The Natural Products Association (NPA) sent a letter to Dr. Robert Califf regarding his recent confirmation to become the new commissioner of the U.S. Food and Drug Administration (FDA). In the letter, NPA congratulated Califf on his confirmation by the U.S. Senate and outlined its priorities for the new commissioner. NPA also requested a meeting with Califf at his earliest convenience.
In the letter, NPA asked Califf what his plans are to use all of the legal tools at his disposal to enforce the laws and regulations related to the supplement industry. The NPA asked if he will be collaborating with Department of Justice (DOJ) to take up misdemeanor cases to deter unscrupulous companies selling adulterated or mislabeled supplements which have traditionally flown under FDA’s radar because of their small size. The organization also asked if he would be working to identify dietary ingredients found to be unsafe and remove them from the marketplace through the use of the 402(f)(1)(B) charge more frequently; and using all tools available, including mandatory recall authority, administrative detentions, and the use of seizures, in favor over injunction, as a method to more appropriate curb and deter adulteration and misbranding.
“NPA also strongly supported the elevation of the Division of Dietary Supplements at FDA to an Office,” said Dr. Daniel Fabricant, executive director and CEO of NPA. “This is a long overdue step within FDA that we hope will empower the ODS to exercise all the authorities it has to regulate this important industry. To that end, we are interested knowing when a strategic plan for the new office of dietary supplements will be developed and what the FDA anticipates its budget will be for FY 17.”
NPA also expressed some concerns over past comments made by Califf, and asked the newly appointed commissioner to clarify them. “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,” said Fabricant. “We would ask that you please clarify these comments, as such a drastic change in regulatory practice would not only significantly increase the cost it takes to produce, manufacture and sell supplements, but also limit consumers’ access to millions of supplements that are taken safely each and everyday.”
In conclusion, NPA said that it looked forward to having a “constructive dialogue that furthers shared interests in protecting American consumers, including the millions of those who safely use dietary supplements everyday.”
For more information, visit www.npainfo.org.