Tensions between the Natural Products Association (NPA) and the US Food and Drug Administration (FDA) continue as the trade group this month accuses the regulator of – once again – actions at odds with the Trump Administration’s stated commitment to cut business red tape.
The trade group said that new FDA proposals, which would obligate American companies to share sensitive business information with foreign governments, amounted to worrying regulatory overreach.
Under the proposals, companies would be required to provide information related to administrative actions including warning letters and inspection outcomes. NPA says the FDA wants to use this data to create a list of US companies in compliance with federal regulations and share it with foreign governments who are importing products from US companies.
NPA has questioned FDA’s authority to provide an “eligibility screening service” for foreign governments and requested the release of documents and requests submitted to the Agency from each foreign government. It says it is unclear what criteria FDA is using to determine eligibility.
“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”
“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,” said Daniel Fabricant, president and CEO of NPA (picture). “US 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.”
Talking to nutraingredients.com, Fabricant said: “This is a case of regulatory mission creep. Why are we required to provide more and more information, but we can’t find out if a company, say a competitor in China, is selling from a registered facility?”