WARNING LETTER
NextL3vel Services Group, LLC dba This Stuff Is Good For You
MARCS-CMS 610446 —
December 22, 2020
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Michael L. Cabarus and Ryan A. Rodriguez
Recipient Title
Managing Members
NextL3vel Services Group, LLC dba This Stuff Is Good For You
3400 W. Desert Inn Rd. Suite 2
Las Vegas
,
NV
89102
United States
admin@thisstuffisgoodforyou.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
December
22, 2020
RE: 610446
Dear Mr. Cabarus and Mr. Rodriguez:
This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.thisstuffisgoodforyou.com in September and December 2020 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 https://www.facebook.com/tsigfy and https://www.instagram.com/tsigfy; these websites direct consumers to your website www.thisstuffisgoodforyou.com to purchase your products. In addition, we observed that your website offers CBD products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19
[1]
in people. The claims on your website and social media website establish that all strengths and varieties of your CBD products for human use
[2]
are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a). 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). In addition, your products reLeaves 40mg CBD Pet Shampoo, reLeaves Full-Spectrum CBD Dried Dog Treat Cookies (all strengths), reLeaves CBD Broad Spectrum Tincture (all varieties), and reLeaves CBD Full Spectrum Tincture (all varieties) are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
The Agency is particularly concerned that you market your CBD products for use in children. For example, a February 11, 2020 post on your Facebook page at https://www.facebook.com/tsigfy, includes a graphic that features a young child beside the statement “CBD FOR CHILDHOOD ADD/ADHD.” Your post states “How Does CBD Oil Help Kids with ADHD? . . . you can use CBD to treat ADHD . . .  #ADD #ADHD #ChildhoodADD #ChildHealth #CBDoil #CBDforADD #CBDforADHD #HempCBD.” Your products have not been evaluated by the Agency for safety, effectiveness, and quality. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations such as children who may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.
In addition, your CBD Vape products are particularly concerning to the agency because the ingredients and potential impurities in oral inhalation products may trigger laryngospasm and bronchospasm and may be toxic to the tissues in the upper or lower airways. Inhalation products that are intended to act locally in the respiratory system also may be absorbed and exert undesirable systemic effects, such as increased heart rate or elevated blood pressure.
Further, your reLeaves Vision+ 20mg CBD Eye Drops product is especially concerning from a public health perspective because ophthalmic drug products can pose serious risk of harm to humans and/or animals if toxic substances are introduced directly into the eye because irreversible damage, including vision loss, can result.
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
.
Unapproved New Drugs
Based on our review of your websites, your CBD products for human use 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 at www.thisstuffisgoodforyou.com and your social media websites at https://www.facebook.com/tsigfy and https://www.instagram.com/tsigfy that establish the intended use of your products as drugs include, but may not be limited to, the following:
On your Facebook page at https://www.facebook.com/tsigfy/:
On December 7, 2020, your reposted an August 6, 2020 post that states: “EXPERTS SAY CBD FOR COVID19 TREATMENT - Experts from the University of Nebraska and the Texas Biomedical Research Institute are recommending scientists study the potential use of cannabis-derived CBD in anti-viral therapies, due to its known anti-inflammatory properties . . . FOR immediate relief you can trust choose reLeaves Full-Spectrum CBD only at TSIGFY.com  . . . #CBD #reLeaves #FullSpectrumCBD #Covid19Treatment #NaturalCures #GoodStuff  #Immunity”
On your product page for reLeaves Vision+ 20mg CBD Eye drops, at https://thisstuffisgoodforyou.com/product/releaves-vision-20mg-cbd-eye-drops/:
“Excellent for Ocular Degeneration or disorders such as but not limited to Glaucoma, Cataracts, Diabetic Retinopathy.”
On your webpage titled “What is CBD? Commonly known as Cannabidiol,” at https://thisstuffisgoodforyou.com/what-is-cbd-commonly-known-as-cannabidiol/:
Under “CBD Benefits”
“It also has anti-oxidant properties for treatment of nerve related conditions. Anti-tumoral and anti-cancer properties to combat tumor and cancer cells. And anxiolytic and anti-depressant properties to fight anxiety and depression.”
“[C]BD-rich cannabis . . . makes this an ideal option for people seeking relief from inflammation, pain, anxiety, psychosis, seizures, spasms, and other conditions . . . Long story short, CBD is now available as CBD Hemp Oil, and is used as a medicine for various purposes . . .”
“The medicinal applications of CBD are wide. CBD is current[
sic
] being used for . . . diabetes, seizures and even cancer.”
