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FDA Sends Warning Letters to Curaleaf

By Aaron G. Biros
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Curaleaf Hemp, a well-known and publicly traded cannabis company, made headlines this week for all the wrong reasons. The US Food & Drug Administration (FDA) sent a warning letter to Curaleaf President Joseph Lusardi for making unsubstantiated health claims and for misbranding their products as drugs.

FDAThe health claims in question appear to be removed from their website and social media accounts. In the warning letter, the FDA cites numerous claims made on Curaleaf’s website, Twitter and Facebook accounts. You can check out the health claims they found here, but it’s essentially a list of instances where Curaleaf said their products can be used to treat specific conditions. They claimed their CBD vape pen can be used for chronic pain and said another one of their products is a “[S]oothing tincture for chronic pain.”

For most of the health claims the FDA cited, it appeared they were articles or blog posts on Curaleaf’s website. Take a look at some examples of statements that should not be posted on a CBD products website (taken from the warning letter found here):

  • “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 is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
  • “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
  • “CBD has been demonstrated to have properties that counteract the growth of spread of cancer.”
  • “CBD was effective in killing human breast cancer cells.”
  • “Heart disease is one of the leading causes of death in the United States each year, and CBD does a number of things to deter it. The two most important of these are the ability to lower blood pressure, and the ability to promote good cholesterol and lower bad cholesterol.”

While the FDA is expediting their push to roll out hemp and CBD regulations, companies should still be cautious when marketing their products for interstate commerce. Dr. Amy Abernathy, Principal Deputy Commissioner and Acting CIO, said in a series of tweets earlier this month that the FDA is eager to get to work and plans to report on their progress by the end of summer. The public hearing they held back in May helped jumpstart their efforts to begin investigating regulation of the market.

Still, companies need to be careful when marketing CBD products. The FDA has made it abundantly clear in a lot of warning letters that drug claims are not allowed. Here are two articles that give advice on how companies should proceed with marketing and how to go about properly labeling their products.

MJ Freeway Hardships Linger

By Aaron G. Biros
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MJ Freeway, a seed-to-sale traceability software company with a number of government contracts, has been making headlines this year for all the wrong reasons. A series of security breaches, website crashes and implementation delays have beleaguered the software company throughout 2017.

Just this morning, the Philadelphia Inquirer reported the company’s services crashed Saturday night and Monday afternoon. That article also mentions an anonymous hacker tried to sell sensitive information from the Washington and Nevada hacks in September. Back in April, when Pennsylvania awarded the state’s contract to MJ Freeway for its tracking system, Amy Poinsett, co-founder and chief executive officer of MJ Freeway told reporters “I think I can confidently say we are the most secure cannabis company in this particular industry.” It is safe to say this is now being called into question.

Earlier this week, New Cannabis Venture’s Alan Brochstein reported that MJ Freeway is unable to meet Washington’s October 31st deadline to integrate their software with the state, forcing customers to manually report data.

Roughly a month ago, Nevada suddenly cancelled their contract with MJ Freeway, just two years into their five-year deal. Back in June, the company’s source code was stolen and published online. And back in January of this year, the company’s sales and inventory system was the target of a cyber attack.

According to an email we obtained, all of MJFreeway’s clients in Spain experienced an online outage, but that services were restored within 24 hours. In an email sent to clients in Spain, the company told customers that the problems were the result of a system failure. “Our initial analysis indicates that this was a system failure and unfortunately none of the data was able to be successfully retrieved from the backup archive due to an error but we can assure you that none of your data was extracted or viewed at any moment,” reads the email. “We are extremely distressed regarding the event that occurred with the system and the service interruption that occurred yesterday. We recognize that this is a situation that is very serious and negatively impacts your club.” The email says that MJ Freeway is addressing those problems in a few ways, one of which being ongoing audits of their data backups. “The event has led us to reconstruct our “hosting environment” in Europe to use the latest technology from Amazon Web Services with the best redundancy, flexibility and security, using the highest stability measures in the AWS environment,” reads the email. While the site will be restored fully, according the email, historical data is lost. The company is working with their clients to help them get data back into the system.