FDA's CBD Puzzle: 'Criminals' Continue Or Prohibition Ends And Research Grows
Executive Summary
Agency seeks comment, at May 31 public hearing and docket open through July 2, on health and safety risks, manufacturing and product quality and marketing/labeling/sales around allowing cannabis-derived ingredients non-drug products. It wants input from across sectors of stakeholders, including opponents as well as proponents of allowing cannabis-derived ingredients in any category of regulated products other than drugs.
Allowing cannabis-derived ingredients' use in any non-drug product available in the US allows "criminals" in "the marijuana industry" to profit, the Food and Drug Administration heard from speakers at a 31 May public hearing.
On the other hand, speakers during the agency's first-ever hearing on the use of cannabis-derived ingredients in products subject to its oversight also suggested that the FDA leverage its authorities to help establish uniform regulations nationwide about access to hemp and cannabidiol in food and dietary supplements.
Additionally, a panel of 12 FDA senior officials also heard from representatives of drug development firms who asked the agency to loosen limits on researchers' access to cannabis-based substances. Helping drug firms access substances to research potential treatments that target a variety of conditions by reaching the endocannabinoid system, which is responsible for observable effects seen from consuming CBD and other cannabis-derived ingredients, but are not cannabis substances also was recommended during the hearing at the FDA's White Oak campus headquarters in Silver Spring, Md.
(This article is the second in a series HBW Insight is publishing on comments and information at the FDA's first-ever public hearing on using cannabis and cannabis-derived ingredients in products subject to the agency's regulatory oversight. See the first article in the series below.)
The agency sought comment, at the hearing and to a docket – FDA-2019-N-1482 – open through 2 July, on questions in the categories of health and safety risks; manufacturing and product quality; and marketing/labeling/sales. And it sought comments from across the sectors of stakeholders with interest in whether cannabis-derived ingredients receive its clearance for use in any category of regulated products other than drugs. (Also see "CBD Public Hearing Could Extend FDA's Hand Further For Help From Congress" - HBW Insight, 29 May, 2019.)
David Evans, an attorney active in litigation targeting pharma firms marketing opioid drugs and also general counsel for a group targeting cannabis product firms –"Cannabis Industry Victims Educating Litigators" – spoke at the FDA hearing to ask for a prohibition on the use of cannabis-derived ingredients in any non-drug product subject to the agency's oversight.
Evans told the panel that "anybody that's selling marijuana as a medicine or as a food that is not approved by the FDA" is part of "the marijuana industry."
"The reality is these people are criminals. They are doing this in violation of the federal Controlled Substances Act and also the Food, Drug and Cosmetic Act … and the federal government has allowed for this to go on for a long, long time," he said.
Rather than moving off its official policy that cannabis-derived ingredients are not eligible as dietary ingredients because some are approved or are being studied as drugs, Evans said the FDA should instead begin enforcing the prohibition.
"It's not debatable. There is no regulatory ambiguity you. You guys have said, 'don’t sell this stuff. It's illegal'," he said.
"These people have been operating for years and they've ignored you. What makes you think that anything will be different if you come out with something now? The only way it's going to be different is if you enforce it and you have not been doing that."
CBD and hemp are available in the US in supplements, food and cosmetics because the FDA has practiced an enforcement policy that allows sales of products that are not marketed with drug or other violative claims and that are otherwise compliant with relevant agency regulations. A docket to consider allowing the use of hemp and CBD as dietary ingredients was opened after Congress in December 2018 passed legislation reauthorizing spending for US Department of Agriculture programs, the farm bill, that included a provision removing hemp from the Drug Enforcement Administration's schedule of controlled substances; the bill defined hemp as cannabis plants and derivatives containing no more than 0.3% concentration, on a dry weight basis, of tetrahydrocannabinol, the psychoactive ingredient in cannabis. (Also see "FDA To Consider Regulatory Shift Making Cannabis Ingredients Officially Eligible For Use In Dietary Supplements" - HBW Insight, 28 Dec, 2018.)
However, the farm bill didn't remove exempt hemp and CBD from the FDA's authority for use in products under its oversight; instead it stated that the agency can make CBD and other cannabis-derived ingredients eligible for use in food and supplements.
In addition to Evans for CIVEL, representatives for opponents of allowing cannabis-derived ingredients in non-drug products including Marijuana Victims Alliance, Partners in Safety and Smart Approaches to Marijuana Canada wre among the more than 100 speakers during the hearing.
Opportunity To Expand Access
A former federal prosecutor now investing through private equity, Sheri Orlowitz, offered the FDA a suggestion diametrically opposed to Evans'. "This creates an unprecedented opportunity," said Orlowitz, a founding partner at Artemis Holdings Group LLC and an attorney in the Marijuana Policy Project.
