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Thursday, February 2, 2023

FDA CBD Regulations On The Way (Sorta)

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he was there Lots of talking From the Food and Drug Administration (“FDA”) about cannabidiol (“CBD”) regulations that make one’s head spin. Years ago, everyone wondered when, or even ifThe Food and Drug Administration proposes and approves regulations for CBD. So far, while receiving input from the public on this topic, the FDA has mostly been involved in implementation, at times In tandem with the Federal Trade Commission (“FTC”), v. CBD Retailers. Despite this, the Food and Drug Administration appears to be Grand About CBD regulations in the context of both food and dietary supplements.

A little history of CBD

Until recently, CBD resided in the semi-legal shadow as cannabis was still scheduled in the federal Controlled Substances Act and could not be grown without a Drug Enforcement Administration (“DEA”) permit. with passing 2014 Bell FarmHemp-derived CBD—if grown according to a state pilot research program—got a precarious bit of legal cover. None of this stopped the FDA from taking the position that CBD is not a supplement, and that it cannot be an ingredient in foods and beverages for humans or pets without violating the Food, Drug, and Cosmetic Act (“FDCA”). The marketing of any physical or therapeutic effects of CBD was (and still is) prohibited. Accordingly, the Food and Drug Administration routinely sends enforcement letters To a variety of CBD retailers.

2018 Bell Farm

In 2018, the federal government legalized hemp and all of its derivatives, including CBD, with the passage of the Agriculture Improvement Act of 2018 (known as the “Agriculture Improvement Act”).2018 Bell FarmThe 2018 Farm Bill did not group CBD though. Instead, it acknowledges the authority of the Food and Drug Administration to organize products Contains hemp-derived products, including CBD. Moreover, Congress has Repeatedly urge The Food and Drug Administration to complete a rule-making process to resolve the proliferation of CBD products, especially for foods and dietary supplements, that are being sold in clear violation of FDA law. However, since the passage of the 2018 Farm Bill, the FDA has not yet adopted formal regulations, and is still sending out these enforcement letters (with the FTC activeis very).

Countries do their own thing

An interesting and complicating factor is that even though the FDA is backtracking on CBD, different states have decided to move forward with their own CBD regulations for food and beverages. Many states now allow CBD in foods and beverages for consumption by humans and animals.

The future of FDA CBD regulations

In The Wall Street Journal interview Released on December 27, 2022, “FDA agency officials state that… within months the FDA will decide how best to regulate legal cannabis and whether that will require new agency rules or new congressional legislation…” Although, this decision will only come after the Food and Drug Administration has fully studied the effects of consuming CBD through food and dietary supplements. And the decision is important because, among other things, it likely teaches us all whether CBD can be safely used (according to the FDA) in food and supplements; Or whether it should be treated as a drug (and thus, undergo clinical trials for legal use).

It’s not like the FDA unaware of the massive, unregulated CBD market that already exists in the United States, so trying to place CBD in the “drug” category of the FDA’s regulation can be difficult. Right now, according to a Wall Street Journal interview, “the agency is focusing enforcement efforts on products that pose an immediate public health risk, such as candy that children could accidentally eat, or products that are meant to be consumed by food-producing animals.”

What lies ahead for FDA and CBD regulation

In the end, no matter what the FDA finally decides on the regulatory or legislative recommendations front, the bomb will go down in the current CBD industry.

If the FDA decides to regulate CBD for foods and dietary supplements, we can expect a painful transition in the CBD world where companies can either: 1) exist in conflict between existing state laws and FDA regulations or 2) comply with the administration Food and Drug Regulation. Option 2 is likely to be very costly: we will see an increase in business failures as well as market consolidation.

Alternatively, the FDA may specify that CBD may not be safely consumed in food and dietary supplements. However, any kind of FDA regulation would undoubtedly open the door to commercial investment, including even larger players (food or drug companies, for example) who come into the space to try to generate some market share. It’s really anyone’s guess what lies ahead. Stay in touch!

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