FDA appoints new Human Foods Program Director

USA – The Food and Drug Administration has appointed its first deputy commissioner for human foods in efforts to re-organize the agency’s oversight of food safety after contaminated baby formula caused major shortages last year.

James “Jim” Jones, a former EPA official, will start his new role on September 24, leading the new Human Foods Program, which will oversee food safety, chemical safety, nutrition and other areas.

The proposed Human Foods Program will consolidate several food safety programs under the FDA into a single program overseen by Jones, who will report directly to Commissioner Robert Califf.

“Our proposed reorganization is the largest undertaking of its kind in recent history for our agency. I’m confident that under Jim’s leadership, we will build a stronger organization that will be integrated with other components of the FDA,” Califf said in a statement.

“He will also focus on keeping the foods we regulate safe and nutritious while ensuring the agency remains on the cutting edge of the latest advancements in food science and nutrition.”

The FDA proposed the re-organization after an analysis by the Reagan-Udall Foundation’s independent expert panel for foods, which found the current structure “reinforces duplicative or competing roles and responsibilities, siloed work and inadequate internal and external engagement.”

Califf requested the review after criticism of the agency’s handling of the infant formula shortage, which was caused by FDA-ordered closures of plants in Michigan that produced contaminated baby formula.

The review concluded that the work conducted by the Office of Food Policy and Response, the Center for Food Safety and Applied Nutrition and relevant parts of the Office of Regulatory Affairs did not have a clear leader or decision-maker.

Jones was part of the independent expert panel that wrote that report and is intimately knowledgeable of the agency’s challenges and opportunities,” the FDA said in a statement.

In his new role, Jones will set and advance priorities for the Human Foods Program and exercise decision-making over all of its entities when the reorganization takes effect.

“I now look forward to helping the agency realize its vision for the proposed Human Foods Program, including carrying out important nutrition initiatives to improve the health of our country,” Jones said.

According to the FDA, requirements for infant foods are found in the Federal Food, Drug, and Cosmetic Act.

It indicates that all manufacturers of infant formula must begin with safe food ingredients, which are either generally recognized as safe (GRAS) or approved as food additives for use in infant formula.

FDA has provisions that include requirements for certain labelling, nutrient content, manufacturers’ quality control procedures, as well as company records and reports.

Meanwhile, the FDA is also working to finalize a proposed rule for good manufacturing practices, quality control procedures, quality factors, notification requirements, and reports and records, for the production of infant formulas.

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