WARNING LETTER
Whole Leaf Organics, LLC
MARCS-CMS 593176 —
November 22, 2019
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Recipient:
Recipient Name
Jane Kim
Whole Leaf Organics, LLC
14900 Magnolia Blvd #57347
Sherman Oaks
,
CA
91413
United States
janeatwholeleaf@gmail.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
WARNING LETTER
November 22, 2019
RE: 593176
Dear Ms. Kim:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at
www.wholeleaforganics.com
in September 2019 and
has determined that you take orders there for the products “CBD-EX,” “CBD MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame,” all of which you promote as products containing cannabidiol (CBD).
The claims on your website establish that your “CBD-EX,” “CBD MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame”
products
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, these products 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-EX,” “CBD-MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame” products 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).
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
.
Dietary Supplement Labeling
Information on your website at
www.wholeleaforganics.com
indicates that you intend to market your “CBD-EX,” “CBD MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame”
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.
[1]
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.
[2]
Unapproved New Drugs
Based on our review of your website, your “CBD-EX,” “CBD MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
Examples of claims observed on your website that establish the intended uses of your products as drugs include, but may not be limited to, the following:
On your product page for “CBD Defend”:
“CBD Defend contains CBD…associated with decreasing the risk for cancer development…fighting DNA damage and reversing manipulation at the cellular level.”
On your product page for “CBD-EX”:
“[W]hole Leaf Organics CBD-EX…CBD isolate and Curcumin. Touted for their cancer fighting properties…”
“Typically used in cancer proactive protocols, CBD-EX is beneficial for people and animals struggling with arthritis, auto immune disorders, and skin dermatitis.”
On your product page for “CBD-Rx”:
“CBD-Rx...Eight times stronger then [
sic
] traditional CBD, our formulation can be used in cancer proactive protocols…”
“CBD-Rx is…recommended for inflammatory issues and immune related disorders.”
On your webpage titled “High Intensity Inflammation Relief”:
“CBD-Enflame…Why People Choose Enflame. Advanced Stage Cancer…Enflame attacks cancer cells and help those struggling with advanced stage cancers…”
On your webpage titled “Extraordinary Genius”:
“CBD-EX seeks to inhibit the spread of mutated malignant cells…mitigate the spread of cancer cells…”
Under the heading “Nothing But Extraordinary”:
“CBD-EX…effective in regards [
sic]
to inhibiting the growth of cancerous cells.”
“[P]roven to be effective when combating cancer cells…it has been able to kill cancer cells, as well as prevent additional cells from growing.”
Under the heading “Why People Choose CBD-EX”:
“Cancer”
“Histamine Related Issues…CBD-EX can assist in fighting against histamine responsive cancers…”
On your webpage titled “CBD-RX: Innovation At Its Finest”:
“Whole Leaf Organics CBD-Rx is a … cannabinoid nutraceutical line. Our formulations have been proven to be effective at reducing inflammation, and minimizing the way cancer cells manipulate neighbor cells . . . ”
“Our prescription strength CBD-Rx products are effective for both therapeutic and maintenance needs … [O]ur cannabinoid extracts focus specifically on inflammation reduction, minimizing manipulation of other cells as tumors spread and work to ravage through the body.”
“While effective in combatting cancer, cannabinoids have been proven to be beneficial in reducing arthritis, and immune mediated responses.”
Under “Why People Choose CBD-RX”:
“Blood Cancers … Effective for both people and animals.”
“Seizures…reduce the occurrence of seizures in children, people as well as animals.”
“Auto Immune…useful in regards [
sic
] to fighting against…auto immune disorders.”
“Multiple Sclerosis…cannabinoids can help reduce inflammation assisting those suffering from nervous system and brain disorders like Multiple Sclerosis.”
On your webpage titled “Take Control of Your Life”:
“Our CBD-EX formulation is specifically created to combat cancer…”
“Cancer division…CBD MAX…works to inhibit the division of mutated cells.”
