WARNING LETTER
BIOTA Biosciences LLC
MARCS-CMS 605164 —
April 09, 2020
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Recipient:
Recipient Name
Patrice Romulus
BIOTA Biosciences LLC
1601 5th Ave, Suite 1100
Seattle
,
WA
98101
United States
hq@biotacbd.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
April 9, 2020
RE: 605164
Dear Ms. Romulus:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at biotacbd.com in February 2020 and has determined that your website provides a telephone number that customers can call to order various injectable drug products, including but not limited to “Canabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and “Curcumin Complex.” Injectable drug products can pose a serious risk of harm to users because they are delivered directly into the bloodstream and bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. The claims on your website establish that your “Cannabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and “Curcumin Complex” 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).
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
Your “Cannabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and “Curcumin Complex” 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, https://www.biotacbd.com/cbd-sterile-vials, that establish the intended use of your products as drugs include, but may not be limited to, the following:
• “Fighting the opioid epidemic . . . BIOTA Biosciences produces and distributes effective all-natural alternatives with no side-effects. Join the growing ranks of pain, oncology, psychiatry, naturopathy healthcare professionals utilizing BIOTA Sterile CBD Vials.”
1
• VISION: OPIOID-FREE FUTURE . . . Our goal is to supply the world with pharmaceutical grade, all natural products containing cannabidiol and other natural compounds. We believe strongly that pharmaceutical grade hemp oil will drastically reduce the need for opioid-based pain relief and eliminate the global opioid epidemic by providing a safe and natural alternative . . . Get in touch with us to learn more about how our continuous research & development into increasing the bioavailability of natural compounds with high therapeutic potential and our private label cbd products can help to solve this global issue.”
• “CBD . . . and its ability to suppress pain and aid in the detoxification processes has highlighted it as a promising therapeutic for a wide array of disorders such as epilepsy, including many challenging neuropathy conditions. When patients consider trying a new therapeutic like CBD, there are many options for delivery that can be more efficacious to the patient. One delivery option is BIOTA CBD Sterile Vial Therapy.”
• “Instant relief for patients that are symptomatic of inflammatory auto-immune diseases”
Additional evidence that is relevant to establishing the intended use of your products as drugs is that these products are offered in an injectable form, which you claim will have an immediate effect on the body:
• “Sterile Cannabidiol (CBD) Vial supplementation
Bypass liver absorption completely making CBD immediately 100% bioavailable
Delivers 100% CBD directly into your blood stream
Deliver high concentrations of CBD unattainable with the oral or inhalation route"
Your “Cannabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and “Curcumin Complex” products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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-named products.
Misbranded Drugs
Your “Cannabidiol (CBD) Complex,” “Cannabidiol+Curcumin,” and “Curcumin Complex” 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).
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. According to your website, you manufacture many other types of CBD containing products. 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
_____________________________________
1
On October 26, 2017, the Acting Secretary of the Department of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. 274d, determined that a public health emergency exists nationwide involving the opioid crisis. You market CBD products for the treatment or cure of opioid addiction and withdrawal symptoms. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction.
Content current as of:
04/23/2020
Regulated Product(s)
Drugs