US FDA On Effects From Cannabinoids Potentially Differing By Gender: Stay Tuned
For Pregnant Women, Research Points To CBD Label Warnings
"The use of these products during pregnancy and lactation raises additional questions and concerns,” says Kaveeta Vasisht, FDA Office of Women’s Health director. "There is a great deal that we simply do not yet know about CBD and beyond CBD, even more that we do not know about the other compounds found in hemp," said Douglas Throckmorton, Center for Drug Evaluation and Research deputy director.
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Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA neuroscientist Andrew Shen.
CFSAN regulatory affairs chief Douglas Stearn says a regulatory pathway wouldn’t be an open door for CBD-containing food and supplements due to concerns about the ingredients’ safety. Legislation from Congress might "do something with CBD that’s different than the rest of the Food, Drug and Cosmetic Act," he says.
Supplements containing hemp-derived cannabidiols aren’t typical products subject to FDA’s regulatory oversight, and the document stating its thinking on enforcement in the market submitted to the Office of Management and Budget isn’t a typical draft guidance.