Posts Tagged ‘FDA’

Scientists and regulators at the FDA have identified a critical gap in new drug development and labeling. It is the failure to test new drugs in people with obesity. Where there are differences in clinical responses and safety, labeling – the instructions for safe use – should reflect those differences. But in many cases, they […]

Has the FDA bitten off more than it can chew? Two presidents ago, back in 2016, the FDA told us the agency had begun work to “redefine the term ‘healthy’” for food labels. Good luck with that is a fair summary of our reaction at the time. Seven years later, the quest to define objectively […]

It’s official. Food Is Medicine can now take chocolate under its wings. It only took five years, but the FDA has rendered regulatory judgment to officially permit the following claim for the health benefits of chocolate: “Cocoa flavanols in high flavanol cocoa powder may reduce the risk of cardiovascular disease, although FDA has concluded that […]

Very quietly, just before Christmas, FDA approved a major step forward for treating obesity in teens. The agency issued an approval for Wegovy brand of semaglutide to treat obesity in teens. There was no press release at FDA, none on the corporate website for Novo Nordisk. As late as yesterday, the news of this approval […]

This afternoon at FNCE, Hope Warshaw will be moderating a wide-ranging conversation with David Kessler. He is the FDA commissioner who oversaw the requirement to put Nutrition Facts labels on food back in 1994. That’s when many ideas took shape in the popular imagination about what a healthy food is. Now is a good time […]

What constitutes “healthy” for a packaged food? FDA, prompted by wrangling seven years ago, is out today with a new definition that everyone can fight about. Who cares? Well, just about everyone has an opinion. But the real passion for this subject comes from people who want to sell you more units of their food, […]

Today we will take every little bit of good news we can. So the word that FDA is adding one more obesity treatment option for teens with Qsymia, though incremental, is certainly good news. In approving the drug for this use, FDA noted that the teens taking it lost between five and seven percent of […]

FDA announced yesterday that it is revoking the standard of identity for French dressing. That means food makers can now put any otherwise legal ingredients into a bottle and call it French dressing. To some people, this is obviously trivial news. So what if the FDA no longer cares too much about what goes into French salad […]

It only took five years. But then, the U.S. government has been through a lot in those five years. Yesterday the FDA finally released voluntary guidelines aiming to cut sodium in prepared foods by 12 percent over the next two and a half years. In a joint statement, Acting Commissioner Janet Woodcock and CFSAN Director […]

Limited approval . . . heated debate . . . setback for booster plans. The pathway to rolling out booster shots has been torturous, for sure. But let’s be clear. As the dust clears, the approval of booster shots for the Pfizer-BioNTech vaccine is hardly limited. Everyone over 65 can get it. Under 65, the […]