March 2023 | Volume 14, Issue 8

Read the full article from ABC News.

According to the article, the head of the Food and Drug Administration recently announced an overhaul of the agency’s food safety and nutrition division, vowing that a new structure will better protect consumers and the U.S. food supply.

FDA Commissioner Dr. Robert Califf said he would create a new human foods program led by a deputy commissioner with authority over policy, strategy, and regulatory activities for the part of the agency that oversees 80 percent of the foods Americans eat.

“This is one of the most important changes in the history of the FDA,” Califf said in an interview.

The move merges two existing FDA programs and some regulatory authorities. Tapping a single leader “unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way,” Califf said.

The announcement follows months of scrutiny of the FDA over contamination at a Michigan factory that led to a nationwide infant formula shortage. And it follows a scathing report that found the FDA’s food division was plagued by decentralized leadership, indecisiveness and a culture of “constant turmoil” that impeded actions to protect public health. For years, the agency has been criticized for responding too slowly to outbreaks in produce, heavy metals in baby food and the need to reduce sodium in the U.S. diet, among other issues.

Califf’s actions drew mixed reviews from food safety advocates. Some said it was a good start, while others said he did not go far enough to dismantle ingrained structural problems.

“I think it does a good job of identifying the essential problems and addressing them head-on,” said Dr. Peter Lurie, who heads the Center for Science in the Public Interest, which focuses on consumer nutrition, food safety and health.

Mike Taylor, who previously served as FDA deputy commissioner for foods and veterinary medicine, said the new deputy does not appear to have full authority over the office responsible for inspecting company plants, laboratory testing, imports, and investigations.

“If that's the case, the human foods program at the FDA will remain fragmented and the deputy commissioner will not be empowered to make the change that is necessary,” Taylor said.

Califf said that the deputy commissioner will have authority over the human foods budget and priorities. He said it would be a mistake to create “a monolithic organization" to overcome aversion to change.

“Just because there's been resistance in the past, it doesn't mean it can't work,” Califf added.

The changes aim to straighten out a convoluted leadership structure. The FDA oversees human and veterinary drugs and medical devices, along with much of the U.S. food supply. The Agriculture Department also oversees some food products.

Frank Yiannas, the current FDA deputy commissioner for food policy and response, is leaving his post next month. Susan Mayne, director of the current Center for Food Safety and Applied Nutrition, said in a statement that Califf asked her to stay on through the transition. The new deputy, who will report directly to the commissioner, will be named by spring, Califf said.

The revamped foods program will include a separate center focused on nutrition, including foods such as infant formula, plus an office to coordinate state efforts to identify and prevent foodborne illness outbreaks. The plan also calls for a new expert advisory committee to weigh in on food safety, nutrition, and new food technologies.

Under the new structure, the deputy commissioner will not oversee FDA’s veterinary medicine center. Califf said that is because much of the center’s work involves animal drugs and devices, not food. In addition, the animal feed industry worried that it would become a “subsidiary to human food,” Califf said.

That disappointed Mitzi Baum, president of the nonprofit STOP Foodborne Illness. According to Ms. Baum, human foods, animal foods, and outbreaks are often closely linked, and they should be part of the same program.

“Any change is messy. It’s going to be disruptive,” Baum said. “Why not make all of the changes that need to be made in order to create the most efficient and effective agency?”

Discussion Questions

  1. Describe the Food and Drug Administration's (FDA) mission and functions.
    According to the FDA's website, its mission:

    The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

    The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors.

    The FDA is responsible for advancing public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

    The FDA also plays a significant role in the nation’s counterterrorism capability. The FDA fulfills this responsibility by ensuring the security of the food supply and by fostering the development of medical products to respond to deliberate and naturally emerging public health threats.
  2. The article references alleged leadership and structural issues at the FDA. Conduct some internet research regarding the annual funding of the FDA and the frequency of its inspections of domestic and foreign food production facilities. Based on this research, would you surmise that the FDA has a budgetary (i.e., a financial) problem? Explain your response.
    The total fiscal year 2023 budget for the FDA totals $8.4 billion. Although it is difficult to put a raw number ($8.4 billion) into proper perspective, internet research indicates that FDA inspections of domestic and foreign food production facilities have plummeted in recent years. Obviously, if funding for the FDA were increased, food safety inspections could increase, particularly if additional funding were specifically earmarked for that purpose. Budgets are always about priorities.
  3. As indicated in the article, one of the biggest criticisms of the FDA is that it is often reactive rather than proactive (i.e., it responds to problems when they manifest, rather than preventing problems from occurring in the first place). Is this a valid criticism? Why or why not?
    This is an opinion question, so student responses may vary. As the article indicates, for years, the FDA has been criticized for responding too slowly to outbreaks in produce, heavy metals in baby food, and the need to reduce sodium in the U.S. diet, among other issues. Perhaps this criticism should be tempered by the realization of the massive scope of the FDA’s responsibilities. Still, given the priorities associated with the fulfillment of the FDA’s mission and mandate (in the context of the article, food safety and nutrition), the public will likely continue to criticize the agency until it is perceived as being fully functional.