George Pontiakos, president and CEO of BI Nutraceuticals, told Stephen Daniells at SupplySide West that “a lot of the new interpretations in the NDI draft guidance are incorrect”.
He added: “When DSHEA was written, there was intent by the writers of DSHEA to ensure that there was a vehicle to ensure that there was some level of information prior to release of a product available if necessary.
“There was never intended to be pre-release or hold for approval, none of that was ever initiated in the original documentation.
“If we have issues within this industry then FDA has a mandate to protect the consumer, no question about it,” said Pontiakos. “But if you have a sustained database of 17 years with non-issues, in this time of budgetary crisis within the government and private industry, why do we want to encumber the industry with more costs and why does FDA want to use that budget to survey a non-existent issue.
“I just don’t see the logic.”