On November 22, the Center for Food Safety and Applied Nutrition (CFSAN) division of the FDA, sent a FDA warning letter to CDRL Nutritional, Inc. The warning letter identified numerous CBD products through the company website and related websites. The letter informed the manufacturer that the company products were unapproved new drugs and were being sold in violation of the Food, Drug, and Cosmetic Act (FD&C Act). The products, according to the FDA, are also misbranded pursuant to the FD&C Act.
Some of the identified products included:
- CBD Softgel, 25 mg (Anti-Inflammation, Multi-Symptom, and Sleep-Aid Formulas)
- CBD Pain Relief Cream, 500 mg
- CBD Carnival Gummies, 600 mg
- CBD-Infused Sheet Mask
- CBD Softgels for Kids, 10 mg
Introducing or delivering products into interstate commerce that are unapproved new drugs or misbranded violates the FD&C Act.
Experienced FDA compliance attorneys help manufacturers, distributors, and retailers, of CBD products understand what laws and regulations apply to CBD products and what compliance issues need to be addressed.
How the FDA currently regulates CBD
The FDA position on CBD products can generally be summarized as follows:
So far, only one drug, Epidiolex oral solution has been approved “for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.”
- CBD cannot legally be added to a “food or labeling as a dietary supplement.”
- So far, FDA has only limited data on the safety of CBD. The data indicate strong risks that must be considered before taking CBD.
- CBD products that are being marketed with claims that are not medically proven will be questioned.
- FDA will keep the public informed about CBD uses as the agency learns more.
Some of the risks associated with using CBD
FDA is concerned that CBD can harm consumers in different was such as:
- Causing injury/damage to the liver
- Serious side effects because CBD “can affect the metabolism of other drugs”
- Increased risk of drowsiness and fatigue when CBD is used with alcohol or other “Central Nervous System depressants.” Fatigue can, in turn, cause injury.
- Gastrointestinal distress
- Mood changes such as agitation and irritability
FDA admits that there is a lot of information about CBD that the agency still needs to review such as:
- What happens when someone takes CBS for long periods of time
- How CBD use affects children
- How CBD affects a “developing fetus or breastfed newborns”
- What happens when CBD interacts with botanicals and herbs
- Whether CBD causes male reproductive toxicity in humans, as has been reported in studies of animals
A major red flag – promoting CBD use for children
FDA, in its warning letter, stated that a particular concern was the marketing of the “unapproved new drug products, ‘CBD Softgels for Kids, 10 mg,’ for children.” Drugs which are not tested can have unforeseen and unintended consequences. Children are especially vulnerable for negative reactions “due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.”
Dietary Supplement Labeling
The warning letter includes what is a fairly common complaint with CBD products – that the manufacturer intends to market some of its products with CBD as dietary supplements. Some of the names of the products are giveaways as to the use of the product:
- CBD Softgels
- CBD Oil Drop Tincture
- CBD Carnival Gummies
In addition, the Supplement Facts panel suggests some of the CBD products are dietary supplements. Generally, CBD products cannot be dietary supplements because CBD products do not meet the criteria set forth in the FD&C Act. Based on current available evidence, the FD&C Act excludes CBD products from the dietary supplement definition under 201(ff)(3)(B)(i) and (ii) because:
“if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.”
There is generally an exception if the product in question was marketed as a dietary supplement or as a “conventional food” BEFORE the new drug investigations (NDI) were authorized. FDA does not have evidence that this exception applies to CBD. The warning letter advises, as most FDA warning letters do, that the manufacturer is welcome to submit evidence to the contrary.
Unapproved New Drugs
The warning letter identified from the names of the products and the claims made about the products that the following CBD products are drugs because the products meet the standard FD&C Act definition of drugs – “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.”
- CBD Oil Drop Tincture
- CBD Softgels
- CBD Pain Relief Cream
- CBD Carnival Gummies
- CBD-Infused Sheet Mask
- CBD Softgels for Kids
- Website Blog-News page:
- “However, numerous clinical studies have revealed that CBD you [sic] can have a very impactful reaction against a wide variety of diseases such as multiple sclerosis, Alzheimer’s, anxiety, depression, and more.”
- “In addition to being used for people who suffer from epilepsy, this product has been shown to be therapeutically beneficial for a variety of other ailments as well. These include the following:
- Multiple sclerosis
- Hypoxia-ischemia injury
- Rheumatoid arthritis
- Another page titled – “Benefits of Infusing CBD into Melatonin or Curcumin” included the following drug-based claim:
- “Recent research indicates CBD (cannabidiol) is a non-toxic and non-psychoactive compound that has several beneficial effects including anti-anxiety, anti-inflammatory, antiemetic, anti-psychotic, and much more.”
