WARNING LETTER
Plantacea, LLC dba Kahm
MARCS-CMS 623508 —
May 26, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Casey Bales and Brian Frye
Recipient Title
Managing Members
Plantacea, LLC dba Kahm
8820 W Russell Rd; Suite 140
Las Vegas
,
NV
89148
United States
orders@kahmcbd.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
May 26, 2022
RE: 623508
Dear Casey Bales and Brian Frye:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://kahmcbd.com/ in May 2022 and has determined that you take orders there for various human and animal products, many of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media websites at https://www.facebook.com/KahmCBD, https://www.instagram.com/kahmcbd/, and https://www.youtube.com/channel/UC6RFlgxSlR1TScnz_ig1oUQ; these social media websites direct consumers to your website https://kahmcbd.com/ to purchase your products.
The claims on your website and social media websites establish that your products “CBD Hemp Pellets” and “K9 Soft Chews,” which you promote as products containing CBD for use in animals, are unapproved new animal drugs that are unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (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).
In addition, your CBD products for human use, “Kahm EQUIPASS RELIEF GEL,” “Kahm CBD MUSCLE FREEZE ROLL ON,” “Kahm BODY CREAM,” “Kahm CBD BROAD SPECTRUM HEMP EXTRACT” (all varieties), and “Kahm CBD NANO CBD SALVE” (hereinafter “Kahm CBD products for humans”), as well as your “Tanka 30 day CBD Band,” “Tanka T-FLEX Band” and “Tanka Collagen Band,” with respect to their ingredients intended for delivery through the skin (hereinafter “Tanka products for humans”), are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Furthermore, your Kahm CBD products for humans and Tanka products for humans are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
FDA has also determined that your CBD Gummies products in Blue Raspberry and Raspberry flavors are adulterated under 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. It is a prohibited act to introduce your CBD Gummies products in Blue Raspberry and Raspberry flavors into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
You can find specific information about how FDA regulates CBD at
https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
.
The Agency is particularly concerned that you market CBD products for food-producing animals. Specifically, your “CBD Hemp Pellets” products bear labels that state, “FOR EQUINE & LIVESTOCK” and display an image of a horse and a cow. In addition to raising potential concerns regarding safety for the animals themselves, CBD products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals. There is currently a lack of data on the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and on safe levels of any potential residues for the human consumer. We request that you take immediate action to cease the sale of any unapproved CBD products for food-producing animals.
Unapproved New Animal Drugs
During our review of your website and your social media websites, FDA determined that your firm is marketing the unapproved new animal drugs “CBD Hemp Pellets” and “K9 Soft Chews.” Based on our review of your website and social media websites, these products 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 in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.
Examples of claims observed on your website and your social media websites that establish the intended use of your products as drugs include, but are not limited to, the following:
On your webpage titled “How Kahm CBD can help my horse perform its best” at https://kahmcbd.com/learn/:
• “*Stress – …In short, when a horse is stressed or anxious several of those CB1 receptors become out of balance. Supplementing your horse with either a daily CBD pellet for horses, or a CBD oil (also known as tincture), will allow those receptors that are out of balance to reestablish balance and help support calming in that horse. Using CBD to reduce stress in horses has proven successful time and time again.”
• “*Inflammation – It doesn’t take a scientist to figure out that more wear and tear on a performance horse’s body means more chronic inflammation. Giving our daily CBD pellets for horses twice a day, allows for a constant level of CBD to remain at a therapeutic level. What this means is, if your horse is experiencing muscle soreness, or ECS receptors that are out of balance in the organs, muscles, and connective tissue causing inflammation, CBD will work constantly to find balance in those receptors and reduce the inflammation associated with everyday activity.”
On your Facebook social media page at https://www.facebook.com/KahmCBD, for “Broad-Spectrum Hemp Pellets”:
• January 10, 2020 posting with pictures of your “CBD Hemp Pellets” product, which includes images of a horse and a cow on the label, and the statement “FOR USE IN HORSES AND LARGE ANIMALS”:
o “PROVIDES SUPPORT TO HELP:
 MANAGE NORMAL STRESS
 PROMOTE A CALMING EFFECT
 MAINTAIN A HEALTHY GUT
 MAINTAIN A NORMAL AND BALANCED BEHAVIOR
 MAINTAIN HEALTHY JOINTS
 MAINTAIN A NORMAL INFLAMMATORY RESPONSE”
On your YouTube social media website at https://www.youtube.com/channel/UC6RFlgxSlR1TScnz_ig1oUQ:
• In a Product Display training video dated December 7, 2020 at https://www.youtube.com/watch?v=8BwdqTedTa0, during the discussion of your “CBD Hemp Pellets” (from the 4:52 to 4:55 mark) the presenter states: “It’s also amazing for the anti-inflammatory effects that CBD has.”
