Industry Welcomes New FDA Commissioner, Though Concerns Remain

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The new FDA commissioner, Robert Califf, MD, received a hopeful welcome from several dietary supplement industry trade associations following his official confirmation on Wednesday. Califf’s past statements suggesting supplements be held to the same testing standards as pharmaceutical drugs, however, remain a source of concern for some industry leaders.

The Senate overwhelmingly confirmed Califf, President Obama’s nominee to lead FDA, by a vote of 89–4. Califf has been FDA’s deputy commissioner for medical products and tobacco at FDA since January 2015. Before that he was a cardiologist at Duke University.

Several industry trade associations immediately congratulated Califf and expressed optimism for his management of FDA.

“Based on his confirmation hearing, we feel confident that Dr. Califf will be fully committed to enforcing the laws and regulations for our industry that help protect consumers,” said Steve Mister, president and CEO, the Council for Responsible Nutrition (CRN; Washington, DC). Mister also expressed hope that Califf would continue FDA’s recent work with the Department of Justice (DOJ) to enforce against bad players in the industry.

Troublesome Comments

The Natural Products Association (NPA) joined CRN in congratulating Califf on his confirmation, but it also requested Califf clarify his past comments suggesting dietary supplements be held to drug testing standards.

“We would also like to express concerns regarding some of your past comments suggesting that the same standard in which pharmaceutical drugs are tested be applied to supplements,” wrote Dan Fabricant, CEO and executive director of NPA, in a letter to Califf.

NPA also requested Califf share his plans on using “all of the legal tools at his disposal to enforce the laws and regulations related to the supplement industry,” such as collaborating with DOJ to take up misdemeanor cases concerning adulterated or mislabeled supplements that have flown under FDA’s radar in the past.

Changes at FDA?

CRN’s Mister believes the combination of Califf’s “demonstrated leadership at the agency” and the recent elevation of the Division of Dietary Supplement Programs to its own Office at FDA will “enhance the agency’s ability to fulfill its regulatory responsibilities.”

But will Califf’s appointment change the way FDA deals with the dietary supplement industry? Not necessarily, said Judy Blatman, senior vice president of communications, CRN.

“We don’t have any reason to believe that FDA would change its approach to regulating supplements under Dr. Califf’s leadership, particularly as they have been seeking ways to partner with other government agencies to make the most of the laws on the books,” said Blatman. She added that the industry must continue engaging in self-regulatory efforts, such as CRN’s new requirement that all its members submit product labels to an online database.

Loren Israelsen, president of the United Natural Products Alliance (UNPA; Salt Lake City), also congratulated Califf and expressed hope that he will “use the substantial array of authority the agency has under the Dietary Supplement Health and Education Act [DSHEA] to protect and preserve consumer access to safe and beneficial dietary supplements.”

FDA has not had a Senate-confirmed commissioner since Margaret Hamburg, MD, stepped down last March. Stephen Ostroff, MD, has been serving as acting commissioner.

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Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com