On your Facebook page at https://www.facebook.com/tsigfy/:
On March 14, 2019 you posted: “LUNG CANCER PATIENT'S TUMORS SHRUNK IN HALF AFTER USING CBD OIL - An 81-year-old man, who has not yet been identified, managed to shrink his tumors in half after being diagnosed with lung cancer and refusing traditional cancer treatment such as chemotherapy and radiation. The man, who previously smoked around 18 cigarettes per day but quit 45 years ago, repeatedly refused medical treatments offered by doctors after being diagnosed with adenocarcinoma of the lung, opted to take cannabidiol (CBD) oil instead. After three months of almost daily use, scans of the man’s lungs showed that, not only did the tumors reduce in size by half, but the progression of the disease was completely reversed. <READ MORE..> #CBD #CBDOIL #CANNABISOIL #CANCER #LUNGCANCER #TSIGFY”
On your Instagram page at: https://www.instagram.com/tsigfy:
On August 19, 2020 you posted a graphic that includes: “THIS STUFF is GOOD for YOU.COM . . .VISION+CBD Eye DROPS . . . Also assists in combating ocular degeneration or inflammatory conditions such as (but not limited to) #glaucoma, #cataracts, #floaters, and diabetic #retinopathy. #HempCBD #CBDeyeDrops #EyeHealth”
On March 13, 2020 you posted a graphi­c that includes: “PREMIUM­­ Full-Spectrum HEMP CBD,” “reLeaves,” “CBD,” “Inhibits cancer cell growth,” and “HIV/AIDS.”
Your
CBD products for human use
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). 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) unless they are over-the-counter (OTC) drugs lawfully marketed under section 505G of the FD&C Act (which is not the case for these products). 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 products for human use
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. 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, under 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved applications are in effect for them. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
301(ll) and Adulterated Human Foods
We note that your CBD Sleep Syrup (all flavors), Day Time CBD Vegan Gummy’s, Night Time CBD Vegan Gummy’s, Chronic Candy CBD Infused Lollipop (all flavors and strengths), and Chronic Candy CBD Gourmet Chocolate Budz (all flavors) products appear to be promoted as conventional human foods. For example, your product webpages for your CBD Sleep Syrup products direct consumers to “[p]our . . . into a favorite beverage and ENJOY!” You describe your Day Time CBD Vegan Gummy’s and Night Time CBD Vegan Gummy’s as “delicious.” Additionally, both your CBD Infused Lollipops and your CBD Gourmet Chocolate Budz are sold under the “Chronic Candy” brand. Furthermore, your CBD Infused Lollipops product webpages state, “[i]ndugle your tastebuds in a classic lollipop treat,” and that “[f]eeling great just became that much tastier!” Your CBD Gourmet Chocolate Budz product webpages describe them as “chocolate treats.”  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.
[3]
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.
[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.
We also note that your website indicates that melatonin is an ingredient in your
CBD Sleep Syrup products
.  You should be aware that there is no food additive regulation which authorizes the use of melatonin.  We are not aware of any information to indicate that melatonin is the subject of a prior sanction (see 21 CFR 181).
Furthermore, we are not aware of any basis to conclude that melatonin is GRAS for use in conventional foods.
We know of no basis for general recognition of safety for melatonin based either on scientific procedures or common use in food prior to January 1, 1958 (see 21 CFR 170.30).  Melatonin is a neurohormone that is used for medicinal purposes, primarily as a sleep aid in the treatment of sleep-related disorders.  Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of melatonin in food meets the criteria for GRAS status.  On the contrary, reports in the scientific literature have raised safety concerns about the use of melatonin.  Among these are concerns about effects on blood glucose homeostasis, and effects on the reproductive/developmental, cardiovascular, ocular and neurological systems.  Therefore, based on our review, the use of melatonin 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 melatonin for use as an ingredient in a conventional food. Therefore, melatonin added to a conventional food is a food additive under section 201(s) of the Act, 21 USC 321(s), and is subject to the provisions of section 409 of the 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.  Melatonin 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).
Unapproved New Animal Drugs
During our review of your firm’s website, www.thisstuffisgoodforyou.com, and your social media sites, https://www.instagram.com/tsigfy and https://www.facebook.com/tsigfy/
,
FDA determined that your firm is marketing the unapproved new animal drugs reLeaves 40mg CBD Pet Shampoo, reLeaves Full-Spectrum CBD Dried Dog Treat Cookies (all strengths), reLeaves CBD Broad Spectrum Tincture (all varieties), and reLeaves CBD Full Spectrum Tincture (all varieties). Based on our review of your websites, your products
reLeaves 40mg CBD Pet Shampoo, reLeaves Full-Spectrum CBD Dried Dog Treat Cookies (all strengths), reLeaves CBD Broad Spectrum Tincture (all varieties), and reLeaves CBD Full Spectrum Tincture (all varieties) are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.
Examples of claims observed on your website www.thisstuffisgoodforyou.com and social media site https://www.instagram.com/tsigfy that show the intended uses of your products as drugs include, but are not limited to, the following:
On your product webpage for reLeaves 40mg CBD Pet Shampoo, at https://thisstuffisgoodforyou.com/product/4oz-releaves-40mg-cbd-pet-shampoo/:
Under “Description”:
“Medicinal grade pet shampoo, derived from premium hemp extract, designed to relieve inflammation... and promote healing.”
On your Instagram page:
On a March 5, 2019 post with a photograph of your reLeaves 40mg CBD Pet Shampoo product: “Or maybe your #pup is a trifle #anxious or has some type of skin disorder?? These conditions can be aided by our medicinal grade pet shampoo! ... designed to relieve #inflammation, ... and promote #healing…”
On your product webpage for reLeaves 150mg Full-Spectrum CBD Dried Dog Treat Cookies, at https://thisstuffisgoodforyou.com/product/releaves-150mg-full-spectrum-cbd-dried-dog-treat-cookies-30x5mg/:
Under “Description” and on a graphic in the product photograph section:
“CBD is GOOD for Your Pet’s…Pain. Anxiety. Seizures. Tumors. Arthritis....”
On your product webpage for reLeaves 300mg Full-Spectrum CBD Dried Dog Treat Cookies, at https://thisstuffisgoodforyou.com/product/cbd-dried-dog-treat-cookies/
:
On a graphic in the product photograph section:
“CBD IS GOOD FOR YOUR PET’S…PAIN. ANXIETY. SEIZURES. TUMORS. ARTHRITIS....”
Additional claims observed on
your social media site https://www.instagram.com/tsigfy
include, but are not limited to, the following:
On a February 6, 2020 post with a video: “reLeaves CBD Dog Treats.... Excellent for seperation [sic] anxiety or anxiety in general, ...pain-management relief, antiseizure [sic], gut inflammation, pancreatitis, cancers and benign tumors, anti-inflammatory,, sleep aid...! ... ... #reLeaves #reLeavesPets #PetAnxiety ...#CBDPETS #PETPAINMANAGEMENT”
For your reLeaves 40mg CBD Pet Shampoo, reLeaves Full-Spectrum CBD Dried Dog Treat Cookies (all strengths), reLeaves CBD Broad Spectrum Tincture (all varieties), and reLeaves CBD Full Spectrum Tincture (all varieties) additional claims observed on
your social media site https://www.instagram.com/tsigfy
include, but are not limited to, the following:
On a February 20, 2020 post: “... CBD Pet Treats, CBD Oils and Tinctures, CBD Pet Care ... Premium Bath & Body Products. reLeaves Full-Spectrum CBD is GOOD for your pet's seperation [sic] anxiety, anxiety in general, ...natural anti-inflammatory [sic]...,  siezures [sic], pain-management, tumor and cancer fighting...!”
On a January 7, 2019 post: “... Our #CBDtinctures are safe to use for #dogs, #rabbits #birds and #cats, #horses!!” The post includes a graphic that states, “CBD IS GOOD FOR YOUR PETS…ANXIETY. TUMORS. ARTHRITIS. SEIZURES …!”
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-l. These products are not approved or index listed by the FDA, and therefore these products are considered unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of these adulterated drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
301(ll) and Adulterated Animal Foods
Moreover, 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, as described above.
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.
[5]
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 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).
Conclusion
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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.
You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to
FDAADVISORY@fda.hhs.gov
.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/S/
Eric Nelson
Director of Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Food and Drug Administration
/S/
William A. Correll
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[1]
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.  In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.  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 such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
[2]
Your CBD products for human use include but are not limited to: your reLeaves Vision+ 20mg CBD Eye Drops, your tinctures, such as reLeaves CBD Broad Spectrum Tincture (all varieties) and reLeaves CBD Full Spectrum Tincture (all varieties), your topical products, such as reLeaves Maximum Strength Muscle Gel (all varierties), your CBD vape products, such as TKO CBD Vape Oil, your capsule products, such as reLeaves CBD Full Spectrum (all varieties), your CBD Sleep Syrup (all flavors), your Day Time CBD Vegan Gummy’s, your Night Time CBD Vegan Gummy’s, your Chronic Candy CBD Infused Lollipop (all flavors and strengths) and your Chronic Candy CBD Gourmet Chocolate Budz (all flavors).
[3]
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
Sativex Commences US Phase II/III Clinical Trial in Cancer Pain
and
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.
[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.
Content current as of:
12/22/2020
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages