Is CBD Ready to Make its BIG Move in the U.S.?

Is CBD Ready to Make its BIG Move in the U.S.?
Is CBD Ready to Make its BIG Move in the U.S.?
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Business forecasts vary widely. But a median forecast of the potential size of the U.S. market for hemp-derived CBD products is $6 billion by 2025.

Standing in the way of those billions is one federal agency. This is preventing any national market for CBD-derived products in the U.S.

The U.S. Food & Drug Administration (FDA) has been a consistent obstacle toward commercializing cannabis in the United States. It may finally be about to get out of the way and allow the cannabis industry to effectively commercialize CBD.

Cannabidiol (CBD) is one of the two most common cannabinoids in the cannabis plant, along with tetrahydrocannabinol (THC). But unlike THC, CBD is entirely non-psychoactive.

CBD has been widely touted as providing numerous medicinal and health-promoting benefits. The World Health Organization (WHO) has already released a report indicating “no public health risks or abuse potential” associated with it.

In addition, CBD can be sourced from hemp. Hemp is the sub-species of cannabis that has near-zero levels of THC. For that reason, hemp has already been legalized nationally in the U.S. for commercial applications.

This means that since early this year there should have been nothing standing in the way of commercializing CBD-related products – at the very least those derived from hemp. But that hasn’t stopped the FDA from getting in the way.

The problem?

After 100 years of cannabis Prohibition (and anti-cannabis information), residual ignorance towards cannabis is still found throughout the U.S. government and its assorted bureaucracies.

This blind ignorance was highlighted in June when the FDA conducted its first-ever hearing specifically on the cannabinoid, CBD.
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]

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?

Cannabis (including the CBD contained) has a remarkable safety/tolerance profile. This is allowing biopharma companies to fast-track clinical research on cannabis-based drugs. Overseeing such drug research is the same FDA.

Cannabis (and CBD) is very, very safe.

If the chemical monstrosities now being marketed by Big Pharma were 1/10th as safe, then drug companies wouldn’t have to devote half of their drug commercials to warning potential users about the dangerous side effects.

CBD can be (and is) widely used to treat medicinal problems and promote health in numerous ways. The same is true with Vitamin C. It’s also added to food products to make them “healthier”. Is Vitamin C a drug?

No. The FDA exerts authority over Vitamin C in consumer products via its parallel jurisdiction over foods (and dietary supplements).

Is the dinosaur mentality toward CBD about to change at the FDA? Maybe.

A July 16, 2019 MarketWatch article was cautiously optimistic.
Cannabis stocks were mostly higher on Monday, after the U.S. Food and Drug Administration said it is expediting its effort to create a regulatory framework for CBD with plans to publish a report on its progress by early fall.

But this isn’t because of enthusiasm at the FDA toward cannabidiol. Rather:
… with many companies anxious to launch products containing CBD, the FDA has come under pressure to devise rules sooner, rather than later. Clinical trials typically take several years to complete. Former FDA Commissioner Scott Gottlieb proposed congressional action to speed things up, based on using very low doses of the substance.

The FDA is currently “tolerating” sales of topicals and oils containing CBD. But only if the products don’t make any specific health claims.

The FDA hearing was open to public input. It fielded "thousands of comments" from interested parties. The vast majority urged the FDA to allow broad distribution of CBD-related products.

Such products can already be produced within cannabis-legal states. Making such products legal on a national level does more than just allow the full commercialization of CBD. It also means standardization and greater product consistency for consumers.

A Bloomberg article notes:
Investors are pouring money into massive CBD extraction facilities and processing plants in the U.S., hoping to be ready when Coca-Cola Co., Procter & Gamble Co., and other consumer giants finally embrace cannabis.

These multinationals won't be interested in the CBD space as long as there is no national market for these 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.

Hemp is legal in the United States, including the CBD it contains. But if you take the CBD out of the hemp plant and try to market it, companies are still severely restricted.

The FDA might be about to advance its regulation of CBD to the 21st century. However, given its attitudes and prevailing track record, this is far from a slam-dunk.
Cannabis Focus, Cannabis Industry, Investing News
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