NDI Notifications For CBD ‘Excluded’ On Arrival But US FDA Still Explains Where Safety Evidence Fails
Executive Summary
CFSAN Office of Dietary Supplement Programs tells Charlotte’s Web and Irwin Naturals that not providing sufficient evidence of a reasonable assumption of safety for an NDI's intended use wasn’t the only reason each notification was rejected.
You may also be interested in...
Naturopath, Regulatory Expert MacKay Returns To DC As CHPA’s Supplement Industry Strategy Chief
Consumer Healthcare Products Association names Duffy MacKay as its first senior VP for dietary supplements. Former CRN executive moves from CV Sciences back into trade group world.
Cannabinoid NDI Notification Failures Thicken Regulatory Cloud Over US Market
Clarity needed to remove unlawful label for using hemp- and cannabis-derived ingredients in supplements and food available in US. Rejections of two CBD NDI notifications could sour other firms on complying with requirement for cannabinoids or other ingredients, says food and drug law attorney Kristi Wolff.
After US FDA Objects To CBD Safety As NDIs, Supplement Industry Responds, What Else Is New?
Rejection of two firms’ proposals for using hemp-derived CBD in supplement isn’t stirring US businesses selling CBD supplements to pull products from market. For one firm that filed an unsuccessful NDI notification for full-spectrum hemp extract CBD, FDA rejection was agenda item with numerous other business, regulatory and legislative developments in its latest quarter.