On April 24, 2019, Claudia Lewis was quoted in Nutra Ingredients on the recent issuance of warning letters marking a new era in the FDA's scrutiny of the status of dietary supplement ingredients.
According to the article, the eleven letters, eight of which focused on DMHA and three on phenibut, were unique in that they addressed only whether these ingredients qualified as legal dietary ingredients. The letters had nothing to say about company operations, such as whether illegal disease claims were being made or if the companies had failed to observe Current Good Manufacturing Practices.
"This is the first time in my experience where the agency is not raising all of these ancillary issues," Lewis said. "It does signal that the agency is evaluating whether you qualify as a dietary ingredient."
Safety questions about these ingredients had been raised in prominent scientific papers and by industry trade associations. This is probably why FDA chose to act on these two ingredients in this manner, Lewis said.
"Safety is the first and last question that the agency usually asks," Lewis said. "But in recent years the agency has been kind of silent with respect to the safety profiles of some new ingredients."
Lewis said the new warning letters signal that that free pass might have expired.