Thousands Ask FDA to Allow CBD in Food and Supplements
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The Food and Drug Administration’s open call for public comment on CBD regulation closed last Tuesday, leaving the administration with several thousand responses to review.
At the end of May, the FDA held a public hearing on the use of CBD products, with the purpose of discussing how stakeholders and members of the public would like to see the authority regulate the products.
Over 100 speakers from a diversity of backgrounds testified at the hearing, but for those who were unable to speak or submit written testimony, the administration established a docket for public comment. Through the docket interested parties were able to submit electronic or written comments to be considered by the FDA as it considers its future policy directions on CBD products.
The initial comment period was due to close on July 2, but was extended by two weeks in light of the high number of responses from the public. By the eventual close of the comment period on July 16, the docket contained over 4,400 submissions from a mixture of individuals and organizations.
All electronic and written comments received have been made available by the FDA to view online.
Hundreds share personal experiences with CBD
Some of the most emotional comments come from individuals sharing stories of how CBD has helped them manage a variety of medical conditions, such as post-traumatic stress disorder, anxiety, and surgical pain. Others submitted comments telling of how CBD has helped them wean themselves off addictive and potentially dangerous prescription medications, like opioid painkillers.
“I have been using CBD products as part of my treatment plan to manage my autism spectrum disorder and ADHD,” wrote one respondent. “They grant me a sense of emotional stability and well-being that no prescription medication has ever been able to provide.”
“Preventing the use of CBD in dietary supplements, food, and interstate commerce makes it difficult for people to access the compound,” they continued. “Should I want to use CBD while traveling (a necessity given the distress it imposes to people on the autism spectrum), I must bring my own supply with me wherever I go. It would be not only convenient, but medically-expedient to have the option of having access to as many CBD products as possible wherever I go.”
Another commentator detailed their struggle recovering from cancer-related surgeries while also suffering from fibromyalgia and other chronic conditions.
“As a chronic pain sufferer who was taking hydrocodone on a daily basis for pain from cancer surgeries, severe fibromyalgia and arthritis as well as sufferings from severe tinnitus, I can definitely say that CBD oil has changed my life,” they wrote.
“I was very skeptical whether CBD oil would make any difference but after trying it at the urging of my oncologist I found that I [now have] another tool in fighting my chronic pain.”
“I still wake up at night with severe pain and need to take the hydrocodone, but the severity of the pain is somewhat lower and I am able to sleep longer before the pain wakes me up. All in all, I have found that the CBD oil has made quality of life much better.”
Professional associations offer statements in support of CBD supplements
Also among the submissions to the docket were a number of official statements from medical and industry organizations, recommending that CBD be regulated as a health supplement.
“Our patient community has used non-FDA approved CBD and other cannabis-based products when other options have failed to provide seizure control for their family member with Dravet syndrome,” wrote the Dravet Syndrome Foundation in their statement. “Due to reports of extreme variations in product consistency and frequent label misrepresentation, we would welcome standardized labeling for cannabis based dietary supplements and foods including concentration, ingredients, and stability.”
The National Cannabis Industry Association (NCIA) also submitted an official statement, alongside a 49-page report full of “relevant prior work” for the consideration of the FDA.
“We are grateful that FDA is accepting public comments from the CBD/hemp industry and interested parties,” wrote Andrew Kline, director of public policy, on behalf of the NCIA.
“Given the substantial interest in this topic and the need for regulations and standardization throughout the industry, [we] are providing specific insight into all facets the FDA would like to examine, including health and safety risks, manufacturing and product quality, and marketing, labeling, and sales.”
The statement was co-signed by Aaron Smith, the executive director of the NCIA, as well as by a number of other cannabis/hemp entrepreneurs, scientists, and medical professionals who are members of the NCIA and form part of a new “expert coalition” formed by the NCIA for the explicit purpose of working with the FDA to answer their questions and generally provide industry insight.
A number of other prominent organizations, including the National Association of State Departments of Agriculture (NASDA), New York State Bar Association, National Grocers Association, U.S. Hemp Roundtable, Vote Hemp, and the Center for Science in the Public Interest (CSPI) also provided comprehensive responses to the FDA’s request for information.
Dozens of state attorneys general want federal cooperation in protecting consumers
Thirty-seven state attorneys general also came together to pen a statement to the FDA, submitted as a part of the docket.
“As the primary enforcers of our respective states’ consumer protection laws, we offer a unique perspective as to the new legalized market of certain cannabis and cannabis-derived compounds, including CBD products,” the state officials wrote. “Although products containing cannabis or cannabis-derived compounds may well offer real benefits to consumers, it is important that consumers have reliable risk and benefit information to make informed choices about initiating and continuing the use of these products.”
The attorneys general also expressed that they want to see the FDA continue to “explore manufacturing, testing, and marketing best practices” so that consumers are not put at risk from misleadingly advertised products, or products containing undisclosed dangerous additives.
FDA to accelerate CBD rule making process
Shortly before the official closure of the comment period, the FDA chief information officer and principal deputy commissioner Dr Amy Abernathy confirmed via Twitter that the FDA is “expediting its work to address the many questions about cannabidiol” and announced that the agency plans to release a progress report detailing its findings “around end of summer/early fall.”
Lawmakers have been urging the FDA to speed up its handling of the rule making process in this way for months.
Due to the large number of responses to process, it remains unknown whether the FDA will be able to announce any material developments beyond the publishing of the progress review by the fall, but hopes are that additional information could be released in August, when an FDA policy official is scheduled to deliver a keynote speech at a major hemp industry conference.