Requests that the FDA enforce the laws and regulations with regards to cannabis (plant family of Cannabaceae excluding Humulus), cannabis-derived products, delta9-tetrahydrocannabinol, and cannabidiol.
Citizen Petition CDER enforce the laws and regulations with regards to cannabis (plant family of Cannabaceae excluding Humulus), cannabis-derived products, deltaO- tetrahydrocannabinol and cannabidiol OPEN
2019-10-24 2019-09-12 2019-12-16 2019-10-30 2019-11-05 2019-11-19 2019-07-22 2019-09-12 2020-07-01 2019-09-27
FDA-2019-P-2945-0049 FDA-2019-P-2945-0030 FDA-2019-P-2945-0063 FDA-2019-P-2945-0051 FDA-2019-P-2945-0053 FDA-2019-P-2945-0054 FDA-2019-P-2945-0024 FDA-2019-P-2945-0031 FDA-2019-P-2945-0069 FDA-2019-P-2945-0043
04:00:00 04:00:00 05:00:00 04:00:00 05:00:00 05:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0049 https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0030 https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0063 https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0051 https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0053 https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0054 https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0024 https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0031 https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0069 https://api.regulations.gov/v4/comments/FDA-2019-P-2945-0043
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There is a need for HHS, Surgeon General, FDA, and CDC to educate the medical community about the appropriate usage of cannabis medications (yes, the FDA approved drugs) and the facts about street grade cannabis medication (ie not FDA approved drugs)..To provide some patient identity privacy I am using her/him to cover the patients identity:  Shortly after Colorado began allowing the sales of recreational cannabis in 2014,  my spouse was hospitalized in a Colorado hospital on the Front Range.   My spouse was admitted on a Sunday afternoon,  had major chest surgery on Monday afternoon, and Tuesday AM while in ICU recovering, the hospital physical therapist came to the room to tell her/him that physical therapy had been ordered and would be set up for him/her over the next day or so.   It took me a bit of time to figure out what was wrong with the PT -- she couldnt not get three words out without giggling.  At first, I thought this poor woman must be so timid and then....it dawned on me.....at 8 A.M. this physical therapist was stoned.   I was grateful that she apparently was too stoned to attempt any future doctor ordered physical therapy for my spouse.   THAT was my wake up call to the crisis of Colorados legalizing cannabis that adversely affected medical services in May 2014.Several days later the patient was moved to a regular floor.  As the nurse was dispensing medications to the patient,  I asked what the patient was being given.  The patient was still to sedated to be able to ask such questions for him/her self.At about this time the hospitalist physician arrived and told me that one of the medications was Marinol which he prescribed to increase the patients appetite.  WHOA!!!!   I knew that this was not the appropriate usage of Marinol to prescribe to a patient post surgery!   Marinol is supposed to be a last resort medication for persons with a wasting disease not someone still working off the sedation from major surgery.   The patient was eating because I was placing the food orders and feeding the patient who was tethered to all sorts of monitors and IVs at the time.  Furthermore, the patient had several health issues that made prescribing Marinol contra-indicated.    The physician did not seem interested in suspending his prescribing Marinol -- I finally had to tell the doctor that This patient is exercising his/her Patients Bill of Rights and refusing Marinol.I dont know how many other physicians are as ill-informed as this hospitalist but the FDA et al needs to educate the physicians about prescribing this drug of last resort ---its purpose and when it is contra-indicated etc.  I dont know if this hospitalist physician was dumber than a rock -- or if he was doing a Marinol study and not telling the patients (ie no informed consent) --- but for whatever reason this hospitalist was prescribing medication that was contra-indicated and for which no appetite stimulating medications were even needed.   I couldnt agree more with the Citizens Petition nine action steps including the dire need for the Food and DRUG Administration to educate physicians, nurses, hospital administrators, medical schools, and veterinarians on the cannabis derived products be they FDA approved or not.  Sign me as a Colorado resident who has had adverse experiences with weed impaired hospital staff and ill-informed physician prescribing Marinol. To Food and Drug Administration ---- there are many cases of violence in the USA and abroad where the bad actor had a history of using cannabis and some news reports that the bad actor was high on cannabis during their violent acts upon others.  