- Delivery Method:
- Via Email
- Product:
- Drugs
- Issuing Office:
- Office of Unapproved Drugs and Labeling Compliance
United States
Secondary Issuing Offices
WARNING LETTER
December 22, 2023
East Fork Hemp, LLC
6258 SE Foster Rd
Portland, Oregon 97206
RE: # 654211
Dear Mason Walker and Tricia Chin:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://eastforkcultivars.com/ and https://eastforkhemp.com/ in September 2023 and has determined that you take orders there for various products which you promote as products containing cannabidiol (CBD).1 We also reviewed your social media websites at https://www.facebook.com/EastForkCultivars/ and https://www.instagram.com/eastforkcultivars/, where you direct consumers to your websites, https://eastforkcultivars.com/ and https://eastforkhemp.com/, to purchase your products. The claims on your websites establish that your CBD products including, but not limited to, all strengths and varieties of your Rescue Rub CBD, CBD Oil, and Peak CBD Solution tinctures for humans (also referred to as “your CBD products”) are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). In addition, these products are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
Unapproved New Drugs and Misbranded Drugs
Based on our review of your website and social media websites listed above, your CBD products are drugs as defined by 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:
From your website https://eastforkcultivars.com/blog:
- A March 15, 2022 blog post titled “Cannabis And COVID-19: Understanding New Scientific Studies” which contains claims such as “Each aspect offered new evidence that CBD (cannabidiol) can inhibit infection by SARS-CoV-2. In human cells, CBD above a certain threshold concentration was effective at blocking replication early in the infection cycle and six hours after the virus had already infected the cell. (It did not affect the ability of SARS-CoV-2 to enter the cell.) In live mice, pretreatment with CBD for one week prior to infection with SARS-CoV-2 suppressed infection both in their lung and nasal passages, indicating that CBD can prevent viral replication in live animals.”
- A November 12, 2020 blog post titled “CBD, COVID-19, And The Novel Coronavirus” which contains claims such as “On the more promising side of research, a research team based out of Augusta University (GA) found a potential protective role for CBD as part of the treatment of COVID-19. . .. The researchers concluded, ‘Our results… may extend CBD as part of the treatment of COVID-19 by reducing the cytokine storm, protecting pulmonary tissues, and re-establishing inflammatory homeostasis.’”
From your website https://eastforkhemp.com/ and your February 15, 2023 posts on your social media websites https://www.facebook.com/EastForkCultivars/ and https://www.instagram.com/eastforkcultivars/:
- From the post titled “Does CBD Need THC to Work?” which contains claims such as “Experimental evidence is limited and more research is needed, but studies on pain and inflammation, breast cancer, epilepsy, and other conditions have found a greater therapeutic effectiveness of whole-plant or full-spectrum cannabis products than isolated cannabinoids.”
From your social media website https://www.instagram.com/eastforkcultivars/:
- A March 17, 2022 post which references your March 15, 2022 blog post: “University of Chicago Study: - Offered new evidence that CBD can inhibit infection by SARS-CoV-2. - The COVID-blocking effects of CBD were demonstrated ONLY by high concentrations of CBD isolate. - CBDA, CBDV and THC were also tested, but did NOT show the same infection-blocking ability as CBD.”
From your social media website https://www.facebook.com/EastForkCultivars/:
- A November 15, 2020 post which references your November 12, 2020 blog post: “CBD, COVID-19, and the Novel Coronavirus
Have you heard people saying that cannabis can prevent infection by the novel coronavirus, or that CBD is a possible treatment for COVID-19? . . .
Specifically, the potential therapeutic ECS mechanisms include: reducing overactive inflammatory mechanisms (including cytokine storm) that worsen COVID-19; and...
Head to our blog to keep reading this article by our Director of Education and Director of Cannabis Class, Anna Symonds: https://eastforkcultivars.com/.../cbd-covid19-and...”
Your CBD products are not generally recognized as safe and effective for their above referenced uses and, therefore, 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). There are no FDA-approved applications in effect for your CBD products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
In addition, your CBD products are misbranded under 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 layman can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Your CBD 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 CBD products are not exempt from the requirement that their labeling bear adequate directions for use because no FDA-approved applications are in effect for these products. The introduction or delivery for introduction into interstate commerce of misbranded drugs is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action 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 any 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, 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/
CAPT Tina Smith
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
__________________________
1 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.
