I asked our AI friends – What are the pros and cons of replacing FDA Commissioner Makary with me – here is the response? This is a very timely question — Makary resigned as FDA Commissioner today, May 12, 2026, amid reports of internal tensions and policy clashes, with the vaping dispute reportedly being a […]
Look what’s in the Federal Register – https://www.federalregister.gov/documents/2022/11/18/2022-25140/expansion-of-fsis-shiga-toxin-producing-escherichia-coli-stec-testing-to-additional-raw-beef Not sure why this is not in a press release – but as my friends “down under”say: “Good on ya mate.” AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice. SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing that on February 1, 2023, the Agency […]
Statement of Jerold Mande, CEO, Nourish Science FDA Proposed Redesign of Human Foods Program I congratulate Dr. Califf and FDA for making a serious effort to address FDA’s many food failings. Unfortunately, they failed to use this hard work to produce a plan that solves the fundamental problems. The #1 problem is inadequate resources including […]
It is past time for Congress and the Administration to step in and solve the FDA organizational problems that seems to elude the FDA bureaucracy. Safe food should not be a political issue. Perhaps, because after 30 years in the food poison trenches, I had a good idea what was going to happen (or not), […]
Tomorrow is the long-anticipated day that Dr. Califf is set to announce his intentions on how or if to implement the recommendations of the Reagan-Udall Foundation panel’s review of the FDA’s human foods program. On behalf of the 48,000,000 Americans sickened by a foodborne illness yearly in the U.S. and the millions who die of […]
Dr. Califf, I have deep admiration for your past and ongoing public service. The hard work of trying to protect the food and drug supply in the United States is a difficult and at times thankless task. The fact that you have taken this responsibility on more than once speaks volumes to your character. Your decision post the […]
This just hit my inbox. I’ll have more to say. January 25, 2023 Dr. Califf: This letter is to inform you that I am resigning my position as FDA Deputy Commissioner for FoodPolicy and Response effective February 24. In December of 2018, I joined the FDA with the goal of helping to modernize the food […]
In the 30 years since the Jack in the Box outbreak, food safety has come a long way. Here are some of the people who have shaped it. JANUARY FEBRUARY 2023 – https://www.qualityassurancemag.com/article/the-food-safety-set/ Food Safety Over the Last 30 Years By Steven Mandernach, executive director, Association of Food and Drug Officials When I talk to […]
Here are some cases where prosecutors brought criminal charges: In 1998 in what the first criminal conviction in a large-scale food-poisoning outbreak was, Odwalla Inc. pleaded guilty to violating Federal food safety laws and agreed to pay a $1.5 million fine for selling tainted apple juice that killed a 16-month-old girl and sickened 70 other […]
Abbott Under Federal Criminal Investigation Over Baby Formula Michigan plant at center of probe was temporarily closed by the company last year after potentially deadly bacteria was found. https://www.wsj.com/articles/abbott-under-criminal-investigation-over-baby-formula-11674255871?mod=business_lead_pos1 The Justice Department is investigating conduct at the Abbott Laboratories infant-formula plant in Sturgis, Mich., that led to its shutdown last year and worsened a nationwide formula shortage, people […]
I must admit I was a bit suspect when I flew from Seattle to DC a few months ago to testify for 5 minutes before the Independent Expert Panel. Putting aside if they would pay attention to me, but would the panel take to heart the experience and thoughtfulness of all the panels and the […]
Here is the link – https://www.audible.com/pd/Poisoned-Audiobook/B0BPKLLS2T?action_code=ASSGB149080119000H&share_location=pdp
Criminal sanctions – Please. Here are the low lights of the FDA Warning Letter to Big Olaf’s on December 9, 2022. According to the Centers for Disease Control and Prevention (CDC), 28 ill people from 11 states were infected with the outbreak strain of L. monocytogenes. One patient died and there was a miscarriage in […]
According to the CDC, as of December 29, 2022, a total of 15 people infected with the outbreak strain of Salmonella have been reported from three states Nebraska (8), Oklahoma (1) and South Dakota (6). Illnesses started on dates ranging from December 2, 2022, to December 13, 2022 linked to SunSprout alfalfa sprouts. That number is likely […]
Famous Anthony’s “About Us” Page in its website tells the story of a family run, Roanoke institution that has been taken to its knees in bankruptcy because one employee was not vaccinated against hepatitis A. Sadder still are the 50 customers sickened, some so severely that they required liver transplants, and in four instances they […]