WARNING LETTER
Haniel Concepts, Inc. DBA Free State Oils, LLC
MARCS-CMS 623510 —
May 26, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Joy Neely
Recipient Title
Owner
Haniel Concepts, Inc. DBA Free State Oils, LLC
4919 Ferguson Rd
Perry
,
KS
66073
United States
contact@freestateoils.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
VIA EMAIL
May 26, 2022
Joy Neely, Owner
Haniel Concepts, Inc.
dba Free State Oils, LLC
4919 Ferguson Rd
Perry, Kansas 66073
contact@freestateoils.com
RE: 623510
Dear Joy Neely:
This letter is to advise you that the U.S. Food and Drug Administration  (FDA) reviewed your website at the Internet address  www.freestateoils.com in May 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/freestateoils, www.instagram.com/freestateoils,  and twitter.com/freestateoils;  these websites  direct consumers to your website www.freestateoils.com to purchase your products. In addition, FDA has observed that your website offers CBD-containing products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19
1
in people.
The claims on your website and social media websites establish  that your products “Whisper’s Soothing Grains CBD for Farm Animals,” “Snoop’s Chews CBD Dog Treats” (including “Pack of 6 Chews” and “Jar of 45 Treats”), “Snoop’s Drops CBD Tincture for Dogs (300mg & 1000mg),” and “Eli’s Drops CBD Tincture for Cats,” 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, the claims on your website and social media websites establish that your CBD-containing products for humans
2
are unapproved new drugs sold in violation of sections 505(a) and 301(d) of 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 “CBD Honey Straws” (flavored and unflavored) and “CBD Gum Drops” 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. It also is a prohibited  act to introduce your “CBD Honey Straws” (flavored and unflavored) and “CBD Gum Drops” into interstate  commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).
There is currently a global outbreak of respiratory  disease  caused by a novel coronavirus that has been named “severe acute respiratory  syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus  Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued  a declaration  of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.
3
In addition,  on March 13, 2020, there was a Presidential  declaration  of a national emergency in response to COVID-19.
4
Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization  by FDA, claim to mitigate, prevent, treat, diagnose,  or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized  products for the mitigation,  prevention, treatment, diagnosis, or cure of COVID-19.
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 one of your CBD products for food-producing animals. For example, your “Whisper’s  Soothing Grains CBD for Farm Animals” is marketed for “horses, swine, poultry and other farm animals and pets.” 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 www.freestateoils.com, and your social media websites at www.facebook.com/freestateoils, www.instagram.com/freestateoils, and twitter.com/freestateoils, FDA determined that your firm is marketing CBD-containing products that are unapproved new animal drugs: “Whisper’s  Soothing Grains CBD for Farm Animals,” “Snoop’s Chews CBD Dog Treats,” “Snoop’s Drops CBD Tincture for Dogs,” and “Eli’s Drops CBD Tincture for Cats.” Based on our review of your website and social media websites, these products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended  for use in the diagnosis, cure, mitigation, treatment, or prevention of disease  in animals. 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 www.freestateoils.com that establish the intended use of your products as drugs include, but are not limited to, the following:
•    Whisper’s Soothing Grains CBD for Farm Animals
o “Formulated by a veterinarian, Whisper’s  Soothing  Grains CBD Pellets for Farm Animals are for horses,  swine, poultry and other farm animals and pets. … especially  formulated to help animals with pain, inflammation, stress, anxiety…”
o “… formulated to help farm animals with stress,  anxiety, pain, inflammation, injuries…”
•    Snoop’s Chews CBD Dog Treats
o “… great for nervous dogs, dogs with pain issues and much more.”
o “… especially  formulated to help canines with pain, inflammation, stress, anxiety…”
o “… formulated to help canines with stress, anxiety, pain, inflammation, injuries…”
•    Snoop’s Drops CBD Tincture for Dogs
o “… specially  formulated to help your pup with pain, inflammation, stress, anxiety…”
o “… specially  formulated to help your dog or cat with stress,  anxiety [sic] pain, inflammation…”
•    Eli’s Drops CBD Tincture for Cats
o “… specially  formulated to help your kitty with pain, inflammation, stress, anxiety…”
Additional  claims observed on your website www.freestateoils.com  that establish  the intended use of your products as drugs include, but are not limited to, the following:
On your webpage titled “About CBD” at https://www.freestateoils.com//about-cbd- cannabidiol:
•    “CBD is a potent pain reliever. CBD reduces inflammation. This is important because inflammation is at the root of so many diseases.  CBD is very effective at stopping  epileptic seizures…”
•    “CBD IS PURPORTED TO HELP:
…Anxiety…Arthritis…Cancer...Epilepsy…Chronic  Pain…Neurodegenerative Diseases…Seizures…Stress…”
On your webpage titled “CBD Dosages  for Animals” at https://www.freestateoils.com/animal-dosages:
•    “Anti -ANXIETY || Anti - INFLAMMATORY || Anti - ARTHRITIC || Relieves PAIN || Anti - SEIZURE || Alleviates  MANY SYMPTOMS OF CANCER”
•    "CBD can be used in an especially  effective and non-toxic way to ease various medical problems in your pets and farm animals.”
