Over the past several months, the US Food and Drug Administration has been tasked with making a series of decisions about how cannabidiol (CBD) products can be produced, sold, and consumed.
In the meantime, without formal rules in place, CBD products are popping up in mainstream stores, from CVS to American Eagle, and in products from ice cream to cocktails to dog treats. The enormity of the FDA’s undertaking is difficult to overstate, but the FDA is, as evidenced by the ubiquity of CBD products, behind. This may be why on Friday the FDA decided to speed the process up.
Principal deputy commissioner and acting CIO Amy Abernethy tweeted, “FDA is expediting its work to address the many questions about cannabidiol (CBD). This is an important national issue with public health impact, & an important topic for American hemp farmers and many other stakeholders.” A progress update is expected by late summer or early fall.
A short rundown of how we got here:
• CBD was already just about everywhere when the 2018 Farm Bill, signed into law in December, removed hemp from the Controlled Substances Act and further ignited the consumer craze. Hemp legalization, by extension, legalized CBD, one of many cannabinoids found in found in both hemp and marijuana (as they are both of the genus Cannabis).
(Cannabis Wire has been covering the efforts of regulators and lawmakers across the country to rein in and/or craft regulations for these products.)
• A rub: just months before, in June 2018, the FDA for the first time approved Epidiolex, a CBD-based cannabis plant extract, as a medicine available by prescription. Typically, compounds undergoing clinical trials or approved as medicine cannot be put into foods, which CBD commonly is. (Read about the approval of Epidiolex on Cannabis Wire.)
• So, this May, the FDA hosted an historic public meeting about how to regulate products that contain cannabinoids like CBD. (Read Cannabis Wire’s comprehensive coverage and our takeaways.)
With the public comment period closing tomorrow, July 16, Cannabis Wire sifted through the >3,500 online comments to share some of the most noteworthy (with the caveat that some people and entities filed confidentially, and that this list will likely be updated).
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Protect consumers while “fostering growth within this new emerging industry.”
NASDA, which represents the commissioners, secretaries, and directors of the state departments of agriculture, wrote: “If no federal action is taken, states will be forced to develop regulatory structures for these products, and the result will be a patchwork and an inability to potentially sell across state lines. A federal framework is crucial to ensure that interstate commerce continues in the CBD and hemp markets.”
Approve more sources of research-grade cannabis (and make the research process easier and clearer).
“We believe it would be appropriate for the FDA to indicate its support for expansion of the sources of cannabis available to researchers, as increased research on the health effects of the types of cannabis products that are in ‘real world’ use would support the overall FDA mission of protecting public health.”
Lawyers are caught in the confusion.
“Following the 2018 Farm Bill, many of our clients hope to work with the FDA to conduct clinical research for hemp- and CBD-containing products, while navigating the myriad of conflicting federal and state laws, including the uncertainty concerning the ability to freely market their products.”
The association specifically called for clarity around issues including: interstate commerce, import/export, allergen testing, and terminology like “THC free.”
Protect patients against false claims.
“At this time, cannabis is essentially an untested drug with regard to Alzheimer’s and dementia, and like any untested drug, it cannot be responsibly recommended for human use. This lack of evidence creates substantial risks for individuals and their families. Only large, randomized, controlled clinical trials can provide reliable evidence of efficacy or safety of any drug. The Alzheimer’s Association believes that more research in this area is needed, and we applaud the FDA’s commitment to protecting the health and safety of individuals until such evidence becomes available.”
Consumers want grocers to carry CBD products.
“To meet growing consumer demand for CBD products, NGA urges FDA to take quick and decisive regulatory action to clarify the federal rules surrounding the sale of CBD. Given the overwhelming evidence that CBD products promote general health and wellness, NGA urges FDA to create a legal pathway for retailers to carry CBD products on their store shelves. We suggest that FDA clearly distinguish CBD as a dietary supplement and food additive rather than a human drug under FDA’s Section 505 regulations requiring clinical trials before going to market.”
Quality control standards are coming.
The USP, which “develops public quality standards for the identity, strength, and purity of medicines, foods, and dietary supplements” and develops “reference standards for analytical testing” wrote:
“From our interactions with various stakeholders throughout the last several years, we have learned of the critical and growing need for scientific articulation for quality attributes for cannabis and related products to help protect patients and consumers from harm. As more products become available and sourced more broadly, and states continue to adopt initiatives allowing the use of cannabis, potential exposure to, and associated risk of harm from contaminated, substandard, or super-potent products is increasing … we plan to publish our work in a scientific paper to make it available to interested stakeholders.”
Medical technology companies are watching. (And this one wants to tackle contamination.)
The global medical and healthcare products company wrote, “It is recommended that FDA approve or strongly advocate for the acceptance of irradiation as a safe and effective method to reduce the risks related to microbial contamination and consequentially potential health risks associated with the use of cannabis containing products. The available information from current applications in analogous food products and for the irradiation of cannabis shows that there is a clear benefit in providing microbial reduction and that at the levels recognized as providing this benefit, the use of irradiation will not detrimentally impact the most important active components (THC and CBD) attributed to medicinal cannabis.”
Beware of supplements.
BIO, which is a major trade group that represents “biotechnology companies, academic institutions, state biotechnology centers and related organizations” across the US and internationally, wrote:
“FDA has made clear in many of its statements generally that both THC and CBD-containing products fall outside the parameters of the dietary supplement regulations… It is imperative for this regulatory distinction to guide FDA’s enforcement priorities in the current dietary supplements arena.”
“We are concerned that a lack of enforcement against unsupported medical claims by dietary supplement manufacturers will reduce incentives to study and invest in more targeted drug products in this similar ingredient category. This could rob patients of the potential for new treatments that may evolve from intensive and thorough research, and instead increasingly subject them to relying on unsubstantiated claims being marketed by non-compliant dietary supplement product.”
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