Curaleaf, FDA and The Future of CBD
On July 22, 2019, the United States Food and Drug Administration issued a harsh warning to Curaleaf, Inc. The FDA informed the well-known multi-state operator that they must immediately cease from making medical claims relating to CBD treatment. The flagged claims were numerous, ranging from “relief from chronic pain” to “the benefits of CBD Oil for ADHD,” and many other similar claims. What precisely does this all mean? What impact will it have on the products that are available to consumers? Does this mean that CBD is a placebo at best, and snake-oil at worst? Let’s break it down.
What is the FDA and Why Do We Need It?
Before going down a rabbit-hole of Big Pharma conspiracies and the suppression of “real” science, understand this: The FDA exists to protect American consumers. Furthermore, it has done an excellent job of protecting Americans since forming over one-hundred years ago. Without the FDA, there would be no way of knowing which drugs worked, which foods are healthy for human consumption, etc. It’s also important to understand that the FDA isn’t going out of the way to pick a fight with weed. The same rules that the cannabis and CBD industry are being asked to comply with, apply equally to other forms of natural treatments ranging from acupuncture to homeopathic supplements. Basically, it all comes down to peer-review.
In simple terms, peer-review demonstrates that experiments have been performed to test a specific claim. Should this claim be corroborated with evidence collected in the lab, other scientists working in the field will review the data. These peers will look at how the experiment was designed to see if the data was subject to possible corruption by using faulty methods, confirmational bias, etc. They will also check to see if the test is repeatable with the same results each time. If the experiment is sound and produces the same results each time it’s performed, the scientific community can agree that the hypothesis has been tentatively confirmed. Thus, the experiment has passed peer-review. But it doesn’t end here. Once a hypothesis has been provisionally confirmed, new tests are devised that might further establish or falsify the initial hypothesis. The scientific method stuff is pretty serious business. And it should be; it’s allowed humans to go from near extinction on account of the Plague to landing on the moon in about 500 short years.
CBD (and THC) therapy are relatively brand-new arrivals to the scientific scene because marijuana’s prohibition prevented scientists from conducting extensive research. By now everyone has heard incredible anecdotal (“word-of-mouth”) evidence surrounding CBD and THC and how it’s helped them. Does this mean we should ignore these claims because CBD hasn’t been tested in a laboratory yet? Of course not. But it does mean that we should take all CBD product claims with a healthy grain of salt. The greatest scientific achievements have all started with an observation, but observation is only the beginning of science. CBD users today are on the cutting-edge of scientific advancement.
How Does This Effect of the CBD Industry?
Because CBD is in the beginning stages of being studied for what it can (and cannot) do, it cannot be marketed legally as a medicine. Once again, it’s essential to understand that while this may be frustrating for the Cannabis industry as a whole, it seeks to protect the consumer. Because the process of passing peer-review is so (necessarily) burdensome, the results carry much more weight once positive results are received. Peer-review allows consumers to have confidence knowing that they are using methods, medicines and substances that have been proven to work in the most rigorous of scientific conditions. Everyone wins.
How Does This Affect the Consumer?
The FDA only regulates products marketed as foods or medicine. This situation creates a grey area in which other products falling outside of these categories can operate, including homeopathic remedies, dietary supplements, and yes… CBD. Without an FDA regulating these grey areas, manufacturers have complete freedom in terms what goes into their products. Sadly, there are many “CBD” products out on the market containing almost no CBD at all, as a direct result of not being regulated. Until CBD products are officially declared medicine and thus, regulated by the FDA, the onus on the consumer to do their product research. However, by shopping at Botanicam you’re ahead way of the game because we do all of the research for you. We take it very seriously.
Central to our core business is our Twelve-Star Stamp of Approval. We guarantee that every product offered on our site;
• Uses organic or sustainable raw materials;
• Uses the most efficient carriers available;
• Makes batch third-party, independent lab results available online;
• Uses green-conscious extraction methods, preserving plant elements;
• Is packaged with the recommended dosage and a list of ingredients;
• Are manufactured using cGMP/HACCP or FDA-approved standards;
• Have certified online reviews from verified users;
• Include superior customer service;
• Contain extensive product information and details;
• Have never been tested on animals;
• Contain no artificial chemicals or preservatives;
• Come with a financial assistance program for low-income individuals and veterans.
An Article By David Glassner
After over a decade as Marketing Director for Sony Pictures, David Jaxon switched gears to join MedMen—one of the original seed-to-sale, multi-state operators working within the emerging industrial Cannabis space—as their Senior Technical Writer. David now consults throughout the cannabis space writing marketing materials, technical documents, policies, and procedures.