Washington, D.C.—The Natural Products Association (NPA) said in a press release that it submitted comments to the FDA regarding a new proposal to share data collected from U.S. companies with foreign governments. NPA noted that the proposal lacks transparency and is out of step with the Trump Administration’s goals to streamline regulations.
The proposal, NPA says, would require companies to provide information related to administrative actions, including warning letters and inspection outcomes. The FDA would use the data to create a list of U.S. companies in compliance with federal regulations and share it with foreign governments who are importing products from U.S. companies.
The release noted that much of this information is already collected by the FDA. It further pointed out that under the Bioterrorism Act of 2002, companies must submit their name and facility address to the FDA, but the FDA refuses to share this information under Freedom of Information Act requests. This information would be shared with foreign governments.
NPA questioned FDA’s authority to provide an “eligibility screening service” for foreign governments, particularly as it is unclear what criteria FDA is using to determine eligibility.
Daniel Fabricant, Ph.D., president and CEO of NPA, said in the release, “At a time when FDA is being asked to do more with less, dumb rules like this are just busy work that sap money from important priorities. U.S. companies have a right to know how their information is being shared with foreign governments. Furthermore, the FDA’s proposal requires companies to re-submit information the Agency should already have in its possession. We are concerned the lack of transparency and redundancy in the FDA’s proposal is out of step with the Trump Administration’s commitment to streamlining regulations to make them more efficient for consumers and small businesses.”