FDA seeks external review of problematic food and tobacco products

The Food and Drug Administration ordered a review of its food and tobacco programs following public outrage over shortages of infant formula and concerns about flavored nicotine products.

Dr. Robert Califf, head of the FDA, said the agency was facing issues that “tested our regulatory framework and highlighted 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. His directors include leaders of non-profit, academic, corporate and trade associations.

Congressional lawmakers criticized the agency for how it handled lack of baby food, stating that he was slow to heed the whistleblower’s warning about the troubled plant and did not prioritize food safety. For several years now, the agency has also come under scrutiny for what some see as a failure to curb the teen vaping crisis.

At a congressional hearing on Wednesday, D. Kaliff defended the agency but said there was still room to examine the structure, funding and leadership of its food safety division, which had powers to oversee consumer products such as infant formula.

“We have the safest food in the world,” says the doctor. This was reported by Kaliff to members of the Senate Subcommittee on Appropriations. “Every expert I’ve spoken to — the CDC is following this closely — has said that our food is safer than ever. Therefore, to say that it does not work, in my opinion, is simply wrong. This does not mean that it cannot be much better and that there are no serious problems. So, you know, that’s why we’re doing this top-down review and plan to make significant changes.”

Dr. Kaliff said the country’s food system is threatened by supply chain problems and climate change and could better embrace the technology revolution.

The agency is also seeking scrutiny of its tobacco division and enforcement operations as it faces a “growing number of new products with the potential to have major public health implications,” according to data. statement. Among them were powerful hemp products, including vapes, that have been linked to addiction and psychosis in adolescents.

Legislators and the public are pressuring the FDA to take action against flavored manufacturers. synthetic nicotine e-cigarettes with flavors that appeal to young people. Congress gave the agency the authority to remove such products from the market in April, and enforcement powers were introduced earlier this month.

However, the agency said it reviewed marketing applications from about one million applicants from about 200 companies. He issued warnings to two companies that sold about 10,000 types of vape products without permission.

However, lawmakers and a group of doctors called on the agency to move faster with a group of pediatricians from Massachusetts General Hospital and others. call for “Fast Action” as more teenagers become addicted to high nicotine e-cigarettes.

The FDA was caught off guard by an infant formula shortage triggered earlier this year following the closure of an infant formula factory due to quality and safety concerns. Agency discovered deadly bacteria called cronobacter sakazakii inside the plant as reports of infant mortality possibly linked to the bacteria began to surface.

Although the death was not conclusively linked to bacteria at the plant, the FDA and the Department of Justice entered into a consent agreement with manufacturer, Abbott Nutrition, to oversee process improvement at its Michigan formula plant.

Dr. Kaliff acknowledged that the FDA had limited understanding of the infant formula supply chain during congressional hearings on the matter. The shortage frightened parents of young children and led to the hospitalization of some children who were dependent on formula. Since then, the agency has allowed the import of some foreign blends and announced changes to help foreign producers gain access to the US market.

Dr. Kaliff promised to conduct a thorough analysis of the steps that led to the lack of mixtures.

The external review of the Reagan-Udall Foundation is expected to take two months.