes to California Hemp Cultivation Laws are on the Horizon

By Griffen Thorne on September 20, 2019

On September 11, 2019, the California Assembly approved SB-153, a bill aimed at making significant changes to California’s hemp cultivation law. As of September 13, 2019, the bill moved to “enrolled” status, meaning that it’s cleared both houses of the California legislature and will move to the Governor’s office for his signature. It is widely expected that the bill will be executed and become law. So what does SB-153 change exactly? Here are some of…

Drug & Device Law

Don’t Forget About OTC Express Preemption

By Steven Boranian on September 20, 2019

Did you remember that there can be express preemption for over-the-counter drugs? We sometimes forget too, but there are really good reasons for that. The Food Drug and Cosmetic Act includes the following provision: [N]o State or political subdivision of a State may establish or continue in effect any requirement – (1) that relates to the regulation of [a non-prescription, over-the-counter drug]; and (2) that is different from or in addition to, or that is…

Food Safety News

City health department still mostly mum on E. coli outbreak investigation

By Coral Beach on September 20, 2019

Philadelphia officials have added more people to the patient list in an E. coli outbreak that is associated with “shared restaurant exposure.” Earlier this month the Philadelphia Department of Public Health reported the outbreak but did not name a specific restaurant or restaurants. The department continues to decline to provide that information. “A total of 19 cases were identified in this cluster. The last report was received on Sept. 6, and our investigation into the…

Food Safety News

Downer pigs will continue to get extra time to recover

By Dan Flynn on September 20, 2019

USDA’s Food Safety and Inspection Service isn’t changing the way it deals with non-ambulatory disabled pigs. An animal activist organization, Farm Sanctuary, had petitioned FSIS to have non-ambulatory disabled pigs (NADs) immediately condemned and “promptly euthanized.” But in an eight-page response, FSIS officially denied the petition on Sept. 16. FSIS said the Farm Sanctuary petition claims that quicking killing NAD pigs would “enhance food safety” and result in “more humane handling,” and would improve inspector…

Food Safety News

Nearly 40 sick in norovirus outbreak in Ireland

By News Desk on September 20, 2019

illustration norovirus — *Graphic illustration of norovirus*

Almost 40 people fell ill with norovirus in August in a region of Ireland. Authorities say some were sickened by contaminated food. Data from the Health Protection Surveillance Centre’s (HPSC) weekly outbreak report shows 36 illnesses from noroviral infection in the Dublin East region for the notification period from Aug. 25-31. The outbreak location is described as “other” and the source of some infections are foodborne while others have person-to-person transmission. The Health Protection Surveillance…

Food Poison Journal

Florida Penn Dutch shut due to Listeria

By Drew Falkenstein on September 19, 2019

Today, the Florida Department of Agriculture and Consumer Services (FDACS) and Commissioner Nicole “Nikki” Fried issued an Immediate Final Order to Penn Dutch Meat & Seafood Market, ordering that they immediately cease operations and close their Margate store. The order was issued after Penn Dutch violated multiple stop-use and stop-sale orders and endangered public health by possibly distributing food products contaminated with Listeria pathogens. “As with any Department inspection process, Penn Dutch was provided an opportunity to…