Latest news with #GRAS
CNN
4 days ago
- Health
- CNN
A former FDA chief's ‘brilliant' move to test the agency's commitment to making America healthy
The former head of the US Food and Drug Administration is testing the Trump administration's commitment to 'Make America Healthy Again' with a challenge to crack down on some of the key ingredients in ultraprocessed foods. In a petition filed Wednesday, the former FDA commissioner, Dr. David Kessler, argued that the agency has the authority to declare that certain sweeteners, refined flours and other additives are not 'generally recognized as safe.' Removing that designation, known as GRAS, would force makers of ultraprocessed foods to remove products from the market and reformulate recipes — or try to prove that those ingredients are not harmful. It would be a sweeping change to the food industry and a significant shift in the Trump administration's MAHA strategy. So far, US Health and Human Services Secretary Robert F. Kennedy Jr. has relied on popular food brands to volunteer to remove artificial dyes and other additives from their products. 'Kessler has given the FDA a way to define the vast majority of ultra-processed foods. In doing so, he has handed RFK Jr a huge gift on the path to regulating these products. It's just what MAHA has asked for. I hope they take it seriously,' Marion Nestle, the Paulette Goddard professor emerita of nutrition, food studies and public health at New York University, said in an email. Kessler proposed that companies have 12 months to submit a petition to keep those food additives in their products and then go on to prove they are safe. 'It's a very appropriate, worthy step to shift the burden of proof where it belongs and have the industry meet that burden, or stop using the substances.' said Michael Taylor, a former FDA food regulator and current co-chair of the nonprofit STOP Foodborne Illness. 'It's using the GRAS tool to really drive a serious safety conversation.' HHS did not respond to a request for comment. Federal health officials announced last month that they are looking for input on how to define ultraprocessed foods, a first step in eventually setting up new regulations, which could take months to years to establish. Kessler's petition could put pressure on that ultimately lengthy timeline; the agency is required to respond to the request within 180 days. Kessler, a physician who served as FDA commissioner under presidents Bill Clinton and George H.W. Bush, and advised President Joe Biden during the Covid-19 pandemic, oversaw the agency when it began requiring nutrition labels on food products. He also spearheaded efforts for FDA to regulate tobacco in the 1990s and sees parallels to that fight. 'What was key in tobacco was finding the regulatory hook,' Kessler told CNN. 'It was about asking the right legal question that would frame the issue.' That has been the tricky part of setting up any regulatory standards for sugary and starchy foods, he said. The term ultra processed foods has resonated with the public, he said, but 'it's going to be hard to define, legally, what's in it.' But there is a pressing need to do that, he argues. The FDA allowed these ingredients under GRAS regulations four decades ago, and rates of obesity, diabetes, and heart disease have climbed in the years since, he wrote in his petition. The argument echoes Kennedy's own case for MAHA reforms to food policy. The petition focuses on refined flours and starches — which the body breaks down into sugars — that are subjected to food extrusion technology, including wheat, corn, tapioca, oat and potato flour. It also references refined sugars, including corn syrup, corn solids, dextrose, xylose, maltose, and high-fructose corn syrups. Finally, the petition targets any manufactured sugars, flours and starches that contain additives commonly used in today's ultraprocessed foods. Tackling the issue of too much sugar is a key to better health, experts CNN spoke with agree, but they say the real genius of Kessler's petition is his focus on additives. 'The food industry uses the emulsifiers, the stabilizers, the gels and the rest to make inexpensive, high volume, industrially processed foods,' said Christopher Gardner, director of nutrition studies at the Stanford Prevention Research Center. 'If you take those tools away from industry it's not that foods will taste bad and icky,' Gardner said. 'They won't be as addictive, as flavorful, as tasty — and industry has made these foods as manipulatively flavorful and manipulatively tasty. That's the problem.' Several food and nutrition experts heralded Kessler's petition as a bold move that would, if enacted by FDA, reshape the food industry. 'This is an important proposal that is based on the true meaning of GRAS, which would exclude the majority of foods on our grocery shelves,' said leading nutrition researcher Dr. Walter Willett, professor of epidemiology and nutrition at Harvard T.H. Chan School of Public Health and professor of medicine at Harvard Medical School in Boston. The GRAS standard, created in 1958, was originally intended to narrowly apply to commonly used ingredients in the nation's food supply, such as oil, vinegar and baking soda. Manufacturers that used those products could rely on existing research to show their safety but are supposed to file GRAS petitions for newer ingredients like refined sugars. FDA updated its system in the late 1990s — amid a backlog of petitions for new additives — allowing companies to voluntarily notify the agency that they had determined their ingredients were generally safe. A 2022 analysis conducted by the Environmental Working Group found that nearly 99% of new chemicals used in food or food packaging since 2000 were green-lit for use not by the FDA but by the food and chemical industry. During that period, food manufacturers asked the FDA's permission to introduce a new substance only 10 times, according to the analysis. Barry Popkin, the W. R. Kenan, Jr. Distinguished Professor at the Gillings School of Global Public Health in Chapel Hill, North Carolina, called Kessler's petition 'a brilliant move.' 