FDA allows drugs Kava-kava and St John’s Wort in foods, and we’ve already had a half-dozen years of massive CBD diffusion, ie: “real world experience.” There are 20,000 unregistered NDIs like CBD, but only CBD raises their ire. But only if crossing state lines. Intrastate/10A FTW.
“Jessica Wasserman, a Washington DC-based cannabis attorney, told Schiller that the FDA is “being a little disingenuous” in regard to the drug preclusion law, saying the companies that have submitted NDIs have invested a great deal of time and money in developing toxicity studies and other research.
She asked why companies would invest in additional research and studies if the FDA is just going to reject them due to the drug preclusion rule.
Shiller countered that the application of a substance that has been approved as a prescription drug as a food additive or dietary supplement has never been done before. He added that the FDA would need significant data first.
“People are pretty well aligned that they don’t want (drugs) in food to be consumed in products that can’t be controlled. This has enough risks. …. Health and safety components have to be worked through.””