On July 22, 2019, the FDA issued a warning letter to Curaleaf, Inc. located in Wakefield, Massachusetts. The letter began by stating that it had reviewed:
- The company website. The site indicated they take customer orders for the following products which the company promotes as containing cannabidiol (CBD):
- CBD Lotion
- CBD Pain-Relief Patch
- CBD Tincture (5 versions)
- CBD Disposable Vape Pen (5 versions)
- Bido CBD for Pets (3 versions)
- Facebook account and Twitter accounts which direct social media readers to the company website where they can buy the CBD products
Makers and consumers of THC and CBD products need to understand which federal and state laws apply. While there may be health benefits, there are legal risks.
The FDA found the following violations:
- Unapproved drugs. The FDA concluded that the first four products (the lotion, patch, tincture, and vape pen) were “unapproved drugs” and were being sold in violation of the federal Food, Drub and Cosmetic (FD&C) Act – sections 505(a) and 301(d). The FD&C Act is located at 21 U.S.C. 355(a) and 331(d).
- Misbranding. The FDA also found that the four drugs were “misbranded” under section 502(f)(1) of the FD&C Act. 21 U.S.C. 352(f)(1).
- Unapproved animal drugs. The pet CBD product was determined by the FDA to be an “unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).”
They also found that the company made claims that indicate the CBD products qualify as dietary supplements.
The Need of Businesses to respond to FDA Warning Letters
FDA warning letters are generally just that – a warning – although they indicate that if the company does not comply, FDA will follow up with more serious enforcement, such as seizure of goods, fines and penalties.
Legal counsel should review the FDA’s CBD product warning letter advise the company r what sections of the law were violated, why the FDA believes there were violations, and what the Company must do to comply. The FDA normally gives the respondent a timeline for either making the necessary compliance adjustments or explaining to FDA’s satisfaction, why the initial FDA interpretation of the law or facts is wrong.
Generally, the FDA, focuses on the following compliance issues:
- Current good manufacturing practices (CGMP)
- Improper labeling
- Dishonest marketing
Failure to respond adequately and effectively to the FDA warning letter can result in fines and penalties. Among other things, he FDA may seek an injunction precluding any further development or sales of the product. In some cases, the company may be forced to cease business operations.
Unapproved New Human Drug Products
The FDA found that the four non-pet products were drugs “because they are 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.” Section 201(g)(1) of the FD&C Act defines a drug as:
“(1) The term “drug” means:
(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
(D) articles intended for use as a component of any article specified in clause (A), (B), or (C).” …
The website claims that led the FDA to find the non-pet products were drugs
The finding that the products should be classified as drugs were based on the following claims (from the company website):
- On your product webpage for CBD Disposable Vape Pen (Relieve): “[F]or chronic pain.”
- On your product webpage for CBD Tincture (Relieve): “[S]oothing tincture for chronic pain.”
- On your webpage titled “Can CBD Oil be Used for ADHD?”
- “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety …ADHD.”
- “The Benefits of CBD Oil for ADHD… It’s not unusual for people with ADHD to feel anxious and on the edge. CBD is known for its anti-anxiety properties that can promote relaxation and stress relief. It can also help to restore focus and ability to concentrate on specific tasks, as well as reduce impulsivity.”
- On your webpage titled “How to Use CBD Oil for Anxiety”
- “CBD can successfully reduce anxiety symptoms, both alone and in conjunction with other treatments.”
- “CBD oil can be used in a variety of ways to help with chronic anxiety.”
- On your webpage titled “CBD Benefits: Top 5 Research-Backed Benefits of CBD”
- “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.”
- On your webpage titled “Hemp Oil vs. CBD Oil: Everything You Need to Know”
- “CBD …can be used to help manage a wide range of health conditions, such as . . . Anxiety and depression… Chronic or arthritic pain…”
- On your webpage titled “How to Choose the Best CBD Oil for You”
- “Some of the most common reasons to use CBD oil include… Chronic pain …Mental conditions like anxiety, depression, and PTSD…”
The FDA reviewed other webpages that promoted CBD oil as good for depression, anxiety, post-traumatic stress discords, and even schizophrenia
The social media claims that led the FDA to find the non-pet products were drugs
The FDA noted the following claims on the company social media accounts that suggested, in FDA’s view, that the products were drugs:
- On your Facebook Social Media Account:
- April 8, 2019 posting – “CBD Can be a powerful ally if you’re suffering from chronic inflammation and pain.”
- March 14, 2019 posting – “The top five research backed benefits of CBD include: 1) neuro[de]generative disease 2) depression and anxiety treatment 3) pain treatment 4) aids in the treatment of cancer and related symptoms to cancer…”
- On your Twitter Social Media Account:
- March 27, 2019 posting – “#CBD to help lower anxiety…”
- March 25, 2019 posting – “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
The FDA review of the various website and social media claims
The FDA determined that the four non-pet products “are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).”
“New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).”
Note that this is typical FDA warning letter language. When FDA finds a violation of its claims and labeling rules, FDA classifies the product as a “new drug.”
And FDA will not approve a product as a new drug until scientific data and review determines that the drug is safe and also effective.
Misbranding of Products
The FDA further found that the four non-pet products were “misbranded” because their labeling didn’t provide adequate directions on usage. According to the Code of Federal Regulations, the FDA defines “adequate directions as directions under which a layperson can use a drug safely and for the purposes for which it is intended.”
The FDA further added that the four non-pet CBD products were not capable of adequate directions because they weren’t “amenable to self-diagnosis and treatment by individuals who are not medical practitioners.”
The FDA found that no exemptions applied to the company’s CBD human products because there were no FDA-approved applications in effect for the products. The federal Food Drug & Cosmetic Act precludes the entry of misbranded drugs into interstate commerce.
Again, this is standard warning letter fare. FDA looks to rules such as the prohibition against misbranding and cites these rules against the CBD product manufacturer.
Additional findings by the FDA – Misbranded as a dietary supplement
In addition to finding that the company promoted their products as drugs and misbranded them due to faulty labeling requirements, the FDA also warned the company because the online claims suggested that the company “may intend to market your CBD products as dietary supplements.”
The United States Food and Drug Administration (FDA) regulates much more than food and drugs. It regulates dietary supplements, cosmetics, medical devices, tobacco products, animal food, […]
Some of these dietary supplements claims included the following:
- The statement, “Cannabidiol (CBD) is a natural constituent of industrial hemp and is a dietary supplement.”
- “You also display a photo of a CBD product with a supplement facts panel that appears to be your “CBD Tincture” (Relax version) on your social media accounts.”
This is a huge area of concern for CBD product manufacturers: the fact that FDA currently does not allow those products to be classified as dietary supplements.
According to FDA, the products above don’t qualify for the definition of dietary supplement – as set forth in the FD&C Act. Articles (such as CBD) can be found to be outside the definition of a dietary supplement:
- If the article is an “active ingredient in a drug product that has been approved under section 505 of the FD&C Act” 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.”
There is an exception to the dietary supplement classification
- “If the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.”
The FDA found that company’s CBD human products failed to meet these definitions or exceptions and, based on the claims made by the company, should not be labeled or promoted as dietary supplements.
The FDA warning letter continued by detailing the claims regarding the pet CBD product which indicate that that product was an “unapproved new animal drug.”
The company was given 15 days to notify the FDA how it would comply with the letter including explaining the steps the company would take to stop recurring violations – or to explain why the products are not in violation of the FD&C Act.
The excitement over the removal of hemp-based CBD products from the Controlled Substances Act due to the 2018 Farm bill needs to be tempered with the reality that the FDA still needs to approve any product that may be classified as a drug, food, or a cosmetic. Experienced CBD healthcare lawyers can explain what products the FDA can regulate, how to comply with their regulations, and how to respond to any warning letters.
Contact Cohen Healthcare Law Group, PC to review your CBD product compliance requirements before you begin operations. We can help you understand the current FDA compliance requirements for CBD oil and CBD products.