'Knowing the FDA like he does - he's put industry in a real bind,' Popkin said. 'They have to show that without a reasonable doubt that carbohydrates, along with additives, are healthy, and do not hurt health. And that's next to impossible. 'It's the strongest play a citizen can do to affect our food supply that I've ever seen.' But Kessler's proposed changes are likely to meet significant pushback from major food brands. Michael Taylor was FDA's deputy commissioner for foods in 2015 when the agency revoked the GRAS status of partially hydrogenated oils, or trans fats, citing extensive research about their links to risks of heart disease and stroke. The agency gave companies three years to comply and remove those oils from their products. But at that time, 'the handwriting was on the wall' for industry and many companies had already stopped using those trans fats, Taylor said. 'Obviously the substances that [Kessler] is describing, it's a lot of … highly processed, fine carbohydrates, and a lot of products.' The petition lands as Trump administration officials, led by Kennedy, prepare to release their second MAHA report. While the MAHA Commission's first dispatch in June singled out potential drivers of chronic illnesses in children — including ingredients in ultraprocessed foods — its second installment is expected to lay out proposed policy changes. The report is due by Tuesday.
CNN
5 days ago
- Health
- CNN
A former FDA chief's ‘brilliant' move to test the agency's commitment to making America healthy
The former head of the US Food and Drug Administration is testing the Trump administration's commitment to 'Make America Healthy Again' with a challenge to crack down on some of the key ingredients in ultraprocessed foods. In a petition filed Wednesday, the former FDA commissioner, Dr. David Kessler, argued that the agency has the authority to declare that certain sweeteners, refined flours and other additives are not 'generally recognized as safe.' Removing that designation, known as GRAS, would force makers of ultraprocessed foods to remove products from the market and reformulate recipes — or try to prove that those ingredients are not harmful. It would be a sweeping change to the food industry and a significant shift in the Trump administration's MAHA strategy. So far, US Health and Human Services Secretary Robert F. Kennedy Jr. has relied on popular food brands to volunteer to remove artificial dyes and other additives from their products. 'Kessler has given the FDA a way to define the vast majority of ultra-processed foods. In doing so, he has handed RFK Jr a huge gift on the path to regulating these products. It's just what MAHA has asked for. I hope they take it seriously,' Marion Nestle, the Paulette Goddard professor emerita of nutrition, food studies and public health at New York University, said in an email. Kessler proposed that companies have 12 months to submit a petition to keep those food additives in their products and then go on to prove they are safe. 'It's a very appropriate, worthy step to shift the burden of proof where it belongs and have the industry meet that burden, or stop using the substances.' said Michael Taylor, a former FDA food regulator and current co-chair of the nonprofit STOP Foodborne Illness. 'It's using the GRAS tool to really drive a serious safety conversation.' HHS did not respond to a request for comment. Federal health officials announced last month that they are looking for input on how to define ultraprocessed foods, a first step in eventually setting up new regulations, which could take months to years to establish. Kessler's petition could put pressure on that ultimately lengthy timeline; the agency is required to respond to the request within 180 days. Kessler, a physician who served as FDA commissioner under presidents Bill Clinton and George H.W. Bush, and advised President Joe Biden during the Covid-19 pandemic, oversaw the agency when it began requiring nutrition labels on food products. He also spearheaded efforts for FDA to regulate tobacco in the 1990s and sees parallels to that fight. 'What was key in tobacco was finding the regulatory hook,' Kessler told CNN. 'It was about asking the right legal question that would frame the issue.' That has been the tricky part of setting up any regulatory standards for sugary and starchy foods, he said. The term ultra processed foods has resonated with the public, he said, but 'it's going to be hard to define, legally, what's in it.' But there is a pressing need to do that, he argues. The FDA allowed these ingredients under GRAS regulations four decades ago, and rates of obesity, diabetes, and heart disease have climbed in the years since, he wrote in his petition. The argument echoes Kennedy's own case for MAHA reforms to food policy. The petition focuses on refined flours and starches — which the body breaks down into sugars — that are subjected to food extrusion technology, including wheat, corn, tapioca, oat and potato flour. It also references refined sugars, including corn syrup, corn solids, dextrose, xylose, maltose, and high-fructose corn syrups. Finally, the petition targets any manufactured sugars, flours and starches that contain additives commonly used in today's ultraprocessed foods. Tackling the issue of too much sugar is a key to better health, experts CNN spoke with agree, but they say the real genius of Kessler's petition is his focus on additives. 'The food industry uses the emulsifiers, the stabilizers, the gels and the rest to make inexpensive, high volume, industrially processed foods,' said Christopher Gardner, director of nutrition studies at the Stanford Prevention Research Center. 'If you take those tools away from industry it's not that foods will taste bad and icky,' Gardner said. 'They won't be as addictive, as flavorful, as tasty — and industry has made these foods as manipulatively flavorful and manipulatively tasty. That's the problem.' Several food and nutrition experts heralded Kessler's petition as a bold move that would, if enacted by FDA, reshape the food industry. 'This is an important proposal that is based on the true meaning of GRAS, which would exclude the majority of foods on our grocery shelves,' said leading nutrition researcher Dr. Walter Willett, professor of epidemiology and nutrition at Harvard T.H. Chan School of Public Health and professor of medicine at Harvard Medical School in Boston. The GRAS standard, created in 1958, was originally intended to narrowly apply to commonly used ingredients in the nation's food supply, such as oil, vinegar and baking soda. Manufacturers that used those products could rely on existing research to show their safety but are supposed to file GRAS petitions for newer ingredients like refined sugars. FDA updated its system in the late 1990s — amid a backlog of petitions for new additives — allowing companies to voluntarily notify the agency that they had determined their ingredients were generally safe. A 2022 analysis conducted by the Environmental Working Group found that nearly 99% of new chemicals used in food or food packaging since 2000 were green-lit for use not by the FDA but by the food and chemical industry. During that period, food manufacturers asked the FDA's permission to introduce a new substance only 10 times, according to the analysis. Barry Popkin, the W. R. Kenan, Jr. Distinguished Professor at the Gillings School of Global Public Health in Chapel Hill, North Carolina, called Kessler's petition 'a brilliant move.' 'Knowing the FDA like he does - he's put industry in a real bind,' Popkin said. 'They have to show that without a reasonable doubt that carbohydrates, along with additives, are healthy, and do not hurt health. And that's next to impossible. 'It's the strongest play a citizen can do to affect our food supply that I've ever seen.' But Kessler's proposed changes are likely to meet significant pushback from major food brands. Michael Taylor was FDA's deputy commissioner for foods in 2015 when the agency revoked the GRAS status of partially hydrogenated oils, or trans fats, citing extensive research about their links to risks of heart disease and stroke. The agency gave companies three years to comply and remove those oils from their products. But at that time, 'the handwriting was on the wall' for industry and many companies had already stopped using those trans fats, Taylor said. 'Obviously the substances that [Kessler] is describing, it's a lot of … highly processed, fine carbohydrates, and a lot of products.' The petition lands as Trump administration officials, led by Kennedy, prepare to release their second MAHA report. While the MAHA Commission's first dispatch in June singled out potential drivers of chronic illnesses in children — including ingredients in ultraprocessed foods — its second installment is expected to lay out proposed policy changes. The report is due by Tuesday.
New York Times
6 days ago
- Business
- New York Times
Kennedy's Crusade Against Food Safety Rule Threatens Supplement Industry
In his first weeks as health secretary, Robert F. Kennedy Jr. declared war on an obscure regulatory process that many argue has been exploited by the food industry for decades. The pathway allows companies to introduce new ingredients or chemicals into food products without a Food and Drug Administration review, as long as they self-certify them as 'generally recognized as safe,' or GRAS for short. The designation has allowed new chemicals to be viewed as 'innocent until proven guilty,' leading to thousands of ingredients flooding the American food system, Mr. Kennedy said at his confirmation hearing in January. 'It needs to end, and I believe I'm the one person who's able to end it,' he added. In March, Mr. Kennedy directed the Food and Drug Administration to revisit the GRAS rule, describing it as a 'loophole' that needed to be eliminated. Food companies and ultraprocessed snacks may be the target of Mr. Kennedy's ire. But the elimination of GRAS would also be a significant setback for the growing multibillion dollar supplement industry, which has regularly used the pathway to quickly bring new ingredients to market with little oversight. Mr. Kennedy's announcement has rattled the industry, prompting concerned calls from supplement makers and intense lobbying in Washington by the trade associations that represent them. Since March, leaders of four dietary supplement trade associations have met multiple times with F.D.A. officials to lobby the agency on the designation's benefits. Want all of The Times? Subscribe.
