Health

F.D.A. Seeks Outside Review of Troubled Food and Tobacco Units

The Food and Drug Administration has commissioned a review of its food and tobacco program in response to public anger over powdered milk shortages and concerns about flavored nicotine products.

Dr. Robert Caliph, head of the FDA, said the authorities faced a problem of “testing the regulatory framework and emphasizing the operation of the authorities,” prompting a review released Tuesday.

The review is conducted by the Reagan-Udall Foundation, a non-profit organization affiliated with the agency.this is director Includes non-profit, academic, corporate and trade association leaders.

Parliamentarians beat authorities to address the shortage of infant formula, saying they were slow to listen to whistleblowers’ warnings about problematic plants and did not prioritize food safety. did. For several years, the agency has also scrutinized what some people see as unable to curb the crisis of teenage e-cigarettes.

At a parliamentary hearing on Wednesday, Dr. Calif defended the agency, but said there was room to consider the structure, financing and leadership of the food safety sector, which has oversight of consumer goods such as infant formula.

“We have the safest food in the world,” Dr. Caliph told members of the Senate Expenditure Committee. “All the experts I’ve talked to — the CDC is watching this closely — said our food is safer than ever. So to say it’s not working is to say In my view, it’s just wrong. That doesn’t mean it can’t be much better, nor is it without major problems. So we’re doing this top-down review and it’s important. That’s why we plan to make major changes. “

Dr. Caliph said the country’s food system faces supply chain and climate change issues and can better embrace the technology revolution.

Authorities are also seeking an investigation into the tobacco sector and enforcement operations as they face “an increase in the number of new products that can have significant public health consequences.” statement.. They included very powerful cannabis products, including Ark, which are associated with teenage addiction and psychosis.

Lawmakers and the general public are pressing the FDA to take action against manufacturers of flavored synthetic nicotine e-cigarettes that appeal to young people. Parliament empowered authorities to remove such products from the market in April, and enforcement powers began earlier this month.

Still, the agency Said We were reviewing the marketing applications of about 1 million applicants submitted by about 200 companies. It issued a warning to two companies that sold about 10,000 types of arc products without permission.

However, a group of lawmakers and doctors urged institutions to act faster, along with a group of pediatricians at Massachusetts General Hospital and others. In search of “Rapid action” as more teenagers become addicted to high nicotine e-cigarettes.

The FDA was noted earlier this year that the shortage of infant formula was spurred after the closure of the infant formula plant due to quality and safety concerns. Authorities have discovered a deadly bacterium called Cronobacter sakazaki in the factory as reports of infant mortality that may be related to the bacterium have begun to appear.

Death was not clearly associated with plant bacteria, but the FDA and the Justice Department have signed a consent decree with manufacturer Abbott Nutrition to oversee process improvements at the Michigan manufacturing plant. ..

At a parliamentary hearing on this issue, Dr. Caliph acknowledged that the FDA had limited insights into the infant formula supply chain. The deficiency scared the infant’s parents and led to the hospitalization of some children who were dependent on infant formula. Since then, the agency has allowed imports of some foreign-made formulas and announced changes to give foreign manufacturers access to the US market.

Dr. Caliph promised a thorough review of the steps that led to the lack of prescription.

An external review by the Reagan-Udall Foundation is expected to take two months.

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