Judge Sides with FDA on Cannabinoid Supplement Challenge


The District of Columbia District Court granted a motion for summary judgment requested by the Food and Drug Administration (FDA) in an order issued Monday. The FDA and its prior commissioner, Janet Woodcock, are being sued by Jeffrey Nathan Schirripa, an entrepreneur who developed a dietary supplement containing cannabinoids. Because of the items in the supplement, it requires approval from the FDA, which Schirripa has yet to gain, the opinion said.

Schirripa filed for a reconsideration petition after the FDA denied his first petition for approval. When filing for the second time, he included samples and detailed the possibility for a proposed partnership with the FDA on his product. Despite his efforts, the reconsideration petition was also denied. This prompted Schirripa to file pro se suit against the FDA commissioner at the time, his argument being that “there is substantial evidence that would lead a reasonable person to conclude that there is no rational basis” for denial. He specifically alleged that the FDA did not properly consider the sample that had accompanied the second petition.

Following the filing of the suit by Schirripa, the FDA requested that the court enter summary judgment in the case. They argued that Schirripa’s request for reconsideration did not meet four of the necessary factors required for reconsideration. Based on this, they concluded that “it would neither be in the public interest nor the interest of justice to grant the reconsideration petition.” Further, they asserted that the plaintiff’s suit “lacks standing, and the agency decision conformed to standards of rationality,” when denying his reconsideration petition.

While the court disagreed with the FDA on the matter of standing, they did find “ample justification for the agency’s decision,” and granted the FDA’s request for summary judgment.