WARNING LETTER
Homero Corp DBA Natures CBD Oil Distribution
MARCS-CMS 605222 —
April 20, 2020
Delivery Method:
Via Overnight Delivery
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Mr. Michael Johnson
Homero Corp DBA Natures CBD Oil Distribution
297 S. Willow St. Unit 1
Manchester
,
NH
03103
United States
info@naturescbdoil.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Center for Veterinary Medicine
Center for Food Safety and Applied Nutrition
WARNING LETTER
April 20, 2020
RE: 605222
Dear Mr. Johnson:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://naturescbdoilnh.business.site/ (directs consumers to https://naturescbdoil.com/) in March 2020 and has determined that you take orders there for various human and animal products, all of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media website at www.facebook.com/naturescbdoil/; this website directs consumers to your website https://naturescbdoil.com to purchase your products. The claims on your website and social media website establish that all strengths and varieties of “Natures Pure CBD Oil,”
1
various topical CBD products
2
and CBD edibles
3
(hereinafter all called “your CBD-containing products for humans”) are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (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). In addition, your CBD products for dogs and cats
4
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). FDA has also determined that your “CBD Froggies 25mg,” “CBD Froggies 50mg,” “CBD Edibles 200mg Frogs,” “CBD Edibles 100mg Frogs,” and “CBD Gummies” products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your “CBD Froggies 25mg,” “CBD Froggies 50mg,” “CBD Edibles 200mg Frogs,” “CBD Edibles 100mg Frogs,” and “CBD Gummies” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find 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/publichealth-focus/fda-regulation-cannabis-and-cannabis-derived-products-includingcannabidiol-cbd.
Dietary Supplement Labeling
Information on your website at https://naturescbdoil.com/ indicates that you intend to market your “Natures CBD 300 mg” (all flavors), “Natures CBD 600 mg” (all flavors) and “Natures CBD 1000 mg” (all flavors) products as dietary supplements. However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.
5
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.
6
Unapproved New Drugs
Based on our review of your 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 https://naturescbdoil.com/ that establish the intended use of your products as drugs include, but may not be limited to, the following:
On your webpage titled “Opioid Addiction: How CBD Oil Can Help”:
• “Natures Pure CBD has had success in alleviating severe withdrawal symptoms associated with opiate dependency. Natures Pure CBD also has taken off the ball and chain around the opiate addicts’ neck and has relieved the addiction totally by using Natures Pure CBD restoring the person back to a quality of life worth living.”
• “The Opiate addiction rate of recovery is low and Natures Pure CBD oil offers promise for those suffering from chronic opiate use.”
• “Natures Pure CBD oil works for these medications which all have addictive properties to them: opium, fentanyl, heroin, hydrocodone, oxycodone, methadone, morphine and hydromorphone. Natures Pure CBD Oil has been effective in the treatment and eradication of opiate use.”
On your webpage titled “CBD Oil Helps with Alcohol and Drug Addiction”:
• “CBD Oil for the treatment of cannabis withdrawal syndrome.”
• “Early Phase in the Development of CBD as a Treatment for Addiction: Opioid Relapse Takes Initial Center Stage”
• “CBD Oil Inhibits the reward-facilitating effect of morphine”
On your webpage titled “CBD Oil Benefits”:
• “CBD Oil for AIDS Virus”
• “CBD Oil for Alzheimer’s Disease”
• “CBD Oil for Autism”
• “CBD Oil for Cancer”
• “CBD Oil for Diabetes”
• “CBD Oil for Alzheimer’s Disease”
• “CBD Oil for Heart Disease”
• “CBD Oil for Kidney Disease”
• “CBD Oil for Liver Disease”
• “CBD Oil for Parkinson’s Disease”
• “CBD Oil for Prion/Mad Cow Disease”
• “CBD Oil for Stroke and TBI”
On your webpage titled “CBD Oil for Asthma”:
• “Vaping CBD Oil to Treat Asthma . . . Your best best [sic] to combat Asthma is by vaping CBD Oil. When you vape cbd oil, the cbd oil goes directly into your lungs, and you will notice a positive difference in your Asthma usually in day 1. Sometimes it takes people longer up to 2 weeks to feel the difference in their Asthma when vaping cbd oil.”
• “CBD creates a natural calm which would be very useful during an asthma attack.”
On your webpage titled “Nature’s Oil – Types of Products”:
• “Natures Pure CBD is a strong anti-oxidant that can alleviate lower epileptic seizures, psychotic disorders, and has neuroprotective qualities.”
• “CBD can change gene expression and help remove amyloid plaque associated with Alzheimer’s disease.”
• “CBD Oil Tincture with CBD Pain Cream works incredibly fast for people that suffer major health issues such as Inflammation issues, Rheumatoid Arthritis, Back and Joint Pain.”
• CBD Edibles work great also. Real easy and great for on the go.
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). 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 FDAapproved 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. 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
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 food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD. There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on the available evidence discussed above, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), prohibits the introduction into interstate commerce of any food to which CBD has been added, but you may present FDA with any evidence bearing on this issue.
According to your product labeling, your “CBD Froggies 25mg,” “CBD Froggies 50mg,” “CBD Edibles 200mg Frogs,” “CBD Edibles 100mg Frogs,” and “CBD Gummies” products are foods 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.
7
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act (21 U.S.C. 348(a)), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
There is no food additive regulation which authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).
We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS status. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. Therefore, based on our review, the use of CBD in your products does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food. Therefore, CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act 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 Froggies 25mg,” “CBD Froggies 50mg,” “CBD Edibles 200mg Frogs,” “CBD Edibles 100mg Frogs,” and “CBD Gummies” products are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Animal Drugs
During our review of your firm’s website www.naturescbdoil.com, FDA determined that your firm is marketing CBD-containing products for dogs and cats that are unapproved new animal drugs: “Natures Pet CBD,” “CBD Drops Small Dog,” “CBD Drops Large Dog,” “CBD Drops Medium Dog,” and “CBD Drops Cat Formula.” Based on our review of your website, your CBD-containing products for dogs and cats 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 www.naturescbdoil.com that show the intended use of your products for dogs and cats as drugs include, but may not be limited to, the following:
On your webpage titled “CBD Oil For Pets”, along with each of your product pages for your CBD-containing products for animals:
• “Works incredibly well for joint pain for pets.”
• “Works especially well for pets that have seizures.”
• “Works great for anxiety in pets.”
• “Works great for aggression in pets.”
On your webpage titled “Who Can Use CBD Oil”:
• “CBD oil works great for pets that have anxiety issues, hyperactive issues, and ptsd issues.”
On your webpage titled “Natures CBD Oil -Types of CBD Products”:
• “
CBD For Pets
works great for older dogs and cats. Perfect for pets that have joint pain, seizures and anxiety issues.”
Additional claims observed on your social media site www.facebook.com/naturescbdoil/ include, but may not be limited to, the following:
• September 5, 2018 post:
o “What is CBD oil known to do for pets? Works incredibly well for joint pain for pets. Works especially well for pets that have seizures. Works great for anxiety in pets. Works great for aggression in pets.”
Your CBD-containing products for animals are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-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).
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 the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or 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 Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
____________________________________________________
1
Specifically, your CBD oil products are “Natures CBD Medical Formula 350 mg,” “Natures CBD Medical Formula 600 mg,” “Natures CBD Medical Formula 1200 mg,” “Natures CBD Medical Formula 1500 mg,” “Natures CBD Medical Formula 2000 mg,” “Natures CBD Enhanced Formula 300 mg,” “Natures CBD Enhanced Formula 750 mg,” “Natures CBD Enhanced Formula 1200 mg,” “Natures CBD Enhanced Formula 2500 mg,” “Natures CBD 300 mg” (all flavors), “Natures CBD 600 mg” (all flavors), and “Natures CBD 1000 mg” (all flavors), listed for sale at https://naturescbdoil.com/natures-pure-cbd-oil-tinctures/
2
Specifically, your CBD topical products are “Natures Pure CBD Pain Cream 2000 mg” and the following Green Roads products: “Muscle and Joint Heat Relief 250 mg,” “Muscle and Joint Heat Relief 300 mg,” “Muscle and Joint Heat Relief 500 mg,” and “CBD Pain Cream 150 mg,” listed for sale at https://naturescbdoil.com/best-cbd-pain-cream/
3
Specifically, your CBD “edible” products are the following Green Roads’ products: “CBD Froggies 25mg,” “CBD Froggies 50 mg,” “CBD Edibles 200 mg Frogs,” “CBD Edibles 100 mg Frogs,” “CBD Gummies,” and “CBD Capsules 750 mg,” listed for sale at https://naturescbdoil.com/best-cbd-ediblesfor-anxiety/
4
Specifically, your CBD products for dogs and cats are “Natures Pet CBD” and the following Green Roads products: “CBD Drops Small Dog,” “CBD Drops Large Dog,” “CBD Drops Medium Dog,” and “CBD Drops Cat Formula,” listed for sale at https://naturescbdoil.com/cbd-oil-for-pets/.
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 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.
6
We also note that the labeling for your “Natures CBD 300 mg” (all flavors), “Natures CBD 600 mg” (all flavors), and “Natures CBD 1000 mg” (all flavors) products states that the products are “designed for dual purpose use, sublingual under the tongue, or for vapes.” 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 sublingual products are intended to enter the body directly through the skin or mucosal tissues, they are not intended for ingestion. Similarly, because vaping products are intended for inhalation, they are not intended for ingestion. Therefore, your “Natures CBD 300 mg” (all flavors), “Natures CBD 600 mg” (all flavors), and “Natures CBD 1000 mg” (all flavors) products do not meet the definition of a dietary supplement under the FD&C Act for this additional reason.
7
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:
04/23/2020
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages