The Food and Drug Administration has launched a review of its food and tobacco programs after public outcry over a shortage of baby formula and concerns about flavored nicotine products.
FDA chief Dr. Robert Califfe said the issues the agency faced have “tested our regulatory framework and stressed the agency’s operations,” prompting the review announced Tuesday.
The review will be conducted by the Reagan-Udall Foundation, a non-profit organization affiliated with the agency. Its directors include non-profit, academic, corporate and trade union leaders.
Congressional lawmakers slammed the agency for its handling of infant formula shortages, saying it was slow to heed a whistleblower’s warning about the beleaguered plant and didn’t prioritize food safety. For several years, the agency has also been investigating what some have seen as an inability to stop the teen vaping crisis.
At a congressional hearing on Wednesday, Dr. Calif defended the agency, but said there was still room to investigate the structure, funding and leadership of its food safety division, which has oversight authority over consumer goods such as infant formula. was.
“We have the safest food in the world,” Dr. Calif told members of the Senate Appropriations Subcommittee. “Every expert I’ve spoken with – the CDC monitors this carefully – said that our food is as safe as it has ever been. So to say it’s not working is wrong in my opinion. That doesn’t mean it can’t get much better and there isn’t a big problem. So, you know, that’s why we’re doing this top-down review and plan to make significant changes.”
Dr Califf said the country’s food system is being challenged by supply chain problems and climate change and it can better embrace the revolution in technology.
According to a statement, the agency is also investigating its Tobacco Department and enforcement actions as it faces “an increasing number of new products that could potentially have significant consequences for public health”. They included highly potent cannabis products, including vapes, which are being linked to addiction and psychosis in teens.
Lawmakers and the public are pressing the FDA to take action against makers of synthetic nicotine e-cigarettes with flavors that young people may like. Congress gave the agency the authority to remove such products from the market in April, and enforcement powers began earlier this month.
Still, the agency has said it is reviewing marketing applications from nearly one million applicants submitted by about 200 companies. It issued warnings to two companies that were selling around 10,000 types of vape products without authorization.
A group of lawmakers and physicians have urged the agency to act swiftly, however, with a group of pediatricians and others at Massachusetts General Hospital calling for “rapid action” as more teens are exposed to high nicotine levels. – Get addicted to cigarettes.
The FDA was shielded from a baby formula shortage earlier this year after it closed a baby formula factory over quality and safety concerns. The agency discovered a deadly bacterium called Cronobacter sakazakii inside the plant after reports of infant deaths possibly linked to the bacteria began to emerge.
Although the deaths were not definitively linked to bacteria in the plant, the FDA and the Justice Department entered into a consent decree with the manufacturer, Abbott Nutrition, to oversee process improvements at the Michigan Formula Plant.
Dr. Califf acknowledged that the FDA had limited infant formula supply chain insight during congressional hearings on the matter. The shortage scared parents of young children and led to hospitalization of some children who relied on formula. Since then, the agency has allowed some foreign formula imports and announced changes to help foreign manufacturers gain access to the US market.
Dr Califf promises a thorough review of the steps that led to the formula’s shortage.
An external review by the Reagan-Udal Foundation is expected to take two months.
(This story has not been edited by seemayo staff and is published from a rss feed)