Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your “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).
Passage 2The 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.
Passage 3your “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.
Passage 4On 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.”
Passage 5January 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.”
Passage 6January 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.”
Passage 7July 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”
Passage 8“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.”
Passage 9“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.”
Passage 10Your “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).