FDA Crackdowns on False Claims for Medicinal Cannabis Products
False Claims, Fake Medicines and Counterfeit News – Why the U.S. FDA is cracking down on cannabis-product advertising claims and unsubstantiated efficacy statements.
Are U.S. medicinal cannabis suppliers preying on vulnerable populations with deceptive ads? The FDA is taking stronger actions to reduce deceptive advertising practices by cannabis distributors in the USA, who are putting public health at risk by posting fake information about the effectiveness, suitability and safety of their non-approved ‘medicines’ for treating children. Warning letters from the FDA and the U.S. Federal Trade Commission (FTC) were sent in mid-October 2019 to a Florida-based ‘cannabis medications’ distributor. The distributor posted numerous unsubstantiated claims about the effectiveness and safety of their products for a variety of conditions. These unlawful advertisements directly targeted vulnerable parents and their families, who would have been duped by a false sense of medication safety and potential efficacy for treating children.
Unapproved CBD Products with Unsubstantiated Claims
Cannabidiol medications are no doubt changing the face of pharmaceutical and herbal medicine cultivation and production. Cannabis medications show unprecedented promise as a new treatment for nausea, eating disorders, chronic pain relief and seizure control, possibly even treating anxiety and depression.
Approved, well-researched cannabis formulations — cultivated, produced and tested per PICS/GMP (or EU GMP) requirements — are one thing. These products have undergone clinical-research and quality testing to back up their safety, quality and efficacy claims.
The trouble is that vulnerable people — especially distressed parents and extremely ill patients — can be readily misled about the benefits of cannabis medications, including unapproved CBD-based pharmaceuticals and oils being marketed online….products neither FDA approved nor adequately researched, nor quality and safety tested. These can prove exceptionally risky to patients of all ages, yet alone to younger generations.
So, too, can investors in cannabis cultivation operations be misled, when they fail to fully understand the many cannabis cultivation challenges facing the industry.
These challenges can range from choosing an inappropriate cultivation site or inefficient cannabis facility design due to a lack of industry knowledge, to licencing application delays, to the many pests and diseases that can ruin your million-dollar cannabis crop.
There’s also the complex decision about which method of cultivation is best for your region and operational objectives. Should you choose indoor cannabis cultivation methods or opt for the broadacre approach — and what are the operational costs and risks of doing so?
Too many would-be-operators and investors are also under-informed about GACP and GMP requirements, and other quality controls, including the need to ensure your employees, facilities and workflow processes meet licence, security and regulatory requirements.
Scientists Views of CBD Medications – Safety, Quality and Efficacy
Few scientists doubt cannabis plant-based medications will prove efficacious for treating a number of conditions where existing treatments fail. However, robust data on the efficacy, safety and dosing of newer formulations with CBD or TCH APIs, simply isn’t available yet…with very few exceptions.
That’s why there are so few TGA or FDA approved medication formulations at this point in time.
That’s also the reason unapproved cannabis medicines are often difficult to attain, as well as being relatively expensive compared to approved drugs covered by public health benefits or insurance schemes.
These new formulations can also be potentially risky to public health. They can vary tremendously in safety and efficacy factors, such as variable API percentages when a manufacturer isn’t compliant with GACP/GMP.
Deceptive Certificates of Analysis (CoA or CofA) for Medicinal Cannabis
There’s also the issue of fraudulent ‘laboratory quality testing’ documents — Certificates of Analysis (CoA/CofA) — being used to dump contaminated/mold-laden flowers and buds to less discerning distributors — and consumers — in the medicinal cannabis industry.
List of currently FDA approved cannabis medications
Evidence-based CBD and THC medications approved by the FDA – what’s the real story?
Are ANY cannabis-derived drugs approved by the FDA?
The few currently FDA approved cannabis-based (or synthetic-cannabis/THC/CBD/cannabinoid medications) available in the USA include:
- Epidiolex (the U.S. FDA approved Epidiolex in July 2018) – Epidiolex is currently the only FDA approved drug containing CBD
- Marinol and Syndros (medications with the active ingredient dronabinol/synthetic cannabis) which gained FDA approval for treating conditions like anorexia, cancer-treatment nausea and/or weight loss in patients with HIV/AIDS
- Cesamet is another FDA approved medication that uses a synthetic form of TCH (nabilone).
Other cannabis medications on the market are currently unapproved.