The MPP since 1995 has worked to change federal law to allow states to determine their own marijuana policies, to allow the medical use of cannabis in all states and territories and to regulate marijuana like alcohol. The project will provide a report on states' marijuana and hemp/CBD laws as part of its comments to the FDA docket.
Orlowitz said that while she once prosecuted drug cases as a Department of Justice attorney, she currently works to "get rid of the cannabis prohibition." In addition to the marijuana remaining a controlled substance under federal law, an impediment to wider consumer access to cannabis products, she said, is the variety of regulations among the states.
For instance, she said, California current prohibits using CBD derived from hemp in food but allows using the substance derived from marijuana. Those and other rules and regulations that limit business growth as well as consumer access could be made more uniform with FDA's help.
"We suggest that the FDA work hand in hand with the states," Orlowitz said.
Questions Form Pharma, Too
Drug firms Corbus Pharmaceuticals Holdings Inc., Full Spectrum Omega Inc. and CV Sciences Inc. also support broader use of cannabis-derived ingredients under the agency's oversight, but comments by their representatives at the hearing reflect how the current regulation of cannabis by the FDA and the Drug Enforcement Administration create impediments in their work.
Corbus is developing treatments for cystic fibrosis, systemic sclerosis and other conditions through a non-cannabis ingredient that target the endocannabinoid system but avoid interaction with cannabinoid receptors in the brain and focus on the immune system outside the brain,
"It is not medical cannabis nor is it a cannabis-derived substance," said Robert Discordia, the Norwalk, Mass.-based firm's vice president for pharmaceutical development and manufacturing.
"Yet, because [Corbus' exploratory drug] is categorized as a cannabinoid, we face obstacles that other drug developers targeting the same indications with non-cannabinoid, exploratory drugs do not," Discordia told the FDA panel.
He added that same type of restriction delays Corbus from conducting clinical trials in Canada and Australia but not in 27 other countries. "FDA should develop a transparent, consistent, fair and practical framework to support the investigation and development of drugs targeting the endocannabinoid system … to have a clinical development path that mirrors as closely as possible that of other investigational drugs without the need for unnecessarily onerous regulatory barriers."
At Full Spectrum Omega, founder and CEO Richard Brumfield has difficulty obtaining cannabis-derived ingredients for development of low-THC medicinal cannabinoid elixirs and topical products. In addition to developing products for FDA approval, the Log Angeles-based firm has an agreement with the National Institute of Allergy and Infectious Diseases’ Radiation and Nuclear Countermeasures program to test its products in a federal laboratory as a wound healing treatment after radiation exposure and is working with a Department of Defense on a proposal on pain relief products.
Even with those research credentials, Full Spectrum Omega doesn't have clearance to move its materials from California to other states for additional testing and development because the 2018 farm bill didn't left up to states whether to allow interstate transportation of hemp and CBD. (Also see "Legalizing Marijuana Would Calm CBD Regulatory Storm – CV Sciences' MacKay" - HBW Insight, 22 May, 2019.)
Brumfield said tests with ingredients the firm has not maintained control of won't work. "We need to find a way to bridge that gap where innovators like myself are not handicapped and have to use a subpar product," he said.
"If we don't have control of our raw material now, how can we not have a drug shortage later on? It is imperative that we have control of our own raw materials," Brumfield added.
Unlike Corbus and Full Spectrum Omega, CV Sciences is interested in marketing nutritional products containing hemp and CBD as well as developing drugs with cannabis-derived ingredients. Duffy MacKay, senior vice president of scientific regulatory affairs, said the Las Vegas-based firm recognizes the difference between a dietary ingredient and a drug ingredient even when the substances are derived from the same source.
The FDA should acknowledge the difference, too, and recognize that it has multiple options for clearing hemp and CBD's use as dietary ingredients, MacKay told the panel.
The agency has been clear that ingredients approved or studied as drugs, such as highly purified and isolated CBD, aren't allowed for use as dietary ingredients. However, the FDA has " to separate an agricultural commodity from controlled substance," he said, adding that "hemp extract is a significantly different article from a highly purified CBD."
Existing FDA regulations support the agency's evaluation and approval of GW Pharmaceuticals PLC's Epidiolex (purified CBD) oral solution for treatment of syndromes of rare forms of pediatric epilepsy, and allowing hemp and CBD's use as a dietary ingredient can be done, MacKay said.
"A product intended to treat children with epilepsy is a drug and it should come with the pre- and post-market rigors required of FDA-approved drugs. ... However, for a food product that provides nutrition or a supplement that supports a healthy lifestyle, we have regulatory paradigms that appropriately correspond to those uses."