Yahoo
29-07-2025
- Business
- Yahoo
ClostraBio, Inc. Obtains Self-Affirmed GRAS Status for Next-Gen Probiotic Ingredient CLB101™
CHICAGO, July 29, 2025--(BUSINESS WIRE)--ClostraBio, Inc., a biotech company pioneering microbiome-based solutions for gastrointestinal health, today announced that its unique, next-generation probiotic strain, Anaerostipes caccae CLB101™, has been granted self-affirmed GRAS (Generally Recognized as Safe) status by a panel of scientific experts. This milestone clears the path for CLB101™ to enter the U.S. market as the first and only commercially available strain of Anaerostipes caccae. A strict anaerobe isolated from a healthy human, CLB101™ has been identified as a strain critical to gut health through its direct production of butyrate in targeted areas of the lower intestine. Butyrate is widely known as a key molecule to support gut health, and its mechanisms of action include strengthening intestinal barrier integrity, providing immune support, and promoting a diverse microbiome. "Receiving GRAS status marks a critical milestone for ClostraBio and validates the safety of CLB101™ as we move towards commercial launch," said Ritu Shah, CEO of ClostraBio. "This recognition reinforces our commitment to advancing safe, science-driven solutions that can help support gut health for the many people who are struggling today." The GRAS designation follows rigorous review of safety data, including genomic characterization, multiple toxicology studies, and a demonstrated manufacturing process with stringent quality control. ClostraBio is preparing to launch CLB101™ as a probiotic supplement in Fall 2025, through both direct and partnered distribution channels, including a strategic collaboration with a leading healthcare practitioner-focused supplement brand. For more information on ClostraBio and CLB101™, please visit About ClostraBio: ClostraBio is leveraging a science driven, multi-pronged approach to address conditions of the lower gut, using novel biotechnology to harness natural pathways. The Company is developing a next-generation probiotic that produces butyrate in the lower gut to impact intestinal barrier function and promote gut health, as well as a novel polymeric prodrug platform designed to deliver small molecules to the lower gut. ClostraBio was spun out of the University of Chicago and is incubated at Portal Innovations. View source version on Contacts Media Contact:Nick Pennebaker, Sr. Director of Marketing and CommunicationsPortal InnovationsEmail: Company/Business Contact:Ritu Shah, CEOClostraBio, info@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
29-07-2025
- Business
- Business Wire
ClostraBio, Inc. Obtains Self-Affirmed GRAS Status for Next-Gen Probiotic Ingredient CLB101™
CHICAGO--(BUSINESS WIRE)--ClostraBio, Inc., a biotech company pioneering microbiome-based solutions for gastrointestinal health, today announced that its unique, next-generation probiotic strain, Anaerostipes caccae CLB101™, has been granted self-affirmed GRAS (Generally Recognized as Safe) status by a panel of scientific experts. This milestone clears the path for CLB101™ to enter the U.S. market as the first and only commercially available strain of Anaerostipes caccae. A strict anaerobe isolated from a healthy human, CLB101™ has been identified as a strain critical to gut health through its direct production of butyrate in targeted areas of the lower intestine. Butyrate is widely known as a key molecule to support gut health, and its mechanisms of action include strengthening intestinal barrier integrity, providing immune support, and promoting a diverse microbiome. 'Receiving GRAS status marks a critical milestone for ClostraBio and validates the safety of CLB101™ as we move towards commercial launch,' said Ritu Shah, CEO of ClostraBio. 'This recognition reinforces our commitment to advancing safe, science-driven solutions that can help support gut health for the many people who are struggling today.' The GRAS designation follows rigorous review of safety data, including genomic characterization, multiple toxicology studies, and a demonstrated manufacturing process with stringent quality control. ClostraBio is preparing to launch CLB101™ as a probiotic supplement in Fall 2025, through both direct and partnered distribution channels, including a strategic collaboration with a leading healthcare practitioner-focused supplement brand. For more information on ClostraBio and CLB101™, please visit About ClostraBio: ClostraBio is leveraging a science driven, multi-pronged approach to address conditions of the lower gut, using novel biotechnology to harness natural pathways. The Company is developing a next-generation probiotic that produces butyrate in the lower gut to impact intestinal barrier function and promote gut health, as well as a novel polymeric prodrug platform designed to deliver small molecules to the lower gut. ClostraBio was spun out of the University of Chicago and is incubated at Portal Innovations.
