FDA warns CBD company to stop making unsubstantiated claims

Last week the FDA came out with a press release stating that they had officially warned the CBD company, Curaleaf, for selling CBD products backed by unsubstantiated claims that the products could be used to treat cancer and Alzheimer’s disease.

Curaleaf Hemp is a subsidiary of Curaleaf Holdings Inc

The full warning letter, addressed to the President of Cualeaf, cited the company’s website, social media accounts and product listings where the company makes erroneous claims that CBD can be used to treat any number of diseases and ailments. To be clear, the FDA does not have any qualms with the sale of CBD itself, in fact it’s openly encouraging the progression of the space, it is only after those companies making sweeping claims about the benefits of CBD that have not been backed by research and that are intended to mislead consumers.

Why did the FDA go after Curaleaf?

CBD, although legalized this past December by the 2018 Farm Bill, is still floating in somewhat of a grey area where the FDA is considered. The FDA has not issued a specific ruling on how it will classify CBD. In fact, it likely will be quite some time before this ruling comes. At the end of May, the FDA had its first official hearing on CBD. At this hearing it invited CBD manufacturers, doctors, researchers and even members of the public to testify and say ‘their piece.’ You can read our recap on this hearing here. Since the FDA has not yet released any regulations in regard to CBD and hemp products, it appears to just be attacking large manufacturers, retailers and distributors who are making out-sized claims about the benefits of CBD.

The main quandary that the FDA faces is whether or not to classify CBD as a drug or as a dietary supplement. In the eyes of this federal regulatory agency, these two categories are treated differently. Drugs must be regulated more stringently and all drugs must be approved by the FDA for the safety of all consumers and to ensure that the drugs actually do what they claim they do. For example, Epidiolex is an FDA approved prescription drug, whose main active ingredient is CBD and is used to treat rare and severe forms of epilepsy. Dietary supplements, on the other hand, are not as heavily regulated.

CBD is unique because stakeholders have approached the FDA from both sides of this argument; some are arguing for CBDs effectiveness at treating serious medical conditions and others are arguing that it should just be a dietary supplement. This also puts the FDA in a unique predicament since it has already approved CBD, albeit in high concentrations, as a prescription medication.

Photo credit: PBS

The following is from an FDA release posted on July 17th:

While the Agency continues to believe that the drug approval process is the best way to ensure the safety of new drugs, including those made with CBD, the Agency is committed to evaluating the regulatory frameworks for non-drug uses, including products marketed as foods and dietary supplements. We remain steadfast in our effort to obtain research, data, and other safety and public health input to inform our approach and to address consumer access in a way that protects public health, maintains incentives for cannabis drug development, and creates a robust administrative record needed to support the initiation of any rulemaking. As we learn more, we will continue to update the public about our path forward and provide information that is based on sound science and data.

FDA is Committed to Sound, Science-based Policy on CBD

It is clear that the while it is continuing to obtain this “research, data and other safety and public health input”, the FDA will not stand for those attempting to outpace the regulatory framework and make claims that are unsubstantiated.

Who is Curaleaf?

Curaleaf Hemp is a sub-brand or subsidiary of Curaleaf Holdings Inc, one of the largest cannabis dispensary ecosystems in the United States. From their own website, “Curaleaf has a presence in 12 states, owns and operates 44 dispensaries, 12 cultivation sites and 11 processing sites with a focus on highly populated, limited license states, including Florida, Massachusetts, New Jersey and New York.”

Interestingly, Curaleaf (CURLF) is a publicly traded company and has been so since November of 2018. Share prices fell slightly after the FDA’s warning was released last week and now sit slightly above Curaleaf’s initial offering at $7.90 USD.

It is unclear if the Curaleaf Hemp site has since been revised, but according to the official FDA warning the site made the following claims:

  • “CBD has also been shown to be effective in treating Parkinson’s disease.”
  • “CBD has been linked to the effective treatment of Alzheimer’s disease . . ..”
  • “CBD was effective in killing human breast cancer cells.”
  • “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety . . . ADHD.”

The letter went on to list pages and pages of claims made on website pages, blogs and social media accounts hosted by Curaleaf.

Why can’t CBD companies claim that CBD helps cure cancer?

It would be misleading, unfounded and unsubstantiated for CBD companies to make claims like this when they are not backed by research and are not approved by the FDA in any capacity. It’s one thing for a company to post research articles from reputable institutions that highlight how CBD might be found to be able to help with some of the symptoms of anxiety and pain. It’s a whole different ball-game for companies to claim that CBD can kill cancerous cells. Is there research being conducted into this? Absolutely. Have some of the results been positive? Sure thing. Is there enough evidence to conclude that CBD is a cure for cancer? Not a chance.

This is why pharmaceutical companies have to have that guy read super fast the list of warnings and side-effects at the end of commercials about allergy medications. It’s because in order to be permitted to make claims that your medicine or drug can help cure an ailment it has to undergo rigorous testing to ensure it’s safe and doesn’t have significant short or long-term side effects when doing so.

This strict regulation and ensuing monetization is also what has many consumers worried about the pending FDA regulation; if the FDA decides to regulate CBD as a drug and not as a dietary supplement it’s not unrealistic that it may be taken off of the market for a period of time and it’s more than likely that “big-pharma” will dominate the market share and be able to charge a premium for the drug.

As we continue to press into the uncharted waters that are the future of the world of CBD, it’s important to make sure that you’re putting your faith in CBD companies that are vetted, trustworthy, transparent and have quality products. Hemp Crate Co can do all of that for you.

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