U.S. FDA Holds Historical First Hearing On CBD Legality

Published on May 31, 2019

Over the past year, cannabis-related products have flooded the United States market with strong claims to the effect of relieving pain, increasing immune functionality, and minimizing depression. There’s no question that there are plenty of smoke and mirrors surrounding the cannabis market and CBD. In an era of “fake news,” how do we know what’s real and what’s not?

On Friday, the U.S. Food and Drug Administration (FDA) held its first hearing to assess the safety and efficacy of cannabinoids, or CBD products.

In its opening remarks, the FDA’s acting commissioner, Dr. Ned Sharpless, stated that there are “critical questions remain[ing] about the safety of these items.”

“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” Sharpless emphasized.

Lighting Up the Smoke and Mirrors of CBD

For many people, CBD and cannabis are linked, but the truth is much clearer. CBD is the ingredient found in marijuana and hemp. This differs significantly from tetrahydrocannabinol, or THC, which acts as the main psychoactive component of cannabis. In other words, the reason an individual “gets high” is due to the THC, not the CBD.

Last year, the Agricultural Improvement Act of 2018, or the 2018 Farm Bill, passed by President Trump, removed hemp as a Schedule I controlled substance, and reclassified it as an “agricultural commodity.” However, as Sharpless pointed out in Friday’s hearing, much of the research into cannabis looked at the cannabis plant as a whole, rather than the specific components like CBD.

“When hemp was removed as a controlled substance, this lack of research, and therefore evidence, to support CBD’s broader use in FDA-regulated products, including in foods and dietary supplements, has resulted in unique complexities for its regulation, including many unanswered questions related to its safety,” he said.

Is CBD Legal?

So, is CBD legal in all 50 states? It depends.

Friday’s hearing was a historical breakthrough with respect to regulation on cannabis and cannabis-derived products. Advocates, industry representatives, regulators, health professionals, and marijuana legalization opponents stood up before the FDA to share their perspectives on how best to approach the regulation of CBD.

The biggest takeaway, which was supported by Andrew Kline, the director of public policy for The National Cannabis Industry Association (NCIA), was that the FDA needs to quickly act on clarifying the regulatory environment.

“Because there are significant confusions in the market, businesses don’t know what is legally permissible and some are making health claims in the absence of clear regulatory guidance,” he said. “Most significantly, banks and payment processors don’t understand [the regulatory rules] and as a result many CBD companies are at risk of losing financial services.”

The NCIA also provided the FDA panel with extensive written testimony it compiled from more than 100 industry representatives, scientists, and attorneys in support of establishing clear regulatory guidelines for CBD.

The legality of CBD can vary from state to state and federally, as we are learning, but the first question to ask is whether the CBD is derived from hemp or marijuana. While close relatives, these plants are classified very differently under the law, as the FDA hearing began to emphasize on Friday.

Hemp and marijuana are both classifications of plants in the cannabis genus, and both produce an abundance of CBD. The difference between the two is the chemical level in which THC is present.

Hemp is characterized by producing a nearly non-existent amount of THC, less than 0.3%, while marijuana can produce an abundance of THC, approximately 30 percent. It is because of these high levels of THC that individuals who consume marijuana experience mind-altering or psychedelic effects (e.g. getting high), which is why it is considered to be federally illegal in the U.S. and many other countries.

Previously, CBD products have been available in most head shops, but for the past two years, they have started to pop up in natural food stores, beauty aisles, cafes, and doctors offices. Products such as oils, lotions, chocolates, and even dog food have begun to enter the stream of commerce.

With respect to online markets and dispensaries, regions like Nevada, Colorado, and North Carolina are beginning to grab user’s attention.

Take North Carolina, for example. Marketplaces like cbdMD in these regions offer CBD products which contain less than 0.3% THC. When individuals are traveling to regions like these, it is important to identify the components of the CBD and marijuana products they are purchasing, as almost all markets and dispensaries are required to place labels on their products informing buyers as to the source and components of the product.

Friday’s Hearing

So what did Friday’s hearing leave the general public with?

The FDA would begin its journey towards learning how to address and regulate CBD.

Last June, the FDA approved for the first time, a cannabis plant-derived, CBD-based drug called Epidiolex. This drug was approved to treat two severe and rare forms of epilepsy: Draviet Syndrome and Lennox-Gastaut syndrome, for patients two years of age and older.

Since the Farm Bill, the FDA has not approved any other CBD-containing product, according to a tweet by Dr. Amy Abernathy, principal deputy commissioner of the FDA and head of the agency’s CBD working group.

So, what’s the bottom line?

  1. It is illegal to introduce CBD or THC into the food supply or market as a dietary supplement
  2. Marijuana continues to remain illegal under federal law. That is unlikely to change anytime soon
  3. At least ten (10) states have moved forward and legalized the purchase and possession of recreational marijuana, while thirty-three (33) states allow the use of medical marijuana.
  4. Since 2015, the FDA has issued 48 warning letters about the marketing of CBD products.

A $22 Billion Market?

According to Rolling Stones Magazine, the CBD market is estimated to be worth $20 billion by the year 2020, assuming the cannabis industry expands at its current rate. But, what about the hemp-CBD market?

Cannabis industry analysts believe this market alone could hit almost $22 billion by 2022.

The biggest fear, according to Jonathan Miller, general counsel for the U.S. Hemp Roundtable, an industry-backed advocacy group, is the continued spread of false information.

“The industry wants regulation. Our biggest enemy isn’t the FDA or the DEA, but CBS companies making false claims.”

For more information about the FDA’s regulation of cannabis and cannabis-derived products, please click here.

Andrew "Drew" Rossow is a former contract editor at Grit Daily.

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