Recently, the FDA held a highly anticipated hearing on the regulations surrounding CBD products such as capsules and oils.  The hearing was well attended by companies and individuals with invested interest in pushing their agenda forward, including individuals talking about the potential suicidal effects of cannabis, entrepreneurs looking for answers regarding the safety of CBD in products such as cosmetics, and lawyers suggesting potential regulatory frameworks to help guide CBD’s entrance into the market.  Because the current regulations surrounding CBD products are so discordant and ill-defined, the current moment remains a fertile time for companies and individuals to gain a foothold in influencing the regulatory laws of CBD.

Why Did the FDA Hold a Hearing?

The most recent FDA hearing on the regulatory guidelines of CBD was provoked by findings suggesting the potential toxicity of CBD products.  In an effort to address these health concerns, the FDA held a hearing to gather more data on CBD including its safety, marketing and regulatory issues.  During the hearing, they asked speakers to submit well-documented clinical studies to back their claims—focusing more on obtaining data than opinions. The FDA’s decision to hold a hearing on CBD was a step forward on the path to clarifying what types of regulations companies and individuals might come to expect moving forward.

Regulatory Confusion

One of the primary areas of confusion surrounding the regulation of cannabis comes from the fact that cannabis is primarily comprised of two basic substances, CBD and THC, which are separately regulated in very different ways.  For instance, THC, unlike CBD, is heavily regulated by the DEA and is not acceptable at the federal level, whereas CBD enjoys a less heavy-handed regulation and can be considered federally legal depending on its presence of THC and proposed use.  The myriad of laws surrounding these two cannabis substances makes the proper, legal promotion of CBD a difficult undertaking for companies which run the risk of inappropriately marketing their products.  If a company or individual is found to be violating this complicated network of federal laws, for example, in the case of inappropriate promotions, they face serious consequences including major fines and criminal punishment.  It is crucial for companies to therefore carefully consider how they market their cannabis products to ensure that they remain within FDA-approved boundaries, especially considering how quickly the regulations are changing in the cannabis industry.

The Dangers of Inappropriate Promotions

Although cannabis has become legalized in many different states both for medical and recreational use, companies and individuals still run the risk of incurring fines or penalties when it comes to the actual use of the product itself.  For instance, many medical shops contain recreational cannabis products that are marketed by using medical claims, which is a dangerous move for companies to make because it means that they may end up violating federal and state laws and regulations.  Many states also require that medical cannabis be marketed according to federal laws relating to the promotion, manufacturing, or sale of such products. This jumble of federal and state laws surrounding the promotion of cannabis products has made it exceptionally difficult for companies to successfully navigate the regulatory space and ensure that they do not face penalties or fines. 

What Does this Mean for Cannabis Companies?

It remains a difficult task for companies selling cannabis products, including CBD, to remain compliant with state and federal laws and regulations because of the FDA’s lack of overall clarity.  As a consequence of the discordant laws governing the marketing and sale of cannabis products, many companies and individuals are already facing harsh punishments including numerous fines and jail time.  This means that companies in the cannabis industry must remain very well-informed on the constantly shifting regulatory framework surrounding the sale of cannabis-derived products—particularly now that the FDA is taking steps toward clarifying its stance on these drugs.

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.