FDA Withdraws Proposed Food Modernization Plan

As part of a major restructuring of the nation’s food safety programs, federal regulators have announced plans to withdraw a proposed rule for food modernization, and have launched a search for a new deputy commissioner to head the program.

Both announcements, made February 28, came about a month after the U.S. Food and Drug Administration (FDA) called for sweeping changes to food safety programs.

On Tuesday, the FDA announced it is withdrawing a 2005 proposed rule for food modernization, the Food Standards; General Principles and Food Standards Modernization, following public comments by stakeholders, who said the changes were overly complicated and relied on old data and science.

The comments came at hearings held in July and September of 2019, after the proposed rule lay fallow for 14 years without a final decision about whether to implement it. Stakeholders told the FDA that manufacturing technology, food technology, nutrition science and marketing trends has changed drastically since 2005, making many of the technical aspects of the changes obsolete.

The proposed rule’s goal was to establish a set of general principles for the FDA and the U.S. Department of Agriculture’s Food and Safety Inspection Service (USDA-FSIS).

“Many of the comments submitted suggested that the general principles be revised and consolidated to make the principles easier to understand and implement,” the FDA stated in the press release announcing the rule withdrawal. “The FDA and USDA-FSIS agree and are withdrawing the proposed rule to reconsider how best to approach general principles and food standards modernization to ensure any future revised general principles are consistent with the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act.”

FDA officials say they plan to reconsider how to approach food standards modernization to allow future rules to be consistent with current food safety rules.

The second announcement this week indicates that the FDA is launching a search for a deputy commissioner, as part of the update to the Human Foods safety program.

The deputy commissioner will have direct authority over the Human Foods Program, which includes the existing components of the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and some human foods-related aspects of the Office of Regulatory Affairs.

FDA Faces Ongoing Criticism Over Food Safety

The position will also help direct food inspections and provide authority over resource allocation. The announcement comes after the previous deputy director stepped down following an independent review that leveled significant criticism at the FDA’s response to last year’s Similac infant formula recall and resulting shortage, suggesting the agency was slow to address the shortage and other food safety issues that affect American health.

However, critics warn these steps are not enough to fully address the problems, claiming that, based on the current model, the deputy commissioner would not have adequate authority to overhaul the programs as needed to make food safer for the country.

Criticism focuses on the failure of the plan to allow for significant structural or cultural change within the food safety program and would simply lead to failure from the get-go.

Roughly a month ago, the FDA announced a major redesign of the food safety program and these two announcements are the first steps in completing that program redesign. The full proposed reorganization plan for food safety and a new structure is slated for the fall.

After the proposed plan is issued, a review would be conducted before it is submitted for final approval.

Similac Recall Lawsuits

Abbott Laboratories first announced the infant formula recall involving Similac, Alimentum and EleCare products in February 2022, after FDA inspections confirmed the presence of bacteria throughout the Michigan facility, and identified widespread manufacturing problems. By the time the problems were disclosed to families, contaminated formula had already caused hundreds infant illnesses and hospitalizations nationwide, including several deaths.

Shortly after the recall, it became apparent that Abbott and the FDA knew about the Similac contamination problems since at least September 2021, when the Minnesota Department of Health began investigating a case involving an infected infant. However, the formula continued to be distributed, remained on store shelves and families nationwide continued to feed the contaminated products to infants for another several months.

Abbott was forced to temporarily close the Sturgis, Michigan plant where the formula was contaminated for several months last year, due to widespread safety problems, which shut down production at one of the major sources of infant formula in the United States. This contributed to a nationwide shortage of infant formula earlier this year.

Abbott now faces a growing number of Similac recall lawsuits brought by families of infants nationwide who were diagnosed with Salmonella, Cronobacter or other infections linked to bacteria at the manufacturing facility, and serious questions are being raised about why the problems were not addressed much earlier.