WARNING LETTER
Kingdom Harvest
MARCS-CMS 625058 —
May 04, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Shelle Rogers
Recipient Title
CEO
Kingdom Harvest
212 South Church Street
Hendersonville
,
NC
28792
United States
info@kingdomharvest.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
May 4, 2022
RE: # 625058
Dear Ms. Rogers:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.kingdomharvest.com from October 2021 through April 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://www.facebook.com/originalkingdomharvest/ and
https://www.instagram.com/kingdomharvest/?hl=en
;
which direct consumers to your website
www.kingdomharvest.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, “D8 sublingual oil,” “Delta 8 Disposable Vape Cartridge,” “Whole-Spectrum Hemp Extract,” “CBD Vape,” “Blood Sugar Support,”
“CBD Gummies,” “Stella’s Baby Care Diaper Cream,” “Pain Relieving CBD Cream
,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,”
“Immune Boost Water Soluble Mix,” “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Delta 8 Chewing Gum,” “Delta 8 Gummies,” “Delta 8 Peanut Brittle,” and “Delta 8 Syrup,” (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 (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your CBD and Delta-8 THC products for humans are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
FDA has also determined that your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Delta 8 Chewing Gum,” “Delta 8 Gummies” (all varieties), “Delta 8 Peanut Brittle,” “Delta 8 Syrup,” “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets” products 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. Furthermore, it is a prohibited act to introduce your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).
In addition, the claims on your website and social media websites establish that
your products, “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” “Pet Essentials Joint Support Tablets,” “CBD Infused Pet Shampoo,” and “CBD Infused Pet Paw Balm,” 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 FD&C Act, 21 U.S.C. 360b(a), and are adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
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
.
The Agency is particularly concerned that you market CBD products for food-producing animals. Specifically, your website promotes your “Ranch & Livestock Natural Whole-Spectrum Hemp Extract” product for use in cows and other large variety ranch and livestock animals. 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.
Over the past several years, FDA has warned the public on various illegally marketed CBD containing products, including those marketed for infants, such as your “Stella’s Baby Care Diaper Cream.”
[1]
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.
We also observed that your website makes claims that your products may be intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
[2]
Dietary Supplement Labeling
Information on your website at www.kingdomharvest.com indicates that you intend to market some of your CBD products, including, but not limited to, “Immune Boost Water Soluble Mix,” and all varieties of “Blood Sugar Support” and “CBD Gummies” as dietary supplements. For example, the product website describes “Immune Boost Water Soluble Mix” with reference to the goal of creating a “high-quality supplement” and the product websites expressly describe each “Blood Sugar Support” and “CBD Gummies” product as a “dietary supplement.” 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.
[3]
There is an exception if the substance was “marketed as” a dietary supplement or as a conventional human 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 websites, 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 observed on your product labeling, including your website and social media websites, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
From your Facebook and Instagram social media websites www.facebook.com/originalkingdomharvest/ and www.instagram.com/kingdomharvest/:
May 11, 2020 postings:
“Cannabidiol (CBD) changes neurotransmission systems . . . Alters behavior response to Opioids . . . Pain management during Opioid withdrawal . . . Reduces Heroin cravings and relapse”
“Fighting Opioid Addiction with Whole-Spectrum Hemp Extract . . . CBD Oil (otherwise known as cannabidiol) is scientifically proven to block the rewards of opioids”
“CBD Reduces Need for Opioid Use in Pain Treatment”
“64-81% of acute trauma patients reduced opioid usage with cannabis while still managing pain”
April 27, 2020 postings:
“Israeli researchers have launched three clinical trials that utilize CBD’s anti-inflammatory properties as potential COVID-19 treatment . . . Last week, InnoCan Pharma announced a collaboration with Tel Aviv University to instill CBD medicine through exosomes . . . The unconventional method will utilize the exosomes as “homing missiles,” as they can uniquely target cell organs damaged by COVID-19. Researchers then believe CBD’s anti-inflammatory properties will repair the damaged cells through a synergistic effect.”
