WARNING LETTER
BioMD Plus LLC
MARCS-CMS 618460 —
May 04, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Jonathan M. Levitt
BioMD Plus LLC
1371 Sheffield Pkwy
Marietta
,
GA
30062
United States
support@biomdplus.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
May 4, 2022
RE: #618460
Dear Jonathan Levitt:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.biomdplus.com in February 2022 and has determined that you take orders there for various human and animal products, which you represent as containing cannabidiol (CBD) or Delta-8 tetrahydrocannabinol (THC).
We have also reviewed your social media websites at https://twitter.com/bioMDplus
, https://www.facebook.com/bioMDplus/ and
https://www.instagram.com/biomdplus/, which
direct consumers to your website
www.biomdplus.com to
purchase your products.
The claims on your website and social media accounts establish that your products,
some of which are available in multiple varieties, “CBD Oil,” “CBD Capsules,” “Vegan CBD Gummies,” “CBD Pain Relief Cream,” “Delta 8 THC Gummies,” and “Delta 8 THC Vape Cartridge” (hereinafter referred to as “your CBD and Delta-8 THC products for humans”) are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
In addition, your “Natural Pet CBD Oil” is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and is adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
FDA has also determined that certain food products that you market are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive.
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find specific information about how FDA regulates cannabis-derived products at
https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
.
Over the past several years, FDA has warned the public on various illegally marketed CBD-containing products. FDA has also observed a proliferation of products containing another cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. See
https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc
. This letter is to inform you that your firm markets Delta-8 THC-containing products, and Delta-8 THC may pose a serious health risk to consumers.
Dietary Supplement Labeling
Information on your website at www.biomdplus.com
indicates that you appear to market your CBD-containing “CBD Capsules” and “Vegan CBD Gummies” as dietary supplements. For example, the product webpages display a product label image with “hemp supplement” on them. However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, 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.
[1]
There is an exception 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. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.
Unapproved New Human Drugs
Based on a review of your website and social media accounts,
your CBD and Delta-8 THC products for humans
are
drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), 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.
Examples of claims from your website www.biomdplus.com and social media accounts,
https://twitter.com/bioMDplus
, https://www.facebook.com/bioMDplus/ and https://www.instagram.com/biomdplus/, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
From your website www.biomdplus.com:
On your blog post titled, "Best CBD Oil for Stress & Depression: Can CBD Oil Help?":
“Many are turning to consume CBD oil for anxiety, depression, and bipolar disorder.”
“The pre-clinical data support the possible use of CBD with Panic Disorder (PD), Obsessive-Compulsive Disorder (OCD), and Post Traumatic Stress Disorder (PTSD), and Bipolar Disorder.”
On your blog post titled, “CBD for Psychosis vs CBD Oil for Schizophrenia: Breaking News…”:
“People are now taking CBD for anxiety, stress relief, proper pain medication, and to help fight addiction.”
“High-level CBD can help manage symptoms of psychosis that come from schizophrenia.”
On your blog post titled, “CBD Oil Benefits”:
“Relief for Chronic Pain . . . [t]hose who suffer from chronic pain from diseases such as fibromyalgia find relief in CBD. Taking CBD can relieve pain and even prevent the degeneration of the nervous system.”
“IBD . . . [s]everal studies have suggested that one of the most important effects of CBD is that it may help patients with inflammatory bowel disease such as ulcerative colitis and Crohn’s disease.”
On your blog post titled, “CBD Oil for Sundowning, Dementia, Alzheimer’s Disease & Disorientation”:
“The dementia-related conditions that can be helped by CBD Oil include Alzheimer’s disease, Vascular Dementia, Dementia with Lewy bodies (DLB), Parkinson’s disease, Frontotemporal dementia and Huntington’s disease.”
“CBD could help remove dementia from brain cells.”
On your blog post titled, “Delta-8 THC: Discover This New Cannabinoid from Cannabis”:
“[D]elta-8-THC was administered to eight children being treated for hematologic cancers. The children were 3 to 13 years old . . . [t]hey all experienced vomiting because of the chemo . . . they received delta-8-THC with their chemotherapy treatments, every single child stopped vomiting during and after their chemo sessions!”
“[D]elta-8-THC has also been used to relieve pain, ease anxiety”
On your blog post titled, “How Long Does It Take For Results Using CBD Oil To Take Affect With OCD?”:
“CBD oil is an effective natural treatment for OCD.”
