Oregon Senators Implore FDA to Change CBD Stance

Oregon Senators Implore FDA to Change CBD Stance

Much like dietary fat and the keto diet, marijuana, hemp, and CBD have been the topic of fervent debate the past year. Specifically, interest in all things CBD has skyrocketed due and the compound can now be found in everything from pills to food to lotions and tinctures.

Despite the surging popularity of CBD, its legal status, along with that of hemp, has been rather murky in the eyes of the all-seeing Food and Drug Administration (FDA). Complicating the matter is the recent passage of the Hemp Farming Act, which is a provision in the Agriculture Improvement Act (Farm Bill) of 2018.

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While passage of the bill was viewed as a win for hemp growers and CBD product manufacturers and suppliers, FDA Commissioner Scott Gottlieb was quick to quash the enthusiasm by restating the FDA’s stance regarding CBD -- it is a drug, and thus illegal to add into health or food products without approval from the FDA. To further drive their point home, the FDA has continued sending warning letters to various companies who make health claims for CBD.

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In the follow-up statement to the bill’s passage, Gottlieb wrote: [1]

“Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective.”

The statement by the FDA also outlined parts of the hemp plant that are acceptable for use in food, beverage, and dietary supplements, but CBD remained persona non grata despite the passage of the Hemp Farming Act.

Recently though, a pair of senators from Oregon who worked alongside Senate Majority Leader Mitch McConnell to pass the Hemp Farming Act have requested that the FDA update their policies and regulations to allow for the use of hemp and CBD products in food, drink and dietary supplements.

In a letter to FDA Commissioner, Oregon’s two senators, Ron Wyden and Jeff Merkley, stated that farmers in Oregon, and across the country, stand to make considerable profits for themselves and their respective communities (which in turn improves the state and national economy) if the FDA would rescind their ban on CBD.

“In recent years, the public has developed a widespread interest in the production and use of CBD, one of the primary non-psychoactive compounds in Cannabis sativa L. We, therefore, request the FDA immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and give U.S. producers more flexibility in the production, consumption, and sale of hemp products.” [2]

The senators went on to assure the FDA that a move to loosen the reins on CBD would honor the spirit and purpose of the Hemp Farming Act. In particular, the provision of the larger Farm Bill expanded federal authority over the production and marketing of hemp.

In the bill, hemp is defined as cannabis (Cannabis sativa L.) containing low concentrations of THC (delta-9-tetrahydrocannabinol), the psychoactive constituent of marijuana.

More importantly, under this new act, hemp would no longer be a controlled substance.

The senators’ letter continued:

“We will be closely engaged in the ongoing implementation of our legislation, as it was Congress’ intent to ensure that both U.S producers and consumers have access to a full range of hemp-derived products, including hemp-derived cannabinoids.” [2]

However, one key caveat in the new bill is that while it loosened restrictions on the production of hemp, it did not alter, restrict, or end the FDA’s ability to regulate the sale of CBD products.

In fact, since 2015, the FDA has been adamant in its stance that CBD- and THC-containing products are illegal and cannot be sold in food, drink, or dietary supplements.

At the time of the bill’s passage, Gottlieb stated:

“Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.” [3]

However, Gottlieb provided hemp and CBD proponents a modicum of hope when he disclosed that the FDA is considering the possibility of issuing a regulation that would authorize the use of CBD in consumer goods, thus legalizing the sale of CBD-inclusive food, drink, and beverage.

“...the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients.” [3]

One possibility by which CBD could be mainstreamed to legalization is if the secretary of the U.S. Department of Health and Human Services issues a regulation following notice and comment—for CBD in foods, beverages, and dietary supplements.

CBD market analysts project revenue to be upwards of $1.4-1.5 billion by 2022, and potentially up to $3 billion if the FDA signs off on CBD legalization.

In the senator’s closing comments of their statement to the FDA, they posed four big questions to Gottlieb and the agency at large, requesting a response within 30 days of the governments reopening (they are currently shut down as of this writing):

What steps is FDA advancing to clarify to the public the authority the agency has in the production and marketing of hemp, specifically Cannabis sativa L. and its derivatives?

What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverage or dietary supplement, including into interstate commerce?

Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverage or dietary supplement by the agency?

Will the agency consider issuing a regulation or pursuing a process, that would allow Cannabis sativa L. and its derivatives in food, beverages or dietary supplements that cross state lines?

Suffice it to say that manufacturers, distributors, and sellers of CBD products are ecstatic by the latest move by the pair of Oregon senators.

The question on everyone’s mind now is most likely when (not if) will the FDA legalize the sale of hemp and CBD extracts. After all, if an industry can generate upwards of $3 billion dollars per year, wouldn’t you think the government wants a little piece of that pie? All the more so when you consider that they are shut down due to budget problems.

What do you think?

Should the FDA allow for the sale of hemp and CBD-containing foods, drinks, and dietary supplements?

Have you used any CBD products and experienced improvement mentally, physically, or psychologically?

Leave a comment down below with your thoughts.

References

1) "FDA Casts Shadow on Hemp Win, Calling CBD Products Illegal." AP NEWS, 22 Dec. 2018, www.apnews.com/68a5b1d3181e44d180382b273f6187c4.

2) Home | U.S. Senator Ron Wyden of Oregon, www.wyden.senate.gov/imo/media/doc/011519%20FDA%20CBD%20Hemp%20Letter.pdf.

3) "Statement from FDA Commissioner Scott Gottlieb, M.D., on Signing of the Agriculture Improvement Act and the Agency’s Regulation of Products Containing Cannabis and Cannabis-derived Compounds." U S Food and Drug Administration Home Page, 20 Dec. 2018, www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628988.htm.

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