What the FDA should do with CBD

In the United States, the Food and Drug Administration (FDA) is responsible for maintaining the safety of the nation’s food and medicine supply. Since the passage of the Farm Bill in late 2018, Cannabidiol derived from hemp has been definitively legal in the United States, but the FDA has yet to promulgate rules directing its use in consumer products.

Currently, the only FDA rule on CBD dates from before the Farm Bill -- and it bans the use of CBD in food or drink in the United States. But many states and local governments have their own rules allowing CBD, while others are waiting for direction from the FDA. The result is an unpredictable patchwork of regulations that greatly complicates the lives of those of us working on CBD products.

Fortunately the FDA is taking action. On May 31, the FDA held a hearing seeking input from the public on its CBD rulemaking. Cultivating Wellness submitted these comments. You can submit your own: the public comment period is open until July 2.

While CBD products are often advertised as a way to help people sleep or relieve pain and anxiety (functional claims that are prohibited for most supplements by the FDA), CBD supplements typically lack extensive testing and research—a harmful practice for the industry. Companies that overstate the therapeutic value of a CBD product both harm the consumer seeking relief and diminish the credibility of other CBD companies taking the proper steps to ensure accuracy and safety.

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Since Cultivating Wellness was founded in 2018, we’ve sought to bring well-made, consistent, and extensively tested CBD products into the general consumer marketplace. We sell CBD products and we also help well-known consumer brands enter the CBD sector.

Every product we sell passes through a comprehensive evaluation process that creates a 360 degree picture of the product’s quality. We look at many dimensions, including cannabinoid lab test results, hemp cultivation licenses, manufacturing certifications, non-CBD ingredients, processes and procedures, marketing and label compliance, and more.

But we can only do so much on our own. Fostering a healthy CBD sector in which consumers can be sure they are buying the best quality, safest product possible requires the kind of level regulatory playing field that only Federal regulators can provide.

If all CBD from hemp products were grown under state licenses, manufactured according to the FDA’s Current Good Manufacturing Practice (CGMP), and adhered to existing FDA labeling requirements, no further measures to ensure product safety would be necessary. But without regulatory incentives, these will not become the standards in the industry.

Meanwhile, pharmaceutical CBD, which is regulated as a drug by the FDA, is on the market with very high standards of dosing and consistency -- but also very high prices. Creating a healthy CBD sector that provides pharmaceuticals to people who need them and supplements to people who need them, safely and consistently, will be critical to the widespread mainstream utility of CBD.

Fortunately, there exists a relatively clear pathway towards achieving this. While pharmaceutical CBD products are compounded with pure, isolated CBD, supplements include both isolate and different kinds of hemp extracts with varying levels of CBD. This bifurcation provides an easy solution for the FDA: reserve CBD isolate for the pharmaceutical sector, and extracts for the supplement sector.

Though this path would require many supplements to reformulate, it would create a clear dividing line between pharmaceutical and supplemental CBD, and would allow both parts of the sector to focus on what they do best: single molecule therapies on the pharmaceutical side, and whole plant entourage products on the supplement side.

By establishing this clarity in the marketplace, the FDA could unleash the true potential of CBD to transform millions of peoples’ lives for the better.

Cultivating Wellness encourages the FDA to put the needs of Americans first in making this important decision, and we encourage you, dear reader, to join the movement to make CBD rules clear and effective by submitting a comment to the FDA before the July 2 deadline.