The Food and Drug Administration’s dietary supplements program remains a crucial priority, the agency’s top official said Monday.

Josh Long, Associate editorial director, Natural Products Insider

August 14, 2023

2 Min Read
Dr. Robert Califf
Dr. Robert Califf is commissioner of the Food and Drug Administration.Photo courtesy of Food and Drug Administration (via flickr)

The Food and Drug Administration’s dietary supplements program remains a crucial priority, the agency’s top official said Monday.

In an Aug. 14 blog post, FDA Commissioner Robert Califf, M.D., addressed the impact of a proposed reorganization of FDA’s human foods program on the agency’s dietary supplements program.

“This proposed structure is designed to ensure that the dietary supplements program remains a critical priority for the agency,” Califf wrote.

FDA has proposed creating an Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI) as part of its broader plans to transform its myriad food programs into a unified Human Foods Program.

This summer, industry trade associations whose members produce and sell vitamins, probiotics and other supplements expressed concerns that FDA’s new proposal will undermine the benefits of an independent dietary supplement office that was created in late 2015.

“Removing ODSP’s separate status and combining it with these other functions would unwind a structure that has ensured dedicated funding and attention to programs for the growing market for these health-promoting products,” Robert Marriott, director of regulatory affairs with the American Herbal Products Association (AHPA), told Natural Products Insider in a June 30 statement.

Related:FDA proposes new office combining ‘food chemical safety’ with ‘supplements’

FDA has no plans to reduce the capabilities or resources of the Office of Dietary Supplement Programs (ODSP), Califf wrote in his blog post, “and it will remain the lead office responsible for executing the agency’s responsibilities under the Federal Food, Drug and Cosmetic Act as amended by the Dietary Supplement Health and Education Act.”

“The vision for the new OFCSDSI is to modernize and strengthen the assessment of food chemicals and facilitate safe and innovative ingredients for use in foods and dietary supplements,” the FDA commissioner added. “ODSP will remain a distinct office executing the agency’s responsibilities under the Federal Food, Drug and Cosmetic Act for dietary supplement products.”

Califf said a unified Human Foods Program would help to streamline operations, accelerate decision-making and ensure FDA is focusing its efforts on the greatest risks to the public.

He also signaled his agency is developing new surveillance methods and tools to improve FDA’s ability to make decisions based on science and commence risk assessments. These capabilities, he added, provide opportunities to accurately and swiftly identify potential threats to public health.

“It is critical that we have access to all available data about dietary supplements and the resources and tools to assess and integrate these data to sustain this high-priority program area,” Califf stated. “Leveraging modern computational, analytical, toxicology and research methods and tools across the HFP will further improve our oversight of dietary supplements.

“Our proposal will fully integrate the dietary supplement program into the broader HFP, thus strengthening our enforcement and oversight of dietary supplements,” he concluded in the blog.

As more details are finalized, Califf said he looked forward to sharing additional information later in the year on how FDA’s dietary supplement program is positioned within the Human Foods Program.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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