This story first appeared in Cannabis Business Times
[Canniseur: Here’s a warning we should take seriously. There are too many producers of CBD products in the U.S. They’re mostly good and reputable companies. But there are always a few bad actors in any business, especially a newly legal business like CBD. Take the warning and stay away from products by these companies until they’re cleared by the FDA.]
The violations include marketing unapproved new human and animal drugs, selling the products as dietary supplements, and adding CBD to human and animal foods.
The U.S. Food and Drug Administration (FDA) issued warning letters to 15 companies Nov. 25 for illegally selling CBD products in ways that violate the Federal Food, Drug, and Cosmetic (FD&C) Act, according to a press release.
The agency also published a revised Consumer Update that outlines its broader safety concerns about CBD products, including potential liver injury, interactions with other drugs and more.
The companies that were issued warning letters have been marketing CBD products on webpages, in online stores and on social media to treat diseases, for therapeutic uses, as dietary supplements, and in human and animal foods, according to the release.
These companies include:
- Koi CBD LLC, of Norwalk, Calif.
- Pink Collections Inc., of Beverly Hills, Calif.
- Noli Oil, of Southlake, Texas
- Natural Native LLC, of Norman, Okla.
- Whole Leaf Organics LLC, of Sherman Oaks, Calif.
- Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colo.
- Apex Hemp Oil LLC, of Redmond, Ore.
- Bella Rose Labs, of Brooklyn, N.Y.
- Sunflora Inc., of Tampa, Fla./Your CBD Store, of Bradenton, Fla.
- Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, Calif.
- Private I Salon LLC, of Charlotte, N.C.
- Organix Industries Inc., doing business as Plant Organix, of San Bernardino, Calif.
- Red Pill Medical Inc., of Phoenix, Ariz.
- Sabai Ventures Ltd., of Los Angeles, Calif.
- Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Ky.
The FDA has requested that the companies respond, indicating how they plan to correct the violations, within 15 working days. Companies that fail to correct the violations may face legal action, including product seizure or injunction, according to the release.
This is not the first time that companies have been issued warning letters for illegally marketing CBD products. Curaleaf, for example, received a warning letter this summer for selling unapproved products with unsubstantiated health claims that the products treat cancer and Parkinson’s disease, among other health conditions. Curaleaf responded by removing the health claims from its website and social media accounts.
In its announcement, the FDA indicated “that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”
The FDA continues to explore ways for CBD products to be legally marketed, according to the release, and it plans to provide an update on its progress “in the coming weeks.”
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., in a public statement. “In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate. We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety—including reports of products containing contaminants, such as pesticides and heavy metals—and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
Source: FDA Warns 15 Companies for Illegally Selling CBD Products
[Canniseur: This makes me see red and not because of the charities that are refusing the donations. Our congress has thus far refused to act on any normalization of cannabis laws so companies who are in the cannabis production and sales space can have legitimate access to the banking system. Congress needs to act. NOW! Our society can’t truly de-stigmatize cannabis consumption until we get to a place where, even if the federal government won’t legalize, we can at least have a normal commerce system.]
Canna Provisions CEO Meg Sanders says charity organizations declined her company’s monetary donations due to a lack of federal guidance on banking.
Cannabis companies eager to give back to their communities may find that charity organizations won’t take their money. This was indeed the case for Meg Sanders, CEO of Canna Provisions, an adult-use dispensary group in Massachusetts.
“There were a few different charities, locally and regionally, that we tried to donate to here in Massachusetts, and they wouldn’t take our money,” Sanders tells Cannabis Business Times. “The fear is that because a lot of them are federally funded, if they take our cannabis money, they might lose their federal funding. … I can’t say I haven’t run into a philosophical issue, as well, that maybe people just don’t believe in this product being available, but mostly it seems that the pushback is around federal funding.”
Although Massachusetts has financial institutions that work with medical and adult-use cannabis businesses, Sanders says that many charity organizations believe accepting donations from the industry is too risky until federal guidance on banking is issued.
“Until we have some type of federal legislation on the books that promotes safe banking—like the SAFE Banking Act, for example—it’s just one of those things where it’s a gray area and it’s too risky,” she says. “I think solving the banking issue goes a long way in creating opportunities for people to take our money.”
Until a solution is found, cannabis businesses looking to donate money to their favorite organizations continue to face pushback, particularly in Massachusetts, Sanders says, where charity is a large part of the state’s cannabis industry. The state requires cannabis business license applicants to outline a plan for positive impact in their community as part of their application, and this plan is reviewed as part of the licensing process.
“A lot of what’s happening in Massachusetts is very charity-based, equity-based, making sure that we’re hitting areas with disproportionate impacts through hiring [and] education,” she says. “That’s part of not just our corporate ethos, but also what the state of Massachusetts’ regulatory body, which is the Cannabis Control Commission, has laid out. Charity and giving has been a big part of our plan, and not just because of that, but because our experience in other states has shown that participating at that level in the community really helps move the needle in terms of acceptance of our products.”
Five organizations have accepted monetary donations from Canna Provisions, Sanders says, and oftentimes, the organizations have asked the company to describe its business and overall mission. Sometimes, she adds, the organizations have even consulted their boards for approval before accepting the donations.
“There are a lot that will take our money, but there are always a couple that won’t, so we have to do a lot of asking before we know exactly,” she says.
While some organizations refused monetary donations from Canna Provisions and other cannabis companies that Sanders has worked for over the years, she says the team has still been able to contribute manpower to various charitable projects, and she has taken advantage of these opportunities when possible.
“We not only write checks, but we spend a lot of time with volunteer hours,” she says. “I can say right now we have over 85 hours in our volunteer bank, as far as what our employees have done, and that’s anything from taking flowers to the assisted living facility on Mother’s Day to give to patients to several … sponsored cleanups of creeks or streets or that kind of thing. … We’ve also volunteered with the chamber of commerce to hang all the beautiful flower baskets for the summer season along the main street in our hometown, and we have several more in the works. It’s just so great for people to meet us and understand we’re great people and a great place to do business and encourage them to support our efforts here in Massachusetts.”
Massachusetts Cannabis Company Says Charities Refused Its Donations appeared in Cannabis Business Times