- The webpage with the title “CBD for Post-Traumatic Stress Disorder” contained the following claim:
- “As you might imagine, this is one of the reasons why PTSD victims all over the U.S. (and the globe) have recently been drawn to CBD – for going on half a decade now, it has represented a potentially effective treatment with very promising results, and virtually no side effects.”
- “In other words, it is becoming more and more clear that in terms of a safe and effective treatment for PTSD, CBD oil could be the answer.”
- On the webpage titled “CBD for Depression” this claim was made:
- “A growing number of people are using cannabidiol (CBD) products to assist in recovering from depression. If you’re considering adding CBD oil to your self-care routine, we’ve put together this article to help you understand the current scientific research about CBD and depression. Although clinical trials are lacking, there is good evidence that it could help your brain recover from depression.”
- Another webpage titled “CBD for Sleep Disorder” claimed:
- “Sleep apnea is a serious sleep disorder when your breath repeatedly starts and stops. People who suffer from sleep apnea get repeatedly awakened by their own breathing because of the narrowed airway. Therefore, you feel tired even after a snoring sleep. This can cause high blood pressure, fatigue, diabetes etc. Studies have revealed that CBD suppresses sleep apnea, as it is a muscle relaxant.”
- “According to Studies, CBD oil, an extract from the cannabis plant relieves pain. It has been found useful to treat joint pain, arthritis, back pain etc.”
- Other pages include claims that CBD product appears safe and may be beneficial for treating a range of anxiety-related disorders
- Panic disorder
- Obsessive Compulsive Disorder (OCD)
- Social phobia
- Post-Traumatic Stress Disorder (PTSD)
- Generalized Anxiety Disorder (GAD)
- Mild to moderate depression
- Temporary relief for pain and discomfort “from arthritis, muscle strain, bruises, sprains, joint aches, and backache.”
- relief for joint paint, inflammations, and muscle-pain
FDA concluded that these CBD products are not generally considered safe and effective for the above disorders. FDA stated these CBD products should be considered “new drugs” which cannot be introduced or delivered into interstate commerce without FDA preapproval. FDA preapproval requires scientific data and studies to show the products are safe and effective.
Another standard FDA complaint, set forth in the warning letter, is that products are misbranded because the labels fail to provide adequate directions for use. This analysis is based on the following findings:
- Adequate directions test: The FD&C Act defines “adequate directions for use” as essentially directions that a layperson could follow safely for the intended purpose.
- Medical products generally cannot have adequate directions: Since the products with CBD are offered for medical conditions that cannot be self-diagnosed and the users are not physicians then there’s no set of directions that can be adequate.
- Prescription drugs: The general exemption to the adequacy test for FDA-approved prescription drugs does not apply because there are no FDA-approved applications for the CBD products other than Epidiolex which has been approved for epilepsy in children.
- Interstate commerce: Therefore, introducing these misbranded drugs into interstate commerce violates the FD&C Act.
301(ll) and Adulterated Foods
One product, “CBD Carnival Gummies, 600 mg” was cited by FDA because the claims for the product suggest it is a “conventional food.” Examples of these claims include the words – “snack” and “tasty treat.”
FDA&C Act does not permit any food to be introduced into interstate commerce where an approved drug (for which substantial clinical investigations have been instituted and the public has knowledge of those investigations) has been added to the food. The exception for premarket approval where the substance was “marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted” does not apply because premarket approval has not been authorized by FDA for CBD products.
FDA also raised questions about introducing a “food additive” – unless “the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.” Food additives also require premarket approval otherwise the product may be considered “adulterated.” So far, FDA has not approved CBD as a food additive.
Reply required by the CBD product manufacturer
The manufacturer was given 15 working days to set forth the steps they took to correct these violations, explain why the violation assessment is not accurate, or state the reasons why more time is required to comply and the estimated completion date for making the corrections.
This FDA warning letter to a CBD manufacturer that its products are considered drugs was based primarily on claims that were made on the manufacturer’s company website and social media websites. New drugs generally require extensive scientific review. Most CBD products that are classified as drugs generally also fail the requirement that the labels have adequate instructions for use. CBD products that FDA classifies as drugs are regularly cited for adulteration and misbranding.
Contact Cohen Healthcare Law Group, PC for legal counsel on healthcare transactions, regulatory compliance, and FDA and FTC law. Our experienced healthcare & FDA attorneys advise healthcare companies and healthcare providers ranging from medical centers, to integrative and functional medicine practices, cosmetics and supplement companies, and medical device manufacturers.