On your blog post titled, “How To Take CBD Oil For Crohn’s Disease? Finding The Right Dosage”:
“The study suggests that cbd oil or a derivative of it could be a useful treatment for Crohn’s.”
On your blog post titled, “Is CBD Oil Good For Idiopathic Pulmonary Fibrosis? The Ultimate Therapeutic Guide”:
“[T]here are numerous studies that suggest CBD oil has the potential to treat a wide variety of health issues and could be effective in treating IPF [idiopathic pulmonary fibrosis].”
On your Delta 8 Gummies product webpage:
“Another benefit that many people don’t know is that Cannabidiol can help with the growth and healing of damaged tissue, and it can also help reduce chronic pain and the likelihood of developing certain cancers, such as breast and prostate.”
“The benefits of Delta 8 are the following . . . Reduce depression . . . Reduce anxiety and panic attacks . . .”
On your CBD Pain Relief Cream webpage:
“bioMDplus Pain Cream in 500mg strength is a new formulated pain relief topical cream that made for use on sore muscle areas and areas where there is pain. bioMDplus Pain Cream infused with the Quality Full Spectrum CBD. bioMDplus CBD Cream provides effective, fast and long-lasting pain relief.”
“Begin by rubbing small amounts of CBD cream to the affected area and wait for about an hour. You can increase the quantity depending on how fast it works. If the effects of the cream are slow to kick in, then its [
sic
] recommended to re-apply CBD cream after every 3-4 hours. . . . Using CBD cream is like using a moisturizing lotion, but making sure to apply the optimal dosage of CBD cream isn’t easy. Users have to determine the milligrams of CBD in the cream and decide whether it’s good enough for pain relief. CBD creams with low amounts of CBD will probably be less useful than those with higher concentrations. Begin by using small amounts of CBD cream before slowly increasing it until you find relief. Moreover, applying CBD cream on the body isn’t known to produce any significant side effects.”
“CBD creams work when directly applied to the skin, which makes them an excellent alternative to traditional creams when it comes to pain relief. . . . For the most part, the effects of CBD cream can be felt 15-20 minutes and can keep working for as long as 6 hours or more.”
“Applying CBD-infused creams is generally a straightforward process. Look for the areas of your body most affected by pain and discomfort, and apply small amounts of CBD cream around those areas for local treatment. . . . Elbows, knees, and joint . . . Bottoms of the feet and impact points . . . Face, particularly around the temples and the nose . . . Neck and shoulders”
From your social media websites:
On your Facebook Social Media page https://www.facebook.com/bioMDplus/:
July 28, 2020 post – “Recent research has linked CBD with several benefits for the heart and circulatory system, including the ability to lower high blood pressure. High blood pressure is linked to higher risks of a number of health conditions, including stroke, heart attack, and metabolic syndrome.”
April 14, 2020 post – “500mg: CBD & Menthol Pain Cream . . . bioMDplus 500mg CBD Pain Cream is a newly formulated pain relief topical cream made to soothe sore muscles and alleviate chronic joint pain. Derived from our signature potent hemp oil infused with peppermint oil, eucalyptus oil, menthol and our signature terpene blend, this cream allows for a unique and STRONG combination of natural ingredients and CBD to aid in POWERFUL relief. You can use our new topical pain cream to FIGHT back against sore muscles and achy joints!”
April 7, 2020 post – “Just what does CBD do for the body and why are people so interested in this substance? . . . Pain relief from arthritis or inflammatory diseases . . . Treatment of insomnia . . . Lowering anxiety levels . . . May lower diabetes risk . . . Could lower levels of obesity”
On your Twitter Social Media Page
https://twitter.com/bioMDplus
:
August 4, 2021 post – “62% of CBD users used it to treat health conditions. The most common uses were for pain, anxiety and depression.”
July 25, 2021 post – “CBD Oil for Depression, Anxiety, and Bipolar disorder.”
On your Instagram Social Media Page https://www.instagram.com/biomdplus/:
July 4, 2020 post – “75% of PTSD patients saw a reduction in PTSD symptoms, when they were using CBD products compared to when they were not.”
November 5, 2019 post – “A recent study showed that CBD administration can prevent the death of the neurons and reduce brain damage in the event of a stroke. CBD also reduced stroke-related seizures.”