Additional  claims observed on your social media sites www.facebook.com/freestateoils, www.instagram.com/freestateoils, and twitter.com/freestateoils  include, but are not limited to, the following:
•    On an August 29, 2020 post on your Facebook, Instagram, and Twitter with a graphic that includes a photograph of your Snoop’s  Drops states, “BENEFITS OF HEMP OIL FOR DOGS” and includes,  “Relieves Inflammation,” “Reduces Anxiety & Stress,” and “Reduces Muscle Spasms.”
•    On a May 12, 2019 post on Instagram  states, “What can #CBD do for #animals and our #furbabies ~ #anxiety #inflammation #arthritis #pain #seizures  #cancer #cbdoil #health #dogs #cats #horses #cows #freestateoils  ->> freestateoils.com/hemp-cbdpellets-for-farm-animals.”  The post includes a graphic with photographs  of several farm animals and pets, and includes statements such as, “Anti-ANXIETY || Anti - INFLAMMATORY || Anti - ARTHRITIC ||
Relieves PAIN || Anti - SEIZURE || Alleviates  MANY SYMPTOMS OF CANCER” as well as “Helps lower blood sugar levels.”
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
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.
5
According to your product labeling,  your “Whisper’s  Soothing  Grains CBD for Farm Animals” and “Snoop’s Chews CBD Dog Treats” are animal foods to which CBD has been added. Specifically, your product label depicted on your website www.freestateoils.com refers to “Whisper’s  Soothing  Grains CBD for Farm Animals” as “pellets” for horses, swine, poultry, and other farm animals and pets. Additionally,  your product label
depicted on your website www.freestateoils.com refers to “Snoop’s Chews CBD Dog Treats” as “soft treats just for dogs,” which are “beef flavored and easy to digest.” 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.
6
Food additives  require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in animal food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the animal food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
There is no animal food additive regulation that authorizes  the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection  Act, or the Meat Inspection Act). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods. FDA’s regulations  in 21 CFR 570.30(a)-(c) describe the criteria for eligibility  for classification of an animal food ingredient  as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before1958, through experience based on common use in animal food (see 21 CFR 570.30).
We know of no basis  for general recognition  of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available  literature, the data and information necessary  to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including,  but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.
FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient  in animal food. Therefore, CBD added to animal food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act, 21 U.S.C. 348. Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated  within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Therefore, your “Whisper’s Soothing Grains CBD for Farm Animals” and “Snoop’s Chews CBD Dog Treats” are adulterated  within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of an adulterated  animal food into interstate commerce is prohibited  under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Dietary Supplement Labeling
Information on your website at www.freestateoils.com  indicates  that you intend to market some of your CBD-containing products for humans as dietary supplements, including your “Allay CBD Soft Gels,” “Zing CBD Soft Gels,” “Fusion  Water-Soluble  CBD Liquid,” “Water-Soluble  CBD Powder,” and “Fusion Water-Soluble  CBD Vials.” We also note that you may intend to promote your “CBD Honey Straws” (flavored and  unflavored) as dietary supplements.  Specifically, there is Supplement Facts information on the web pages for all of the products listed above, including  your “CBD Honey Straws” (flavored and unflavored). 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.
7
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.
8
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 and social media websites that establish the intended use of your products as drugs include, but may not be limited to, the following:
On your website https://www.freestateoils.com/about-cbd-cannabidiol:
•    “Here are some of the things medical studies have found so far:
o CBD is a potent pain reliever
o CBD reduces inflammation.  This is important because inflammation is at the root of so many diseases.
o CBD is very effective at stopping epileptic seizures.
o CBD can help PTSD and potentially  other mood disorders in a safe and reliable  way according to a 2013 study.
o CBD can treat and protect you from neurodegenerative  diseases such as Alzheimers [sic], Multiple Sclerosis and Parkinson’s  Disease.”
•    “CBD IS PURPORTED TO HELP:
o ADD/ADHD
o Addiction
o Allergies
o Alzheimer’s  Disease
o Anxiety
o Arthritis
o Autism
o Cancer
o Epilepsy
o Chronic Pain
o Crohn’s Disease
o Delusions
o Depression
o Fibromyalgia
o Gastrointestinal  Issues
o Hallucinations
o Headaches
o Huntington’s  Disease
o Inflammation
o Inflammatory Bowel Disease (IBD)
o Insomnia
o Irritable Bowel Syndrome (IBS)
o Migraines
o Multiple Sclerosis
o Neurodegenerative  Diseases
o Obsessive Compulsive Disorder (OCD)
o Parkinson’s  Disease
o Psoriasis
o Psychosis
o Post-Traumatic  Stress Disorder (PTSD)
o Schizophrenia
o Seizures
o Skin Conditions
o Spasms
o Stress
o Withdrawal Symptoms”
On your Facebook, Twitter, and Instagram  social media websites at https://www.facebook.com/freestateoils,  https://twitter.com/freestateoils, and https://www.instagram.com/freestateoils/  from posts on December 19, 2020:
•    “CBD has been studied for its direct anti-neoplastic  properties  alone and in combination with standard cancer therapies,  yielding encouraging results  . . . Study reports taking CBD reduced cancer cells.”
