FDA public hearing: cannabis and its derivatives under the spotlight

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On May 31st, the American Food and Drug Administration agency (FDA) held its first public hearing to discuss the use of cannabis and cannabis-derived products in different commercial sectors, like pharmaceuticals and edibles.

When announcing the public hearing a few months ago, the FDA revealed that the purpose of this hearing was obtaining “scientific data and information about the safety, manufacturing, product quality, marketing, labelling, and sale of products containing cannabis or cannabis-derived compounds”.

To meet this end, the event’s agenda comprised more than 110 people speaking and was attended (both presently and remotely) by more than 1.000 people. The speakers presented their studies, findings, and opinions on many different perspectives and areas, ranging from business and manufacture to health and scientific research.

The involved parties pleaded for a clarification of the legal contours of using CBD in edibles, dietary supplements, and medicines. Despite the rising market expansion all over the US and Europe, the law is still unclear in the US, and people from all the different sectors involved demanded the FDA finally issued clear regulations regarding the use of cannabis and cannabis-derived products.

In fact, and although hemp is now legal in the US under the Farm Bill, the FDA reminds all manufacturers that CBD use is still regulated under the Federal Food, Drug & Cosmetic, and Public Health Service Acts, thus remaining dependent on strict approval from the FDA in each particular case.

Also, given the fact that cannabis and compounds like cannabidiol (CBD) and tetrahydrocannabinol (THC) are currently classified as “drugs”, the FDA states that the Federal Food, Drug & Cosmetic Act clearly prohibits the addition of drugs to commercial foods (either for humans or animals).

After the hearing, the FDA is now open to receive comments from all attendants until July 2.

According to Norman Sharpless, director of the National Cancer Institute and acting commissioner of the FDA, the attendees’ comments “will help inform the FDA”, in the process of considering “the important policy options related to the regulation of products containing cannabis or cannabis-derived compounds”.

The FDA has already approved medicines containing cannabis-derived compounds, such as Epidiolex (which contains CBD), Marinol, and Syndros (both of which contain a synthetic form of THC called dronabinol). However, the free use of cannabis and compounds such as CBD and THC is still highly restricted, since cannabis is still considered a schedule 1 drug under federal law.

Nonetheless, and due to the existing laws in Europe and other countries, manufacturers, producers, and consumers all over the US are now expecting the FDA to reconsider and draw a clear line between what can and can’t be done with cannabis and cannabis-derived products.

Sharpless refers that there are “many unanswered questions” regarding the safety of CBD, representing “significant gaps” in the FDA’s current knowledge. Nonetheless, he assures that potential and legal pathways for CBD products are under evaluation and that he has requested “an internal group” to address what the FDA considers to be data gaps.

This decision made by the FDA reveals the importance of cannabis and cannabis-derived products and may very well signify a change in the current US law. After the hearing, financial specialists discussed the impact that this uncertainty may have on CBD-related stocks, and some defend that this may create “a great buying opportunity”.

This issue has been considered and analyzed for quite some time, not only in the US but also in Europe. The world is now waiting as both the FDA and the European Commission (EC) address the issue of using cannabis and cannabis products in edibles and other commercialized products.

In the European Union, the EC has reclassified hemp and CBD under the Novel Foods Act, meaning that any CBD-containing products need a clear pre-market approval before being able to legally enter the European market.

Several consumers have expressed their anger towards this decision, and it has already been disputed as The European Industrial Hemp Association submitted a request for hemp-derived CBD to be removed from the Novel Foods list. The request is now under consideration by the European regulatory authorities.

These decisions may greatly impact both the US and European cannabis and cannabis-derived products market, as the consumers’ expectations and market demands keep rising. Stockholders, investors, and pharmaceutical representatives are also highly interested in the final decisions since they can dramatically shape the worldwide cannabis products’ market.

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