WARNING LETTER
Discover Health, LLC d/b/a Discover CBD and Strain Snobs
MARCS-CMS 661488 —
November 16, 2023
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Justin L. Hays
Recipient Title
CEO
Discover Health, LLC d/b/a Discover CBD and Strain Snobs
2255 Reliable Circle
Colorado Springs
,
CO
80906
United States
sales@discoverCBD.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
WARNING LETTER
November 16, 2023
RE: 661488
Dear Justin L. Hays:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at https://discovercbd.com/ and https://www.activecbdoil.com from June to August 2023. We note that your firm is the U.S. distributor for the Active CBD Oil brand of various products, which you represent contain cannabidiol (CBD), cannabigerol (CBG), hexahydrocannabinol (HHC), and Delta-8 Tetrahydrocannabinol (THC).
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Your website, www.activecbdoil.com provides a direct link to the website, www.discovercbd.com where consumers can purchase the Active CBD Oil brand of products.
2
The claims on your website, https://discovercbd.com establish that your products, “Active CBD Oil – Full Spectrum Distillate Cartridge,” “Active CBD Oil – Full Spectrum CBD Salve,” “Strain Snobs- 99% Pure CBD Isolate powder,” “Active CBD Oil-CBD Lotion,” “CBG Isolate Powder,” “HHC Cartridge- OG Kush,” and “Strain Snobs Δ8 THC Salve,” are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1) and sold in violation of 301(a) of the FD&C Act, 21 U.S.C. 352(f)(1) and 331(a).
FDA has also determined that your “Active CBD Oil Infused Coffee,” “Active CBD Oil Gummies,” “CBD Living Water,” and “Strain Snobs™ Delta-8 Plant-Based Gummies” products offered for sale on your webpages, https://www.activecbdoil.com/1, https://discovercbd.com/, and https://strainsnobs.com 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 “Active CBD Oil Infused Coffee,” “Active CBD Oil Gummies,” “CBD Living Water,” and “Strain Snobs™ Delta-8 Plant-Based Gummies” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll). Consumers may confuse these products with traditional foods; therefore, with these products there is a risk of unintended consumption of CBD and Delta-8 THC.
In addition, the claims on your website, https://discovercbd.com/ and your social media webpage, https://www.instagram.com/discovercbd, establish that your “Active CBD Oil Savory Pumpkin Treats,” “Active CBD Oil 120mg CBD Pet Tincture – Bacon,” and “Active CBD Oil 300mg CBD Broad Spectrum – Chicken” products, which you offer for sale 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). Furthermore, these 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 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.
Unapproved New Drugs
Based on a review of your websites, your “Active CBD Oil – Full Spectrum Distillate Cartridge,” “Active CBD Oil – Full Spectrum CBD Salve,” “Strain Snobs- 99% Pure CBD Isolate powder,” “Active CBD Oil-CBD Lotion,” “CBG Isolate Powder,” “HHC Cartridge- OG Kush,” and “Strain Snobs Δ8 THC Salve” 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, and/or intended to affect the structure or any function of the body.
Examples of claims from your website https://discovercbd.com that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
On your “CBD and Breast Cancer” webpage https://discovercbd.com/blogs/cbd-news/cbd-and-breast-cancer:
“The American Association for Cancer Research published a study on how CBD may be able to induce cell death in breast cancer cells. The study suggested that CBD played in [sic] a role in the coordination of apoptosis and autophagy. The coordination of apoptosis and autophagy can help to target breast cancer cells and causes programmed cancer cell death. . . . Most antineoplastic agents used today have side effects that can damage other parts of the body and healthy cells. Because there are no known major negative side effects to using CBD, the interest in CBD as a possible treatment for breast cancer continues to grow.”
“A study done in Italy . . . suggested that out of all the cannabinoids, CBD was the most potent inhibitor of cancer cell growth.”
On your “CBD for Kids: Answering FAQ’s” webpage https://discovercbd.com/blogs/cbd-news/cbd-and-kids-answering-faqs
“CBD has also been scientifically shown to treat is [sic] epilepsy. There have been many clinical studies done on how CBD may help kids with epilepsy with great results . . . If your child struggles with ADD/ADHD they may also benefit from CBD as it has been shown to be potentially effective with helping hyperactivity.”
On your “5 Little known benefits of CBD” webpage https://discovercbd.com/blogs/cbd-news/5-little-known-benefits-of-cbd:
“Studies have proved that CBD can help in PTSD (post traumatic stress disorder) treatment . . . CBD provides a calming effect that has antipsychotic benefits hence providing a stable mental environment for people trying to recover from . . . PTSD.”
“Did you know that over 400 million people globally suffer from Diabetes resulting in close to 5 million deaths annually? Substantial scientific evidence concludes that CBD could come in handy in preventing and managing this chronic ailment.”
“Reliable studies have proved that cannabis is likely help control insulin levels by lowering insulin resistance.”
On your “What is CBG? Webpage in the FAQ section https://discovercbd.com/blogs/cbd-news/what-is-cbg:
“It has been shown to reduce intraocular pressure, which is important in the treatment of glaucoma. In studies on breast and skin cancer, it has shown anti-recurrence properties.”
On your “Strain Snobs Delta 8 THC Dab Review” webpage https://discovercbd.com/blogs/cbd-news/strain-snobs-delta-8-dab-review:
“Another good thing about the delta 8 THC Dabs by Strain Snobs is that it can be used to make concentrates at home if you have a decent dab rig. The company says that the extract has been sent to the lab for testing and according to TMMR, this extract was tested three times in order to ensure its quality. All these tests showed positive results which means that delta 8 THC dabs are top notch grade products that are meant to provide . . . cancer treatment etc.”
On your “Delta 8 for Sleep Better Than the Dead” webpage https://discovercbd.com/blogs/cbd-news/delta-8-thc-and-cbn-for-sleep:
“Delta 8 is a non-psychoactive cannabinoid compound that helps . . . reduce seizures. Delta 8 THC is also known to assist in helping treat cancer . . .”
On your “HHC vs Delta 8: What’s the Difference” webpage https://discovercbd.com/blogs/cbd-news/hhc-vs-delta-8:
“HHC is an anti-depressant that has been proven effective in all areas, from anxiety reduction to euphoria and sedation.”
On your “CBD & Opioid Addiction” webpage https://discovercbd.com/blogs/cbd-news/cbd-helpful-for-addicts:
An image that includes text such as, “addiction,” “drug abuse,” “psychological symptoms,” “physiological dependence,” and “mental disorder”
“So, how does CBD help with addiction? Researchers have found that CBD can help block these associations through the serotonin system. The serotonin system is usually associated with mood, but it's also associated with addiction. The CBD interacts with the serotonin system to block opioid reward-seeking behavior showing a reduction in adverse side effects.”
“Although there hasn't been a lot of research with CBD in the field of addiction, all signs point toward more studies being done to try to find the answers and help bring an end to the opioid epidemic. With over 60,000 deaths in 2016 we desperately need something to help, and CBD may just be the answer.”
On your “Post-Acute Withdrawal Syndrome: Could CBD be the Silver Bullet?” webpage https://discovercbd.com/blogs/cbd-news/tagged/treatment:
“CBD presents an astounding array of potential benefits to those in recovery from addiction: alleviating symptoms associated with post-acute withdrawals, managing triggers, and helping individuals cease behaviors that predict relapse . . . If you are in recovery from addiction, and in light of all the evidence supporting the use of CBD to assist in the recovery process, why wouldn’t you add CBD to your toolkit?”
The Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving the opioid crisis.
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You market your CBD products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction.
Your “Active CBD Oil – Full Spectrum Distillate Cartridge,” “Active CBD Oil – Full Spectrum CBD Salve,” “Strain Snobs- 99% Pure CBD Isolate powder,” “Active CBD Oil-CBD Lotion,” “CBG Isolate Powder,” “HHC Cartridge- OG Kush,” and “Strain Snobs Δ8 THC Salve” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for any of the above-mentioned products. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
Misbranded Drugs
Your “Active CBD Oil – Full Spectrum Distillate Cartridge,” “Active CBD Oil – Full Spectrum CBD Salve,” “Strain Snobs- 99% Pure CBD Isolate powder,” “Active CBD Oil-CBD Lotion,” “CBG Isolate Powder,” “HHC Cartridge- OG Kush,” and “Strain Snobs Δ8 THC Salve” products are 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.) Your 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 these products. The introduction or delivery for introduction into interstate commerce of misbranded drugs is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
301(ll) and Adulterated Human Foods
According to your product labeling, your “Active CBD Oil – CBD Infused Coffee,” “Active CBD Oil Gummies” and “CBD Living Water” products are foods to which CBD has been added.
We note that your various strengths of “Active CBD Oil Gummies” products appear to be promoted as a conventional human food. Specifically, you promote these gummies as “delicious, fruity candy.” 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. 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.
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 it becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.
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Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a) and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
There is no food additive regulation which authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).
We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS status. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. Therefore, based on our review, the use of CBD in conventional food products does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food. Therefore, CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act 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. 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). Therefore, your “Active CBD Oil Gummies,” “Active CBD Oil – CBD Infused Coffee,” and “CBD Living Water” products are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because they bear or contain an unsafe food additive. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Further, according to your product labeling, your “Strain Snobs™ Delta 8 Plant-Based Gummies” product is food to which Delta-8 THC has been added. 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 your product does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exception to the food additive definition that would apply to Delta-8 THC for use as an ingredient in a conventional food. Therefore, Delta-8 THC added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Delta-8 THC is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Therefore, your “Strain Snobs™ Delta 8 Plant-Based Gummies” product is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because it bears or contains an unsafe food additive. Introduction of this 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 firm’s website https://discovercbd.com/, and your social media webpage https://www.instagram.com/discovercbd, FDA has determined that your firm offers for sale the unapproved new animal drugs “Active CBD Oil Savory Pumpkin Treats,” “Active CBD Oil 120mg CBD Pet Tincture – Bacon,” and “Active CBD Oil 300mg CBD Broad Spectrum – Chicken.” Based on our review of your website and social media webpage, these 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 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 from your website and social media webpage that provide evidence of the intended use of these products as animal drugs include, but may not be limited to, the following:
On your “CBD for Pets For Sale” webpage, https://discovercbd.com/collections/pets, under the heading “The Benefits of CBD Oil for Pets”:
“Lowers Anxiety”
“Reduces Pain . . . CBD promotes anti-inflammatory properties . . .”
“Helps With Seizures ”
On your “CBD Oil for Dogs” webpage, https://discovercbd.com/blogs/cbd-news/cbd-oil-for-dogs:
“CBD may be an option for dogs dealing with issues, such as, inflammatory problems, seizures, pain, and anxiety.”
“CBD has been extensively researched as a cancer-fighting substance. Studies have shown CBD may slow the growth of cancer causing tumors. CBD has also been known to kill cancer cells by blocking their ability to produce energy. CBD oil may also be helpful for nausea that comes along with many cancer treatments , as it’s known to be an excellent anti-nausea med. Studies have also shown that it may significantly reduce cancer-related pain as well.”
“Researchers at Colorado State University got excited when they studied CBD as an option for treatment in dogs with epilepsy. The results are astounding! 89% of dogs that received CBD had a reduction in their seizures. CBD may reduce the frequency and severity of seizures . . . ”
“Anxiety is a common reason why dog owners turn to CBD. Anxiety in dogs can appear in many different ways, such as, noise phobia, separation anxiety, aggression, and fear.”
“CBD can be used internally for allergies, or externally for more hot spots.”
On your “CBD For Cats! Making Life Easier For Your Feline Companion” webpage, https://discovercbd.com/blogs/cbd-news/cbd-for-cats-making-life-easier-for-your-feline-companion:
“Whether they suffer from stress disorders, hyperactivity, adventure-related injuries, or joint pain from old age, CBD may be a wonderful addition to their daily diet. “
“By giving Bonsai daily doses of CBD with her meals, we have completely eliminated her destructive nervous habit and she seems happier and more calm in general.”
“CBD can have anti-inflammatory and analgesic painkilling properties, without the negative sedative effects of heavy pharmaceutical painkillers . . . ”
On your March 15, 2023, Instagram post found on your social media webpage www.instagram.com/discovercbd:
“I rescued Charlie from a shelter when he was 10. Shortly after, due to the natural aging process he began developing arthritis. . . the moment he tried DiscoverCBD’s 300mg Chicken Tincture we never looked back. Thanks to this product Charlie is able to go for walks, get in and out of the car with ease, conquer stairs like a champion, and has little to no separation anxiety! An added bonus is he’s much calmer during loud holidays such as the fourth of July!”
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, 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). 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 “Active CBD Oil Savory Pumpkin Treats,” “Active CBD Oil 120mg CBD Pet Tincture – Bacon,” and “Active CBD Oil 300mg CBD Broad Spectrum – Chicken” products are animal foods to which CBD has been added. Specifically, your product labeling refers to your “Active CBD Oil Savory Pumpkin Treats” product as “treats.” Additionally, your CBD products for animals claim to have nutritional value for dogs. For example, your “Will CBD Oil Work For My Dog?” webpage,
https://discovercbd.com/blogs/cbd-news/94865734-can-cbd-oil-work-for-my-dog, states, “A compelling reason for considering CBD oil for your dog is for the nutritional value it delivers . . . A daily dose or two of CDB oil for pets can help satisfy a dog’s dietary requirements.” 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 “Active CBD Oil Savory Pumpkin Treats,” “Active CBD Oil 120mg CBD Pet Tincture – Bacon,” and “Active CBD Oil 300mg CBD Broad Spectrum – Chicken,” 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).
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
We offer the following additional comments:
Dietary Supplement Labeling
Information on your website at https://discovercbd.com indicates that you intend to market your CBD products “Active CBD Oil Capsules Gold Label Hemp Supplement,” “Active CBD Oil Full Spectrum CBD Capsules,” and “Active CBD Oil Tinctures (1250-2500 mg)” as dietary supplements. The product webpages display an image of these products with a Supplement Facts panel. 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 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 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/
Jill Furman
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
/S/
Neal Bataller
Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Food and Drug Administration
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1
FDA has observed a proliferation of products containing the 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 puts 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 informs you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers.
2
Your “About Us” webpage, at https://www.activecbdoil.com/about-us, states, “Contact our US distributor DiscoverCBD.com at info@discovercbd.com”
3
Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued October 26, 2017, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
4
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.
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
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:
11/21/2023
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages