The U.S. Food and Drug Administration (FDA) has denied a request for a hearing by Meunerie Sawyerville and has debarred the Canadian animal feed company for five years from importing or offering to import food into the United States.
“FDA bases this order on a finding that Meunerie Sawyerville was convicted of felony offenses for conduct relating to the importation of food into the United States. In determining the appropriateness and period of Meunerie Sawyerville’s debarment, FDA has considered the relevant factors listed in the (Federal Food, Drug, and Cosmetic) Act. Meunerie Sawyerville has failed to file with the agency information and analyses sufficient to create a basis for a hearing concerning this action,” FDA said in a notice filed in the Federal Register.
The order began March 1.
Background
According to the Federal Register, on November 9, 2015, in the U.S. District Court for the District of Vermont, Meunerie Sawyerville pleaded guilty to two felony counts related to the importation of food into the United States. The offenses occurred between September 2012 and January 2013.
Meunerie Sawyerville admitted to knowingly and intentionally making a false statement by “listing a fictitious importer, namely, Ted Taft, and presenting such documents to Customs and Border Protection [Customs] officials . . . knowing and believing that Ted Taft was not the true importer of the goods described in the manifest.”
The company also admitted to introducing an adulterated drug -- cattle feed containing monensin -- into interstate commerce “with the intent to defraud and mislead.” Under regulations, “a drug is adulterated if it is an animal feed bearing or containing a new animal drug that is unsafe within the meaning of the FD&C Act.”
In a letter dated July 21, 2017, the Office of Regulatory Affairs (ORA) notified Meunerie Sawyerville of a proposal to debar it from importation into the U.S. for five years and provided an opportunity for Meunerie Sawyerville to request a hearing. Meunerie Sawyerville requested a hearing on the proposal on August 14, 2017, but the request was denied by the Director of the Office of Scientific Integrity (OSI).
OSI said “Meunerie Sawyerville has not established a basis for a hearing because hearings will be granted only if there is a genuine and substantial issue of fact for resolution at a hearing. Hearings will not be granted on issues of policy or law, on mere allegations, denials, or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged. … OSI has considered Meunerie Sawyerville’s arguments and concludes that they are unpersuasive and fail to raise a genuine and substantial issue of fact requiring a hearing.”
