9 April 2019 - Deborah Wilkes
The US Food and Drug Administration (FDA) is holding a public hearing on potential ways of regulating products containing cannabis and cannabis-derived compounds including cannabidiol (CBD).
In addition to the public hearing on 31 May 2019, the FDA is setting up an internal working group to "explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed".
FDA commissioner Scott Gottlieb said the working group would consider "what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health".
The working group will be co-chaired by Amy Abernethy, the FDA's principal deputy commissioner, and Lowell Schiller, the FDA's principal associate commissioner for policy.
Gottlieb stressed this was a "complicated topic" and was expected to "take some time to resolve fully". Nevertheless, he said the working group planned to begin sharing information and/or findings with the public "as early as summer 2019".
Response from industry
Responding to the announcement, the US Consumer Healthcare Products Association (CHPA) urged the FDA to establish "clear regulatory pathways for CBD as a new dietary ingredient".
The industry association said it supported the FDA's position that CBD could not be lawfully included as an ingredient in a dietary supplement because it had been authorised for investigation as a new drug and the FDA was not aware of prior marketing as a food or dietary supplement.
However, the CHPA pointed out the FDA had the "authority to develop a regulation to allow CBD to be a lawful dietary supplement ingredient through the new dietary ingredient (NDI) pathway". This route, said the CHPA, required "sufficient information to provide reasonable assurance the ingredient does not present a significant or unreasonable risk of illness or injury".
Comments on hemp oil
The CHPA said hemp oil, including hemp oil with naturally-occurring CBD, was already an appropriate dietary supplement ingredient.
Noting that hemp or hemp oil had been used in food and dietary supplements "since at least the early 2000s", the CHPA said an exception in the law allowed a substance to be marketed as a dietary supplement or conventional food if the substance had been marketed as a dietary supplement or conventional food before a new drug investigation had been authorised.
Commenting on medicines, the CHPA noted that a regulatory pathway already existed. "The existing drug approval process provides a pathway for sponsors to develop data to bring cannabis-derived medicines to market once shown safe and effective," said the industry association.
The FDA has already approved Epidiolex, a prescription drug for some seizure disorders that contains highly-purified CBD.
The CHPA said it supported the "new drug path for cannabis-derived products that make disease-related claims, either prescription or OTC, that are supported by appropriate evidence with FDA-approved labelling".
FDA's enforcement action
The industry association is keen for the FDA to increase enforcement action against dietary supplements claiming to contain CBD, particularly those that make "unlawful, outlandish and unsubstantiated drug claims".
The FDA said it would continue to take action against companies illegally selling products. "I am deeply concerned about any circumstance where product developers make unproven claims to treat serious or life-threatening diseases," commented Gottlieb, "and where patients may be misled to forgo otherwise effective, available therapy and opt instead for a product that has no proven value or may cause them serious harm."
The FDA recently issued warning letters to Advanced Spine and Pain, Nutra Pure and PotNetwork Holdings.
The three companies had made unsubstantiated claims for more than a dozen different products, said the FDA, spanning multiple product webpages, online stores and social media websites. One claim said "CBD successfully stopped cancer cells in multiple different cervical cancer varieties", while another stated "For Alzheimer's patients, CBD is one treatment option that is slowing the progression of that disease".
Concerns about safety
Commenting on the public hearing and related public comment period, Gottlieb said it would allow stakeholders to "share their experiences and challenges with these products including information and views related to product safety".
Gottlieb said the availability of CBD products had increased dramatically in recent years but "open questions remain regarding the safety considerations raised by their widespread use".
During the review of the marketing application for Epidiolex, he noted, the FDA had identified "certain safety risks, including the potential for liver injury".
"These are serious risks that can be managed when the product is taken under medical supervision in accordance with the FDA-approved labelling for the product," said Gottlieb, "but it is less clear how this risk might be managed in a setting where this drug substance is used far more widely, without medical supervision and not in accordance with FDA-approved labelling."
Gottlieb said there were also "unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products". Furthermore, he added, there were "questions regarding the intended functionality of CBD in such products".
"Additionally, there are open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance," said Gottlieb.
Unanswered questions must be addressed
Gottlieb said it was "critical" that these unanswered questions about CBD and other cannabis and cannabis-derived products were addressed.
The FDA wants to know if there are particular safety concerns that it should be aware of as it considers the regulatory oversight and monitoring of these products.
The regulatory agency noted, for example, that it was seeking comments, data and information on a variety of topics. These include: what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery – ingestion, absorption, inhalation – affects the safety of, and exposure to, these compounds; and how cannabis and cannabis-derived compounds interact with other substances such as drug ingredients.
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