What they’re saying: 10 highlights from the FDA’s query on how to regulate CBD

What they’re saying: 10 highlights from the FDA’s query on how to regulate CBD

In its open call for suggestions related to how cannabis extracts should be regulated, the U.S. Food and Drug Administration (FDA) received more than 4,000 responses.

Respondents ranged from state and local health departments to CBD manufacturers to the American Medical Association.

The agency is looking at cannabis extracts from both marijuana and hemp varieties in response to a boom in over-the-counter CBD sales.

The FDA said it will expedite guidance on the topic, a nod to mounting public interest in cannabinoid treatments.

Hemp Industry Daily reviewed the public comments to see what people were saying and highlight some top takeaways. Here’s what we found:

National Cannabis Industry Association:

“Cannabis testing provides important public health and safety benefits to consumers and society at-large. But it also increases the incremental costs of cannabis products.

“During this initial phase of cannabis implementation and development, increased costs could push price-conscious consumers back into the illicit market. As such, it is vital that policymakers consider ways to ensure that testing is performed efficiently as well as effectively. The frequency of mandated third-party testing is the most significant driver of testing costs. …

“The NCIA hopes that the FDA will act with due deliberation and speed in effectuating a regulatory regime that works for the industry and regulators alike.”

George Pertot, hemp farmer, Colorado:

“All-natural, full-spectrum unadulterated hemp oil should be classified as a food supplement and a dietary supplement, only in its pure unadulterated form as full-spectrum crude hemp oil or distillate only.

“Foreign CBD isolate should undergo strictest testing standards before import … in order to protect the populace from outdated and illegal pesticides and herbicides from foreign-grown plants and transferred through heavy metals biologically to the isolate powder crystals which get sold to the U.S. from China and Indonesia.”

National Association of Chain Drug Stores:

“There is still considerable confusion regarding many of these products being marketed for sale in the United States. … We urge the FDA to act swiftly.”

Plant Life Group, Connecticut:

“Given the level of consumer interest in CBDs and the benign risk profile (based on currently available research), it’s hard to envision a reduction in demand in the near term – or a pharma-only consumer path.

“Applying the existing FDA framework for NDIs (New Dietary Ingredients) to hemp products containing nontrace levels of active cannabinoids would seem to be the logical path. ”

American Psychiatric Association:

“Regarding psychiatric disorders, there is no current scientific evidence that cannabis is beneficial for treatment. In fact, several studies have shown that cannabis use may exacerbate or hasten the onset of psychiatric illnesses. …

“While there is no current evidence pointing to its effectiveness to treat psychiatric disorders, we cannot ignore the current surge of cannabis-derived products available to the public. We urge the FDA to take bold action to strengthen its infrastructure for regulating the current market.”

Arthur Ellis, vice president for research and graduate studies, University of California:

“Researchers are unable to study cannabis that is comparable in potency to what is currently available in states that have passed medical and recreational cannabis laws. Such a restriction hinders scientific understanding of cannabis use and its effects.

“Efforts should be made to expand the sources of cannabis that can be studied, allowing researchers to conduct research on cannabis that is in actual ‘real world’ use (such as cannabis that is routinely available from dispensaries and retail outlets operating in states that have legalized certain cannabis use and sales).”

American Medical Association:

“Ongoing surveillance to determine the impact of cannabis legalization and commercialization on public health and safety will be critical.

“Surveillance should include, but not be limited to, the impact on patterns of use, traffic fatalities and injuries, emergency-department visits and hospitalizations, unintentional exposures, exposure to secondhand smoke and cannabis-related treatment admissions. At-risk populations, including pregnant women and children, should be a focus of attention. ”

Irwin Naturals, California:

“We recognize that populations chronically exposed to high levels of CBD and other cannabinoids should be closely monitored to ensure long-term safety.”

Pulak Sharma, co-founder, Kazmira, Colorado:

“Clamp down on operators manufacturing hemp oils with contaminants, including heavy metals, pesticides, mold.

“To be more specific, dilution of the hemp oil to bring the contaminant below the limit is not acceptable. Dilution is not the solution.”

Anson Tebbetts, secretary, Vermont Agency of Agriculture, Food and Markets:

“As a crop, hemp cultivation requires chemical inputs, including pesticides.

“As the EPA is moving toward developing tolerances for hemp crops … disallowing hemp and hemp-derived products in food removes the ability to effectively regulate pesticide tolerances at both the state and federal level.”

To read what other companies and individuals are saying, click here.

The responses above have been edited for length and clarity.

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