“The Battle Against COVID-19 Has A New Natural Weapon . . . University Launches CBD Treatment . . . kingdomharvest.com”
April 7, 2020 postings – “Whole-Spectrum Hemp Extract & CBD & The Fight Against COVID-19.”
From your website
https://kingdomharvest.com/
:
On your website homepage:
“Studies Show Our Whole-Spectrum Extract Utilizing CBDa Can Prevent Infection From COVID-19”
On your blog post titled, “Cannabinoids Block Cellular Entry of COVID-19 and the Emerging Variants”:
“Importantly, cannabigerolic acid and cannabidiolic acid were equally effective against the SARS-CoV-2 alpha variant B.1.1.7 and the beta variant B.1.351.”
“. . . [C]annabinoids . . . have the potential to prevent as well as treat infection by SARS-CoV-2.”
On your blog post titled, “Let’s [
sic
] Us Introduce You to Delta-8 THC”:
“If we try to list the properties or the effects of Delta-8 THC, it causes . . . pain relief, full-body relaxation and sleep.”
“Delta-8 THC flower is an ideal option for medical users of cannabis who want to enjoy the benefits of THC without the sedative effects.”
On your blog post titled, “How Does CBD Work for Relieving Pain & The Best CBD Pain Relief Product?”:
“CBD is among the most misinterpreted things on the planet . . . It is a magical medicine that has provided relief for countless people with chronic pain, from cancer pain to arthritis pain, migraine pain, body pain, and much more.”
On your blog post titled, “Discover the Benefits of CBD for Your Health and Wellness”:
“
Hemp CBD can improve your overall health and wellbeing by providing relief for several medical ailments, including chronic pain, depression, anxiety, epilepsy”
“
Other benefits of hemp CBD include managing post-traumatic stress disorder (PTSD), sleep disorders and cancer treatments.”
“CBD has been shown to have
positive effects on adults and children who experience PTSD.”
“One study
found hemp CBD helps slow tumor growth, reduces tumor invasion and induces tumor cell death.
Another study
suggested CBD could provoke cell death and improve the effect of radiation on glioblastoma cells while causing no damage to healthy cells.”
“
Initial studies have suggested CBD can help make life easier for an individual with Parkinson's by easing muscle movements to prevent tremors. There is also research that suggests CBD can reduce the severity of psychosis symptoms, including hallucinations, delirium and delusions without causing any adverse effects.”
On your product webpage for “D8” sublingual oil
:
“Delta-8 consumers report many of the same effects as THC . . . and relief from some symptoms such as pain . . . Delta-8 can also help with insomnia.”
On your product webpage for “Stella’s Baby Care Diaper Cream”:
“Our Organic Diaper Cream contains our natural organic Whole-Spectrum Hemp Extract and just 7 other natural ingredients.
In contrast, the leading diaper rash cream is 57% petroleum!”
On your webpage explaining the “
Effects of delta-8”:
“Delta-8 consumers report many of the same effects as THC, such as . . . relief from some symptoms such as pain . . .. Delta-8 can also help with insomnia.”
On your product webpage for “
Delta-8 THC Syrup”:
“Delta-8 THC Syrup from Kingdom Harvest is ideal for anybody experiencing a sleeping disorder or other ailments looking to be relieved.”
On your product webpage for
“Blood Sugar Support”:
“Kingdom Harvest Blood Sugar support pills contain three active ingredients that work at the same time and may help you to maintain a healthy blood glucose level and prevent further complications.”
“Cinnamon powder contains many antioxidants that may help to reduce oxidative stress due to high blood glucose, improve insulin sensitivity, lower blood sugar levels, and prevent complications.”
“Meanwhile, alpha-lipoic acid . . . may help with glucose uptake in muscles and enhance insulin sensitivity.”
“Finally, cannabidiol (CBD) . . . prevents neurodegeneration, and decreases retinal complications.”