- Small studies and case studies for several new cannabis medications show promise
- But without robust, double-blind studies, they do not provide a golden standard level of evidence required for pharmaceutical prescriptions and marketing
This is, in part, the reason new cannabis medications available through special access schemes (such as Australia’s Special Access Scheme), are not yet on the Pharmaceutical Benefits Schedule (PBS). The TGA’s approval processes require a higher ‘golden standard’ of safety, quality and efficacy testing (drug approval processes requiring sufficient clinical trial data for scientific assessments). Read the article on the Special Access Scheme: SAS and cannabis medication user statistics (Australia) or the blog on setting up a Clinical Trial for cannabis research studies.
Cannabis Medication Cost Differences
The cost of unapproved cannabis medications compared to approved medications
Not being listed on the Pharmaceutical Benefits Scheme (PBS) — or the FDA approved medications lists — means unapproved medications can be relatively expensive to purchase, compared to currently approved treatments.
- The process for applying for medicinal cannabis use can be daunting to patients and doctors alike (the Special Scheme Access process for medicinal cannabis is governed at the State Level).
- But the ODC is also involved, and Doctors must have adequate training before they can prescribe medications containing cannabis.
Advertised CBD cannabis medication treatment claims — true or false?
- Other than the short-list of currently FDA approved medications (above), evidence-based research remains sparse about the effectiveness of other CBD products and cannabis plant-based medications currently being studied
- From an objective, scientific viewpoint, we still know very little, other:
- cannabis medications are likely to have wide-ranging potential across a number of conditions and diseases, and
- cannabis use by humans has occurred for social, medicinal, cultural and ‘spiritual’ for thousands of years
- Rumors suggest that Shakespeare’s most inspired writings may have been influenced by his use of cannabis, a hotly debated discussion
- No doubt many luminaries along the way have at least tried cannabis on one or more occasions, however, as up to 30% of the population in well-studied cultures have tried cannabis at least once in their lifetimes, with up to 1 in 10 people admitting to frequent or daily consumption
For the majority of currently available cannabis medicines — and widely-sold CBD-based products and beverages being marketed in the USA — we still lack robust, objective and scientific data. Placebo effects aside, this means current claims about the benefits of CBD-based products and medications are speculations, more than science.
Until evidence-based data from substantial clinical trials is gathered, analysed and published, CBD medicine claims are, at best, optimistic and unproven….and at worst, they are false and misleading. The FDA is cracking down.
Why is so little currently known about what CBD products can —- or cannot — accomplish for specific health conditions and patient populations?
The gaps in our knowledge about cannabis medications arise from many interactive factors. One dynamic involves a long history of cannabis bans, which thwarted cannabis research in many regions across the globe. There’s also been ongoing resistance to acknowledging the potential value of psychoactive medications in treating a variety of diseases — including the fear of making them worse.
Sadly, despite the plant showing promise as an herbal medicine resource, there also remains a great deal of stigma — and ill-informed stereotyping — about cannabis users and would-be patients.
Clinic Trials and Completion Dates (Targets): When will key cannabis studies be completed?
- Several larger international studies are nearing their completion dates
- Yet with countries staggered in cannabis legality approvals and research participation enrollments, there’s still a far way to go
- The clinical research data will still need to be compiled and analyzed, and potentially confounding factors will need to be explored
- Some early study findings are suggesting positive efficacy, some are revealing none; and others are showing a need to investigate toxicity on organs, such as liver toxicity/kidney damage
Factors which interact to result in TGA or FDA medication approval delays for cannabis medication include:
- The new legality of cannabis
- Delays in getting ethics approvals for clinical trials
- Difficulties standardizing strains/cultivars to create standardised-API percents in medications
- The costs of conducting and publishing robust clinical trials
- Crop contamination or plant pests and diseases
- Export/importation limitations across international borders
These dynamics mean we’re still a few years off from having solid data upon which regulatory authorities (the FDA in the USA, the TGA in Australia), can access to make an informed decision about the safety, quality and efficacy of emerging cannabis-derived medicines.
CBD Medicine Clinical Studies: Fake Medical Claims by Producers Being Targeted by the FDA
While robust clinical research studies into cannabis-derived medications will shed light on the efficacy and acceptable dosing ranges of these new medicines – including quantifying the risks of unwanted drug effects – companies in the USA are, sadly, marketing cannabis medications with numerous false claims.
Unsubstantiated medical benefit claims are inherently false. CEOs of cannabis companies who allow, and even encourage, employees to make unsubstantiated claims on social media pages and other channels — are getting FDA warning letters. This could signal a likelihood of licence suspensions and fines, or even criminal charges if patients end up being harmed.