Your “CBD-EX,” “CBD MAX,” “CBD-RX,” “CBD Defend,” and “CBD Enflame”
products 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 FDA-approved applications in effect for any of the above-mentioned products.
Misbranded Drugs
Your “CBD-EX,” “CBD MAX,” “CBD-RX,” “CBD Defend,” and “CBD Enflame”
products 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, 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).
Unapproved New Animal Drugs
During our review of your firm’s website, www.wholeleaforganics.com, FDA determined that your firm is marketing the unapproved new animal drugs “CBD-EX,” “CBD-MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame.” Based on our review of your website, your CBD-EX,” “CBD-MAX 1000 mg,” “CBD-RX,” “CBD Defend,” and “CBD Enflame” 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 mitigation, treatment, or prevention of diseases 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 firm’s website www.wholeleaforganics.com that show the intended uses of these products include, but are not limited to, the following:
On your webpage titled “Perfect For Your Pets”:
“Dogs suffering from cancer, it is no different from a person struggling through the same. Supplements that target specific issues, we believe should be universal. Whole Leaf Organics supplements, CBD tinctures, and full spectrum probiotics - are effective at combatting disease in our animals.”
On your webpage titled “Making A Difference: Connecting you back to that place within your life…”:
“Beneficial and safe for both people and animals, CBD has been known to reduce inflammation, assist with chronic fatigue, alleviate joint and muscle pain, and help in regards to the management of stress and anxiety.”
On your webpage titled “CBD-RX: Innovation at its Finest”:
“CBD-RX is crafted to focus specifically on minimizing cell mutation, reducing inflammation at the cellular level. Effective for both people and animals.”
“Reducing systemic inflammation, isolating specific cannabinoids can be beneficial in helping to reduce the occurrence of seizures in children, people, as well as animals.”
On your webpage titled “Extraordinary Genius”:
“…CBD EX combines the most effective cancer and immune regulating clinically tested components into one simple supplement.”
“Effective in regards to animal cancer as well Curcumin is an effective inflammation reducing compound, safe for both cats and dogs.”
On your product webpage for “
CBD-RX
”:
“Clinically tested, our CBD-Rx is practitioner formulated and Naturopath recommended for inflammatory issues and immune related disorders.”
“Eight times stronger then traditional CBD, our formulation can be used in cancer proactive protocols, as well as daily life to maintain a healthy immune system and minimize histamine causing inflammatory compounds.” (
sic
)
On your product webpage for “CBD-EX”:
“Touted for their cancer fighting properties, Coriolis PSP (Turkey Tail) and Curcumin offer anti inflammatory benefits…”
“Containing clinically tested ingredients, CBD-EX reduces inflammation on the cellular level. Typically used in cancer proactive protocols, CBD-EX is beneficial for people and animals struggling with arthritis, auto immune disorders, and skin dermatitis.”
On your product webpage for “CBD Defend”:
“Silymarin is associated with decreasing the risk for cancer development by boosting the immune system, fighting DNA damage and reversing manipulation at the cellular level.”
On your product webpage for “CBD MAX 1000mg”:
“…that works to site target areas in the body that are compromised and inflamed.”
“CBD Max its the ultimate in high intensity immune system and inflammation support.” (
sic
)
On your product webpage for “CBD Enflame”:
“…that work reduce inflammation at the cellular level.” (
sic
)
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, unless the drug was marketed in animal food before any substantial clinical investigations involving the drug were instituted.
[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 prohibits the introduction into interstate commerce of any animal 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 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.
[4]
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.  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).
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, CDER/OC/Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by email 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
[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 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.
[2]
We also note that your “CBD Enflame,” “CBD Rx,” and “CBD Defend” products bear directions for use as sublingual products. 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. Therefore, your “CBD Enflame,” “CBD Rx,” and “CBD Defend” products do not meet the definition of a dietary supplement under the FD&C Act for this additional reason.
[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)(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:
11/25/2019
Regulated Product(s)
Drugs