We advise many of our clients, and particularly our clients the CBD and skincare spaces, on how to navigate the complex state and federal regulations that apply to marketing and labeling their products. And one of the persistent concerns we address from clients in this industry is how to run a compliant business that does not wind up on the receiving end of an enforcement action from the Food and Drug Administration (FDA). Some related topics we’ve written on are CBD comestibles, CBD pet products, CBD in alcohol, and CBD topicals.
We’ve also written about the enforcement actions issued by the FDA to CBD companies, including those issued to CBD companies selling topical products, and on April 23, 2020, the FDA announced its latest round of enforcement. In this case, letters were issued to CBD companies claiming that their products could treat medical conditions, including opioid addiction, or serve as an alternative to opioids. The fact that these claims won’t fly should be obvious to everyone in the industry by this point, but alas, companies continue to make egregious medical claims about their CBD products. This is a great way to receive FDA scrutiny.
According to the FDA’s press release:
The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a health care provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.
This round of warning letters were issued to two companies:
- BIOTA Biosciences, LLC of Washington state, which markets and distributes injectable CBD products as well as an injectable curcumin product. The products are marketed for serious diseases and as an alternative to opioids. BIOTA Biosciences markets private label CBD and wholesale CBD extracts, and their products include beverages, bulk CBD extracts, and water-soluble CBD, as well as injectable curcumin.
- Homero Corp DBA Natures CBD Oil Distribution of New Hampshire, which markets and distributes CBD products as a treatment to opioid addiction as well as other serious diseases. The company is an own label distributor for CBD products as well as a retailer for Green Roads CBD products.
Here are some examples of the types of statements that got both of these companies into hot water (the kinds of statements that no CBD company should be making on their websites or in their marketing materials):
Fighting the opioid epidemic . . . BIOTA Biosciences produces and distributes effective all-natural alternatives with no side-effects. Join the growing ranks of pain, oncology, psychiatry, naturopathy healthcare professionals utilizing BIOTA Sterile CBD Vials.”
VISION: OPIOID-FREE FUTURE . . . Our goal is to supply the world with pharmaceutical grade, all natural products containing cannabidiol and other natural compounds. We believe strongly that pharmaceutical grade hemp oil will drastically reduce the need for opioid-based pain relief and eliminate the global opioid epidemic by providing a safe and natural alternative . . . Get in touch with us to learn more about how our continuous research & development into increasing the bioavailability of natural compounds with high therapeutic potential and our private label cbd products can help to solve this global issue.
CBD . . . and its ability to suppress pain and aid in the detoxification processes has highlighted it as a promising therapeutic for a wide array of disorders such as epilepsy, including many challenging neuropathy conditions. When patients consider trying a new therapeutic like CBD, there are many options for delivery that can be more efficacious to the patient. One delivery option is BIOTA CBD Sterile Vial Therapy.
Natures Pure CBD has had success in alleviating severe withdrawal symptoms associated with opiate dependency. Natures Pure CBD also has taken off the ball and chain around the opiate addicts’ neck and has relieved the addiction totally by using Natures Pure CBD restoring the person back to a quality of life worth living.
The Opiate addiction rate of recovery is low and Natures Pure CBD oil offers promise for those suffering from chronic opiate use.
Natures Pure CBD oil works for these medications which all have addictive properties to them: opium, fentanyl, heroin, hydrocodone, oxycodone, methadone, morphine and hydromorphone. Natures Pure CBD Oil has been effective in the treatment and eradication of opiate use.
The list goes on, and we recommend that every company operating in the hemp-CBD space take the time to review the letters issued to all of these companies in order to understand the types of statements that are impermissible. The FDA has continually reiterated its position that CBD products cannot be marketed for therapeutic or medical uses without having been reviewed for safety and effectiveness by the FDA. This requirement applies to all CBD products, including topical products, cosmetic products and comestible products.
Making claims about your products that place them within the definition of a “drug” is certain to land you in the FDA’s crosshairs. Thoroughly reviewing packaging, marketing copy, and websites for these types of claims will be crucial for every company offering topical CBD products for sale. We also recommend speaking with an attorney well-versed in this subject if you are uncertain about the ways in which you are marketing your products.