On your product webpage for “K9 Soft Chews” (in the picture of the back of the product label):
• “Our canine soft chews are formulated using CBD isolate, passion flower, valerian root, and ginger root to provide relief and support for anxiety, stress, pain, and digestive issues.”
These products are "new animal drugs" under section 201(v) of the FD&C Act, 21 U.S.C. § 321(v), because they are 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. These products are not approved or index listed by the FDA, and therefore these products are 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). The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).
301(ll) and Adulterated Animal Foods
To the extent that you market any of your products containing CBD as animal food, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any animal food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD.
1
You should also 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 its becoming a component of any animal 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.
2
There is no animal food additive regulation that authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of 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). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods. FDA’s regulations in Title 21, Code of Federal Regulations 570.30(a)-(c), 21 CFR 570.30(a)-(c), describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30). We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.
Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal 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, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Dietary Supplement Labeling
Information on your website at https://kahmcbd.com/ indicates that you intend to market your Kahm CBD BROAD SPECTRUM HEMP EXTRACT products (all varieties) as dietary supplements.
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However, these 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. 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, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), but you may present FDA with any evidence that has bearing on this issue.
In addition, although your website shows Supplement Facts panels for the “Tanka T-FLEX Band” and “Tanka Collagen Band,” your products’ labeling states that the products are intended to be worn on the wrist. For example, your website describes how the “patented macromolecular technology works through direct contact with the skin to provide timed controlled-release of up to 30 days.” The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your “Tanka T-FLEX Band” and “Tanka Collagen Band” products are not intended for ingestion. Therefore, your “Tanka T-FLEX Band” and “Tanka Collagen Band” products do not meet the definition of a dietary supplement under the FD&C Act.
Unapproved New Drugs
Based on our review of your website and social media websites, your Kahm CBD products for humans and Tanka 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 observed on your website and your social media websites that provide evidence of the intended uses of your Kahm CBD products for humans and Tanka products for humans as drugs include, but may not be limited to, the following:
On your Instagram social media website at https://www.instagram.com/kahmcbd/ from posts on July 24, 2018:
• “An article published in the February 2013 issue of The British Journal of Clinical Pharmacology states, ‘CBD. . . inhibits cancer cell migration, adhesion, and invasion.’”
• “A 2016 research study published in the scientific journal Clinical Hemorheology and Microcirculation concluded, ‘CBD was shown to lower the incidence of diabetes in non-obese diabetic mice.’”
On your website https://kahmcbd.com/:
• From your "Blog" webpage posting titled "8 Benefits of CBD Oil":
o "You've asked . . . about the benefits of CBD oil . . . What can you use it for? Here's a list . . . Reduce dependencies . . . management of pain . . . depression or anxiety . . . you can rely on it for these ailments and avoid any addictive tendencies."
• From your “Kahm EQUIPASS RELIEF GEL” product webpage:
o “Equipass pain relief gel provides soothing relief from discomfort associated with . . . competition, sore muscles, wounds, and minor injuries. This product can be used with and without bandages or magnetic therapy and will not burn or blister. . . . Our all-natural topical relief gel is formulated high-quality herbs, colloidal silver, and Water-Soluble CBD. Making our relief gel extremely effective and safe for both human and animal use.”
• From your “Kahm CBD MUSCLE FREEZE ROLL ON” product webpage:
o “Our CBD muscle freeze gel with full-spectrum CBD is a great product to use topically on all of your muscle aches and pains. It goes to work fast using medicinal ingredients as well as our Nano CBD.”
• From your “Tanka T-FLEX Band” product webpage:
o “Effective for:
 Arthritis and Reumatoid [sic] arthritis pain relief
 Joints inflamation [sic]
 Muscle Soreness
 Antidioxidant [sic]
 Improves skin elasticity
 Minimize wrinkling”
• From your “Tanka Collagen Band” product webpage:
o “Effective for:
 Muscle Mass
 Arthritis
 Skin Elasticity”
Based on the above labeling claims, your Kahm CBD products for humans and Tanka products for humans 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 Kahm CBD products for humans and Tanka products for humans 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,
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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 Kahm CBD products for humans or Tanka products for humans. 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 Drugs
Your Kahm CBD products for humans and Tanka 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 their intended 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).
Prescription drugs, as defined in section 503(b)(1)(A) of the Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner. Based on claims in their labeling, including website labeling, the aforementioned products are offered for conditions that are not amenable to self-diagnosis or treatment by individuals who are not medical practitioners, such as cancer, diabetes, depression, and anxiety and arthritis. Therefore, these products are considered prescription drugs and adequate directions for their 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 for your products. Consequently, your Kahm CBD products for humans and Tanka products for humans are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
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,
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and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. In addition, your “Kahm EQUIPASS RELIEF GEL” product would also be misbranded under section 502 of the FD&C Act because it is labeled to contain colloidal silver. Under a final determination issued under 21 CFR part 330, as published in the Federal Register on August 17, 1999 (64 FR 44653, 44658, establishing 21 CFR 310.548), the Agency determined that no over-the-counter drugs containing colloidal silver are GRASE under section 201(p)(1) of the FD&C Act and that all such products are deemed to be new drugs and require an approved new drug application under section 505 of the FD&C Act to be lawfully marketed. The Agency further determined that in the absence of an approved new drug application or abbreviated new drug application, such product is also misbranded under section 502 of the FD&C Act.
The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
CBD-containing Drugs
Even if your Kahm CBD products for humans and Tanka 30 day CBD Band products were considered nonprescription drugs, 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. CBD has known pharmacological activity with demonstrated risks.
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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. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. 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).
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301(ll) and Adulterated Human Foods
We note that your CBD Gummies products in Blue Raspberry and Raspberry flavors appear to be promoted as conventional human foods. For example, the Blue Raspberry product is displayed with a Nutrition Facts label on your website. However, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, as described above. There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. 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 section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), prohibits the introduction into interstate commerce of any food to which CBD has been added, but you may present FDA with any evidence bearing on this issue. According to your product labeling your CBD Gummies products in Blue Raspberry and Raspberry flavors are foods to which CBD has been added. Therefore, the introduction or delivery for introduction into interstate commerce of these products is a prohibited act under section 301(ll) of the FD&C Act.
You should also 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 its 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.
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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 which authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that CBD 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 CBD 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 CBD in food meets the criteria for GRAS status. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. Therefore, based on our review, the use of CBD in conventional food 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 CBD for use as an ingredient in a conventional food. Therefore, CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act, 21 U.S.C. 321(s), and is subject to the provisions of section 409 of the FD&C Act, 21 U.S.C. 348. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD 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. 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).
Conclusion
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 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. 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.
Your response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov.
Sincerely,
/S/
Neal Bataller
Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Food and Drug Administration
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/S/
Ann M. 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
Under section 201(s)(5) of the FD&C Act, 21 U.S.C. § 321(s)(5), new animal drugs are excluded from the food additive definition. If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
3
The CBD-containing products for humans that are marketed as dietary supplements include “Broad Spectrum Hemp Extract” (also referred to as “CBD Tincture (Oil)” in various flavors and sizes and Broad Spectrum Hemp Extract soft gels (also referred to as “CBD Soft Gels”).
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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. However, your products could not be lawfully marketed under section 505G, because based on claims made in their labeling, including website labeling, your products are marketed for uses not considered nonprescription indications. Further, even if certain of your products, such as your Kahm CBD products for humans or your Tanka T-FLEX and Collagen Band products, were marketed only for nonprescription indications, they would not meet the conditions under section 505G for lawful marketing without an approved application, notably because CBD, glucosamine, and collagen peptides (respectively)—considered active ingredients under 21 C.F.R. 201.66(b)(2) due to their prominent featuring on the product labeling—were not an active ingredient in any applicable final monograph or tentative final monograph issued under 21 CFR part 330, for purposes of section 505G(a) of the FD&C Act, nor was marketing of these products permitted by an administrative order under section 505G(b) of the FD&C Act.
5
See footnote 4, supra.
6
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.
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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. Additionally, an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage. As noted, CBD has known pharmacological activity with demonstrated risks. It is unknown whether the levels of CBD used in your CBD products have pharmacological activity or pose any concern for safety events.
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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:
05/26/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages