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USDA and FDA reach agreement to regulate cell-cultured food products

By Judy Reed

In only a few years, you may be eating a fast food burger with meat that was grown in a lab instead of a pasture.

In the future you could eat a burger that never came directly from a cow.

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) announced on March 7 they had reached a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.

The formal agreement describes the oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce. 

“Consumers trust the USDA mark of inspection to ensure safe, wholesome and accurately labeled products,” said USDA Deputy Under Secretary for Food Safety Mindy Brashears. “We look forward to continued collaboration with FDA and our stakeholders to safely regulate these new products and ensure parity in labeling.”

Under the formal agreement, the agencies agree upon a joint regulatory framework wherein FDA oversees cell collection, cell banks, and cell growth and differentiation. A transition from FDA to FSIS oversight will occur during the cell harvest stage. FSIS will oversee the production and labeling of human food products derived from the cells of livestock and poultry.

On Oct. 23-24, 2018, FSIS and FDA held a joint public meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry. The public meeting focused on the potential hazards, oversight considerations, and labeling of cell cultured food products derived from livestock and poultry.

According to the FDA, “Animal cell culture food technology refers to the controlled growth of animal cells from livestock, poultry, fish, or other animals, their subsequent differentiation into various cell types, and their collection and processing into food.”

During the joint meeting, USDA secretary Sonny Perdue spoke about the projected world population growth of 9 billion people by 2050, and the need to feed them by whatever means available and necessary. “Both agencies must be open to innovation and welcome innovation that feeds people. The projected population of our planet demands it,” he remarked.

Dr. Scott Gottlieb, Commissioner of the FDA, spoke at the meeting about how cell-cultured food technology has advanced rapidly over the last few years, with numerous companies working to develop new products. “The FDA has been contacted by several firms wanting to use cell-cultured animal cells from various species,” said Gottlieb. “It’s clear to us cell-cultured products will take many forms—livestock and poultry, and seafood is also on the horizon. At the FDA, we foresee this technology could be used for a variety of multi-component food and food products that can only be imagined right now. And it won’t be long until these products reach a wide marketplace.”
Gottlieb noted that the cost of producing cell-cultured food products is 1/50th of the cost it was just three years ago. “I don’t have a crystal ball to see the future, but I wouldn’t be surprised to see cell-cultured burgers on restaurant menus in the coming years,” he added.

Gottlieb went on to say that safety of the products is at the forefront of their work. He explained that the technology started in the medical field, and that the FDA had already approved many cell-cultured products and issued guidelines for those products. He also noted that a cell-cultured product inserted in the human body was very different than cell-cultured products that are ingested.

You can view the recorded webinar from the public meeting on the FSIS website at www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/past-meetings.

According to a 2017 article titled “Cellular Agriculture: The Future of Food,” by CellAgri, a research and insights platform that provides the latest insights on a range of topics relating to cellular agriculture, several companies have already produced meat and milk products using the technology. It also explains how it works and the reasons to consider it. “Instead of raising, for example, a cow from birth for milk and meat, cellular agriculture presents an alternative way to get the exact same real product without all of the problems associated with raising livestock.”

Advantages it cites to using cellular agriculture is less use of land and water; less gas emissions (methane) into the atmosphere; no antibiotics in the meat, and no E. coli or salmonella infections. The industry often refers to its product as “clean meat.” The article can be found at https://www.cell.ag/cellular-agriculture-future-of-food.

Another article on the website explains more in depth how the process works. In a nutshell, the process takes cells from animals, and grows the cells using liquid solutions in controlled conditions in a laboratory or “brewery.” Read about that at https://www.cell.ag/cell-ag-from-lab-to-market.

An article in Ag Week, titled “Cultured meat: Good or bad, promise or peril?” gives reactions from both proponents and skeptics. Those in favor list some of the same things as above. Skeptics say much more data is needed to support the argument that cell-based meat on a large scale would provide major environmental benefits. One noted that since the cell-based meat isn’t currently mass-produced it’s hard to know how much energy it would use, and that grass eaten by the cows is produced with free solar energy.

Another skeptic in the article noted a UN report that listed cows as “Upcyclers.” 

“A key line from the report said: ‘Livestock, especially ruminants like beef cattle, play a key role in a sustainable food system. They allow us to produce food on marginal lands that are unsuitable for cultivated agriculture. Cattle act as “upcyclers” in our food system—they upgrade plants into high quality protein for people.’ The report also found that 86 percent of what livestock eat globally — mostly grass on land unsuited for crops—is inedible for humans.” Read the entire article here: https://www.agweek.com/business/agriculture/4568613-cultured-meat-good-or-bad-promise-or-peril

Many cattle producers object to the cellular agriculture industry calling their product “clean meat.” That was made obvious in the public comment section that USDA and FDA made available about the issue. In fact, the Tennessee Farm Burea commented in the USDA and FDA public comment section on their website expressing that view. 

“New products should not be able to use the good name of meat and poultry to attract consumers. Likewise, new products should not be allowed to diminish the reputation of traditional meat and poultry products in the labeling. The use of the term “clean-meat” or other such terms designed to rhetorically signify the cell cultured products are of higher quality should not be allowed,” they wrote. To read more of the comments, go to https://www.regulations.gov/docket?D=FSIS-2018-0036.

The Post spoke with some local residents to find out what they thought about this new food technology. Most had not heard of it and were skeptical, wondering how they would know what was in the meat. 

Brent and Jenny Skelonc, owners of Six S Dairy in Nelson Township, have an answer for that. They take pride in the grass fed milk and beef, pastured pork and chicken, and free range eggs they can offer customers. “If you are among the growing population who feel it’s important to know exactly what it is you’re feeding your family, this article just drives home the point of how important it is to personally know your farmers. Know your farmer—know your food. Eat local and support your community,” they said.

To read the complete news release from the USDA/FDA go to https://www.usda.gov/media/press-releases/2019/03/07/usda-and-fda-announce-formal-agreement-regulate-cell-cultured-food.

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Various Duncan Hines cake mixes recalled

CHICAGO – Conagra Brands is collaborating with health officials in connection with a positive finding of Salmonella in a retail sample of Duncan Hines Classic White cake mix that may be linked to a Salmonella outbreak that is currently being investigated by CDC and FDA. While it has not been definitively concluded that this product is linked to the outbreak and the investigation is still ongoing, Conagra has decided to voluntarily recall the specific Duncan Hines variety identified (Classic White) and three other varieties (Classic Butter Golden, Signature Confetti and Classic Yellow) made during the same time period out of an abundance of caution.

Five occurrences of illnesses due to Salmonella are being researched by CDC and FDA as part of this investigation. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonellaoften experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Several of the individuals reported consuming a cake mix at some point prior to becoming ill, and some may have also consumed these products raw and not baked. Consumers are reminded not to consume any raw batter. Cake mixes and batter can be made with ingredients such as eggs or flour that can carry risks of bacteria that are rendered harmless by baking, frying or boiling. Consumers are reminded to wash their hands, work surfaces, and utensils thoroughly after contact with raw batter products, to follow baking instructions, and to never eat raw batter.

The products covered by this recall were distributed for retail sale in the U.S. and limited international exports; the specific product information is listed below. No other Duncan Hines products or Conagra Brands’ products are impacted by this recall.

Product Description & Brand Product UPC Best If Used By Date
(located on top of box)
Duncan Hines Classic White Cake 15.25oz. 644209307500 MAR 7 2019
MAR 8 2019
MAR 9 2019
MAR 10 2019
MAR 12 2019
MAR 13 2019
Duncan Hines Classic Yellow Cake 15.25oz. 644209307494 MAR 9 2019
MAR 10 2019
MAR 12 2019
MAR 13 2019
Duncan Hines Classic Butter Golden Cake 15.25oz. 644209307593 MAR 7 2019
MAR 8 2019
MAR 9 2019
Duncan Hines Signature Confetti Cake 15.25oz. 644209414550 MAR 12 2019
MAR 13 2019

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Cereal recalled due to Salmonella

Kellogg Company announced last week that it is voluntarily recalling 15.3 oz. and 23 oz. packages of Kellogg’s ® Honey Smacks ® cereal (with code dates listed below) because these products have the potential presence of Salmonella. No other Kellogg products are impacted by this recall.

