WARNING LETTER
Newhere Inc dba CBDFX
MARCS-CMS 629243 —
November 16, 2022
Delivery Method:
Via Overnight Delivery
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Ali Esmaili
Recipient Title
Chief Executive Officer
Newhere Inc dba CBDFX
19851 Nordhoff Pl Ste 105
Chatsworth
,
CA
91311-6616
United States
Info@CBDfx.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Center for Drug Evaluation and Research
Center for Veterinary Medicine
WARNING LETTER
November 16, 2022
RE: 629243
Dear Mr. Esmaili:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address cbdfx.com in October 2022 and has determined that you take orders there for various human and animal products which you promote as products containing cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/CBDfx, www.instagram.com/cbdfx_/, https://www.youtube.com/c/CBDfx, and twitter.com/cbdfx, which direct consumers to your website cbdfx.com to purchase your products. FDA has determined that your flavored Chill Shots, all strengths and varieties, CBDFx Mixed Berry Gummies 1500mg, CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, 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 flavored Chill Shots, all strengths and varieties, CBDFx Mixed Berry Gummies 1500mg, CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, products into interstate commerce under section 301(ll) of the FD&C Act [21 U.S.C. 331(ll)].
FDA is particularly concerned that some of your products are in forms that are appealing to children. For example, your CBDFx Mixed Berry Gummies 1500mg, CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, products are all in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children. Furthermore, your products have not been evaluated by the Agency for safety, effectiveness, and quality. As discussed below, CBD has been studied as a drug, and it is the active ingredient in the approved drug product Epidiolex. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations, such as children. For example, children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.
In addition, your flavored Chill Shots, all strengths and varieties, CBDFx Mixed Berry Gummies 1500mg, CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, Turmeric and Spirulina CBDFX Gummies, Sleep Gummies with Melatonin 1500mg CBDFX Gummies, Apple Cider Vinegar 1500mg CBDFX Gummies, Multivitamin CBD Gummies for Women and Men, CBD Vape Pens, CBD+Delta-9 THC Capsules Daily Chill Blend, CBD+CBN Oil Calming Tinctures, Focus Mushroom+CBD Drops and CBG Energy Blends, CBD Balm Calming Sticks, CBD Cream For Muscle & Joint, and CBD Balm Stick Muscle & Joint (hereinafter all called “your CBD-containing products for humans”) are unapproved new drugs which were introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act [21 U.S.C. 355(a)], and are misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1))]. Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act [21 U.S.C. 331(d) and (a)]. These violations are described in more detail below.
Further, the claims on your website and social media websites establish that your CBD-containing products for animals including Dog Tincture (all strengths), Cat Tincture, Pet Tincture (all breed sizes/strengths), Pet Tincture (also referred to as CBD Oil for Cats), Stress and Anxiety Pet Treats, Joint and Mobility Pet Treats, and Calming and Moisturizing Pet Balm (hereinafter all called “your CBD-containing products for 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 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 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
.
Adulterated Human Foods and 301(ll)
According to your product labeling, your CBD Chill Shots, and CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, are foods to which CBD has been added. We analyzed a sample of your CBD Lemonade Chill Shot and CBD Chocolate Chip Cookies with Protein 20mg products and confirmed that the product contains CBD. We also note that you may intend to promote your Mixed Berries Gummies 1500mg as a conventional food product. Specifically, you describe these gummy products as “
Gummies
— like classic gummy bears — are one of the most popular candy treats on the planet. People love the burst of flavor that comes with these delicious chews.“
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 your products does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exception to the food additive definition that would apply to 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 [21 U.S.C. 342(a)(2)(C)(i)]. Therefore, your CBDFX Mixed Berries Gummies 1500mg, CBD Chill Shots, and CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. 342(a)(2)(C)(i)] because they bear or contain an unsafe food additive. 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)]. To the extent you intend to promote your CBDFX Mixed Berries Gummies 1500mg, CBD Chill Shots, and CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, products as conventional food products, they would be 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)] for the same reason.
Further, in regard to your CBD Chill Shots, and CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, and to the extent you intend to promote your CBDFX Mixed Berries Gummies 1500mg as conventional food products, 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, including 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.
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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 the available evidence discussed above, 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.
Unapproved New Drugs
Based on our review of your website and social media website, your CBD-containing 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 YouTube social media account that establish the intended use of your CBD-containing products for humans as drugs include, but may not be limited to, the following:
From your website www.cbdfx.com:
On the June 9, 2021 blog titled, “CBD FOR SLEEP: BEATING INSOMNIA THE NATURAL WAY,”:
• “CBD FOR SLEEP: BEATING INSOMNIA THE NATURAL WAY”
• “Can CBD Help with sleep apnea? . . . In some areas, like sleep apnea, we have to rely on anecdotal evidence and our own reasoning” with the words “anecdotal evidence” hyperlinked to an article, “Finding a Natural Remedy for Sleep Apnea.” The article, “Finding a Natural Remedy for Sleep Apnea” includes statement such as, but not limited to:
o “CBD for sleep apnea . . . helped both my husband and me get better sleep at night.”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your CBD-containing products for humans for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
On the “What is CBD” webpage:
• “There’s so much more we’d love to say about the soothing, calming effects of CBD, but we can’t make any “claims” about the actual benefits of CBD (as instructed by the FDA). Fortunately, anecdotal evidence of its effectiveness is everywhere. Take a look at our customer reviews to see what other folks have experienced” with the words “customer reviews” hyperlinked to a page titled “CBDFX VERIFIED PRODUCT REVIEWS.” The CBDFX VERIFIED PRODUCT REVIEWS webpage includes testimonials, but not limited to, the following:
o “Awesome pain relief!”
o “Eases my back pain.”
On your blog post titled, “Can Cannabis Compounds Help Protect Against COVID-19 Infection?”:
• “A recent study from Oregon State describes how certain cannabinoids latch onto the Covid-19 protein, creating spikes that prevent it from entering cells . . . Cannabinoid acids CBGA and CBDA are the two cannabinoids featured in the Oregon State study . . . that’s why the combination of the two has been a focus of many of our wellness products.”
• “Oh, and let’s not forget that our Focus Mushrooms + CBD Drops: CBG Energy Blend . . . the cannabinoid new research suggests might help you avoid Covid-19.”
On your blog post titled, “4 Natural Ways to Beat Depression”:
• “Nature supplies plenty of natural remedies, such as . . . CBD, to beat depression.”
On your blog post titled, “CBD for Stress”:
• “[W]e can share other reports, including this 2015 report, which found evidence that ‘established CBD as an effective treatment for numerous types of anxiety disorders, including generalized anxiety disorder (GAD), posttraumatic stress disorder (PTSD), panic disorder (PD), obsessive-compulsive disorder (OCD), and social anxiety disorder (SAD). In fact, this same article quotes multiple studies which showed CBD as effective when used for anxiety.”
• “[T]his study in Neurotherapeutics, states that ‘preclinical evidence conclusively demonstrates CBD’s efficacy in reducing anxiety behaviors relevant to multiple disorders, including PTSD, GAD, PD, OCD, and SAD.’”
On your blog post titled, “Is CBD Oil Safe for Long-Term Use?”:
• “Tests performed on mice show CBD helping to reduce acute anxiety . . . and even reduced symptoms that can lead to dementia and Alzheimer’s.”
On your CBD Cream For Muscle & Joint product webpage:
• “CBD Cream For Muscle & Joint: Cooling Formula 1000-3000mgmg . . . Broad spectrum CBD . . . Proven natural pain relievers, white willow bark & caffeine . . . Menthol for cool, long-lasting pain relief”
• “Dr. Sahin Yanik . . . MEDICALLY REVIEWED . . . CBD Cream for Muscle and Joint: Cooling Formula from CBDfx is a great water-based cream for aches and pains in muscles, joints and other deep tissue . . . I like the ingredient profile, which is a nice mix of organic broad spectrum CBD, natural pain relievers white willow bark and caffeine, and menthol. We all know about CBD’s effectiveness, as it interacts with the body’s endocannabinoid system . . . I used the 3000mg cream, which was incredibly effective . . . I need natural pain relief that’s not going to slow me down, and that’s what I got with CBDfx’s CBD Cream for Muscle and Joint.”
• “Our CBD cream is formulated to soothe muscle and joint pain. Made with broad spectrum CBD . . . CBD Cream for Muscle and Joint: Cooling Formula absorbs rapidly, without the greasy residue of other pain creams: CBD or otherwise.”
On your CBD Balm Stick Muscle & Joint product webpage:
• “CBD Balm Stick Muscle & Joint 750mg – 3000mg . . . Broad Spectrum CBD 750mg & 3000mg . . . Camphor oil - warms & loosens tight muscles . . . Peppermint and wintergreen oils - cooling pain relief”
• “Intense relief is at your fingertips. Find soothing relief with the cooling power of menthol, the pain-relieving benefits of essential oils like wintergreen and black pepper, and the addition of broad spectrum CBD.”
• “We’ve combed the earth for the absolute best and most soothing topical ingredients to help you address muscle discomfort, and the result is our brand new CBD Muscle & Joint Balm Stick.”
From your YouTube social media website https://www.youtube.com/c/CBDfx:
• July 16, 2019 video – “CBD has been shown to help with a lot of different things like anxiety, stress, pain, and inflammation, and even help with seizures.” [https://www.youtube.com/watch?v=VTnA4C0kWEI; see 0:45 – 0:55]
Based on the above labeling claims, your CBD-containing 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-containing 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 CBD-containing 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-containing 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). These products are offered for conditions that are not amenable to self-diagnosis or treatment by individuals who are not medical practitioners. 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.
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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).
Unapproved New Animal Drugs
During our review of your firm’s website cbdfx.com, and your social media websites www.facebook.com/CBDfx, www.instagram.com/cbdfx_/, and twitter.com/cbdfx, FDA determined that your firm is marketing CBD-containing products for animals that are unapproved new animal drugs: Dog Tincture (all strengths), Cat Tincture, Pet Tincture (all breed sizes/strengths), Pet Tincture (also referred to as CBD Oil for Cats), Stress and Anxiety Pet Treats, Joint and Mobility Pet Treats, and Calming and Moisturizing Pet Balm. Based on our review of your website, and your social media websites, your CBD-containing 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. 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 cbdfx.com and social media websites www.facebook.com/CBDfx, www.instagram.com/cbdfx_/, and twitter.com/cbdfx, that show the intended use of your products for animals as drugs include, but are not limited to, the following:
Dog Tincture (all strengths)
• “Anti-inflammation: Relieving joint pain for active and older dogs”
• “Thanks to its anti-inflammatory properties, many find that CBD can help with inflammation that causes joint and mobility pain in dogs, cats, and other pets.”
Cat Tincture
• “Anti-inflammation: Relieving joint pain for active and older animals”
• “Thanks to its anti-inflammatory properties, many find that CBD can help with acute and chronic inflammation that causes joint pain in cats and other pets.”
Pet Tincture (all breed sizes/strengths)
• “We have all likely heard stories of CBD potentially helping with seizure disorders, pain control, anxiety, metabolic disorders, cancer, inflammation and nausea, just to name a few.”
• On your Instagram social media website:
o August 13, 2020 posting with photograph of a woman sitting next to and petting a dog in the back of a vehicle:
 “Specifically designed for dogs (and cats!), our Pet Tinctures help manage the stress and anxiety that often accompanies a long car ride.⁠”
• On your Instagram, Twitter, and Facebook social media websites:
o June 7, 2020 postings with photograph of a dog looking at three containers of your pet tincture products:
 “I love this stuff! Especially when my hooman [sic] leaves for what seems like forever and I feel anxious.”
Pet Tincture (also referred to as “CBD Oil for Cats”)
• “CBD can relieve stress, anxiety, and hyperactivity...”
Stress & Anxiety Pet Treats
• “These all-natural, vegan CBD dog biscuits are perfect for settling nerves and easing stress, which can lead to more harmful anxiety.”
Joint & Mobility Pet Treats
• “CBD has anti-inflammatory properties that can help relieve aches and pains your dog may be experiencing. CBD dog biscuits can be just the thing to get your dog up and moving again.”
• “With anti-inflammatory benefits... CBD can provide a potent ingredient in products for joint and muscle pain in dogs and other pets.”
Calming and Moisturizing Pet CBD Balm
• “Not only does this CBD balm for pets feature hemp-extracted CBD… These fatty acids strengthen the skin, assist it in combating infection, and have multiple anti-inflammatory properties.”
• “As with dogs, a cat’s skin, paws and nose can dry out, and get irritated, inflamed or infected. So, it’s a good idea for cat owners to also keep CBD Calming and Moisturizing Pet Balm on hand…”
Your CBD-containing 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 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). 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).
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, as described above.
According to your product labeling, your Stress & Anxiety Pet Treats and Joint & Mobility Pet Treats products are animal foods to which CBD has been added. Specifically, your product labels depicted on your website, cbdfx.com, include the claim “Contains Superfoods...” Additionally, your product page for Stress & Anxiety Pet Treats includes the following descriptions: “And your dog will love the natural sweet-potato flavoring!” and “CBD Dog Treats for Stress and Anxiety are all-natural, organic, non-GMO, human-grade and vegan...” Further, your product page for Joint & Mobility Pet Treats includes the following descriptions: “Made with organic broad spectrum CBD, powerful antioxidants...these...CBD dog treats come in a tail-wagging sweet-potato flavor, sure to delight even the most finicky of pooches!” and “These tasty CBD dog treats contain broad spectrum CBD, plus other antioxidants and nutrients...” 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.
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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 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. Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal food. 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 food 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 CBD Pet Treats for Stress & Anxiety and CBD Pet Treats for Joint & Mobility are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of these adulterated animal foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
* * *
The violations cited in this letter is not intended to be an all-inclusive statement of violations that may exist in connection with your marketed products. You are responsible for investigating and determining the causes of any violations identified above 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.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
We offer the following additional comments:
CBD-containing Drugs
Even if your CBD Cream For Muscle & Joint and CBD Balm Stick Muscle & Joint 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).
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Dietary Supplement Labeling
Information on your website indicates that you intend to market your CBDFx Mixed Berry Gummies 1500mg,Turmeric and Spirulina CBDFX Gummies, Sleep Gummies with Melatonin 1500mg CBDFX Gummies, Apple Cider Vinegar 1500mg CBDFX Gummies, Multivitamin CBD Gummies for Women and Men, CBD+Delta-9 THC Capsules Daily Chill Blend, and Focus Mushroom+CBD Drops and CBG Energy Blend products as dietary supplements; for example, the products’ pages bear Supplement Facts panels or the product is labeled as a “CBD Supplement” or “Hemp-Derived Supplement.” However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.
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There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.
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 the United States Food and Drug Administration at CFSANResponse@fda.hhs.gov. Please include “CMS 629243” in the subject line of your email.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling 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
___________________________
1
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.
2
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.
3
For example, under section 505G of the FD&C Act, 21 U.S.C. 355h, certain nonprescription drug products may be lawfully marketed without an approved application if applicable conditions are met, including conformity with an applicable OTC monograph. However, your products could not be lawfully marketed under section 505G, because based on your claims regarding these products, including on your website labeling, your products are marketed for uses not considered nonprescription indications. Further, even if certain of your products, such as your CBD Cream For Muscle & Joint and CBD Balm Stick Muscle & Joint, 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.
4
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 2) and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
5
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.
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
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.
Content current as of:
11/21/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages