FDA Cracks Down on Curaleaf over CBD ‘Drugs’

FDA Cracks Down on Curaleaf over CBD ‘Drugs’
FDA Cracks Down on Curaleaf over CBD ‘Drugs’
by is licensed under

Just five days ago, The Seed Investor warned cannabis investors that the FDA remains “a consistent obstacle” when it comes to commercializing CBD-derived products.
The problem for the cannabis industry is that as long as the FDA continues to treat CBD as a drug, it will continue to over-regulate it. That will seriously eat into the billions of revenue dollars potentially on the table.

Sure enough, this week the FDA has issued its own warning -- to U.S. cannabis leader Curaleaf Inc, subsidiary of Curaleaf Holdings Inc (CAN:CURA / US:CURLF).

In a letter to Curaleaf’s President, Joseph Lusardi, the U.S. Food and Drug Administration “reviewed” Curaleaf’s website. It found what it considers to be numerous infractions of federal law.

Specifically, it scolded Curaleaf over its “Unapproved New and Misbranded Human Drug Products”. Curaleaf is required to cease selling nine different CBD-based products. It ruled that dozens of health-related “claims” made on Curaleaf’s website also contravene its regulations.

The FDA has given Curaleaf 15 days to “take prompt action to correct the violations cited in this letter.” It then issued a further warning to Curaleaf about what additional actions it would take should the company fail to address these “violations”.

Last week, Curaleaf announced the acquisition of GR Companies (Grassroots). It solidified Curaleaf’s position as the world’s largest cannabis company by revenues.

The U.S. market for CBD-based products is a fast-growing market, with billions of revenue dollars on the table. Standing in the way is the FDA.

As The Seed Investor noted in its previous article, the FDA continues to over-regulate this market.

It is currently conducting hearings (supposedly) aimed at opening up commercialization of CBD. But it prefaced the hearing with yet another warning to the cannabis industry.
The FDA has warned companies that because it views CBD as a drug, it cannot be added to food or beverages or marketed as a dietary supplement in interstate commerce. [emphasis mine]

Because of its highly restrictive classification of CBD, cannabis companies are prohibited from any interstate commerce with such products. This includes any/all ecommerce.

The problem is that the FDA itself has still learned nothing about cannabis. CBD is not a drug. The Seed Investor explained.
CBD is “a drug”? Really?

Here is what we know about cannabis and CBD today, i.e. cannabis
fact rather than cannabis fiction.

Cannabinoids occur naturally in the human body. Medical science now knows they help to regulate and promote human health.

Mothers naturally pass these cannabinoids to infants in their breast milk. This to promote infant health. Are mothers “drugging” their babies with breast milk?

If the FDA believes it has the jurisdiction to regulate the usage of cannabinoids as “drugs”, what’s next? Forcing nursing mothers to attach warning stickers to their breasts, alerting infants to the “drugs” that they are about to be fed?

If the FDA can’t regulate cannabis (and cannabinoid) commerce in a sensible/rational manner, then it shouldn’t. Get out of the way.

Announce that all its existing rules/regulations concerning cannabis are null and void. Admit that 100 years of cannabis Prohibition-based ignorance has left it incapable of regulating the cannabis industry.

Require the producers and distributors of cannabis and CBD-based products to label their products as “unapproved by the FDA”. And let consumers make their own decisions.

Cannabis is safe. It’s non-toxic, non-addictive and even safe to use in combination with other drugs.

Consumers want these products. As Americans gear up for the 2020 election, a new survey reported by Marijuana Moment shows that cannabis legalization is “more popular than a national $15 minimum wage, banning semi-automatic assault guns, free college tuition and a $1,000 universal basic income”.

All of these major social, legal, and economic issues concern Americans at present. But cannabis legalization leads the way in terms of public support.

Are you listening FDA? Are you listening Donald Trump?

Americans want CBD products. They need them for numerous health-based reasons.

They don’t need the FDA. They don’t need any politicians or political parties that continue to obstruct their access to these CBD products.

In the meantime, the U.S. cannabis industry continues to wait for the chance to properly commercialize this multi-billion dollar market.
Cannabis Focus, Cannabis Industry
Thumbnail Photo Credit: by is licensed under