Based on the above labeling claims, your CBD and Delta-8 THC products for human use are drugs. We are not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that any of these products are generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended or suggested in their labeling. Thus, your CBD and Delta-8 THC products for human use are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
With certain exceptions not applicable here,
[2]
new drugs
may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a), 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your CBD and Delta-8 THC products for humans. There is no basis under the FD&C Act under which these products would be legally marketed without an approved application. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
Misbranded Human Drugs
Your
CBD and Delta-8 THC products for humans are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) These products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, because no FDA-approved applications are in effect
your products
.
[3]
The introduction or delivery for introduction into interstate commerce of misbranded drugs is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
CBD-containing Drugs
Even if your “CBD Pain Relief Cream” was considered a nonprescription drug, we note that a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. Nonprescription drug products that include CBD as an active ingredient are not GRASE and are new drugs which require an approved application to be legally marketed. CBD is not an active ingredient in any OTC monograph under section 505G of the FD&C Act. Even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements under section 505G of the FD&C Act under which certain nonprescription drug products may be marketed without an approved new drug application. In particular, such a product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e).
[4]
,
[5]
Adulterated Human Foods
According to your product labeling, your “Delta 8 THC Gummies” product is a food to which Delta-8 THC has been added.
You should be aware that, as defined in section 201(s) of the FD&C Act, 21 U.S.C. 321(s), the term "food additive" refers to any substance the intended use of which results in it becoming a component of any food, 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.
[6]
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
There is no food additive regulation that authorizes the use of Delta-8 THC. We are not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that Delta-8 THC is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).
We know of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. Our review of published scientific literature identified potential for adverse effects on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on our review, the use of Delta-8 THC in your products does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exception to the food additive definition that would apply to Delta-8 THC for use as an ingredient in a conventional food. Therefore, Delta-8 THC added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Delta-8 THC is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act.
Therefore, your “Delta 8 THC Gummies” are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because they bear or contain an unsafe food additive. Introduction of these adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Animal Drugs
Based on our review of your website and social media websites, your
“Natural Pet CBD Oil” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, this product is an unapproved new animal drug and marketing it violates the FD&C Act.
Examples of claims from your website
https://biomdplus.com, and
your social media websites
https://www.facebook.com/bioMDplus/, https://www.instagram.com/biomdplus/
, and https://twitter.com/biomdplus, that provide evidence of the intended use of your “Natural Pet CBD Oil” as a drug include, but are not limited to, the following:
On your product page for “
Natural Pet CBD Oil”:
“Whether you’re using CBD oil for pain relief or anxiety, the right full spectrum CBD oil for dogs dosage depends on a number of factors. . . .”
“[L]inalool [an ingredient in your Natural Pet CBD Oil] may relieve . . . depression.”
“Humulene [an ingredient in your Natural Pet CBD Oil] . . . may help to reduce inflammation.”
On your webpage blog titled, “How Effective Is CBD For Pets?”:
“CBD tinctures are reported to help pets with seizures.”
“Thanks to the natural anti-in
f
lammatory properties in CBD, it also makes for a great candidate in helping with anxiety, in
fl
ammation, and arthritis.”
Under the heading “Top Uses CBD for Pets”:
“Anxiety[:] One of the major bene
fi
ts reported with CBD is that it can help . . . alleviate their anxiety. Most pets will suffer from varying degrees of anxiety, especially dogs and cats.”
“Pain . . . CBD can greatly help with [pain]. So any in
fl
ammatory pain that your pet may be suffering from may be greatly reduced with CBD. Since CBD has natural anti-in
fl
ammatory properties, it works especially well for in
fl
ammation-induced pain.”
“Arthritis[:] Although there are yet to be more tests on the effectiveness of CBD against arthritis, there is a substantial reason and some tests that prove its ef
fi
cacy. Of course, the inherent anti-in
fl
ammatory properties of CBD do make it very valuable in providing substantial relief to arthritis. Moreover, research also supports these claims, ensuring that CBD can be a good substitute for regular arthritis medicine.”
“Seizures[:] Seizures among pets can be a very serious concern, but research suggests that CBD can help in reducing certain types of seizures in dogs. . . . In dogs, research conducted on idiopathic epilepsy showed that CBD assisted in reducing the intensity of seizures. So if your dog suffers from the condition, CBD can prove to be useful in bringing relief.”
On your webpage blog titled, “Full Spectrum CBD Oil for Dogs”:
“
Here are a few problems full-spectrum CBD oil can help treat:”
“
Pain Including Joint Pain[:] It’s believed that CBD oil can reduce pain, especially neuropathic pain in dogs. It’s also said to be effective in reducing joint pain and arthritis, which is why it’s often recommended for older dogs.”
