FDA

TurtleTree CEO

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Approvals

TurtleTree Becomes First to Receive FDA Clearance for Precision-Fermented Lactoferrin

California-based biotech company TurtleTree has secured a “No Questions” letter from the US Food and Drug Administration (FDA) for its precision fermentation-produced lactoferrin, referred to as LF+. This correspondence indicates that the FDA has completed its review of TurtleTree’s Generally Recognized as Safe (GRAS) dossier without raising any safety concerns, allowing the ingredient to be used in food products within the United States. The FDA’s assessment of LF+ encompassed genomic, toxicological, compositional, and functional analyses, which formed part of the GRAS submission. The agency’s “No Questions” letter confirms that the agency has no further inquiries regarding the ingredient’s safety under the intended conditions of use. Fengru Lin, CEO and co-founder of TurtleTree, commented on the FDA’s decision, noting its significance for the company and the …

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Animal testing

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Science

FDA to Phase Out Animal Testing Requirement for Some Drugs in “Win for Public Health & Ethics”

The U.S. Food and Drug Administration (FDA) has announced it will be phasing out animal testing in the development of monoclonal antibody therapies and some other drugs, in what has been described as a “groundbreaking step to advance public health”. Animal testing will be replaced with more effective, human-relevant methods, including AI-based computational models of toxicity and cell lines along with organoid toxicity testing in a laboratory setting. Where a drug has already been tested in humans, the FDA will also use pre-existing, real-world safety data from other countries with comparable regulatory standards. The new regimen will begin immediately for investigational new drug (IND) applications. The approach is designed to improve drug safety, accelerate the evaluation process, reduce animal experimentation, lower research and development costs, …

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FDA headquarters

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Politics & Law

FDA Issues Draft Guidance on Labeling Plant-Based Foods: What Brands Need to Know

The US Food and Drug Administration (FDA) has released draft guidelines aimed at improving transparency in the labeling of plant-based alternatives to animal-derived foods. While this document is non-binding, it gives plant-based brands a preview of what the FDA considers best practices for labeling—and a potential roadmap for future regulations. These recommendations cover plant-based substitutes for eggs, seafood, poultry, meat, and dairy products under FDA jurisdiction, excluding plant-based milk, which is addressed in separate guidance. According to the FDA, the goal is to ensure that “consumers understand the nature or source of individual plant-based alternative foods, including differences among these products, and have the information they need to make informed purchasing decisions.” Clearer statements of identity A key focus of the guidance is the statement …

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Animal-Free Dairy Milk

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Politics & Law

Dairy Farmers’ Letter to the FDA: “It is Baseless, Preposterous and Absurd” to Refer to Animal-Free Dairy as Milk

The National Milk Producers Federation (NMPF) has written a letter to the Food and Drug Administration (FDA) urging it to ban the word ‘milk’ in the labeling of synthetic food products, arguing it violates the federal dairy Standard of Identity. The NMPF argues that milk is “the lacteal secretions of healthy cows (are dairy cows healthy?) and that alternatives made with synthetic dairy proteins simply use the word to masquerade as natural.  NMPF’s highlight of mislabeling is Bored Cow’s animal-free dairy milk made with precision fermentation-derived whey protein and other ingredients such as oils, sugars, water, vitamins, and minerals. Bored Cow’s animal-free milk launched at US natural foods retailer Sprouts Farmers Market this April. The company claims its milk alternative contains 8g of protein per cup (like …

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GOOD Cultured Meat

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Cultivated Meat

FDA Commissioner Calls Biotech in Food a “Huge Interest” for the Agency, Sparking Anger from US Cattle Industry

During a March 29 budget hearing for the US Food and Drug Administration, FDA Commissioner Robert Califf made references to climate change and suggested that the use of biotechnology in food (including cell-cultured meat) was an area of “huge interest” that could help mitigate these issues. Califf’s comments quickly sparked outrage from the US cattle industry, who accused the commissioner of inappropriately promoting an environmental policy and endorsing cultivated meat products.  On Wednesday, Califf testified before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. During the hearing, Representative Julia Letlow (R-LA) asked the Commissioner how the agency plans to coordinate with the US Department of Agriculture (USDA) on pre-market consultation for reviewing cell-cultured chicken products.  In response, Califf …

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GOOD Cultured Meat

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Cultivated Meat

FDA Commissioner Calls Biotech in Food a “Huge Interest” for the Agency, Sparking Anger from US Cattle Industry

During a March 29 budget hearing for the US Food and Drug Administration, FDA Commissioner Robert Califf made references to climate change and suggested that the use of biotechnology in food (including cell-cultured meat) was an area of “huge interest” that could help mitigate these issues. Califf’s comments quickly sparked outrage from the US cattle industry, who accused the commissioner of inappropriately promoting an environmental policy and endorsing cultivated meat products.  On Wednesday, Califf testified before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. During the hearing, Representative Julia Letlow (R-LA) asked the Commissioner how the agency plans to coordinate with the US Department of Agriculture (USDA) on pre-market consultation for reviewing cell-cultured chicken products.  In response, Califf …

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Cultivated chicken FDA approval

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Politics & Law

In Historic Milestone, GOOD Meat Receives US Regulatory Approval for Cultivated Chicken

In a historic milestone, cultivated meat startup GOOD Meat, a subsidiary of Eat Just, announces it has received a No Questions letter from the US Food and Drug Administration (FDA), as part of the agency’s pre-market review process. The decision marks the first time a cultivated meat product has received regulatory approval on multiple continents, as GOOD Meat’s cultivated chicken previously received approval in Singapore.  The move comes just months after Berkeley startup UPSIDE Foods received the FDA’s first regulatory greenlight to sell cultivated meat, poultry or seafood.  According to the Good Food Institute (GFI), the GOOD Meat decision marks only the second time cultivated meat has received US regulatory approval, and signals a major food system transformation.   “Today’s news is more than just another …

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Silk Launches NextMilk Dairy Lovers

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Politics & Law

FDA’s Draft Guidance on Plant-Based Milk Labelling: Experts Respond

Yesterday, the US Food and Drug Administration (FDA) released draft guidance on plant-based milk labelling. The guidance, which is not legally binding, affirms that plant-based products can use the word “milk” on their packaging. The decision has been made based on FDA research which found that consumers are not confused by this usage, with most preferring the term “milk” over others such as “drink” or “beverage”. However, the FDA notes that plant-based milks do not contain the same balance of nutrients as cows’ milk, and suggests that manufacturers should make this clear on packaging with statements such as “50% more calcium than milk” or “Contains a lower amount of potassium than milk”. The document has already proven controversial; some commenters have welcomed the recognition that …

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Plant-based milk requirements

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Politics & Law

“Imposes New Burdens”: FDA Releases Draft Guidance on Plant-Based Milk Labels

Today, the US Food and Drug Administration (FDA) released draft guidance on plant-based milk labeling. According to the agency, the draft guidance, when finalized, is non-binding and will represent the current thinking of the FDA on the topic of naming and voluntary nutrient labeling of plant-based milks. In summary, the agency now says plant-based milk alternatives can be called “milk”, but recommends such products to identify certain nutritional differences from cow’s milk on their front-of-package labeling.  In the guidance document, the FDA notes it has not established compositional requirements for plant-based milk alternatives, and that such products comprise a wide diversity of ingredients and methods of production.  Consumers not confused The agency also acknowledges that, as evidenced by numerous consumer studies and its own focus …

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ProVeg Oat Milk/ Dairy-Free Milk

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Politics & Law

ProVeg Urges FDA to Protect Consumer Choice as Agency Considers Plant-Based “Milk” Ban

Food awareness organization ProVeg International is urging the US Food and Drug Administration (FDA) to refrain from issuing new guidance that could discriminate against America’s rapidly growing plant-based milk sector. The FDA has sent an unpublished guidance document, entitled “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements”, to the Office of Management and Budget (OMB). ProVeg has learned this document may include a ban on the use of “milk” terms for plant-based products out of fear that it misleads consumers.  The organization is now calling on the FDA to protect dairy-free milk products from such labeling restrictions, which it says would discourage and impede food innovation.  Congressional letter Four US Senators, including Cory Booker, Mike Lee and Julia Brownley, already issued a letter to …

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UPSIDE Foods FDA greenlight

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Cultivated, Cell-Cultured & Biotechnology

FDA’s Approval of Cultivated Meat: Industry Leaders Respond

Following this week’s groundbreaking news of UPSIDE Food receiving GRAS status for its cultivated chicken, marking the first time in the world that the FDA has given the green light to a cultivated meat product, industry leaders from the GFI, Stray Dog Capital, BioTech Foods, and Synthesis Capital here provide commentary on the significance of this historic development.   To recap: UPSIDE Foods has now successfully completed the FDA’s rigorous pre-market safety review for its cultivated chicken, demonstrating that it is as safe as conventional chicken. This historic milestone will pave the way for consumers to access these products in restaurants and retail across the country and ultimately across the world.   Seth Roberts, GFI The Good Food Institute Europe (GFI Europe) – the leading …

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Future Fields cultured meat

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Cultivated, Cell-Cultured & Biotechnology

Cell Cultured US Market Entry Edges Closer as USDA Seeks Comments on Labeling

The US Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has published an advance notice of proposed rulemaking (ANPR) with regards to cell-cultured labeling of meat and poultry products. The ANPR will solicit comments and information on labeling and the FSIS will use these comments to inform future regulatory requirements. “We want to hear from stakeholders and will consider their comments as we work on a proposed regulation for labeling these products” – USDA The ANPR requests comment on specific topics to be considered during regulatory approval on labeling of cell-cultured meat and poultry products. Topics include; consumer expectations on nutritional composition and organoleptic qualities, naming of products that are neither false nor misleading, economic data, and any consumer research related to labeling …

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Sternchemie sunflower FDA

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Company News

Sunflower Lecithin From Sternchemie is Recognised as Safe by the FDA for North American Market

Sternchemie has received a GRAS “letter of no objection” from the US Food and Drug Administration (FDA) for its wide range of sunflower lecithins. GRAS stands for “Generally Recognised As Safe” and provides certainty and transparency for food manufacturers. With this determination, the FDA confirms that sunflower lecithin from Sternchemie, whether liquid, de-oiled or hydrolysed, can safely be used in a wide variety of food products.

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lab meat

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Society

USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

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) today announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry.

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In-Vitro-Fleisch in der Petri-Schale

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Society

Memphis Meat and NAMI Ask Trump to Regulate Labelling of Laboratory Meat

The North American Meat Institute (NAMI) and cell-based meat developer Memphis Meats have jointly written a letter to President Trump asking for help in clarifying the regulatory framework for cell-based meat and poultry products. They are calling on the Trump administration to regulate the US protein industry. “Cell-based meat products are meat produced from animal cells in cell cultures. They are an “and”, not an “or” solution, and the latest in a long history of innovation in American agriculture,” the letter says. “In recognition of the common desire to support innovation and feed the world, we will in future use the term “cell-based meat and poultry” to describe products that are the result of animal cell culture.” Uma Valeti, CEO of the Memphis Meats start-up, …

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Tofurky sausages

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Top Stories

New Law on Vegan “Meat” Labelling Threatens Imprisonment: Tofurky Fight Back

American broadcasters CBS news reported this Tuesday that Missouri is the first US state to bring into effect a new law banning the use of the word “meat” to describe any product not derived from an animal. From immediate effect, food manufacturers will be unable to describe products as meat if “not derived from harvested production livestock or poultry.”

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