On your Facebook, Twitter, and Instagram  social media websites at https://www.facebook.com/freestateoils,  https://twitter.com/freestateoils, and https://www.instagram.com/freestateoils/  from posts on August 2, 2020:
•    “I have been asking our customers if they have been infected with the Covid-19 virus.  I haven’t met or spoken to one that has.  So maybe there is truth to CBD keeping Covid-19 away?  Just maybe… Read the article in Forbes this month regarding  the benefits of CBD against Covid-19.”
On your Facebook, Twitter, and Instagram  social media websites at https://www.facebook.com/freestateoils,  https://twitter.com/freestateoils, and https://www.instagram.com/freestateoils/  from posts on June 13, 2020:
•    “CBD for Diabetes?  Study shows:  THCV found in the CBD HEMP Extract could represent a new therapeutic  agent in glycemic control in subjects with type 2 diabetes.”
On your Facebook, Twitter, and Instagram  social media websites at https://www.facebook.com/freestateoils,  https://twitter.com/freestateoils, and https://www.instagram.com/freestateoils/  from posts on June 12, 2020:
•    “CBD Study on Parkinson’s  disease  . . . ‘Treatment with CBD for 4 weeks decreased the psychotic symptoms.’ ‘In addition,  treatment with CBD for 6 weeks improves PD’s patients  [sic] quality  of life . . ..’”
On your Facebook, Twitter, and Instagram  social media websites at https://www.facebook.com/freestateoils, https://twitter.com/freestateoils, and https://www.instagram.com/freestateoils/  from posts on May 27, 2020:
•    “The results,  printed in online  journal Preprints, indicated hemp extracts high in CBD may help block proteins  that provide a ‘gateway’ for COVID-19… Igor, suggested  cannabis  could reduce the virus’ entry points  by up to 70 percent.” Accompanied by an image of a vial labeled “Coronavirus.”
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 your CBD- containing  products for humans.
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 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 CBD-containing products for humans 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
As discussed  above, although you may intend to market some of your products for human use as dietary  supplements, the products do not meet the definition of dietary supplements under section 201(ff) of the FD&C Act. According to your product labeling, your “CBD Honey Straws” (flavored and unflavored) and “CBD Gum Drops” are foods to which CBD has been added. We also note that you may intend to promote your “Fusion Water-Soluble  CBD Liquid,” “Water-Soluble  CBD Powder,” and “Fusion Water-Soluble CBD Vials” as conventional food products. Specifically, you suggest  that consumers  add your “Fusion Water-Soluble  CBD Liquid,” “Water-Soluble  CBD Powder,” and “Fusion Water-Soluble  CBD Vials” to conventional foods such as pudding, cottage cheese, and soup.
In regard to your “CBD Honey Straws” (flavored and unflavored) and “CBD Gum Drops,” and, to the extent you intend to promote your “Fusion Water-Soluble  CBD Liquid,” “Water-Soluble  CBD Powder,” and “Fusion  Water-Soluble  CBD Vials” 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. FDA has concluded that the prohibition  in section 301(ll) applies to CBD, as described above. There is an exception if the substance was marketed in food before the drug was approved or before the substantial  clinical investigations  involving the drug had been instituted.  However, based on available evidence, FDA has concluded that  this is not the case for CBD. FDA is not aware of any evidence that would call into question  its current conclusion that section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), prohibits  the introduction into interstate commerce of any food to which CBD has been added, but you may present FDA with any evidence bearing on this issue.
You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term "food additive" refers to any substance the intended  use of which results in its becoming a component of any food, unless  the substance is generally recognized  as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.
9
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) of the FD&C Act. Therefore, your “CBD Honey Straws” (flavored and unflavored) and “CBD Gum Drops” are adulterated within the meaning of section 402(a)(2)(C)(i) because they bear or contain an unsafe food additive. 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 lead to legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations,  as well as copies of related documentation.  If you believe that your products are not in violation of FD&C Act, include your reasoning and any supporting information for our consideration.  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.
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 e-mail 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
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
1
As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
2
Including, but not limited to:  “CBD Tincture Unflavored 1,000 mg,” “CBD Hemp Balm 500 mg,” “Honey Lip Balm with CBD,” “Allay CBD Soft Gels,” “Unified Mind CBD Vape Refill,” “CBD Honey  Straws,” “CBD Gum Drops,” “Honey Cream Herbal Lotion with CBD,” and “Migraine Mender Roll-on Herbal Headache Relief .” The claims mentioned in this letter relate to all human products sold on your  website. Accordingly, this letter applies to all of your CBD-containing products for human use.
3
Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
4
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential- actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
5
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.
6
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.
7
See Footnote 5 above.
8
We also note that the labeling for your “Unified Mind CBD E-Liquid” is a “Vape Refill.” The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) of the FD&C Act as a product  that is “intended for ingestion.” Because vaping is intended to enter the body directly through inhalation, this product is not intended for ingestion. Therefore, your “Unified Mind CBD E-Liquid”  product does not meet the definition of a dietary supplement under the FD&C Act for this additional reason.
9
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