“Inflammation[:] CBD oil is anti-in
fl
ammatory and can help reduce chronic in
fl
ammation in dogs due to genetics, parasites, metabolic diseases, food allergies, bacterial
overgrowth, and environmental stress.”
“
Anxiety[:] If your dog gets stressed or anxious then you may consider using CBD oil as it has been linked to less anxiety and stress.”
“
Digestion Problems . . . Regular use of full-spectrum CBD oil for dogs can treat this problem as it’s said to eliminate digestive issues”
“Pain Symptoms[:] There are reasons to believe that the best full-spectrum CBD oil for dogs can help alleviate symptoms of pains in dogs. . . . The use of CBD oil may not cure the disease but it can help reduce the pain and suffering.”
“Seizures[:] Some experts are of the belief that regular use of full-spectrum CBD oil can reduce the risk of seizures in dogs. The AKC Canine Health Foundation is working with the Colorado State University to evaluate the use of full-spectrum CBD oil in treatment-resistant epileptic dogs. biomdplus offers the best full-spectrum CBD oil for dogs. Our product is meant to provide all the above-mentioned bene
fi
ts to dogs of all ages.”
On both your Facebook and Instagram social media websites at https://www.facebook.com/bioMDplus/ and
https://www.instagram.com/biomdplus/ respectively:
Facebook and Instagram July 23, 2020 postings with a photograph of a cat looking at your “Natural Pet CBD Oil” product:
“Use bioMD+ CBD products made for cats to help with . . . pain”
Facebook and Instagram October 5, 2019 postings with a photograph of a dog licking a woman’s face:
“For pets who . . . have swollen joints, or separation anxiety CBD has helped many!”
On your Twitter social media website at
https://twitter.com/bioMDplus
:
October 13, 2020 posting of a graphic titled “CBD FOR PETS . . . What can CBD do for your pet?” (checklist at the bottom next to clipboard titled “CONDITIONS TREATED”):
“
?
Allergies”
“
?
Anxiety”
“
?
Cancer Management”
“
?
Inflamation
[sic]
”
“
?
Glaucoma”
“
?
Skin Irritation”
“
?
Seizures and Epilepsy”
“
?
Arthritis”
Your
“Natural Pet CBD Oil” product is a “new animal drug” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-1. This product is not approved or index listed by the FDA, and therefore this product is considered 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). Introduction of this adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
*           *           *
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to
FDAADVISORY@fda.hhs.gov
.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/S/
Neal Bataller
Director
Division of Drug Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Food and Drug Administration
/S/
Ann Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[1]
CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See
GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.  Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
[2]
For example, under section 505G of the FD&C Act, 21 U.S.C. 355h, certain nonprescription drug products may be lawfully marketed without an approved application if applicable conditions are met, including conformity with an applicable OTC monograph. However, your products could not be lawfully marketed under section 505G, because based on your claims regarding these products, including on your website labeling, your products are marketed for uses not considered nonprescription indications.  Further, even if certain of your products, such as your “CBD Pain Relief Cream” were marketed only for nonprescription indications, they would not meet the conditions under section 505G for lawful marketing without an approved application. For example, CBD — considered an active ingredient under 21 CFR 201.66(b)(2) due to its prominent featuring on your product labeling — is not an active ingredient in any OTC monograph under section 505G of the FD&C Act.
[3]
Further, even if your products were marketed only for nonprescription indications,
these products would be misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they would be nonprescription drugs subject to section 505G of the FD&C Act that do not comply with the requirements for marketing under that section (see footnote 1) and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
[4]
21 CFR 330.1(e) requires in relevant part that "the product contains only suitable inactive ingredients which are safe in the amounts administered." A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance). CBD has no known functional role as an inactive ingredient in a finished drug product.
[5]
Additionally, an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage. CBD has known pharmacological activity with demonstrated risks. For example, the labeling for Epidiolex (cannabidiol) prescription oral solution includes risks for the drug such as liver injury, interactions with other drugs or supplements, potential for male reproductive toxicity, somnolence, insomnia, diarrhea, decreased appetite, abdominal pain, upset stomach, changes in mood, irritability, and agitation. See
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210365s005s006s007lbl.pdf
. It is unknown whether the levels of CBD used in your CBD products have pharmacological activity or pose any concern for safety events.
[6]
Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food, (2) pesticide chemicals, (3) color additives, (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act), (5) new animal drugs, and (6) dietary ingredients in or intended for use in a dietary supplement.
Content current as of:
05/04/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages