The Food and Drug Administration has ordered a review of its food and tobacco programs following public outcry over baby food shortages and concerns over flavored nicotine products.
dr. Robert Califf, the head of the FDA, said the agency had had issues that “tested our regulatory frameworks and put pressure on the agency’s activities,” prompting the review announced Tuesday.
The review will be conducted by the Reagan-Udall Foundation, a nonprofit affiliated with the agency. Directors include non-profit, academic, business and trade associations.
Congressional lawmakers have criticized the agency for its handling of the infant formula shortage, saying it was slow to heed a whistleblower’s warning about the troubled plant and not prioritizing food safety. For several years now, the agency has also come under scrutiny for what some consider to be an inability to curb the teenage vaping crisis.
At a congressional hearing on Wednesday, Dr. Califf told the agency, but said there was still scope to examine the structure, funding and leadership of the food safety department that oversaw consumer goods such as infant formula.
“We have the safest food in the world,” Dr. Califf to the members of the Senate Appropriations Subcommittee. “Every expert I’ve spoken to — the CDC is closely monitoring this — said our food is as safe as it’s ever been. So to say it doesn’t work is just inaccurate in my opinion. That means not that it can’t get much better and there aren’t any major issues, so, you know, that’s why we’re doing this top-down review and planning to make some significant changes.”
dr. Califf said the country’s food system was challenged by supply chain issues and climate change and could better embrace the technology revolution.
The agency also wants an investigation into its tobacco division and enforcement activities as it faces “an increasing number of new products that could potentially have significant public health implications,” a statement said. They include highly potent cannabis products, including vapes, which have been linked to addiction and psychosis in teens.
Lawmakers and the public have pressured the FDA to take action against makers of flavored synthetic nicotine e-cigarettes in flavors that appeal to young people. Congress gave the agency the power to take such products off the market in April, and enforcement powers were introduced earlier this month.
Still, the agency has said it reviewed the marketing applications of about a million applicants submitted by about 200 companies. It issued warnings to two companies that sold about 10,000 types of vape products without authorization.
However, lawmakers and a group of doctors have urged the agency to act faster, with a group of Massachusetts General Hospital pediatricians and others calling for “quick action” as more teens become addicted to high-nicotine e-cigarettes.
The FDA was caught off guard by baby food shortages spurred on earlier this year after it closed a baby food factory over quality and safety concerns. The agency had discovered a deadly bacteria called cronobacter sakazakii in the plant after reports of infant deaths possibly linked to the bacteria.
While the deaths were not definitively linked to the bacteria at the plant, the FDA and the Department of Justice 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 insight into the infant formula supply chain during congressional hearings on the matter. The shortages frightened parents of young children and led to hospitalization of some children who were bottle-fed. Since then, the agency has allowed a number of foreign formula imports and announced changes to help foreign manufacturers access the U.S. market.
dr. Califf has promised a major overhaul of the steps that led to the formula shortage.
The external review by the Reagan-Udall Foundation is expected to take two months.
