HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

CBD Health Benefits More Attractive To Women? FDA Prioritizes Research Into Utero Effects

Executive Summary

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.

You may also be interested in...



US FDA On Effects From Cannabinoids Potentially Differing By Gender: Stay Tuned

"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. 

Lawful Use Of Cannabidiols In Supplements ‘Different Than The Rest’ Of US FDA Regulations?

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. 

CBD Drug Approval Not A Sign FDA Will Allow Its Use In Supplements

As a Schedule I controlled substance, CBD is not allowed by FDA for use in dietary supplements. Although CBD will be rescheduled by DEA to a less prohibitive Controlled Substances Act classification before GW Pharmaceuticals can launch its drug FDA approved June 25, its status for use in supplements won't change.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS150739

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel