FDA launches agency-wide AI tool
Why it matters: The model, dubbed "Elsa," is being rolled out weeks ahead of schedule and is designed to help with tasks such as summarizing adverse events to support drug safety profiles, and to generate code for databases.
The big picture: FDA said the technology was built in Amazon Web Services' GovCloud environment, which is designed to host sensitive government data. It isn't being trained with proprietary data submitted by drug and device manufacturers, according to a summary shared ahead of the public rollout.
FDA did not detail specifically what information the model is being trained on, but said it offers a "secure platform for FDA employees to access internal documents."
FDA said it's using the technology to review clinical protocols and speed up scientific evaluations. It soon will be used to identify high-priority targets for inspections, though it did not specify what kind.
Zoom out: Public health experts told Axios last month that using more AI within the FDA is a good idea, but questioned how secure the data will be and how quickly the technology can really be integrated into the agency's workflow.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Wall Street Journal
17 minutes ago
- Wall Street Journal
Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag
Meet Vinay Prasad, a young disciple of Bernie Sanders who ranks as one of the most powerful officials in the federal government. He determines whether patients get access to many life-saving medicines. Or not. Think of him as a one-man death panel. Dr. Prasad was named by Marty Makary, the Food and Drug Administration commissioner, as head of the agency's biologics division in May, and last month as its chief medical and scientific officer. More on why he was tapped to these posts later. But it isn't an exaggeration to say that Dr. Prasad wields more power than Anthony Fauci ever did at the National Institutes of Health.
Miami Herald
3 hours ago
- Miami Herald
Ice Cream Recalled Nationwide As Warning Issued Over Products
Tropicale Foods, based in Ontario, California, announced on Friday a voluntary recall of select Helados Mexico and La Michoacana ice cream products. The decision followed a label audit which revealed that although the products list "cream," they do not explicitly declare "milk"—that could endanger those allergic to milk. Newsweek contacted the company for comment on Sunday via email outside of usual working hours. Milk is a major allergen under federal labeling laws, and its accidental presence in products poses a risk to consumers with allergies or severe sensitivities. Undeclared ingredients can trigger life-threatening reactions, making accurate labeling a critical public health requirement. The company announcement, published on the Food and Drug Administration (FDA)'s website on Saturday, states: "Tropicale Foods of Ontario, CA is recalling certain Helados Mexico and La Michoacana products with specific best by dates, as detailed below because these products contain undeclared milk. "Though these products include 'cream' in the product ingredient lists, the common name 'milk' is not declared. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products." Affected items include single-flavor offerings (such as Coconut, Strawberry, Bubble Gum, Cookies and Cream, Mango), as well as multi-packs (6‑pack, 12‑pack, 16‑pack varieties). The recalled products are as follows: Photos of the affected products are available on the FDA website. The recall covers a wide range of "best by" dates from May 2026 through July 2027. Distribution spanned retail locations nationwide across the U.S. As of the FDA announcement, one consumer illness has been reported. Consumers with affected items who are allergic or sensitive to milk are advised not to consume the products and to properly dispose of them. Food Allergy Research and Education (FARE) states on its website: "When a person with a milk allergy is exposed to milk, proteins in the milk bind to specific antibodies made by the person's immune system. This triggers the person's immune defenses, leading to reaction symptoms that can be mild or very severe." Consumers who have the affected product should dispose of and not consume this product if allergic or sensitive to milk, and consult medical advice if symptoms arise. Anyone with queries may contact the company at 909-563-3090 between 8 am and 5 pm Pacific, Monday to Friday. The FDA will continue oversight and monitor any additional consumer reports or updates. Related Articles Is the FDA Doing Enough About Food Additives?Nationwide Ritz Cracker Recall Update as FDA Issues Risk WarningCanned Fruit Recall Sparks Nationwide Warning to CustomersFDA Issues Highest Risk Warning for Tofu Recall 2025 NEWSWEEK DIGITAL LLC.
The Hill
5 hours ago
- The Hill
Coke with cane sugar may not be that big of a MAHA victory
Coca-Cola is going to offer a cane sugar version of its signature beverage, rather than one sweetened with corn syrup. Major segments of the food industry, including General Mills and Heinz, have pledged to remove certain colored dyes from their products. The fast-food chain Steak 'n Shake is making french fries in beef tallow rather than vegetable oil. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has claimed them all as significant victories for his 'make America healthy again' (MAHA) movement as part of its quest to reform the U.S. food supply. 'Froot Loops is finally following its nose — toward common sense,' Kennedy said on social platform X after cereal-maker WK Kellogg Co. agreed to remove synthetic dyes from its cereal by 2027. 'I urge more companies to step up and join the movement to Make America Healthy Again.' But nutrition and food policy experts say the moves are a far cry from actually making America healthier. While they praised the administration and MAHA for drawing attention to what they said is a broken food system, the victories touted thus far have been largely symbolic and rely on the goodwill of an industry that is eager to appear helpful to avoid strict government regulation. 'I think if we're really curious about improving public health, some of the small health initiatives, like … replacing high fructose corn syrup with cane sugar, are really not where the administration should be channeling their efforts and leveraging the power that they do have,' said Priya Fielding-Singh, director of policy and programs at the George Washington University Global Food Institute. 'I think they should be focusing their efforts on initiatives that actually address the root of the problem, which is essentially a food system that promotes excess sugar, salt and fat,' Fielding-Singh said. Health officials and GOP lawmakers have taken to conservative media in recent weeks to tout the commitments from food and beverage companies to remove synthetic dyes. According to the HHS, nearly 35 percent of the industry has made such a commitment. But there's been no force behind the companies' actions, which experts said is an issue. 'Simply switching from synthetic to natural colors will not make these products less likely to cause obesity,' said Jerold Mande, a former senior official during three administrations at the Food and Drug Administration (FDA), the Department of Agriculture and the Occupational Safety and Health Administration. Barry Popkin, a nutrition professor at the University of North Carolina Gillings School of Global Public Health, said Kennedy could make a major statement by banning all colors and dyes. It wouldn't directly make Americans healthy, but it would go a long way toward making ultra-processed food look less appealing. 'All this voluntary stuff only goes so far. It really does minimal impact,' Popkin said. 'Unless he goes to the FDA and has the FDA change a regulation … there's nothing.' Kennedy has also singled out the use of high-fructose corn syrup as a major contributor to diabetes and obesity. He has previously called it 'poison,' an epithet he repeated in late April when talking about sugar. When Steak 'n Shake said earlier this month it was going to sell Coca-Cola with real cane sugar, Kennedy praised the move. 'MAHA is winning,' Kennedy posted on X. But experts said there's no substantial difference in the benefits of using cane sugar as a substitute for high-fructose corn syrup. 'At the end of the day, a Coke is still a can of Coke. It's not a fruit or a vegetable, right? And so if you're not shifting consumption away from these higher calorie, lower nutrient processed foods, toward nutrient dense, health promoting foods, then you're not actually going to be shifting the health of Americans in the right direction,' Fielding-Singh said. But if Kennedy thinks sugar is poison, 'they're both sugar and would both be poison, in his words,' said Mande, who is now CEO of Nourish Science. Health officials argue industry cooperation is key to the MAHA agenda. 'Working with industry is the best place to start. And we believe in industry to do the right thing when called upon,' Food and Drug Administration Commissioner Marty Makary and Centers for Medicare and Medicaid Services Administrator Mehmet Oz wrote in a joint op-ed in The Wall Street Journal. 'Our agencies are in a strong position to show Americans which companies are doing the right thing when it comes to popular reforms. By the time we're done, we will have built new relationships and be better positioned to hold them accountable,' Makary and Oz wrote. Yet there is plenty the agency can, and should do, that industry has pushed back against. Aviva Musicus, science director of the nonprofit Center for Science in the Public Interest, said MAHA is wasting its political capital. 'It's striking that we haven't seen the administration use policy to improve the food system. It's solely relying on voluntary industry commitments that we've seen repeatedly fail in the past,' Musicus said. 'In pushing the food industry to change, Trump and RFK Jr. have a chance to live up to their promises to fight chronic disease. Coca-Cola is at the table, but they're wasting the opportunity to actually improve health. The administration should focus on less sugar, not different sugar,' Musicus added. Popkin said he would like to see warning labels on ultra-processed foods high in sodium, added sugar and saturated fat. Kennedy 'hasn't tackled ultra-processed food yet. That'll be where he could make an impact on health in the U.S. and all the non-communicable diseases, including obesity. But he hasn't gone there yet,' Popkin said. The coming months will reveal more on the MAHA movement's plans to change how Americans eat. New dietary guidelines will be released 'in the next several months,' Kennedy said recently. In addition, a second MAHA report focused on policy recommendations is expected in August. 'We have to be considering that there could be real potential down the road,' Popkin said. 'But [there's been] nothing yet. That document will tell us if there ever be.'
