WARNING LETTER

House of Alchemy LLC dba CBD Dog Health Hamet & Love LLC dba MycoDog MARCS-CMS 701064 — April 07, 2025

Delivery Method:: Via Email
Product:: Animal & Veterinary
Food & Beverages

Recipient:: Recipient Name

Angela L. Ardolino; House of Alchemy LLC dba CBD Dog Health Hamet & Love LLC dba MycoDog; United States; support@cbddoghealth.com; support@mycodog.com

Issuing Office:: Center for Veterinary Medicine; United States

WARNING LETTER

April 7, 2025

RE: 701064

Dear Angela L. Ardolino:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://cbddoghealth.com, and has determined that you take orders there for various animal products, including those that you promote as products containing cannabidiol (CBD). We have also reviewed your website https://angelaardolino.com/shop-with-angie and your social media webpages https://www.facebook.com/cbddognaturals, https://www.instagram.com/cbddoghealth, https://www.youtube.com/@cbddoghealth, https://www.youtube.com/@angelaardolino, which direct consumers to your website https://cbddoghealth.com to purchase your products. We have also reviewed your website at the Internet address https://mycodog.com, as well as your social media webpages www.facebook.com/mushroomsfordogs, and www.instagram.com/mushroomsfordogs, which direct consumers to your website https://mycodog.com to purchase your products.

The claims on your websites and social media webpages establish that your products, Nina’s CBD Edibles, Blanche’s CBD Edibles, Heal: CBD Oil for Dogs, Ease: CBD for Dogs, Calm: CBD Oil for Dogs, Remedy: Tumors, Cysts, and Infections for Dogs, Soothe: Hot Spots, Bug Bites, and Allergies for Dogs, Nourish: Dry Skin, Elbows and Paws for Dogs, Heal: CBD Oil for Cats, Calm: CBD Oil for Cats, Ease: CBD Oil for Cats, Soothe Topical CBD for Cats, Nourish Topical CBD for Cats, Ease: CBD Oil for Horses, Calm: CBD Oil for Horses, Heal: CBD Oil for Horses, Nourish: Dry Skin, Sweet Itch and Scratches for Horses, Soothe for Horses: Rain Rot, Allergies and Dermatitis, and Remedy: Tumors, Cysts, and Infections for Horses products (hereinafter collectively referred to as “your CBD-containing products for animals”), which you promote as products containing CBD for use in animals, and your Vitality by MycoDog, Digest by MycoDog, Breathe by MycoDog, Clarity by MycoDog, Digest by MycoCat, Clarity by MycoCat, Breathe by MycoCat, and Vitality by MycoCat products (hereinafter collectively referred to as “your MycoDog & MycoCat products for 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 are adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).

Introduction of these adulterated drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Furthermore, your Nina’s CBD Edibles and Blanche’s CBD Edibles 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. Additionally, it is a prohibited act to introduce these products 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. For example, your firm stated in a January 3, 2025 blog post titled “Full Spectrum Hemp Extract: The Complete Package,” on your website, https://cbddoghealth.com, “When it comes to using Full Spectrum Hemp Extract for dogs and pets, FSHE [full spectrum hemp extract] has been proven to be incredibly safe, effective and well tolerated by all mammals, especially our companion animals. At Fire Flake Farm, Angela Ardolino gives all of our CBD Dog Health Full Spectrum Hemp Extract products to the variety of animals on her farm, including dogs, cats, ducks, goats, rabbits, pigs, chickens and more! Beyond our own use on the farm proving CBD’s safety, there are numerous safety studies (like this one) that show without a doubt, Full Spectrum CBD oil for pets (including THC) is safe for all mammals, even at very high doses.” (Emphasis in original).

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 about the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and about 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

Based on our review of your websites and social media webpages, your CBD-containing products for animals and your MycoDog & MycoCat products for animals 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 https://cbddoghealth.com that provide evidence of the intended use of your CBD-containing products for animals as drugs include, but are not limited to, the following:

Nina’s CBD Edibles

On your webpage https://cbddoghealth.com/product/ninas-cbd-edibles-for-dogs:
o “When our founder, Angela Ardolino, was caring for Nina, her Doberman Pinscher who had been diagnosed with osteosarcoma, it was nearly impossible to find pure pet treats that would help ease her symptoms. So, she teamed up with Real Dog Box to create nourishing CBD edibles for dogs, made with real food and mushrooms, and infused with CBD, for treats that would benefit Nina and the rest of the senior dogs on the farm.”

Blanche’s CBD Edibles

On your webpage https://cbddoghealth.com/product/blanches-cbd-edibles-for-dogs:
o “For ANXIETY: 3 TREATS DAILY OR 30 MINS BEFORE ANTICIPATED TRIGGER. ADJUST AS NEEDED …
For ARTHRITIS: 2 TREATS DAILY, ADJUST AS NEEDED …
For ALLERGIES: 2 TREATS DAILY ADJUST AS NEEDED …”

Heal: CBD Oil for Dogs

On your webpage https://cbddoghealth.com/product/cbd-oil-for-dogs-heal:
o “HEAL: Full Spectrum CBD Oil for Dogs may benefit dogs with:
 Seizures and Epilepsy
 Cancer and Tumors
 Cushing’s Disease
 Autoimmune Disorders
 Degenerative Diseases
On your webpage https://cbddoghealth.com/success-stories:
o “Senior chihuahua, (b)(6), was suffering from congestive heart failure (CHF) and severe joint pain due to old age. (b)(6) was administered 1 mL of HEAL 1100 mg Full Spectrum Hemp Extract once daily. With the help of HEAL, (b)(6) owners noticed a change in his joint pain and he is now able to walk and run. They also noticed an improvement in his CHF and he is now living his twilight years happy and healthy. He continues to take HEAL daily.”
o “(b)(6) has two luxating patellas and hip dysplasia in both hips, as well as arthritis. (b)(6) was hardly able to walk when his foster parents took him in. He also suffered from poor appetite. (b)(6) was administered 1 mL of Heal 1100 mg Full Spectrum Hemp Extract once daily in the morning. (b)(6) is now able to walk and run without pain. His foster family also reports that his arthritis and appetite have both improved. His quality of life was minimal until his foster family introduced CBD into his life, but he now is in good health. He continues to take HEAL daily.”

Ease: CBD for Dogs

On your webpage https://cbddoghealth.com/product/anti-inflammatory-for-dogs-ease:
o “EASE is a great CBD for dog pain and is a natural anti-inflammatory for dogs with:
 Allergies
 Arthritis
 Pancreatitis
 Inflammation
 Collapsed Trachea
On your webpage https://cbddoghealth.com/success-stories:
o “When (b)(6) was one-and-a-half years old, she was diagnosed with hemivertebrae – a spine issue… Her owner wanted to wean off of the pain medications and chose to try CBD. (b)(6) was administered 1 mL of EASE 550mg Full Spectrum Hemp Extract daily. After starting her regimen of EASE, (b)(6) back straightened. Now, she’s able to get comfortable at bedtime and sleep. She can also go on longer walks without her toes dragging and her owners haven’t noticed any side effects. (b)(6) continues to take EASE daily.”

Calm: CBD Oil for Dogs

On your webpage https://cbddoghealth.com/product/cbd-oil-for-dogs-calm:
o “We’ve used this on all of our dogs (We have six seniors and one very rambunctious 1 year old). To say this helps with anxiety and stress isn’t accurate as it completely alleviates these issues.”
o “This organic, full spectrum CBD oil for dogs with anxiety is perfect for naturally managing your dog’s chronic anxiety and situational fear…”

Remedy: Tumors, Cysts, and Infections for Dogs

On your webpage https://cbddoghealth.com/product/cbd-salve-for-dogs-remedy:
o “Product Benefits:
 Ideal salve for dogs suffering from Cushing’s disease
 Ideal salve for dogs suffering from tumors, cysts, and infections
 Promotes healthy cell growth.”
o “In multiple preclinical studies, hemp oil (such as in CBD salve for dogs) has been shown to trigger apoptosis (cell death) in cancer, while keeping healthy cells alive. Hemp oil has also been shown to cut off a tumor’s blood supply, constricting its ability to spread and has even stopped tumor growth. In 2020, a new study was released as the first canine-specific hemp and cancer study, showing hemp oil killed cancer cells while keeping healthy cells alive, stopped the tumor from growing or spreading, and improved efficiency of existing cancer treatments. That’s why our CBD Salve for dogs is recommended for dogs with cancer and tumors.”

Soothe: Hot Spots, Bug Bites, and Allergies for Dogs

On your webpage https://cbddoghealth.com/product/cbd-salve-for-dogs-soothe:
o “Our CBD Salve for Dogs is particularly successful against infections because hemp extract contains powerful antibiotic, antiviral, and antimicrobial qualities.”

Nourish: Dry Skin, Elbows and Paws for Dogs

On your webpage https://cbddoghealth.com/product/cbd-salve-for-dogs-nourish:
o “Bug bites, dermatitis, hot spots, yeast, and pollen are some of the most frequent causes of persistent redness, inflammation, and dryness that a CBD ointment for pets can assist with.”

Heal: CBD Oil for Cats

On your webpage https://cbddoghealth.com/product/cbd-oil-for-cats-heal:
o “I have been giving my FIV-positive kitty HEAL twice daily for almost a year. When I started, he had a host of health issues from the virus that manifested in tumors, dental issues and respiratory symptoms. He is now symptom-free and the picture of health. I will continue to give him HEAL twice daily for the rest of his life.”
o “HEAL: Hemp oil for cats may benefit cats with:
 Seizures
 Autoimmune Disorders
 Degenerative Diseases
o “For Cancer: Administer 35-50mg daily as needed.”

Calm: CBD Oil for Cats

On your webpage https://cbddoghealth.com/product/cbd-oil-for-cats-calm:
o “This organic, full spectrum CBD oil for cats’ anxiety is ideal for naturally reducing chronic anxiety and situational fear in your cat. CALM: CBD Oil for Cats Anxiety is an all-natural remedy for stressful situations including as [sic] thunderstorms, fireworks, grooming and vet appointments, travel, and separation anxiety.”

Ease: CBD Oil for Cats

On your webpage https://cbddoghealth.com/product/anti-inflammatory-for-cats-ease:
o “EASE: Full Spectrum CBD Oil for Cats is a great anti-inflammatory
for cats with:
 Allergies
 Pain
 Arthritis
 Pancreatitis
 Inflammation

Soothe Topical CBD for Cats

On your webpage https://cbddoghealth.com/product/topical-cbd-for-cats-soothe:
o “Helps Cats with:
 Cat Allergies
 Cat Dermatitis
 Inflammation in Cats
 Hot Spots on Cats…”

Nourish Topical CBD for Cats

On your webpage https://cbddoghealth.com/product/topical-cbd-for-cats-nourish:
o “Helps with allergies, chronic redness, and skin inflammation”

Ease: CBD Oil for Horses

On your webpage https://cbddoghealth.com/product/anti-inflammatory-for-horses-ease:
o “Anti-Inflammatory Support for Horses with:
 Arthritis
 Allergies
 Laminitis
 Inflammatory Bowel Disease
 Poor Gut Health
 Conjunctivitis
 Aches and Pains
 Lameness”

Calm: CBD Oil for Horses

On your webpage https://cbddoghealth.com/product/cbd-oil-for-horses-calm:
o “CBD can help reduce any stress and/or anxiety our horse is feeling, potentially reducing and eliminating cribbing behavior. An all natural horse cribbing solution.”

Heal: CBD Oil for Horses

On your webpage https://cbddoghealth.com/product/cbd-oil-for-horses-heal:
o “HEAL offers a holistic alternative that supports horses suffering from autoimmune disease, Cushing’s disease, colic, gastric ulcers, and other degenerative diseases. HEAL also promotes a more balanced function of the adrenal and pituitary glands for endocrine disorders.”

Nourish: Dry Skin, Sweet Itch and Scratches for Horses

On your webpage https://cbddoghealth.com/product/cbd-salve-for-horses-nourish:
o “Designed to … reduce the effects of sweet itch…”

Soothe for Horses: Rain Rot, Allergies and Dermatitis

On your webpage https://cbddoghealth.com/product/cbd-salve-for-horses-soothe:
o “CBD has strong antibiotic, antiviral, and anti-microbial properties which is why it’s effective for handling infections.”

Remedy: Tumors, Cysts, and Infections for Horses

On your webpage https://cbddoghealth.com/product/cbd-salve-for-horses-remedy:
o “Perfect for tumors, cysts, papilomas [sic], mange … and infections.”

Examples of claims observed in your blog posts on your website https://cbddoghealth.com that provide evidence of the intended use of these CBD-containing products for animals as drugs include, but are not limited to, the following:

On your blog post titled “DSLD: Degenerative Suspensory Ligament Desmitis in Horses” at the URL https://cbddoghealth.com/dsld-degenerative-suspensory-ligament-desmitis-in-horses:
o “Degenerative suspensory ligament desmitis, also known as DSLD, is a progressive debilitating disorder … DSLD is often extremely alarming to the average horse owner as it often leads to persistent, incurable lameness, and the potential need for euthanization in some horses … CBD has been found to effectively reduce many of the same symptoms as traditional medications like NSAIDs and steroids do without the same adverse effects. CBD has the potential to become a long-term effective, therapeutic alternative to conventional treatments with a natural, safe plan.” (Emphasis in original).
On your blog post titled “CBD for Dogs with Cancer” at the URL https://cbddoghealth.com/cbd-oil-for-dogs-with-cancer:
o An infographic with the title “The Benefits of CBD for Cancer in Dogs” and a photo showing your Remedy and Heal products for dogs with the statement, “Shop Our Power Duo” states:
 “According to research, CBD for dogs with cancer has been shown to:
• Inhibit the formation of blood vessels that feed tumors (angiogenesis)
• Trigger death of cancer cells (via apoptosis)
• Inhibit tumor growth (via apoptosis)
• Discourage the spread of cancer from one part of the body to another (metastasis)
• Improve the efficacy of existing cancer treatments”
On your blog post titled “CBD for Cats with Cancer” at the URL https://cbddoghealth.com/cbd-for-cats-with-cancer:
o “Full Spectrum Hemp Extract CBD oil for cats with cancer might be the right option for pet parents who choose not to pursue conventional methods like chemotherapy, surgery, or radiation. Additionally, FSHE CBD for cancer in cats can also be a highly effective complementary tool to manage symptoms and side effects of conventional cancer drug therapies.”
o “Full Spectrum Hemp Extract has a whole plethora of benefits when it comes to cancer. Full Spectrum Hemp Extract CBD Oil for cats with cancer has been well studied and known to have antitumor and anticancer effects. So if you don’t want to pursue methods like chemotherapy, surgery, or radiation, FSHE CBD oil for cancer in cats might be the right option.”
On your blog post titled “CBD for Diabetes in Dogs & Pets” at the URL https://cbddoghealth.com/can-cbd-help-with-pet-diabetes:
o “So how can CBD for diabetes in dogs and pets help? Diabetes in dogs and pets, at its foundation, is an inflammatory disease. We already know that CBD is one of the best anti-inflammatories there is.”
On your blog post titled “CBD for Periodontal Disease in Dogs and Cats” at the URL https://cbddoghealth.com/cbd-for-periodontal-disease-in-dogs-and-cats:
o “…CBD may also aid in preventing and/or reducing the symptoms of periodontal disease in dogs and cats.” (Emphasis in original).
On your blog post titled “Does CBD help with autoimmune disease in dogs?” at the URL https://cbddoghealth.com/does-cbd-help-with-autoimmune-disease-in-dogs:
o “If your pet is suffering from skin damage, lesions, sores, or tumors due to autoimmune disease, we recommend REMEDY CBD salve one to two times daily.”.”
On your blog post titled “CBD for Kidney Disease in Dogs” at the URL https://cbddoghealth.com/cbd-for-kidney-disease-in-dogs:
o “A full-spectrum hemp extract is an amazingly effective and safe tool in managing kidney disease, whether acute or chronic.”

Examples of claims observed on your social media websites, https://www.youtube.com/@cbddoghealth, https://www.facebook.com/cbddognaturals and https://www.instagram.com/cbddoghealth that provide evidence of the intended use of these CBD-containing products for animals as drugs include, but are not limited to, the following:

On your CBD Dog Health YouTube page within the “About” section:
o “Did you know that animals can benefit from CBD oil even more than humans can? Whether your dog is suffering from:
 Seizures
 Anxiety
 Cancer
 Cushing's Disease
 Allergies
 Arthritis
 Autoimmune Disease
On your November 25, 2024 Facebook post linking to a blog post on your website https://cbddoghealth.com, titled “7 Common Health Issues CBD Can Help Resolve”:
o “Is your dog dealing with health challenges like anxiety, chronic pain, or skin issues? CBD oil has emerged as a natural alternative to pharmaceuticals, offering therapeutic benefits without harsh side effects.”
On your November 15, 2024, Instagram post with a photograph of your Heal: CBD Oil for Dogs, Remedy: Tumors, Cysts, and Infections for Dogs, and Vitality by MycoDog products:
o “…The Power Duo (pointing to a photograph of your Heal: CBD Oil for Dogs and Remedy: Tumors, Cysts, and Infections for Dogs) - Perfect if your dog needs focused, high-potency CBD support for:
Chronic pain
Inflammation
Seizures
Autoimmune conditions

Featuring our HEAL Full Spectrum Hemp Extract, this duo is designed to tackle serious health concerns while supporting overall wellness.

The Power Trio (pointing to a photograph of your Heal: CBD Oil for Dogs, Remedy: Tumors, Cysts, and Infections for Dogs, and Vitality by MycoDogs) - Ideal for dogs who need CBD + immune system support for:

Fighting cancer…
Aiding in auto-inflammatory conditions…
With the addition of Vitality, MycoDog’s medicinal mushroom and adaptogen blend, the Power Trio takes your dog’s care to the next level. It combines CBD's therapeutic benefits with the immune-boosting power of mushrooms like Turkey Tail, Reishi, and Shiitake.”

On your November 14, 2024, Instagram post:
o “Managing pet diabetes can feel overwhelming, but there are natural options that may help ease the journey for both you and your pet. Research into the benefits of CBD for diabetes in pets, like dogs and cats, has shown promising results in helping to reduce inflammation and support overall wellness—both crucial in diabetes management.
How CBD Can Help: CBD is known for its anti-inflammatory and antioxidant properties, which can be particularly beneficial in managing pet diabetes. Studies suggest that CBD may help regulate blood sugar levels and support the endocannabinoid system, which plays a key role in metabolic health. Full-spectrum CBD may help improve circulation and reduce oxidative stress, potentially lowering the need for high insulin doses.”
On your November 7, 2024, Instagram post:
o "My (b)(6) was diagnosed with stage 5 lymphoma b cell type 19 months ago.. we have been using the HEAL CBD and she has been eating, playing, and sleeping like an angel. We're so grateful to find a full spectrum product that has worked so well for our little princess. Cheers to many more months together " - (b)(6).
Lymphoma is one of the most common cancers in dogs, affecting their immune system and spreading quickly through the body. Traditional treatments like chemotherapy can be effective, but CBD can offer additional, natural support to improve your dog’s quality of life during the journey.
How CBD can help:
Boost appetite and reduce nausea, especially during treatmentsSupport natural immune responses and reduce inflammation
Encourage cancer cell death (a process known as apoptosis) while protecting healthy cells
Prevent blood vessel growth in tumors, effectively “starving” cancer cells”

Examples of claims observed on your websites https://cbddoghealth.com and https://mycodog.com that provide evidence of the intended use of your MycoDog & MycoCat products for animals as drugs include, but are not limited to, the following:

On your blog post titled “Mushrooms for Dogs with Cancer” at the URL https://cbddoghealth.com/mushrooms-for-dogs-with-cancer:
o “Mushrooms have the ability to spare healthy cells while destroying cancerous cells. In addition, you can explore integrative cancer care for dogs, combining traditional treatments with holistic approaches like medicinal mushrooms. If your pet is undergoing a conventional cancer therapy like chemo or radiation, mushrooms can still safely and effectively be used alongside these treatment options. They also lower the risk of recurrence (cancer coming back after being in remission).”
o “When used in conjunction with cannabis products like Full Spectrum Hemp Extract, the two create a powerhouse cancer fighting combination that far surpasses any pharmaceutical option. This is due to these substances’ ability to work on several different cancer pathways. Conventional options like chemotherapy can only target one pathway at a time, unlike mushrooms for dogs with cancer.”
On your blog post titled “Benefits of Mushrooms for Cats” at the URL https://cbddoghealth.com/benefits-of-mushrooms-for-cats:
o “Medicinal mushrooms are used for many purposes, to name a few:
 Fight cancer
 Eliminate tumors/growths
 Manage autoimmune disease
 Fight viruses and bacterial infections
 Improve gut microbiome function and balance
 Protect organs like the liver and heart”
o “Using medicinal mushrooms for cats is not only incredibly safe but can help with a variety of conditions and symptoms: … Mushrooms for Cats with Kidney Disease… Mushrooms for Cats with Diabetes… Mushrooms for Cats with Viral Infections… Mushrooms for Cats with IBD… Mushrooms for Cats with Bronchitis & Asthma… Mushrooms for Cats with Arthritis… Mushrooms for Cats with Cognitive Decline… Mushrooms for Cats with Cancer…”
On your webpage https://mycodog.com:
o “While medicinal mushrooms share many of the same benefits, each mushroom has unique characteristics that make it more suitable for specific conditions...
If you’re looking to provide the biggest variety of mushroom benefits, rotating between our blends can offer comprehensive health support. Each blend is formulated to address specific conditions while delivering hundreds of additional benefits for your pet’s overall well-being:
 Vitality: For cancer, autoimmune issues and intense immune support…
 Breathe: For respiratory and cardiovascular support, allergies, and low energy…
 Clarity: For cognitive decline, neurological illness…
 Digest: For IBD, leaky gut, and microbiome support…”
On your webpage titled “Why Give Your Dog Mushrooms?” at the URL https://help.mycodog.com/why-give-your-dog-mushrooms:
o “There are numerous advantages to incorporating a quality mushroom supplement into your dog’s diet…The diverse capabilities of functional mushrooms can be attributed in part to various unique components such as beta-glucans and triterpenes, found primarily in the cell walls of mushrooms. Beta-glucans, renowned for their soluble fiber content, are known to regulate blood sugar levels, enhance immune response, and demonstrate potential in combating cancer cells.”

Examples of claims observed on your social media websites www.facebook.com/mushroomsfordogs and https://www.instagram.com/mushroomsfordogs that provide evidence of the intended use of your MycoDog & MycoCat products for animals as drugs include, but are not limited to, the following:

On your November 22, 2024, Instagram post:
o “Success Story Alert!
Meet (b)(6), a 13-year-old pup who was given just 4-8 weeks after being diagnosed with an inoperable tumor.

Her family explored holistic options, including Vitality, to support her overall wellness—and 8 weeks later, (b)(6) is thriving! She’s staying active, eating well, and still enjoying life with her family.”

On your November 14, 2024, Facebook and Instagram posts:
o Your infographic states, “Medicinal mushrooms can help pets with diabetes by stabilizing blood sugar and regulating the release of insulin.”

These CBD-containing products for animals and these MycoDog & MycoCat products for animals 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, conditionally approved, or index listed by the FDA, and therefore these products are 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). 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

Furthermore, 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

According to your product labeling, your Nina’s CBD Edibles and Blanche’s CBD Edibles products are animal foods to which CBD has been added. For example, the product labeling on your website refers to these products as “Real Food Bites for Dogs.” 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 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

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 animal 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 (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 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). Therefore, your Nina’s CBD Edibles and Blanche’s CBD Edibles products are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. 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).

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 lead to 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 FD&C Act, include your reasoning and any supporting information for our consideration.

Your response should be directed to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by e-mail to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 701064” in the subject line of your email.

Sincerely,
/S/

Cindy L. Burnsteel, DVM
Acting Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine

Cc: Joseph H. Straughan, III
support@yournaturaldog.com

____________________

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).