Delivery Method: Via Email Product: Drugs Recipient:
Recipient Name
Joseph Young
Pico IV Inc.
1610 R St. Ste 300
Sacramento, CA 95811
United States
Support@picoiv.com Issuing Office: Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
March 6, 2024
RE: 700591
Dear Joseph Young:
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.picoiv.com in January 2024 and has observed that your website offers “Pico IV,” an intravenous form of cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/profile.php?id=100094470687041 and www.instagram.com/picoivcbd/. Your social media websites direct consumers to your www.picoiv.com website to purchase your products. As described below, your “Pico IV” product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
Your “Pico IV” product is especially concerning from a public health perspective because injectable drug products can pose risks of serious harm to users. Injectable products are delivered directly into the body and therefore bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.
You appear to be marketing your “Pico IV” as a dietary supplement. For example, marketing material found on your website states that “CBD, and other cannabinoids, are considered dietary supplements by the FDA . . . even if they’re administered intravenously.” The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your “Pico IV” (or any intravenously administered product) is not intended for ingestion. For this reason, among others, your “Pico IV” product does not meet the definition of a dietary supplement under the FD&C Act. Based on our review of your social media websites and website (www.picoiv.com), your “Pico IV” is a drug as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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 social media websites and website (www.picoiv.com) that establish the intended use of “Pico IV” as a drug include, but may not be limited to, the following:
On your social media websites at www.facebook.com/profile.php?id=100094470687041 and www.instagram.com/picoivcbd/:
- January 22, 2025 post: “PICO IV CBD IV’s may be a game-changer for active lifestyles. Intravenous delivery allows for rapid absorption, potentially aiding in faster muscle recover, reduced inflammation, and pain relief after intense workouts. CBD interacts with the body’s endocannabinoid system, influencing pain perception, inflammation, and mood. This may translate to improved sleep, reduced anxiety, and overall better recovery.”
- January 13, 2025 post: On your graphic visual, it reads, “PICOIV 6 CANNABINOIDS MAKE UP OUR CBD BROAD SPECTRUM . . . CBD [p]otentially reduce anxiety and inflammation. CBG [c]an support bone health and neuroprotection. CBN [m]ay promote relax.ation [sic] and sleep. CBC [p]otentially have anti-inflammatory properties. CBDa [m]ay have anti-inflammatory and neuroprotective effects. CBGa [c]an have antibacterial properties.”
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January 6, 2025 post: “Potential Benefits of PICO IV CBD Infusions:
Pain Relief: CBD may help reduce chronic pain by interacting with the body’s endocannabinoid system, which plays a role in pain perception.Sleep Improvement: CBD may enhance sleep quality by promoting relaxation and reducing anxiety, which can interfere with sleep.
Neurodegenerative Diseases: CBD has shown potential in supporting brain health and potentially slowing the progression of neurodegenerative diseases.
Anti-inflammatory Effects: CBD may possess anti-inflammatory properties, which could benefit conditions associated with inflammation.
Anxiety Relief: CBD may offer potential benefits for managing anxiety disorders by interacting with neurotransmitters that regulate mood and stress.
If you’re looking for a more effective and efficient way to experience the potential benefits of CBD, consider PICO IV.”
- July 18, 2024 post: “‘Living with Crohn’s has never felt easier.’ If you have a Crohn’s diagnosis, PICO IV might be your next step toward trying to manage your symptoms. As the world’s first sterile CBD IV for infusions, it offers targeted relief, potentially reducing inflammation and easing discomfort. Discover the potential benefits of PICO IV and take control of your health journey. #CBD #PICOIV #Health #Wellness #Hemp #HolisticHealth #IV #CBDIV #CBDInfusion #Intravenous #CBDResearch #CBDBroadSpectrum”
Your webpage https://www.picoiv.com/testimonials contains evidence of intended use in the form of personal testimonials recommending or describing the use of your product for the cure or treatment of disease and/or to affect the structure or function of the body. Examples of such testimonials include:
- “I had a motorcycle accident about 6 months ago and shattered my foot. I have pins and plates in my heel and throughout my recovery process doing these infusions I have had less inflammation and less pain in my foot and with a high threshold of pain comes stress and the CBD has helped relieve some of that stress giving me better sleep. I also love the staff at PicoIV and my experience has been very positive.”
- “I have learned to manage my emotions, but I still suffered from anxiety and was heavily reliant on benzodiazepines to control it. While reading numerous medical journals on the negative long-term effects of Xanax, I realized I had to stop the destructive cycle and search for another way to manage my anxiety . . . I have now completed two PICO CBD infusions (each 14 days apart) and have had no need to take any Xanax. It’s been years since I have been able to go 30+ days without an anti-anxiety pill.”
Your “Pico IV” product is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 is in effect for your product. Accordingly, the introduction or delivery for introduction into interstate commerce of “Pico IV” violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
Conclusion
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. 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 product is 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 by email to FDAADVISORY@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 700591” in the subject line of the email.
Sincerely,
/S/
Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
