WARNING LETTER
Bee Delightful
MARCS-CMS 610689 —
December 22, 2020
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Skyler R. Johnstone
Recipient Title
Principal
Bee Delightful
(b)(6), (b)(7)(C)
United States
skyler@beedelightful.com
Issuing Office:
Division of Human and Animal Food Operations West III
United States
December 22, 2020
WARNING LETTER
CMS # 610689
Dear Skyler R. Johnstone:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.beedelightful.com in October 2020 and determined you take orders for the products “Canna Bees Rescue Blend” (250 mg and 500 mg concentration) in bottles and “snap packs,” which you promote as products containing cannabidiol (CBD). We have also reviewed your social media website at www.facebook.com/BeeDelightfulUSA; this website directs consumers to your website, www.beedelightful.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
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in people. The claims on your website and social media website establish that your “Canna Bees Rescue Blend” 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 “Canna Bees Rescue Blend” 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 “Canna Bees Rescue Blend” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C 331(II) 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 to FDA’s home page at
www.fda.gov.
Additionally, you can find specific information about how FDA regulates CBD at https://www.fda.gov/news-events/public-health-focus/fdaregulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.
Unapproved New Drug
Based on our review of your website, your “Canna Bees Rescue Blend” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C § 321(g)(1), because they are articles intended for the use in 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 www.beedelightful.com that establish the intended use of your products as drugs include, but may not be limited to, the following:
On the “Why Honey + CBD?” section of your website:
“It contains antibacterial and antifungal properties. Did you know that raw honey naturally contains the antiseptic hydrogen peroxide? While it can kill unwanted bacteria and fungus, the effectiveness depends on the type of honey.”
“It can help with digestive issues . . . It may also help with tummy troubles, including ulcers.”
“It can soothe a sore throat. As we well know, a spoonful by itself or melted in a cup of hot tea can go a long way in soothing a sore throat and quieting a cough.”
“Phytonutrients, containing . . . antibacterial and antifungal properties . . . can also help protect us. The phytonutrients in raw honey have also shown to have . . . anticancer benefits.”
“May reduce pain from diseases like multiple sclerosis and rheumatoid arthritis. According to some studies, CBD may help reduce chronic pain by affecting endocannabinoid receptor activity, reducing inflammation and interacting with neurotransmitters.”
“May reduce anxiety and depression. Studies have shown that CBD may act on the brain’s receptors for serotonin, which is a neurotransmitter that regulates mood and social behavior.”
“May alleviate cancer-treatment symptoms. CBD may help with nausea, vomiting and pain.”
“May reduce acne. CBD has anti-inflammatory properties that may have a beneficial effect on acne.”
“May have neuroprotective properties. Limited studies show that CBD may help epilepsy and Parkinson’s disease symptoms as well as possibly slow the progression of Alzheimer’s disease.”
“May benefit heart health. Some studies have shown that CBD may reduce blood pressure and prevent heart damage.”
On the “Hibernate with Honey” section of your website:
“The quality sleep-inducing and supportive properties in the combination of CBD and raw honey are undeniable.”
On your “Benefits of REM Sleep” graphic:
o “Helps fight depression”
“Even sweeter: the other health benefits you can experience from incorporating Canna Bees into your diet and life . . . soothing digestive issues, reducing pain from diseases like multiple sclerosis and rheumatoid arthritis and reducing anxiety and depression.”
On the “Cannabis Sativa L.” section of your website
“What is apparent is that CBD interacts with the ECS system to help relieve pain, nausea and more.”
On the “Raw Honey” section of your website:
“Let’s start by reviewing raw honey’s benefits . . . It contains antibacterial and antifungal properties.”
“It can boost wound healing time and reduce infection.”
“It can help with digestive issues.”
“It can soothe a sore throat.”
On the “Honey Bees Vs. Viruses” section of your website, which has the subheading “WHAT WE CAN LEARN FROM BEES DURING COVID-19”:
“HONEY IS ALSO ANTIVIRAL . . . The antimicrobial properties of honey have been well documented due to honey’s ability to generate hydrogen peroxide by the bee-derived enzyme glucose oxidase. . . . Try a jar of Canna Bees and prepare your immune system for all the invisible viral enemies out there!”
Your website also contains evidence of intended use in the form of personal testimonials found on the homepage under the heading “Share Your Experiences” recommending or describing the use of your product for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials, which appear to be curated by your firm, include:
“[W]henever I’m having a headache or anxiety, I just snap and squeeze [a Canna Bees Rescue Blend snap pack] and I feel better!”
“My 14 year old son has ADHD & anxiety & he asked to try it & he said it [a Canna Bees Rescue Blend snap pack] makes him feel so much better!”
“I used about a tablespoon [of the product] in my tea while I was warding off bronchitis and it soothed my throat . . .”
“I have found this product to help relieve stress, anxiety, depression, pain and muscle tightness”
“This stuff is amazing for my anxiety, life changing.”
“I have scleroderma and have throat issues sometimes. This honey is not only soothing and healing but it calms my throat muscles and I can feel a difference in less than 10 minutes.”
“I have been dealing with chronic stomach pain/digestive issues and your honey is legit medicine to me.”
“Love this product . . . Makes for some of the best sleep I've had in a long time due to an autoimmune disease.”
“LOVE this CBD honey! . . . 1tps at night and I'm sleeping soundly and actually have less anxiety and stress during the day too.”
Additional claims observed on your social media site www.facebook.com/BeeDelightfulUSA include, but are not limited to, the following:
Your July 13, 2020 post:
“Raw honey stabilizes your blood sugar level”
Your June 24, 2020 post:
“CBD can help relax and reduce inflammation in your nervous system which helps ease you into a sleep cycle at night. . . . #cbdhoney #hemphoney . . . #lesspainthenextday #lessanxiety” . . . #cannabees #beedelightful”
Your June 16, 2020 post:
“‘Honey can also kill bacteria and help fight off viral infections,’ explains Patti Mahautmr, MD, physician at Penn Urgent Care South Philadelphia. ‘If you're suffering from a bad cough in addition to your sore throat, honey may also act as an effective cough suppressant.’ Best to Bee Prepared, right?! #antiviral #antibacterial #antifungal #antiinflammatory #rawhoney #immunesystem #coughsuppressant . . . #cannabees #cbdhoney #hemphoney”
Your May 19, 2020 post:
“‘Researchers developed over 400 new cannabis Sativa lines and extracts. The end-strains were high in anti-inflammatory cannabinoid cannabidiol (CBD) since the compound has been proposed to have anti-inflammatory and anti-cancer properties.
By using artificial human 3-D tissue models, they simulated and mapped out how each strain may impact COVID-19 infections in the human oral, airway, and intestinal tissues. Particularly, they monitored each strain's ability to modulate ACE2 levels, an enzyme previously linked to COVID-19 infection.
The lead researcher, biological scientist Dr. Igor Kovalchuk stated some strains showed promising results in ensuring less fertile ground for the virus to take root.
Some reduced the virus receptors by 73%.
According to Kovalchuk, ‘A number of them have reduced the number of these (virus) receptors by 73 percent, the chance of it getting in is much lower. If they can reduce the number of receptors, there’s much less chance of getting infected.’
Moreover, the researchers were able to identify 13 CBD extracts that are able to change ACE2 levels. The data suggested that some strains were also able to down-regulate serine protease TMPRSS2, which is another protein critical for COVID-19 to enter host cells and spread throughout the body.’ . . . #covid19 #coronavirus #cannabis #cbdhoney #cannabees #cbd”
Your December 16, 2018 post:
“No wonder Grandma loves our raw honey so much! Raw Honey and Diabetes What Your Doctor Isn’t Telling You . . . ‘Using raw honey for diabetes improves the effectiveness of medications according to this study!’”
Your “Canna Bees Rescue Blend” products are not generally recognized as safe and effective for the 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 the above-named products.
In addition, your “Canna Bees Rescue Blend” products are misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). A drug is misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), if the drug fails to bear adequate directions for its intended use(s). “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 without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use this drug safely for its 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 its labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved application is in effect for them. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the 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(II), 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.
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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 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 “Canna Bees Rescue Blend” products are a food, honey, to which CBD has been added. Therefore, the introduction or delivery for introduction into interstate commerce of these products is a prohibited act under section 301(II) of the FD&C Act.
Furthermore, as defined in section 201(s) of the FD&C Act, 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.
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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 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 potentials 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 from 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 “Canna Bees Rescue Blend” 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).
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 15 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 15 working days, state the reason for the delay and the time within which you will do so.
Please send your reply to the Food and Drug Administration Dallas District Office, Attention: Rian L. Pope, Compliance Officer, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues cited in this letter, please contact Mr. Pope at
210-308-1415
or at rian.pope@fda.hhs.gov.
Sincerely,
/S/
Edmundo Garcia Jr.
District Director | FDA Dallas District
Program Division Director
Office of Human and Animal Foods
Operations- West Division 3
cc:
Lori Woznicki, Food and Drug Inspections Branch
Manager, Division of Regulatory Services
Texas Department of State Health Services
1100 W. 49th Street
Austin, TX 78756
_________________________
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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.
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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.
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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. 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)
Drugs
Food & Beverages