Kellogg launched an investigation with the third-party manufacturer who produces Honey Smacks immediately after being contacted by the Food & Drug Administration (FDA) and Centers for Disease Control (CDC) regarding reported illnesses.

According to the CDC, use or consumption of products contaminated with Salmonella may result in serious illness. It can also produce serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy individuals infected with Salmonella can experience fever, diarrhea, nausea, vomiting and abdominal pain. The illness usually lasts four to seven days, and most persons recover without treatment. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses.

How to identify the recalled product

The affected product includes the following varieties distributed across the United States as well as limited distribution in Costa Rica, Guatemala, Mexico, the Caribbean, Guam, Tahiti and Saipan. The BEST if Used By Date can be found on the top of the cereal box, and the UPC code can be found on the bottom of the box.

  • Honey Smacks (with limited distribution outside the U.S.)
  • 3800039103 15.3 oz  JUN 14, 2018 through JUN 14, 2019
  • Honey Smacks  3800014810  23 oz  JUN 14, 2018 through JUN 14, 2019

Kellogg is asking that people who purchased potentially affected product discard it and contact the company for a full refund. Consumers seeking more information, can visit kelloggs.com/honeysmacksrecall or call 1-800-962-1413 Monday-Friday, from 9 a.m. to 6 p.m. ET as well as Saturday and Sunday from 10 a.m.  to 4 p.m. ET.

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Blueberry pancake mix recalled


N-Recall1Continental Mills has issued a recall affecting only retail Krusteaz Blueberry Pancake Mix, which involves product manufactured between April 2016 and June 2016.

“The company was notified by our supplier that their product, a blueberry nugget, is made with a small percentage of affected flour which was recalled by General Mills because it may be contaminated with E. coli O121. This is an isolated issue, and only affects specific lots of Krusteaz Blueberry Pancake Mix. Food Safety is our highest priority and this has caused us to take action for the safety of our consumers,” stated the company in a press release.

Most strains of E. coli are harmless, however, others can make you sick. E. coli O121 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. People who experience these symptoms should seek emergency medical care immediately. The very young, seniors, and those with compromised immune systems are the most susceptible to foodborne illness. Anyone diagnosed by a physician as having an illness related to E. coli 0121 should contact state and local public health authorities.

N-Recall2No illnesses have been reported to date from the pancake mix.

FDA and the Centers for Disease Control (CDC) continues to warn that consumers should refrain from consuming any raw products made with flour. E. coli O121 is eliminated by heat through baking, frying, sautéing or boiling products made with flour. All surfaces, hands and utensils should be properly cleaned after contact with flour or dough.

Product was distributed nationwide where consumers purchased product through retail stores.

If you have recently purchased Krusteaz Blueberry Pancake Mix 28 oz. carton with a best by date code between 3/30/2018 and 6/16/2018, and a UPC code 041449001289, please contact our Consumer Relations Team at 1-800-457-7744 for information to receive a full refund. Please dispose of the product.

If you have recently purchased Krusteaz Blueberry Pancake a 3.5 lb. bag, with a best by date code between of 4/27/2018 to 4/28/2018, with a UPC code 041449001487, please contact our Consumer Relations Team at 1-800-457-7744 for information to receive a full refund. Please dispose of the product.

“The quality and safety of our products is of the utmost importance and we are doing everything possible to ensure our customers have all of the pertinent information,” said Andy Heily, Continental Mills’ president.

For more information, please call the Recall Phone Hotline at 1-800-457-7744 Monday – Friday 7 am to 4 pm PT.To see the original recall and updates on the Gold Medal, Wondra and Signature Kitchens flour, go to http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm504192.htm

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