Companies have been found targeting parents and children with cannabis ads that clearly have false claims in view of safety and efficacy. They are using unscrupulous marketing practices to sell their products, which have not yet been approved by regulatory authorities, and which often lack even basic testing to a standard the public expects (despite testing laws). And it would be highly unlikely any well-qualified medical practitioner, scientist or clinical researcher would make a statement about the safety and effectiveness of these medications for use by children who’s neurological systems are still in development — and which will be in development, for years to come.
Unregulated and untested products: Quality and Safety Issues
Not only are advertising claims for unapproved medications/CBD products FALSE:
- Many unapproved products are the subject of public health/product quality concerns
- There have been many incidents of a lack of safety testing and a lack of GACP/GMP/quality assurances in manufacturing practices
- Documented concerns include variances in API percentages for CBD or THC and shelf-life instability (safety, quality and efficacy – the aim of good manufacturing practices).
- Their article states that from 40% to over 80% of ‘street’ cannabis contained major contaminants, such as e-coli bacteria, Aspergillus fungus, even human feces, as well as heavy metals and chemical residues ranging from pesticide poisons to cleaning chemicals and carcinogenic extraction fluids.
- Another recent article found that a large commercial batch of cannabis, for medicinal production use in Canada, was returned to the cultivator (rejected) after quality testing revealed the cannabis supplies contained contaminants including traces of rubber.
Contaminants in medicinal products are dangerous. They could readily lead to serious inflammation and infections in already-vulnerable patients with immune-compromised systems, such as cancer treatment patients, patients with pneumonia, and those with other later stage diseases. This is why following good agricultural and collection practices (GAP/GAC or ‘GACP’ as it’s often called), and good manufacturing practices (GMP/EU GMP), is such a crucial component of public safety when it comes to medicines.
Summary of USA Advertising / TGA Warning Letters for Cannabis-Based Medications / CBD Pharmaceuticals
To make unsubstantiated claims on the benefit(s) of any medical or healthcare product, whether that’s a pharmaceutical product, herbal supplement or medical device — definitely breaches federal regulations monitored by various government agencies interested in protecting public health. Read the list of which global agencies regulate the pharmaceutical industry by conducting PICS/GMP audits, including the TGA and FDA.
Despite a general laxity of drug-marketing guidelines in the USA, which allow pharmaceutical companies to advertise their medications directly to consumers (unlike the strict restrictions on drug advertising in Australia), there are still regulations in view of making unsubstantiated claims (false advertisements for medicines). In the latest of many similar news stories, a group in Florida has been advertising CBD medications and targeting parents of children with Autism, Asperger’s and ADHD.
Scientists who understand the effects of psychoactive ingredients on still-developing brains are appalled by their blatantly unsubstantiated claims, such as safety when used by children.
So, too, are the regulatory agencies and officials who monitor herbal medicine productions, quality testing and distribution practices, including labeling, dosing standards, safety warnings, adverse effects reporting and marketing restrictions.
FDA Warning Letters, Consumer Protection Laws and Criminal Offences
False Claims about Medicinal Benefits of Cannabis Medication
Numerous USA suppliers of cannabis products and unapproved medications are making unsubstantiated claims about their products. Other companies are failing to sufficiently quality-test their products, or are using quality-testing certificates in deceptive manners to try to con the public into thinking their products are safe and effective. They often lack evidence of any kind to support their claims. Such advertising is against the law.”
False advertising claims also place the public, cannabis licence holders (CEOs/Employees/Investors) — and the entire medical cannabis industry — at risk.
Deceptive advertising (unsubstantiated) not only threatens the operator’s licences and operational sustainability (business stability), the CEOs/managers and even employees of these companies could incur direct liability should the public come to harms from product usage.
The regulators have been watching and warning letters sent. And the FDA is catching up with them.”
- False advertisements for the effectiveness of cannabis-based pharmaceuticals and CBD products are also in breach of consumer protection laws
- False marketing claims, combined with adverse effects and other health harms, could result in serious financial penalties and criminal charges (jail time).
- Another issue of concern is fake medicines (counterfeit medications) making their way into consumer markets
Sources/Recommended Reading about Unsubstantiated Claims for Cannabis Products (Unapproved CBD, THC medicines)
Counterfeit Medicines: Global Statistics and Public Health Concerns
Consumer Warnings about Cannabis Medication/Marijuana Medication Advertisements: False Claims, False Drugs
False CBD Product Advertising and FDA responses
FDA warns companies who advertised unsubstantiated claims that medicinal cannabis products could: treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety (FDA warning letter and press announcement, 2019).
Unapproved medications being advertised with unsubstantiated claims: Cannabis companies given warning letters from the FDA
Cannabis treatments that show positive effects and moving into Phase 2 or Phase 3 Clinical Trials