HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Signature Formulations' CBD Products Meet FDA Drug Policy On Claims, GMPs

This article was originally published in The Rose Sheet

Executive Summary

FDA's warning letter to Phoenix firm lists violations of the agency's GMP regulations for drug products found in an October-November 2017 inspections in addition to identifying violative claims for its balms, creams, gels, oils, salves and toothpastes containing CBD and other botanicals.

You may also be interested in...



FDA To Consider Regulatory Shift Making Cannabis Ingredients Officially Eligible For Use In Dietary Supplements

FDA's prohibition against using ingredients derived from the cannabis plant in supplements and food isn't lifted by the farm bill President Trump signed on Dec. 20, but the agency recognizes sales of supplement and food products containing cannabidiol and other cannabis derivatives are exploding in the US.

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.

It's Complicated: FDA Prohibits CBD In Supplements, Enforcement Priority On Disease Claims

As FDA announces its first-ever approval of a drug that contains a substance derived from marijuana, officials say the agency's policy that prohibits CBD's use in dietary supplements or food will not change. They also say, however, that FDA's priority for enforcement actions against dietary supplements containing CBD, an extract from cannabis and hemp plants, will remain on products marketed with drug or disease claims.

Topics

UsernamePublicRestriction

Register

LL1134043

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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