On your product webpage for “Pain Relieving CBD Cream”:
“600MG ▪ CBD / CAPSAICIN MUSCLE PAIN CREAM . . . This topical muscle and joint relief cream act [
sic
] through its two active ingredients: capsaicin and cannabidiol (CBD) . . . Capsaicin is an active component of chili peppers known to help reduce pain intensity. Meanwhile, CBD interacts with endocannabinoid receptors in joints and muscles to promote a healthy inflammatory response and relieve occasional stiffness and soreness. Capsaicin is also known to be a neuroprotectant, as it may protect nerves from being damaged or degenerated.”
On your product webpage for “Pain Relieving Cream”:
“200 MG CBD / LIDOCAINE PAIN CREAM . . . The CBD with Lidocaine Cream contains the same main ingredient as the Capsaicin cream – CBD, which helps promote support and relief. However, the differing active ingredient is lidocaine, a local anesthetic.”
On your product webpage for “CBD & Menthol Pain Freeze Roll-On”:
“800MG CBD / MENTHOL PAIN FREEZE . . . Our Pain Freeze Roll-On is a rich combination of our Organic Hemp Extract, Aloe, and Menthol. Available in a mess-free, roll-on applicator, this topical cream provides a rapid cooling effect, perfect for joint and muscle support.”
Based on the above labeling claims, your
CBD and Delta-8 THC 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 CBD and Delta-8 THC 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,
[4]
new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 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
for your products.
[5]
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
“Pain Relieving CBD Cream
,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,” and “
Stella’s Baby Care Diaper Cream” 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. 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).
[6]
,
[7]
301(ll) and Adulterated Human Foods
We note that your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” and “CBD Infused Organic Tea” products appear to be conventional foods. 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.
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.
[8]
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 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. Some of the available data raise serious concerns about potential harm from CBD. 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 USC 321(s), and is subject to the provisions of section 409 of the FD&C Act, 21 USC 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, 21 USC 342(a)(2)(C)(i). Therefore, your “Broad-Spectrum THC Free Organic Honey,” “Fair-Trade Coffee,” and “CBD Infused Organic Tea” conventional food products contain an unsafe food additive within the meaning of section 409; therefore they are adulterated products within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Further, 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.
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 conventional food does not satisfy the criteria for GRAS status under 21 CFR 170.30.
In addition, according to your product labeling, your “Delta 8 Chewing Gum,” “Delta 8 Peanut Brittle,” and “Delta 8 Syrup” products are foods to which Delta-8 THC has been added.  Specifically, your website promotes your “Delta 8 Syrup” for mixture with “any drink” and recommends “something carbonated.” Your “Delta 8 Chewing Gum” and “Delta 8 Peanut Brittle” are types of products typically considered to be conventional foods. Your “Delta 8 Gummies” (all varieties) also appear to be conventional foods to which Delta-8 THC has been added.
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. 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).
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 “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” “Pet Essentials Joint Support Tablets,” “CBD Infused Pet Shampoo,” and “CBD Infused Pet Paw Balm.” 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 Frequently Asked Questions (FAQ) webpage at https://kingdomharvest.com/pages/faq
, you provide the following information about CBD, which is an ingredient in
“Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” “Pet Essentials Joint Support Tablets,” “CBD Infused Pet Shampoo,” and “CBD Infused Pet Paw Balm”:
“Many CBD users have reported improvements in:
• Stress
• Anxiety
• Sleep
• Pain levels
• Skin conditions including acne and eczema
• Epilepsy”
On your product webpage for “Ranch & Livestock Natural Whole-Spectrum Hemp Extract”:
“Like humans, our larger Ranch & Livestock pets have Endocannabinoid Systems that help bring balance to their bodies.  Introducing a whole-spectrum hemp extract into your horses, cows, alpacas, and any other large variety Ranch & Livestock animals on a daily routine can help promote an overall balance and improved quality of life.  Senior Ranch & Livestock Animals & Pets, those that live with certain conditions, and those in already good health can greatly benefit from a helping hand of natural cannabinoids found in Kingdom Harvest Ranch & Livestock formula.”
On your Facebook and Instagram social media websites at https://www.facebook.com/originalkingdomharvest/ and https://www.instagram.com/kingdomharvest/?hl=en, respectively, for your “Ranch & Livestock Natural Whole-Spectrum Hemp Extract":
May 7, 2020 Facebook posting and May 6, 2020 Instagram posting with photographs of your
“Ranch & Livestock Natural Whole-Spectrum Hemp Extract” next to photographs of a horse, a cow, and an alpaca:
“Like humans, our larger Ranch & Livestock pets have Endocannabinoid Systems that help bring balance to their bodies. Introducing a whole-spectrum hemp extract to your horses, cows, alpacas, and any other large variety Ranch & Livestock animals on a daily routine can help promote an overall balance and improved quality of life.  Elder Ranch & Livestock Animals & Pets, those that live with certain conditions, and those in already good health can greatly benefit from the helping hand of natural cannabinoids found in Kingdom Harvest Ranch & Livestock formula.”
On your Instagram social media website at (https://www.instagram.com/kingdomharvest/?hl=en) for your “Canine Whole-Spectrum Hemp Extract”
:
November 27, 2019 posting with a photograph of your
“Canine Whole-Spectrum Hemp Extract” with a dog in the background:
“Reported benefits include reduction of stress and anxiety, improving mood, pain relief, controlling seizures, and reduction of inflammation.”
On your Facebook and Instagram social media websites at https://www.facebook.com/originalkingdomharvest/ and https://www.instagram.com/kingdomharvest/?hl=en, respectively, for your “Feline Chicken Flavor Zero THC Hemp Extract”
:
May 8, 2020 posting with a photograph of your
“Feline Chicken Flavor Zero THC Hemp Extract” next to a photograph of a cat and photograph of a partially filled medicine dropper held in front of a cat’s face:
“Reported benefits include reduction of stress and anxiety, improving mood, pain relief, controlling seizures, and reduction of inflammation and many more.”
On your product webpage for
“Pet Essentials Joint Support Tablets”:
“Pet Essentials CBD Joint Support helps support your pet’s joint health through six active ingredients: . . .
CBD may help minimize discomfort . . .
Chondroitin . . . may help . . . to reduce discomfort . . .
Turmeric powder has natural properties, which make it a strong anti-inflammatory agent.”
On your product webpage for
“CBD Infused Pet Shampoo”:
“When used directly on your fur baby’s area that you are looking to treat and clean, our CBD Whole-Spectrum PET Shampoo doesn’t just clean, soothe, and alleviate irritations. It fights inflammation at the source.”
On your product webpage for
“CBD Infused Pet Paw Balm”:
“Because CBD PET Paw Balm does not need to be metabolized, a topical dosage is strong, reliable, and starts working quickly. When used directly on the tattooed area that you are looking to treat and protect, our CBD Whole-Spectrum PET Paw Balm doesn’t just alleviate irritations. It fights inflammation at the source.”
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
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.
[9]
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in animal food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the animal 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 animal 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 CBD in animal food. We are not aware of any information to indicate that CBD is the subject of a prior sanction, as described above. 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.
FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in animal food. Therefore, CBD added to animal 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, 21 U.S.C. 348. 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).
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, as described above.
According to your product labeling, “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets,” are animal foods to which CBD has been added. Specifically, your website and social media websites refer to these products being mixed into meals (“Ranch & Livestock Natural Whole-Spectrum Hemp Extract” and “Canine Whole-Spectrum Hemp Extract”) or intended for consumption based on flavor labeling (“Feline Chicken Flavor Zero THC Hemp Extract” and bacon-flavored “Pet Essentials Joint Support Tablets”). 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, 21 U.S.C. 331(ll).
*           *           *
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 M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[1]
As stated in previous FDA warning letters, the use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations. For example, infants may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of infants to absorb, metabolize, distribute, or excrete such drug products or their metabolites.
[2]
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at
https://trumpwhitehouse.archives.gov/presidentialactions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
.
[3]
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(R) 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.
[4]
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 “Pain Relieving CBD Cream,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,” and “Stella’s Baby Care Diaper 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.
[5]
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.
[6]
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.
[7]
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.
[8]
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.
[9]
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).
Content current as of:
05/04/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages