WARNING LETTER
Hope Botanicals, LLC
MARCS-CMS 623509 —
May 26, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Jenna Brown
Recipient Title
President/Manager
Hope Botanicals, LLC
1806 Bentwater Pkwy
Granbury
,
TX
76049
United States
info@hopebotanicals.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
May 26, 2022
RE: 623509
Dear Jenna Brown:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://hopebotanicals.com in May 2022 and has determined that you take orders there for various animal and human products, all of which your firm promotes as products containing cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/hopebotanicalsllc and www.instagram.com/hope botanicals; these websites direct consumers to your website https://hopebotanicals.com to purchase your products.
The claims on your website and social media websites establish that your products “CBD Horse Pellets” (also referred to as “Broad Spectrum CBD Pellets for Horses or Livestock”), “Peppermint Flavor Horse Formula,” “Happy Horse Bites,” “CBD Liniment Gel,” “Natural Flavor Pet Formula” (also referred to as “Broad Spectrum CBD for Pets in Natural Flavor”), and “Beef Flavored Soft Chews,” which you promote as products containing CBD for use in animals, are unapproved new animal drugs that are unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
In addition, your CBD products for human use (hereinafter collectively referred to as “your CBD-containing products for humans”), include all varieties of “Broad Spectrum Tincture” (also referred to as “Broad Spectrum CBD”), “Super Full Spectrum Tincture” (also referred to as “Super Full Spectrum CBD”), “Phytocannabinoid-Rich Broad Spectrum Hemp Oil Softgels,” (also referred to as “25mg Broad Spectrum CBD Gel Caps”), and “Broad Spectrum Nano CBD Salve” are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the the FD&C Act, 21 U.S.C. 355(a) and 331(d). Furthermore, your CBD-containing products for humans are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
FDA has also determined that your Raspberry Gummies 10 mg CBD Isolate Hemp Extract product is adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because it bears or contains an unsafe food additive. Furthermore, it is a prohibited act to introduce your Raspberry Gummies 10 mg CBD Isolate Hemp Extract product 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. In addition to raising potential concerns regarding safety for the animals themselves, CBD products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals. There is currently a lack of data on the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and on safe levels of any potential residues for the human consumer. We request that you take immediate action to cease the sale of any unapproved CBD products for food-producing animals.
Unapproved New Animal Drugs
During our review of your website, https://hopebotanicals.com, and your social media websites at www.facebook.com/hopebotanicalsllc and www.instagram.com/hope botanicals, FDA determined that your firm is marketing the unapproved new animal drugs “CBD Horse Pellets” (also referred to as “Broad Spectrum CBD Pellets for Horses or Livestock”), “Peppermint Flavor Horse Formula,” “Happy Horse Bites,” “CBD Liniment Gel,” “Natural Flavor Pet Formula,” and “Beef Flavored Soft Chews.” Based on our review of your website and social media websites, these products are drugs under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), 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 https://hopebotanicals.com, and your social media websites, www.facebook.com/hopebotanicalsllc and www.instagram.com/hope botanicals, that show the intended use of your products for animals as drugs include, but are not limited to, the following:
On your product webpage for “CBD Horse Pellets,” which states, “Broad Spectrum CBD Pellets for Horses or Livestock”:
• Customer review: “I wanted to ask if these pellets would help my goat,
(b)(6)
has a bad front leg, he holds it up a lot, the vet says it arthritis [sic]…Do you have anything that would ease the pain…”
o Response from Jenna Brown, Hope Botanicals: “Hi
(b)(6)
: Yes, I think the pellets would be beneficial for your goat. We have lots of goat customers! I sent you an email to explain more:) Jenna”
On your product webpage for “Happy Horse Bites”:
• Your product label states, “For Horses and Large Animals Only… CBD is a beneficial nutrient for many things including inflammation, pain and anxiety. It’s a great choice for joint health and digestion and has been known to help horses with general anxiety, muscle pain and joint inflammation.”
On your product webpage for “CBD Liniment Gel”:
• “Use for Pain and Swelling, Inflammation, Arthritis, and Overexertion.”
• Your product label states, “CBD has been shown to be highly anti-inflammatory and can reduce pain and inflammation in ligaments, joints, tendons, and muscles.”
On your product webpage for “Natural Flavor Pet Formula”:
“Dosing for dogs and cats has been established by Dr. Silver. Dr. Robert Silver achieved his lifetime goal of becoming a veterinarian when he graduated from Colorado State University’s (CSU) College of Veterinary Medicine in 1982. In the 1990’s, after creating Boulder’s Natural Animal, a Holistic Wellness Center, Dr. Silver established effective protocols for a number of serious, potentially life-threatening chronic diseases in dogs and cats, such as cancer, allergies, chronic pain, inflammatory bowel disease, canine epilepsy, and behavior problems. Dr. Silver has been using phytocannabinoids [you describe your Natural Flavor Pet Formula as a “phytocannabinoid-rich hemp oil tincture”] to help animals for nearly 20 years.”
On your product webpage for “Peppermint Flavor Horse Formula”:
• Customer review: “Only started it for 3 days and already a WORLD of difference for my mare who suffers from arthititis [sic] in her hocks. I am a believer!!!!”
o Response from Jenna Brown at Hope Botanicals: “Woo hoo! I love to hear these testimonials. I’m so happy it’s making your girl happy!!”
On your webpage https://hopebotanicals.com/2020/03/5-ways-to-help-a-horse-withanxiety/: March 26, 2020 blog posting titled “5 Ways to Help a Horse with Anxiety”:
• “CBD is a known anti-inflammatory, anti-analgesic (pain reducer), and an anxiolytic (anti-anxiety). For this reason, it is an effective anxiety reducer in all mammals.”
On your webpage https://hopebotanicals.com/2019/11/cbd-for-dogs-with-anxiety/: November 5, 2019 blog posting titled “Is CBD Safe for Dogs with Anxiety”:
• “One of the most popular uses of CBD is to treat anxiety. In fact, while there is a growing body of research around the many medical benefits of CBD, one of the most studied effects of CBD is as an anxiolytic (anti-anxiety).”
On your website https://hopebotanicals.com/2019/12/cbd-for-horses/: December 11, 2019 blog posting titled “The Ultimate Guide to Using CBD for Horses”:
• “The commonly accepted properties of CBD are that it is an anti-inflammatory, anti-analgesic (pain reducer), and an anxiolytic (anti-anxiety). The truth is that most conditions and illnesses are a response to inflammation or other imbalance in the body, so CBD can be an effective treatment for many, many things.”
• “Our customers have used our CBD products to treat their horses with these conditions:
o Cribbing
o Pain and inflammation due to old age
o Arthritis
o Anxiety or horses that are easily spooked
o Tummy and digestive issues
o Sweet Itch
o Mood disorders
o Cushing’s Syndrome
o Degenerative Joint Disease
o Ulcers
o Poor kidney function
o Keeping horses calm and comfortable through stall rest”
On your Instagram social media website at www.instagram.com/hope botanicals:
• March 28, 2021 posting with a photograph of your “Beef Flavored Soft Chews”: “Our beef-flavored pet treats have been used by our customers and friends to:
o Reduce anxiety
o Aid in sleep
o Help manage pain”
• July 30, 2020 posting: "Here is
(b)(6)
! He is a 13-14 year old pot belly pig... He has suffered with arthritis over the last couple years that had progressed to severe this last year. … The CBD pellets have changed his quality of life for sure. It even changed his skin! He was getting holes, almost crater like, all over his body. Those are healing up. It is just crazy what these pellets have done for him.”
• July 9, 2020 posting with a photograph of your “Peppermint Flavor Horse Formula”: “Here are some of the things that people use the horse tincture for:
o Ulcers
o Cribbing
o Digestive issues
o Anxiety
o Pain and inflammation
o Sweet itch
o Cushing’s Syndrome”
• June 25, 2019 posting: “Our high-quality pellets can be used for horses as well as other livestock. Customer [
sic
] use them to manage symptoms of:
o ✖ Arthritis
o ✖ Cushings
o ✖ Anxiety
o ✖ Cribbing
o ✖ Aging
o ✖ ... and more!”
On your Facebook social media website at www.facebook.com/hopebotanicalsllc:
• May 13, 2021 posting: “Thank you for sharing,
(b)(6)
! "Hope Botanicals was recommended to me by a friend for my 25 year old gelding, who was showing signs of arthritis. After one month of being on the CBD pellets, he got the spring back in his step and is feeling much better! I am going to now try the pellets for my other gelding who has major anxiety due to a rough past. Definitely recommend their products!"
• July 31, 2020 posting with a photograph of your “Natural Flavor Pet Formula”: “There are a myriad of conditions that can afflict dogs which can by [sic] helped by the use of CBD. Some of our customers have used it to treat:
o -Glaucoma
o -Fatty tumors
o -Anxiety
o -Arthritis
o -Allergies
o -Seizures”
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
On your testimonials webpage https://hopebotanicals.com/category/testimonials/:
• December 13, 2018 testimonial: “
(b)(6)
relief from Polyneuritis…to have a special horse and then have them diagnosed with a disease such as polyneuritis is devastating. This disease is very similar to multiple sclerosis in people.”
o “
(b)(6)
has been on Hope Botanicals CBD pellets for one month now. He is now down to 1/4 tablet of previcox once a day. On Friday, he bucked in his field and cantered in to get fed, for the first time in a year!”
• September 22, 2018 testimonial: “CBD for Goats!!! We wanted to share this testimonial. By now we shouldn’t be amazed by what CBD can do, but we’re always so pleased to hear it first hand [sic]. We love to pass on information like this so we can all learn the benefits.”
o “Hi. I don’t know if you have ever had success stories with use in goats, but I have been using these pellets in a few of my goats now for a month. One has arthritis issues, another just kidded and is stressed as well as has immune system dysfunction from an infection. Its [sic] amazing stuff. I definitely see a shift in their attitude and behavior and I am hoping it helps their pain and discomfort as well!”
• July 14, 2018 testimonial: “Pain Relief for
(b)(6)
... About 6 months ago she really hurt her back digging a hole the size of Texas to get a mole… I ordered CBD unflavored tincture from Hope Botanicals and started giving it to
(b)(6)
two times a day. I’ve decreased her pain meds by half after a month and I can tell she’s feeling great! Dobermans are prone to cancer so I’m thrilled to be giving her CBD for the pain and know that it will kill cancer cells also.”
These products are "new animal drugs" under section 201(v) of the FD&C Act, 21 U.S.C. § 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. §§ 360b, 360ccc, and 360ccc-1. These products are not approved or index listed by the FDA, and therefore these products are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated under section 501(a)(5) of the FD&C Act 21 U.S.C. § 351(a)(5). The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the FD&C Act 21 U.S.C. § 331(a).
301(ll) and Adulterated Animal Foods
To the extent that you market any of your products containing CBD as animal food, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any animal food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD
1
.
You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term “food additive” refers to any substance the intended use of which results in its becoming a component of any animal food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception
2
.
There is no animal food additive regulation that authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods. FDA’s regulations in Title 21, Code of Federal Regulations 570.30(a)-(c), 21 CFR 570.30(a)-(c), describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30). We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.
Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Dietary Supplement Labeling
Information on your website at https://hopebotanicals.com indicates that you intend to market several of your CBD-containing products, including “Broad Spectrum Tincture” (all varieties and also referred to as “Broad Spectrum CBD”), “Super Full Spectrum Tincture” (also referred to as “Super Full Spectrum CBD”), and “Phytocannabinoid-Rich Broad Spectrum Hemp Oil Softgels,” (also referred to as “25mg Broad Spectrum CBD Gel Caps”), for humans
3
as dietary supplements. However, these products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.
Unapproved New Drugs
Based on our review of your website and social media websites, 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 that establish the intended use of your CBD-containing products for humans as drugs include, but not limited to, the following:
On your website https://hopebotanicals.com/category/testimonials/ [similar claims are also found on your website at https://hopebotanicals.com/2018/01/my-husband-was-diagnosed-with-multiple-myeloma/]:
• “On July 7, 2017
(b)(6)
was diagnosed with Multiple Myeloma, a cancer formed by malignant plasma cells (aka blood cancer). This particular type of cancer affects many things, low blood counts, difficulty fighting infections, bone and calcium issues and kidney problems to name a few . . . He started taking Hope Botanicals CBD gel cap, 25 mg twice daily, mostly to see if it would help with fatigue, mood and sleep. While the CBD definitely helped with these symptoms, most noteworthy, we began to see his creatinine levels drop substantially . . . They started him again on the CBD gel caps, 50mg every three hours and within 7 hours, he was pain free. As of today,
(b)(6)
is considered in remission, we believe with help of CBD.
We are very happy to hear such an amazing testimony and very thankful that we could help
(b)(6)
manage his cancer symptoms.”
On your website https://hopebotanicals.com/category/blog-posts/:
• “The Top 8 Uses for CBD Oil”
o In a graphic, you state: “
Cancer
[-] CBD may help cancer patients to manage their symptoms and minimize the effects of more intrusive treatments” and “
ADHD
. . . observational studies show it helps reduce the anxiety and hyperactivity associated with ADHD.”
o “
Cancer
My first customer was a man with multiple myeloma blood cancer. He is in remission . . . The side benefit that my customer didn’t know about is that CBD helped his kidney function. When opiates couldn’t control his pain, CBD did.”
o “
ADHD
Many parents of children with ADHD are looking for other options to prescribed medications for their children. There are many forums for parents researching CBD for ADHD and other subtypes. There is limited research on CBD for ADHD, but observational studies show it helps reduce the anxiety and hyperactivity associated with ADHD.”
Your CBD-containing products for humans are not generally recognized as safe and effective 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 the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-mentioned products.
Misbranded 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 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.) The aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, because no FDA-approved applications are in effect for your products. The introduction or delivery for introduction into interstate commerce of these misbranded drugs is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
301(ll) and Adulterated Human Foods
We note that your Raspberry Gummies 10 mg CBD Isolate Hemp Extract product appears to be promoted as a conventional human food. Specifically, this product is displayed with a Nutrition Facts label on your website. However, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, as described above. There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), prohibits the introduction into interstate commerce of any food to which CBD has been added, but you may present FDA with any evidence bearing on this issue.
According to your product labeling your Raspberry Gummies 10 mg CBD Isolate Hemp Extract product is food to which CBD has been added. Therefore, the introduction or delivery for introduction into interstate commerce of those products is a prohibited act under section 301(ll) of the FD&C Act.
You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term "food additive" refers to any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception
4
.
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act (21 U.S.C. 348(a)), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
There is no food additive regulation which authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).
We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS status. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. Therefore, based on our review, the use of CBD in conventional food products does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food. Therefore, CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act, 21 USC 321(s), and is subject to the provisions of section 409 of the FD&C Act, 21 USC 348. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any conventional food.
Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov.
Sincerely,
/S/
Neal Bataller
Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Food and Drug Administration
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
CC: Velma Sharp, Registered Agent
22926 SW Upper Roy St
Sherwood, Oregon 97140
___________________________________
1
CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
2
Under section 201(s)(5) of the FD&C Act, 21 U.S.C. § 321(s)(5), new animal drugs are excluded from the food additive definition. If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
3
The CBD-containing products for humans that are marketed as dietary supplements include “Broad Spectrum Tincture” (all varieties and also referred to as “Broad Spectrum CBD”), “Super Full Spectrum Tincture” (also referred to as “Super Full Spectrum CBD”), and “Phytocannabinoid-Rich Broad Spectrum Hemp Oil Softgels,” (also referred to as “25mg Broad Spectrum CBD Gel Caps”).
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.
Content current as of:
05/26/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages