Notes on FDA Public Hearing, Morning Session

By Marc Lewis

The hearing opened with a summary of the FDA’s position. Mainly that CBD has been established as a drug and cannot be added to food because drugs cannot be added to foods. Despite CBD being marketed as a dietary supplement, once it was approved as a drug it fell under these regulations, the FDA said.

Dosage, children, and prolonged use were called out as significant issues to be researched and discussed.

Representatives also spoke about how the FDA has sent and will continue to send warning letters to any brands that sell products that they claim can treat or cure serious diseases, such as cancer. Marketing drugs with unsubstantiated claims is against the law.

As the open comment section began, people on the agenda were given two minutes to share thoughts. Quality standards for production and dosing were called for. The first speaker mentioned chronic use, and cited the opioid epidemic as a concern. Next, a cannabis researcher at Johns Hopkins University, who previously researched electronic cigarettes, mentioned that a dose is different for every person and varies by method of administration. He said the delayed effects of gummies may come with the potential for overdose.

Then a representative from the agriculture community noted how hemp has offered new life to struggling farmers. Kentucky farmers were paid $8M on hemp alone last year, he said. He called for an end to the legal uncertainty surrounding the crop. Farmers, he believed, wanted the products to be regulated as food and dietary supplements and he pressed for clearer communication from the FDA.

This back and forth between medical worry and economic potential continued.

The Hemp Seed Coalition cited the nutritional value of hemp and its applications for animal feed. China products were a concern, both for the impact they have on American farmers and the overall quality of products in market. The Hemp Seed Coalition asked the FDA not to label hemp a drug before they had time and data to make a real determination.

Jonathan Miller of the Hemp Roundtable pressed for regulation of CBD as a food and dietary supplement to give clarity to consumers. He also said Congress intended the Farm Bill to allow the manufacture of hemp products and making CBD a drug would obstruct that ability.

A biochemist mentioned that CBD was 400x safer than caffeine. He also noted how much safer cannabis derivatives were compared to other drugs.

Susan Glover, a retailer, said, “We the people deserve, and I daresay demand, no less than safe and unfettered access,” before a mother from Marijuana Victims called for the federal government to regulate marijuana and limit that access. She blames cannabis for the death of her son. She held up a picture of her boy, his suicide note, and his dispensary card and contented that marijuana contributed to her son’s mental decline after his time in the Army.

A nurse from Holyoke Visiting Nurse Association cited predatory practices in the industry that put “profit over people.” She called for more oversight to control the purity of products. This began a trend wherein hemp and marijuana were lumped together.

Dr. Phillip Blair of Elixinol cited his experience helping patients with hemp and CBD with no significant adverse results. The side effects his patients experienced, he said, were mild headaches and fatigue. He also mentioned the WHO report that CBD shows no potential for substance abuse.

The questions FDA panel members asked speakers did not inspire confidence. It seems the average consumer is entering a burgeoning online marketplace with more background than some panelists who will decide the fate of a billion dollar industry.

Wildflower Brands called the hearing a “moment in American history.” When asked why CBD was good for beauty products, the representative blundered. He had no information or evidence to suggest why CBD could be used in a beauty product. He said something about a petition. Inflammation, psoriasis, or acne would have been better answers, but, it seems, “moments in American history” are no time for homework.

Megan Olsen of the Council for Responsible Nutrition said “3 to 5 years as a minimum of rulemaking is too long,” and pressed the FDA to act quickly. She echoed previous sentiment that Americans deserve access to safe supplements. After her a number of speakers said the same. One publisher said CBD was the same as Vitamin C and when asked if he would give his kids CBD he said no, though he’d give his kids Vitamin C, again not having prepared for the simplest of cross examinations.

After a brief recess, a researcher joined by phone to compare the harmful potential of THC to the damage done by heroin. In railing against profiteers there was a mention of Whoopi Goldberg. Then came a presentation on drug interactions. And so continued a CBD hearing that makes five years sound like an ambitious timeline to resolve debate.

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