The Office of Dietary Supplement Programs (ODSP) at FDA will not lose any resources in the proposed restructuring of FDA’s Human Foods Program, according to FDA Commissioner Robert Califf, MD, who addressed dietary supplement stakeholders via teleconference at the Council for Responsible Nutrition’s (CRN) annual conference on Oct. 4.

In fact, during his “fireside chat” with CRN President and CEO Steve Mister, Califf described the current resources earmarked for dietary supplement industry oversight as “woefully inadequate.”

The food side of FDA has been “underserved and underfunded,” he said. “This is a complicated and rapidly growing industry,” he said of the dietary supplement market.

While Califf said he’s not in favor of user fees as a political philosophy, “because I think taxpayers ought to pay for public benefits,” they do often compel industries to come to the table to understand regulations and take part in the regulatory process.

Innovation and Public Health

Califf stood by the proposal to group dietary supplements into a new office that includes food additives and “innovation” (the "Office of Food Chemical Safety, Dietary Supplements & Innovation") saying he believes there’s synergy to be realized across agency experts in those fields.

“FDA, at its best, promotes innovation,” said Califf. “American society right now desperately needs innovation,” he added, citing a recent Washington Post report on declining life expectancy in the U.S.

“Our life expectancy is almost a full decade shorter than Singapore’s, and it’s getting worse,” he said. “Chronic diseases are just devastating the United States right now, particularly in rural areas.”

A cardiologist from South Carolina, Califf said that he personally does not take dietary supplements, and he urged industry to offer “better evidence” on the efficacy of its products.

“We’ve got to do something with what’s happening to the health of America. How can we be in last place among high-income countries in health? I hope you all do your part not just to sell stuff but to get truly valid scientific answers about the health benefits of your products.”

Regulator v. Communicator

Meanwhile, alongside its mandate as a regulator, Califf said FDA must embrace its role as a communicator to address what he called “the enormous amount of misinformation” found online—“much of it purposefully designed to undermine confidence in our institutions.”

To find a path forward, the commissioner had requested that the Reagan-Udall Foundation for FDA—an independent 501(c)(3) created by Congress to advance the agency’s mission—conduct research and consult with experts to better understand how consumers and other stakeholders find, consume, and perceive health information, especially as it pertains to FDA-regulated products. The project was executed over nine months, from January through September 2023.

The day after Califf spoke at CRN’s conference, the foundation issued its report, titled “Strategies for Improving Public Understanding of FDA-Regulated Products,” offering observations, potential strategies, and proposed tactics for the agency’s consideration.

“The digital health information environment and limited public trust in government institutions represent pressing challenges for the FDA,” the report noted. “In particular, Commissioner Califf has highlighted that the growing problem of misinformation undermines confidence in science and public institutions.” For purposes of the Reagan-Udall report, “misinformation” was defined as “false, misleading, or inaccurate information that is shared unintentionally or intentionally.”

“While the spread of inaccurate health information is a long-standing challenge, the ways and speed with which it spreads have changed as the news ecosystem becomes increasingly digital, fragmented, and fast moving,” the report added.

Citing recent published research, the Reagan-Udall report noted that 80% of Americans seek health-related information each year, and 73% of them find information on the internet and social media.

“This report’s overarching finding is that clear, consistent communication, both directly to consumers and via media channels, is critical to the FDA’s mission to protect and promote public health.”

The report added: “Consumers won’t understand or trust policy—and the scientific evidence it is based on—if it is not well communicated to them or if they never hear about it at all. Strong communications reinforce sound policy and science; insufficient communications undermine it.”

Moreover, “efforts to ‘address’ mis- and disinformation can, themselves, be misunderstood and interpreted as intending to silence discussion and are, at best, reactive versus proactive.”

“A strong and continuous communications approach should be viewed as a fundamental aspect of the agency’s work ... In short: sound science, sound policy, and sound communication are each fundamental to the Agency’s mission and should be resourced and approached with the same diligence.”

Preemptive Communication Strategy

Califf himself noted that the agency has spent too much time and resources responding to “clickbait” headlines that don’t depict information accurately.

The Reagan-Udall report noted that “prebunking” is a strategy communicators can deploy to “preemptively build resilience against anticipated exposure to misinformation.”

“This includes both preempting anticipated health rumors and cultivating consumers’ capacity to detect the information manipulation tactics that often drive the spread of ‘disinformation,’ defined as the ‘deliberate dissemination of false, misleading, or inaccurate information to discredit a person or organization.’”

Rumors or misconceptions can spread rapidly in the absence of credible information. “In addition to more deliberate initial communication, the FDA should be more proactive in listening for, spotting, and addressing misconceptions before they escalate.”

“It is important for the American public to trust the FDA, its regulatory process, and its decisions,” the report added. “If they do not, the public cannot be expected to take the appropriate steps based on the FDA’s work to protect and enhance their own health, the health of their families, and the health of the nation. Improving understanding of FDA-regulated products first requires trust.”

During his discussion with Mister at CRN’s conference, Califf said, “It’s important we spend more time speaking in plain English. We’ve got to speak more clearly to the public in a way that’s understandable to the non-scientist.”

He went on to say that various communities, industries, and public institutions have failed the public when it comes to education about nutrition. “It’s an area where we’re having a complete societal meltdown.”