WARNING LETTER

Wellness BioSciences Rx MARCS-CMS 609604 — December 22, 2020

Delivery Method:: Via Email
Product:: Drugs
Food & Beverages

Recipient:: Recipient Name

Barry Cocheu; Recipient Title

CEO; Wellness BioSciences Rx; 9789 Katy Freeway # 1801
Houston, TX 77024
United States; info@wbrxglobal.com; support@wbrxglobal.com

Issuing Office:: Center for Drug Evaluation and Research | CDER; United States

WARNING LETTER

December 22, 2020

RE: 609604

Dear Mr. Cocheu:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://wbrxglobal.com in September and December 2020, and has observed that you take orders there for “WBRx Metered-Dose Inhaler,” “WBRx Balance Softgels CBD,” “WBRx Pure Wellness CBD” (“WBRx Combo Pack”), “WBRx Energy Oil Drops CBD,” “WBRx Relief Balm CBD,” and “WBRx Sleep Oil Drops CBD” (hereinafter referred to as “your CBD products”), all of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media website at https://www.twitter.com/wellnessbiosrx, which directs consumers to your website https://wbrxglobal.com to purchase your products. The claims on your website and social media website establish that your CBD 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 sold in violation of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).

Your “WBRx Metered-Dose Inhaler” is intended to deliver CBD through oral inhalation and, according to your webpage https://wbrxglobal.com/blog/dr-jasani-the-timely-release-of-the-wbrx-metered-dose-inhaler/, you state “CBD has proven to be a great anxiolytic with no addiction or overdose potential and the WBRx MDI inhaler provides this plant based CBD compound in aerosolized form through an inhaler that makes it extremely bioavailable.” This product is particularly concerning to the agency because the ingredients and potential impurities in oral inhalation sprays 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.

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 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 websites that establish the intended use of your CBD products as drugs include, but may not be limited to, the following:

On your website https://wbrxglobal.com/blog/study-finds-cbd-may-be-powerful-nootropic-by-boosting-brain-blood-flow/; from an August 17, 2020 blog posting by Barry Cocheu titled “Study Finds CBD May Be Powerful Nootropic by Boosting Brain Blood Flow”:

“Cannabidiol, more commonly called CBD, has grown in popularity as a medicinal substance, with users claiming a variety of benefits ranging from better sleep to pain relief and more. Select past research has linked the compound with improvements in psychiatric issues, such as easing PTSD, anxiety, and psychotic symptoms in sufferers. As well, there have been indications that CBD may help reduce dementia symptoms in people diagnosed with Alzheimer’s disease . . ..”

On your website https://wbrxglobal.com/blog/cbd-your-immune-system/; from a July 7, 2020 blog posting by Barry Cocheu titled “CBD & Your Immune System”:

“How does CBD affect the immune system? . . . CBD acts as an immunosuppressive agent, tied closely with its anti-inflammatory activity, which helps downregulate overactive immune or autoimmune responses that play prominent roles in disease processes such as multiple sclerosis, diabetes, asthma, rheumatoid arthritis, and many cancers or malignant conditions . . . CBD is able to achieve immunosuppression, by binding CB2 receptors . . . directly causing cell death, inhibiting proliferation/recreations, decreasing immune chemical signalers, and upregulating T regulating cells. . . . [L]et’s have a quick look at the specific disease process and immune responses in the body that are affected by CBD . . . Alters lipid metabolism increasing anandamide (an endocannabinoid) . . . Immune regulation . . . Cell death/Apoptosis . . . Asthma . . . Autoimmune Hepatitis . . . Colitis . . . HIV/Human Immuno-deficiency Virus . . . Diabetes . . ..”

On your website https://wbrxglobal.com/studies-trials-and-important-resources/; webpage titled “Studies, Trials, and Important Resources”:

“Cannabidiol in Anxiety and Sleep: A Large Case Series[,] Objective: To determine whether CBD helps improve sleep and/or anxiety in a clinical population. Conclusion: Cannabidiol may hold benefits for anxiety-related disorders.”
“Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome[,] Background: The Dravet syndrome is a complex childhood epilepsy disorder that is associated with drug-resistant seizures and a high mortality rate. We studied cannabidiol for the treatment of drug-resistant seizures in the Dravet syndrome. Result: Among patients with the Dravet syndrome, cannabidiol resulted in greater reduction in convulsive-seizure frequency than placebo and was associated with lower rates of adverse events.”

On your Twitter social media website https://Twitter.com/wellnessbiosrx:

February 17, 2020 Retweet – “CBD may help with smoking cessation. 24 smokers were assigned a CBD inhaler or a placebo inhaler for one week. . . . The CBD inhaler group reduced their cigarette consumption by 40%.”
April 8, 2019 Retweet – “Smokers who were given a CBD inhaler reduced their cigarette consumption by around a whopping 40%” accompanied by a graphic displaying the text “CBD May Help Smokers Quit Cigarettes, Finds New Study”

Your CBD products are not generally recognized as safe and effective for their above referenced uses; 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 your CBD products.

Misbranded Drugs

A drug is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), if its labeling is false or misleading in any particular. Your CBD products are misbranded, as discussed further below.

Your website homepage and the webpage for “WBRx Metered-Dose Inhaler” include the following statements:

“Discover the amazing benefits of 99% pure CBD in an instant with the only CBD inhaler officially filed with FDA.”
“The only FDA-filed CBD MDI device on the market! . . . THE COMFORT OF FDA QUALITY . . . Each WBRX MDI is produced at a certified cGMP facility in an ISO 8 Clean Room that meets the stringent guidelines required for FDA approval and the WBRx MDI is currently in the process of being approved by the FDA.”

These claims are false or misleading because they suggest that a new drug application has been filed for your “WBRx Metered-Dose Inhaler” , when the agency has neither approved nor reviewed this product. Therefore your “WBRx Metered-Dose Inhaler” product is a misbranded drug under section 502(a) of the FD&C Act.[1]

In addition, your CBD 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.) Your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use because no FDA-approved applications are in effect for them. The introduction or delivery for introduction of a misbranded drug into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Prohibited Act under 301(ll) and Adulterated Human Foods

We note that your “WBRx Balance Softgels CBD,” “WBRx Energy Oil Drops CBD,” and “WBRx Sleep Oil Drops CBD” products appear to be promoted as conventional human foods. For example, these products are displayed with a Nutrition Facts label on your website. However, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD.[2] 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, 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 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.[3]

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 “WBRx Sleep Oil Drops CBD” product. 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).

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 and FDA regulations.

You should take prompt action to address the violations cited in this letter. Failure to promptly address violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that 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/

William A. Correll
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

[1] We also note that Nutrition Facts labels are appropriate only for foods (see generally section 403(q) of the FD&C Act, 21 U.S.C. 343(q), and 21 CFR 101.9).

[2] 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.

[3] 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 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.