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FDA reorg plan sent on to HHS for formal review

The plan to reorganize the U.S. Food and Drug Administration has been forwarded on for an internal review by the U.S. Department for Health and Human Services. It's the first of several steps which are expected to be completed within 2024.

Hank Schultz

December 13, 2023

3 Min Read

At a Glance

  • FDA's reorganization plan was delivered to HHS for review.
  • Focus on supplement industry won't be diminished as a result of planned reorg, agency claims.
  • Reorg expected to be completed before end of 2024.

The FDA reorganization plan has been forwarded to the U.S. Department for Health and Human Services (HHS) for a formal review, FDA announced today. 

The proposed reorganization will create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model. Under the new model, responsibility for the dietary supplement sector would be housed within a newly created office of Food Chemical Safety, Dietary Supplements and Innovation.

FDA: Plan will help fulfill FSMA vision 

FDA asserted if the reorganization is approved in its present form, it will: 

  • Fully realize the preventive vision laid out in the FDA Food Safety Modernization Act (FSMA). 

  • Elevate the importance of nutrition to help reduce diet-related diseases. 

  • Strengthen state partnerships and embrace innovative food and agricultural technologies that will position the agency to more effectively regulate and uphold safety of the nation’s food supply.  

“Moving our proposal forward is an exciting milestone in our ongoing modernization initiative,” said FDA Commissioner Robert M. Califf, M.D. “This is a unique moment in the history of the FDA. We began this journey knowing we had a real opportunity in front of us to make meaningful and lasting change. By working to build a unified Human Foods Program and a more resilient model for our field operations, we also found ways to improve the way we work together as a whole—inside and outside the agency—to better meet our public health mission.”  

Related:FDA's Jim Jones engages with dietary supplement leaders on proposed reorg

In a press release announcing the move, FDA said it is hopeful the review and full implementation of the reorganization will be completed within 2024. 

The reorganization plan review process will incorporate input from an evaluation conducted for FDA by the Reagan-Udall Foundation, a nonprofit public policy group. Among the new authorities the group recommended are premarket label approval authority, expanding the criteria for the suspension of food facility licenses, and strengthening FDA’s ability to oversee medical foods. 

In addition to the HHS review, FDA’s reorganization plan must go through a review by the White House’s Office of Management and Budget, as well as a 30-day notification period to Congress, the issuance of a Federal Register notice and negotiations with labor unions, whose members will be affected by the reorganization. 

Jones: Supplement focus won’t be diluted 

At the end of November, James Jones, FDA’s first deputy commissioner for human foods, met virtually with representatives from the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), Natural Products Association (NPA) and United Natural Products Alliance (UNPA). 

Related:FDA gives update on dietary supplement office status in new Human Foods Program

Jones reportedly reassured the participants in the meeting that the reorganization will not diminish the importance of dietary supplements within the overall agency priorities. Industry stakeholders had raised concerns that a reorganization could adversely affect resources devoted to supplements at FDA. 

“In sum, our proposed structure of a larger Office of Food Chemical Safety, Dietary Supplements and Innovation will ensure that our responsiveness to dietary supplement issues and inquiries will not be diminished,” FDA officials wrote in a recent column published by Natural Products Insider. “To the contrary, we will continue to prioritize additional resources and modernized authorities to strengthen our oversight of the dietary supplement marketplace.” 

 

 

About the Author(s)

Hank Schultz

Senior Editor, Informa

Hank Schultz has been the Senior Editor of Natural Products Insider since early 2023. 

Prior to joining the Informa team he was an editor at NutraIngredients-USA, a William Reed Business Media publication.

His approach to industry journalism was formed via a long career in the daily newspaper field.  After graduating from the University of Wisconsin with degrees in journalism and German, Hank was an editor at the Tempe Daily News in Arizona. He followed that with a long stint working at the Rocky Mountain News, a now defunct daily newspaper in Denver, where he rose to be one of the city editors.  The newspaper won two Pulitzer Prizes during his time there.

The changing landscape of the newspaper industry led him to explore other career paths. He began his career in the natural products industry more than a decade ago at New Hope Natural Media, which was then part of Penton and now is an Informa brand. Hank formed friendships and partnerships within the industry that still inform his work to this day, which helps him to bring an insider’s perspective, tempered with an objective journalist’s sensibility, to his in-depth reporting.

Harkening back to his newspaper days, Hank considers the readers to be the primary stakeholders whose needs must be met. Report the news quickly, comprehensively and above all, fairly, and readership and sponsorships will follow.

When he’s not reporting on the supplement industry, Hank enjoys many outside pursuits. Those include long distance bicycle touring, mountain climbing, sailing, kayaking, and fishing. Less strenuous pastimes include travel, reading (novels and nonfiction), studying German, noodling on a harmonica, sketching and a daily dose of word puzzles in The New York Times.

Last but far from least, Hank is a lifelong fan and part owner of the Green Bay Packers.

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