FDA Seeks External Review of Troubled Tobacco and Food Units

The Food and Drug Administration has authorized a review of the food and tobacco programs after public outrage over shortages of baby formula and concerns about nicotine-containing products having a negative impact on health. smell.

Dr. Robert Califf, the head of the FDA, said the agency had faced issues “having examined our regulatory frameworks and underlined the agency’s work,” prompting the review to be published. on Tuesday.

The assessment will be conducted by the Reagan-Udall Foundation, a nonprofit organization affiliated with the agency. Its director includes leaders from nonprofit, academic, corporate, and trade associations.

Legislators of Congress have asked the agency to handle lack of infant formula, said they were slow to heed whistleblowers’ warnings about the struggling factory and did not make food safety a priority. For several years now, the agency has also come under scrutiny for what some see as its inability to rein in the teen vaping crisis.

At a congressional hearing on Wednesday, Dr. Califf defended the agency but said there was still room to review the structure, funding and leadership of the food safety department that has the authority to oversee the consumer goods such as infant formula.

“We have the safest food in the world,” Dr. Califf told members of the Senate Appropriations subcommittee. “Every expert I spoke to — the CDC oversees this carefully — said our food was as safe as before. So to say it doesn’t work is, in my view, just incorrect. That’s not to say it couldn’t be much better and no big deal. So, you know, that’s why we’re doing this top-down review and plan to make significant changes.”

Dr. Califf says the country’s food system is being challenged by supply chain issues and climate change and that it can better embrace the technological revolution.

The agency is also looking to examine its tobacco enforcement departments and operations as it faces “an increasing number of new products that could have significant public health consequences.” , according to a statement. They include very strong marijuana Products, including vapes, are being tied to addiction and psychosis in adolescents.

Lawmakers and the public have pressured the FDA to take action against flavoring manufacturers Synthetic nicotine Electronic cigarettes with flavors appealing to young people. Congress gave the agency the power to remove such products from the market in April, and enforcement powers went into effect earlier this month.

However, the agency said it reviewed marketing applications of about one million applicants submitted by about 200 companies. It has issued warnings to two companies that are selling around 10,000 types of vape products without authorization.

However, lawmakers and a group of doctors urged the agency to act faster, along with a group of Massachusetts General Hospital pediatricians and others. call “Act quickly” as more and more teenagers become addicted to high-nicotine e-cigarettes.

The FDA caught off guard against a shortage of baby formula earlier this year after shutting down a baby formula factory due to safety and quality concerns. Organ Discovered a deadly bacteria called cronobacter sakazakii inside the plant, when reports began to emerge of infant deaths possibly related to the bacteria.

Although the deaths are unlikely to be related to the bacteria at the plant, the FDA and the Department of Justice sign a consent decree with the manufacturer, Abbott Nutrition, to oversee process improvements at the powdered milk plant in Michigan.

Dr. Califf acknowledged that the FDA had limited details of the infant formula supply chain during congressional hearings on the matter. Shortages frighten parents with young children and lead to some formula-dependent babies being hospitalized. Since then, the agency has allowed the import of some foreign formulas and announced changes to help foreign manufacturers access the US market.

Dr. Califf has promised to scrutinize the steps leading up to the formula shortage.

The Reagan-Udall Foundation’s external review is expected to take two months.

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