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CBD Oil 2019

Consumers flood FDA with comments on CBD’s medical benefits

Comments filed with FDA reveal a compelling narrative that presents challenges for public health officials: Consumers are turning to cannabidiol (CBD)—and cannabis more generally—to manage various conditions, including anxiety, arthritis, insomnia and chronic pain.

Hundreds of public comments have poured into FDA ahead of a May 31 public hearing on how to regulate cannabis in different product categories—including conventional food and dietary supplements.

The comments reveal a compelling narrative that presents challenges for public health officials: Consumers are turning to cannabidiol (CBD)—and cannabis more generally—to manage various conditions, including anxiety, arthritis, insomnia and chronic pain.

Katherine Durbin, an Indiana resident, told FDA she suffers from anxiety, bipolar disorder, chronic depression, epilepsy and other medical conditions.

“I have been legally buying and ingesting CBD-based cannabinoids since they became legal to produce in my state,” she wrote. “They help with my pain, they help with my mental state, and they help with my epilepsy. I may even be able to come off a couple of my meds.”

Indiana legalized hemp extracts in 2018, following a series of raids by local authorities. According to FDA, 33 states and Washington, D.C., authorize the use of medical marijuana, and 14 other states have medical programs circumscribed to CBD products.

In comments filed with FDA, Gina Bellucci-Yeo said she is using CBD to treat her anxiety, pain and related symptoms. She disclosed she has been able to avoid regularly using opioids and benzodiazepines.

“My arthritic, geriatric dog has a much better quality of life because of CBD,” Bellucci-Yeo added.

Will Cunningham said CBD oil has helped him over the long term manage issues from autism and nerve pain. He said he drank alcohol in the past to deal with the effects from his medical conditions but has been sober from more than a year and now can do such things as exercise and volunteer work.

“CBD oil has dramatically changed my life for the better,” Cunningham wrote in his comments to FDA. “Please make it like a vitamin-supplement and not make it by prescription.”

But he requested FDA test products and ensure proper labeling.

Ellen Brawner said CBD and medical marijuana have helped relieve her pain that she controls without the use of opioids and narcotics.

Anxiety is another condition for which consumers are turning to CBD.

“It has allowed me to feel comfortable enough at work to socialize and not be afraid of everyone around me,” Patrick Bennett wrote to FDA. “No other chemical has ever been able to do this.”

Bennett said he has experienced “little to no side effects,” with the worst being a feeling of slight tiredness.

Other comments, some filed anonymously, claimed CBD has helped with various diseases, including epilepsy, endometriosis and neuropathy.

But Patrick Hinson described CBD as “snake oil” in comments to FDA.

“The big hype is mostly a placebo effect that people are experiencing,” he wrote. “THC, on the other hand, is a real and powerful drug that can treat PTSD, anxiety and depression. It should be [legalized] and controlled as a schedule III drug.”

With the exception of Epidiolex, a CBD medicine approved to treat seizures associated with rare and severe forms of epilepsy, CBD has not been proven safe or effective to treat medical conditions, according to FDA.

FDA officials are exploring the feasibility of regulating a compound that is currently sold in myriad products from conventional food and beverages to dietary supplements and lotions.

Demand for CBD has soared in recent years and only escalated after Congress in 2018 removed hemp and its derivatives from the Controlled Substances Act (CSA).

The 2018 Farm Bill defined hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta- 9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.”

The law preserved FDA’s authority to regulate cannabis-containing products. Many consumers and businesses advocating for continued access to CBD maintain the wide variability in product formulations—including the amount of CBD sold in a product—underscores the need for federal regulations.

“It is paramount that cannabis, and all cannabis-derived compounds, be manufactured with the health and safety of those who will be ingesting it being the top priority,” Austin Sachs said in comments to FDA. “In the unregulated market we have today, one can only assume that the cannabis products are manufactured without the use of harmful chemicals, pesticides, molds, fungus and yeast.”

Sachs raised concerns over product manufacturers “cutting corners” as well as “false claims.”

“Sadly, we live in a world where people will do almost anything for more money and better profit margins,” he wrote. “That is why the FDA was created in the first place, to protect consumers from bad products. People are buying products that they think are safe and yet they have no idea because the FDA does not have any regulations put in place for cannabis.”

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