On April 19, 2019, Claudia Lewis was quoted in Law360 regarding a trio of warning letters released by the FDA scolding sellers of phenibut, an increasingly popular synthetic product that is often marketed as a cognition-enhancing "nootropic."
According to the article, the FDA's move follows an offensive launched in November by the nation's top dietary supplement trade groups. In a remarkable joint statement, the groups declared that phenibut "should be considered dangerous" and carries a "great risk for addiction."
The FDA's warning letters did not cite any safety concerns. Sales of phenibut, the FDA wrote, are unlawful because the product isn't a vitamin, mineral, herb, or other substance that fits the statutory definition of "dietary ingredient."
Lewis said that the FDA's broadside against phenibut may have been spurred by the confluence of the trade groups' offensive and former FDA Commissioner Scott Gottlieb's general call for tougher supplement scrutiny.
"Having the support of trade associations, coupled with the FDA's recent efforts to increase its oversight of the dietary supplement industry, may have prompted FDA to take this first bold step," Lewis said.