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 Lotion Firm’s ‘FDA Certified’ Claim For 'OTC Drug' Is Certifiably Noncompliant

Executive Summary

In addition to CBD, Elixicure is formulated with OTC external analgesics monograph ingredients camphor and menthol, But CBD isn't a monograph drug nor approved for use in any pharmaceutical product other than GW Pharmaceutical's Epidiolex.

You may also be interested in...



FDA Budget Request Includes $5M For CBD Regulation With Pathway Unclear

FDA includes cannabis product regulation in FY 2021 food safety priorities, “key areas where resources have been historically underfunded and for which there are rising public health needs as growing markets outpace increases to Agency resources,” it states in its budget request.

Future Of CBD In Supplements: NDI Notification Looms As Regulatory Path

Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.

CBD Products For Children Could Connect The Dots To FDA's Problem For Congress

In addition to FDA and FTC attention, pediatric claims by Rooted Apothecary could get attention of US lawmakers, who FDA is asking to authorize it to more directly enforce against adulterated supplements. Violative claims include “Increasing evidence suggests that CBD oil is a powerful option for pain and autism. It seems like an attractive and safe option for children.”

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

RS149696

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