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  5. Evolved Ayurvedic Discoveries, Inc./BioCBDPlus - 609772 - 02/11/2021
  1. Warning Letters

WARNING LETTER

Evolved Ayurvedic Discoveries, Inc./BioCBDPlus MARCS-CMS 609772 —

Delivery Method:
Via Email
Product:
Drugs
Recipient:
Recipient Name
James Sol Radina
Evolved Ayurvedic Discoveries, Inc./BioCBDPlus

315 S. Coast Highway 101 Suite U75
Encinitas, CA 92024
United States

support@biocbdplus.com
happy@eadlabs.com
Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

WARNING LETTER

February 11, 2021

RE: 609772

Dear Mr. Radina:

This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.biocbdplus.com from August through October 2020 and has determined that you take orders there for “BioCBD+ Total Body Care,” “BioCBD+ Topical Oil Muscle & Joint Support,” and “BioCBD+ Peace Vape” (hereinafter referred to as your “BioCBD+ products”) that claim to contain cannabidiol (CBD). We have also reviewed your social media websites at https://www.facebook.com/BioCBDPlus and https://www.instagram.com/bio_cbd_plus/; these social media websites direct consumers to your website http://www.biocbdplus.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-191 in people. The claims on your website and social media websites establish that your BioCBD+ 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). 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.

Furthermore, your “BioCBD+ Peace Vape” product is 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.

Dietary Supplement Labeling

Your “BioCBD+ Total Body Care” product is labeled as a dietary supplement. However, it cannot be a dietary supplement because it does 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 that, based on available evidence, CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act. 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. 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.2 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.

Unapproved New Drug Products

Based on our review of your websites, your BioCBD+ 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.

Some examples of claims observed on your website and social media websites that established the intended use of your products as drugs include, but may not be limited to, the following:

On your website, www.biocbdplus.com:

From the webpage titled “Health Benefits of Vaping CBD”:

  • “May Support Depression and Mood Disorders”
  • “If you suffer from depression or other mood disorders, vaping CBD may be as effective at fighting these issues as pharmaceuticals, but without the drawbacks and side effects, especially those that are all too common with benzodiazepines such as: Addiction . . . Sexual dysfunction [and] Substance Abuse”
  • “May Prevent Bone Disease”
  • “Reduces the risk of osteoporosis and osteoarthritis.”
  • “May Help Improve Cholesterol and Decrease the Risk of Cardiovascular Diseases”
  • “Decreased cardiovascular inflammation and inflammatory response.”
  • “Slower atherosclerosis progression.”

From the webpage titled “CBD for Children with Autism”:

  • “CBD for autism isn’t a traditional treatment, as of now, but could soon be because CBD is both an anti-oxidant and an anti-inflammatory . . ..”
  • “CBD for autism could help because CBD is a powerful antioxidant with neuroprotective properties that protect the brain against neurodegenerative disorders.”
  • CBD for autism has the following beneficial effects: Anxiolytic. (Reduce anxiety)[,] Anti-inflammatory. (Reduces brain swelling)[,] Antiemetic. (Prevents vomiting) [and] Antipsychotic.”

From the webpage titled “CBD for PTSD: The All-Natural Alternative”:

  • “CBD has shown even more promise for veterans due to CBD’s potential to benefit those with PTSD. Consuming CBD for PTSD could become the norm in a relatively short time period as CBD continues to gain notoriety and momentum.”

From the webpage titled “CBD Oil for Anxiety . . . A Peaceful Solution”:

  • “CBD To The Rescue!! . . . From seizure prevention (most commonly studied with epilepsy), to neuroreceptor protection (support against neurodegenerative disorders, Alzheimer’s, Parkinson’s), the vast range of CBD’s healing potential is just truly beginning to be realized.”

From the webpage titled “CBD Oil for Pain Relief: What to Know”:

  • “From using CBD oil for anxiety, to exploring CBD’s potential effects on epilepsy or rheumatoid arthritis . . . there are a variety of ways that CBD can be administered for different causes.”

From the webpage titled “Can CBD Help Stop the Spread of Viruses?”:

  • “[H]aving a strong immune system right now is our best defense, and CBD may help support your immune system’s strength.”
  • “We also have evidence of great medicinal results of CBD for different diseases and ailments. . .”
  • “[I]f you do contract the virus, you’ll experience mild symptoms and your body will fight it off quickly. For that, CBD may help.”

From May 4, 2020 and June 10, 2020 posts to your Facebook page at www.facebook.com/BioCBDPlus:

  • “As COVID-19 spreads around the world, customers are asking us how CBD can help. . . the good news is, a healthy immune system may support you during this pandemic, and CBD is great for immune support.”

From September 18, 2020 posts to your Facebook and Instagram pages at www.facebook.com/BioCBDPlus and https://www.instagram.com/bio_cbd_plus/, respectively:

  • “Have you tried our topical oil?” accompanied by a graphic with the text ‘I love the product and was about to order more bottles. I have rheumatoid arthritis, and use it on my knees, knuckles and fingers. It really helps me sleep better at night.’”

From a February 26, 2020 post to your Instagram page at https://www.instagram.com/bio_cbd_plus/:

  • “‘BioCBD+ has been a huge relief to my quality of life with Crohns, anxiety . . . #cbdoil’ accompanied by a graphic displaying “BioCBD+ Total Body Care” and “BioCBD+ Topical Oil Muscle & Joint Support.”

Your BioCBD+ 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). With certain exceptions not applicable here, 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 your BioCBD+ products.

Misbranded Drug Products

Your BioCBD+ 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. 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 your products. The introduction or delivery for introduction into interstate commerce of these misbranded drugs is a prohibited act 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/or 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

_________________________

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, there was a Presidential declaration of 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.

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 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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