The Food and Drug Administration has commissioned a review of its food and tobacco programs after public outrage over infant formula shortages and concerns about flavored nicotine products.
dr FDA chief Robert Califf said the agency has faced issues that “have tested our regulatory framework and strained the agency’s operations,” prompting the review announced Tuesday.
The review is conducted by the Reagan-Udall Foundation, a nonprofit organization affiliated with the agency. Its directors include nonprofit, academic, corporate and trade association leaders.
Congressional lawmakers have hammered the agency for its handling of the infant formula shortage, saying it was slow to heed a whistleblower’s warning about the troubled facility and didn’t prioritize food safety. For a number of years, the agency has also come under scrutiny for what some see as an inability to contain the teenage vaping crisis.
At a congressional hearing on Wednesday, Dr. Califf the agency, but said there was still room to examine the structure, funding and governance of its food safety department, which the regulator of consumer products like infant formula had.
“We have the safest food in the world,” said Dr. Califf to the members of the Senate Appropriations Subcommittee. “Every expert I spoke to — the CDC monitors this carefully — said our food is as safe as ever. So to say it doesn’t work is just wrong in my opinion. That’s not to say it can’t be much better and that there aren’t any major problems. 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 issues and climate change, and that it could better embrace the technological revolution.
The agency is also seeking a review of its tobacco division and enforcement efforts as it “faces an increasing number of novel products that could have potentially significant public health consequences,” according to a statement. These included high-potency cannabis products, including vapes, which have been linked to addiction and psychosis in teenagers.
Lawmakers and the public have pressured the FDA to take action against manufacturers of synthetic nicotine-flavored 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 went into effect earlier this month.
However, the agency said it is reviewing the marketing applications of about a million applicants submitted by about 200 companies. It issued warnings to two companies that were selling about 10,000 types of vape products without a license.
But lawmakers and a group of doctors have urged the agency to act faster, with a group of pediatricians from Massachusetts General Hospital and others calling for “act quickly” as more teens become addicted to high-nicotine e-cigarettes.
The FDA was caught by baby formula shortages earlier this year after it shut down a baby formula factory over quality and safety concerns. The agency had discovered a deadly bacterium called Cronobacter sakazakii in the plant when reports of infant deaths potentially linked to the bacteria emerged.
Although the deaths have not been positively linked to the bacteria at the facility, the FDA and Department of Justice entered into a consent order with manufacturer Abbott Nutrition to oversee process improvements at its 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 the hospitalization of some children who depended on formula. Since then, the agency has allowed some foreign formula imports and announced changes to make it easier for foreign manufacturers to enter the US market.
dr Califf has promised a thorough review of the steps that led to the formula shortage.
The external review by the Reagan-Udall Foundation is expected to take two months.