January 24, 2022

FDA Allows Qualified Health Claim For Magnesium and Blood Pressure

The FDA is allowing a qualified health claim for magnesium and blood pressure, that it will not object to the use of certain health claims regarding the consumption of that mineral and a reduced risk of high blood pressure. The claim will be allowed if it is "appropriately worded" to avoid misleading consumers, and if other factors for the use of this claim are met. A petition was submitted on behalf of The Center for Magnesium Education and Research, LLC. It requested that the FDA authorize a health claim about the relationship between the consumption of magnesium and the reduced risk of high blood pressure. A health claim iterates the relationship between a substance and a disease or health-related condition. The petition was reviewed, along with other evidence related to the … [Read more...]

BrightFarms Salmonella Outbreak Investigated by FDA

The BrightFarms Salmonella outbreak that occurred in the summer of 2021 has been investigated by the FDA. In the report released today, the agency states that this is "believed to be FDA’s first domestic investigation of a foodborne illness outbreak associated with leafy greens" that were grown in a Controlled Environment Agriculture (CEA) operation. The CDC investigation of this outbreak is included in the relevant links section of the report. The outbreak, which was associated with the consumption of packaged leafy greens from BrightFarm's indoor hydroponic operation, sickened at least 31 people in four states. Twenty-six of 27 patients said they ate leafy greens before they got sick. The firm's products were specifically named by 14 patients. The outbreak strain of Salmonella … [Read more...]

New E. coli O121:H19 Outbreak on FDA CORE Investigation Table

A new E. coli O121:H19 outbreak has been posted on the FDA's CORE Outbreak Investigation Table. This outbreak, which has sickened at least four people, has already ended. The investigation, however, is still active and traceback has been initiated. The FDA stated, "A new outbreak of E. coli O121: H19 with an unidentified vehicle has been added. This outbreak does not appear to be ongoing, as the last illness onset occurred in November 2021. FDA has initiated traceback and other investigational activities in an effort to learn more about possible sources or routes of contamination." We'll keep you informed as the investigation into this new E. coli O121:H19 outbreak continues. And the outbreak of Salmonella Javiana, which sickened at least 65 people, has also ended with no … [Read more...]

FDA CORE Outbreak Table Has Six Active Investigations

The FDA CORE Outbreak Table has six active food poisoning investigations currently; all but one has been identified or solved. The Salmonella Javiana outbreak, which was announced on November 24, 2021, is still not identified, and the number of people sickened in that outbreak has increased to 64. No recall has been initiated, although traceback has begun, on-site inspection has been started, and sample collection and analysis has been initiated. When there is some concrete action that consumers can take, the FDA should update the investigation. The other five active outbreaks include: The E. coli O157:H7 9outbreak linked to Simple Truth and Nature's Basket Organic Power Greens, which has sickened at least 13 people in six states. Four people have been hospitalized, and one … [Read more...]

New Listeria Monocytogenes Outbreak on FDA Investigation Table

A new Listeria  monocytogenes outbreak has been added to the FDA CORE Investigation Table, and the Salmonella Javiana outbreak added a few weeks ago has grown. The Listeria monocytogenes outbreak has sickened at least 16 people, and the Salmonella Javiana outbreak has now sickened at least 51 people. For the Listeria monocytogenes outbreak, traceback has been initiated, but there has been no on-site inspection, no sample collection, and no analysis. We don't know the illness onset dates or what food may be under consideration as the source of the outbreak. Another Listeria outbreak that the FDA identified earlier this year went unsolved after sickening 20 people. Recent Listeria monocytogenes outbreaks have been linked to Tyson precooked chicken, El Abuelito cheese, deli meats, … [Read more...]

Where Are All the Recalls? Q3 Recalls Drop More Than 10%

Where are all the recalls? This year could see the lowest food recall levels in ten years. In the third quarter alone, FDA food recalls dropped more than 10%, according to Food Safety Tech. In 2020, food recalls hit an all-time low, partly because of the COVID-19 pandemic. There was an average of 128 recalls per year in the four years before the pandemic hit. In 2020, there were only 29 food recalls. Even more alarmingly, of the three majors pathogens (E. coli, Salmonella, and Listeria monocytogenes) there were 26 recalls in each of the four years before 2020. In 2020, there was only one recall for a pathogen, and that was for E. coli. In 2021, FDA food recalls fell more than 11%. USDA recalls increased by just one. While this drop may be considered good news, it seems odd … [Read more...]

FDA Proposes Agricultural Water Safety Rule For Use on Produce

There have been multiple E. coli outbreaks linked to fresh produce, especially leafy greens such as romaine lettuce, in the past few years. In several of those outbreaks, agricultural water has been implicated as the source of that pathogen. So the FDA has proposed a new agricultural water safety rule for use on produce. The rule would require farms to conduct comprehensive assessments that will help them identify and mitigate hazards in water that is used to grow produce. This is the latest step in the implementation of the Food Safety Modernization Act (FSMA) of 2011. This proposed rule will replace some of the existing requirements for agricultural water in the Produce Safety Rule. Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response said in a statement, "There … [Read more...]

Blackstone Labs Conspired to Sell Unlawful Dietary Supplements

Blackstone Labs and two of its executives pleaded guilty to conspiring to sell illegal anabolic steroid and unlawful dietary supplements, according to the U.S. Justice Department. According to court documents, on November 17, 2021, the executives, Phillip Braun and Aaron Singerman, pleaded guilty to distributing controlled substances and to selling unapproved new drugs.in violation of FDA statutes through their company, which was located in Boca Raton, Florida. The defendants admitted that, from 2012 through 2017, they conspired to sell products that were unapproved new drugs and/or illegal controlled substances, while they falsely characterized their products as safe and legal dietary supplements under the Designer Anabolic Steroid Control Act. The products were also falsely … [Read more...]

FDA’s Food Safety and Nutrition Survey Report Released

The FDA's Food Safety and Nutrition Survey, the agency's probability consumer survey designed to assess consumer awareness, knowledge, understanding, and self-reported behaviors regarding food safety, has been released for 2019. The survey was launched to help the FDA make informed regulatory, education, and policy decisions to protect public health. The survey was a mail-push to web methodology. The population includes adults who live in the 50 U.S. states and the District of Columbia. A total of 4,398 responses were collected during ht months of October and November 2019. Before this methodology change, FDA consumer surveys were conducted using phone interviews. The key findings on food safety include consumer knowledge about where they think they may contract food poisoning, … [Read more...]

Jule’s Foods FDA Warning Letter Details Salmonella Contamination

A Jule's Foods FDA warning letter details the Salmonella contamination found at that company's facility, after inspections were launched in relation to a multistate outbreak that sickened at least 20 people in four states and hospitalized five. The outbreak was declared over in early July 2021. The facility is located at 2790 Loker Avenue West in Carlsbad, California. The FDA inspected the facility from April 21 to May 24, 2021. The outbreak included six Salmonella serotypes. Four of those serotypes were found in an environmental swab taken from the company's vegan cashew brie, the vegan cashew brie varieties, and/or the incoming cashew pieces used to make these products. The CDC and FDA determined, based on epidemiologic and laboratory evidence, that the RTE vegan cashew brie … [Read more...]

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