Below are just a few stories of such violent acts where the bad actor was linked to cannabis consumption.  When is the FDA going to respond to this known crisis and work with other law enforcement agencies to stop  or at least reduce a contributing factor to these violent and often deadly events?   The FDA is supposed to oversee drugs and the FDA has classified CBD and/or THC under its oversight and enforcement authority.The ads for using seat belts used to state If it saves ONE life, it is worth it.   Well,  there are thousands of lives that could be saved if the FDA would enforce the laws regarding cannabis -- surely if it saves ONE life from addiction, ONE life from being killed by someone who consumes marijuana,  ONE life from a completed suicide while using cannabis, ONE life from vaping THC/CBD products....it is worth it.  How many lives will be damaged or destroyed as the public waits for the federal governments help to arrive?I live in the heartland of America and I fully support the Citizen Petition from Jesse J. LeBlanc III.  The public needs the FDA to protect us from the harmful effects of the irresponsible states that have legalized recreational and medical-cannabis.Please, come to the rescue of the nation.....~~~~~~~~https://www.thelocal.fr/20190902/lyon-knife-attacker-smoked-cannabis-and-heard-the-voice-of-godInvestigators said the killer appeared to have psychological problems and had smoked large quantities of cannabis before stabbing the 19-year-old man to death and injuring eight others on Saturday afternoon at a bus station. He was found in public records with two identities and three different dates of birth, making him either 33, 31 or 27-years-old, prosecutor Nicolas Jacquet told a news conference in Lyon.~~~~~~~~https://dailycaller.com/2019/08/12/ohio-gunman-friend-arrested/[Betts is the Ohio man who killed numerous persons; Kollie was a friend of Betts.]The charges stem from Kollies confession that he regularly smoked marijuana and used mushrooms with Betts.~~~~~~~https://www.cbsnews.com/news/warrant-denver-man-ate-pot-candy-before-killing-wife/DENVER - Authorities say a Denver man accused of killing his wife while she was on the phone with 911 bought marijuana-infused candy and a pre-rolled joint in the hours before he allegedly shot and killed her.A copy of a search warrant sent to CBS News Crimesider on Thursday by the Denver Department of Public Safety alleges Kristine Kirk, 44, told dispatchers her husband ate the candy before he started hallucinating and frightening the couples three children. The warrant says 47-year-old Richard Kirk also may have taken prescription pain medication before he began acting erratically.~~~~~~~https://www.denverpost.com/2015/12/07/planned-parenthood-gunman-was-a-marijuana-newcomer-say-rural-neighbors/HARTSEL  Robert Dear Jr.s arrival here was part of a frenetic migration some locals derisively call the green rush.Just as people rushed haphazardly into the Rockies for gold in 1858, many of Hartsels newcomers moved here from across the country after recreational marijuana was legalized in 2012, rancher Keith Wells said.Locals identify Dear, the man accused of killing three people at a Planned Parenthood clinic in Colorado Springs, with the marijuana migration because he and they often live in squalid, makeshift homes on the high plains. This story below is a story of a woman who bought legal nocotine and cannabis to vape and it put her in ICU.The FDA is charged with protecting the public health and safety -- these products present a clear danger and harm to the publics health and safety.  There is a solution to this national crisis....enforced the federal laws over THC.  (This citizens petition is addressing THC/CBD and cannabis products -- and the FDA is already aware of its special duties regarding nicotine which is a known carcinogen.  Tobacco products has its own FDA portal to report adverse events such as the story below.)I urge the FDA to adopt the 9 Action Steps listed in the Citizens Petition.  The public clearly is in dire need of federal intervention to protect the public from these products such as discussed in the story below from harm to their health and safety.   The FDA has the ability to protect the nations health.  https://wgntv.com/2019/12/03/it-was-all-legal-then-i-got-sick-woman-warns-of-vaping-dangers-after-lung-illness-sends-her-to-icu/[snipped]It was all legal ... then I got sick: Woman warns of vaping dangers after lung illness sends her to ICUPosted 5:22 PM, December 3, 2019, by Dina Bair and Katharin CzinkAllison Herger thought she was bettering her health. After 28 years of smoking regular cigarettes, a habit she tried to quit four times, Herger made the switch to vaping last year.I loved the buzz and I loved smoking, she said. But I hated the smell and the taste.Her product of choice was flavored Juul cartridges.I was like, Im in love and this is what everybody was doing, she said. Honestly it seemed like it was working it was great. My skin got better, my teeth got better, my cough went away. All signs were pointing to it was a good idea for me.And she vaped marijuana about once a week purchased from dispensaries, not on the streets, in states where recreational use is legal.Buying everything over the counter, whether it was nicotine or marijuana vaping, it was all legal, she said. So I didnt match the statistic. And then I got sick.At first, she said, it felt like the flu - chills, a fever, she was achy and tired.Herger visited her doctor, who sent her to the emergency room concerned Herger was suffering with pneumonia.But within 24 hours, Hergers oxygen levels plummeted.[snipped]  The National Safety Council just released this paper regarding cannabis consumption and worker safety / absenteeism (October, 2019)Yet ANOTHER  concern over the problems of the federal government not enforcing the federal cannabis laws.  View Full Report at this Link:National Safety Council just issued a statement.  https://www.nsc.org/Portals/0/Documents/NSCDocuments_Corporate/Policy-Positions/Workplace/W-Cannabis%20Impairment%20in%20Safety%20Sensitive%20Positions%20-%20153.pdf#153NATIONAL SAFETY COUNCIL Position/Policy Statement Cannabis Impairment in Safety Sensitive PositionsNSC Policy/Position The National Safety Council (NSC) supports policies to mitigate and eliminate the risks of cannabis (marijuana) and other products containing delta-9-tetrahydrocannabinol (THC), the impairing component in cannabis.Safety concerns are paramount as legalization and decriminalization continues.NSC believes it is unsafe to be under the influence of cannabis while working in a safety sensitive position1due to the increased risk of injury or death to the operator and others. Research is clear that cannabis impacts psychomotor skills and cognitive ability. However, the amount of THC detectable in the body does not directly correlate to a degree of impairment.At this time, NSC believes there is no level of cannabis use that is safe or acceptable for employees who work in safety sensitive positions.Need for Policy Position By adopting this position, NSC will be able to increase involvement in the policy discussion about cannabis impairment, and provide guidance for employers as they navigate changing cannabis laws.Cannabis is the most widely consumed illicit substance worldwide.2In 2015, the World Drug Report estimated over 200 million people between the ages of 15-64 have ingested cannabis. According to a study reported by the National Institute on Drug Abuse, employees who tested positive for cannabis had:55% more industrial incidents85% more injuries75% greater absenteeism compared to those who tested negative.3 As this article indicates by this alleged interview of a woman who has been illegally growing, transporting, and selling weed for decades there is an attitude of being above the laws.  The article is linked below and the statements below are extracted from the article.  I thought we were supposed to be a nation of laws -- and when those laws are not enforced we have chaos. https://www.vice.com/en_us/article/ywa4xm/im-a-mom-i-sell-huge-amounts-of-weed-and-i-dont-give-a-fuckA lot of people think selling cannabis is really easy. It takes a lot of focus when youre working with stoned people.by Seth FerrantiNov 1 2019, 8:12amWhat do you sell and where?I sell organic cannabis grown in California, preferably outdoor sun and soil cannabis. It gets sealed up, mailed to me and we ship it all over the country. Some of it I sell legally and some illegally.You move large amounts of weed around. Ever come close to a big bust?I have had multiple sketchy moments, like 12 pounds being shipped to my previous rental address. I had to wait three weeks for it to be rerouted to my current address. I would look out the window every day wondering if they were going to come and get me with big charges. It did show up, but I learned a big lesson. Thats when I went down to two pounds at a time if the customers were choosing to go through USPS.Who are your wholesale customers?Mostly incredibly talented musicians and artists who want to send their children to private school. There are multiple people who have spent decades selling my cannabis and not worked a real job and sent their kids to private school. There are huge numbers of people in our community that do not buy into the nine-to-five, sell your soul for health insurance lifestyle. We enjoy working together and building each other up. Its a really sweet kind of hippie mafia based on organic food and non-governmental lifestyle.As long as there are people in prison for the cannabis plant I will stand firm in believing that we do not pay taxes, we do not support the government, and fund their incarceration nation. Ive never paid taxes and Im 48. This story appeared in USA Today with the quote below from Donald Ashley, Director of the Office of Compliance at FDA.I could not agree more with the statement that Americans EXPECT and DESERVE DRUGS that are SAFE, EFFECTIVE and meet our standards for QUALITY ----  yet today across America cannabis products are being produced, marketed, transported, and sold to the naive public who believe that cannabis from non-FDA approved sources is medication.  The public deserves and expects products marketed as drugs, medication, dietary supplements,  pet drugs or supplements to have met the FDA standards and controls but these state-only legalized products do not met the high standards developed over the decades by the Food and Drug Administration.   People --- infants, children, youth, young adults, and elderly are being harmed by these unregulated and non-FDA approved products marketed as safe, healthy, and effective by an industry whose sole desire appears to be get a few people rich at the cost of the health and safety of the general public.   Recently, a young man in Detroit, Michigan whose lungs were damaged by supposedly vaping THC -- a devise that the FDA has regulated for nicotine only usage --- and THC a controlled FDA/DEA substance had a lung transplant.   Short of death -- how much more severe can this become before bold steps are taken to intervene on this entire cannabis industry in the USA?Vaping devises as used in the medical cannabis industry are medical devises used to deliver medical cannabis.  The FDA has federal, plenary authority to enforce the laws on harmful medical devises.  FDA please adopt the Nine Action Steps submitted in the Citizens Petition.   The public is in dire need of federal intervention-- NOWAmericans expect and deserve drugs that are safe, effective and that meet our standards for quality, Donald D. Ashley, director of the Office of Compliance in the FDAs Center for Drug Evaluation and Research, said in the release. In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans.https://www.usatoday.com/story/money/2019/11/14/dollar-tree-otc-drugs-fda-warning-letter-assured-brand/4199656002/ My youngest has bad hayfever and cannabis is a high pollen plant.  She has extreme reactions when people smoke around us.    So we made sure that we obtained non-smoking housing.  Ha.  Like that helped.  It being a matter of basic survival and life and death we made sure that marijuana smokers were prosecuted.  One moved out and shortly after another would move in.  The landlord would warn them that their neighbors were allergic to cannabis and they just didnt care.  They just puffed away.I have so many friends with small children that cry on their social media on the internet, every day, about a neighbor smoking pot and how it makes their children so upset and miserable.  The babies and moms both crying because they can barely breathe.  There really needs to be a way to keep smoking out of public places and housing. :( The public is in dire need of the Food and Drug Administration boldly stepping forward to protect the public from the now clearly known harms from the foolish states that have legalized cannabis as medicine and as a recreational drug.  Currently, there are federal laws to prohibit the cultivation, processing, sells, and consumption of cannabis please exercise the plenary powers of the federal government to protect our children, our families, and our communities from those who are aggressively marketing what has been commonly known as snake oil or patent medicine.  As is clearly stated in the Citizens Petition which I fully support,  no single substance can cure diseases or health problems yet that is how many states have claimed when they have legalized cannabis.  I am adding this recent article for your review from the FreeBeacon.   Dr. Karen Randall is quoted about the harms she is seeing in the state of Colorado that has legalized cannabis for medicine and for recreational usage.   The fall out from this disaster is clear.   PLEASE work with the DEA,  FBI,  CDC,  DoJ,  Surgeon Generals Office and others to end this disaster brought on by persons with special interests desiring to simply make money off of the ill-informed who have foisted and deceived these bad laws upon the public that cannabis is a safe, harmless, and useful medicine or recreational drug.   It is NOT compassionate to lie to the public that cannabis is a cure-all substance for cancers, seizures, diabetes, etc.   Sound scientific principles and reviews should and must be applied prior to permitting such substances into the stream of medicine.   The FDA has approved four drugs that contain or are derived from cannabis products.  They control for dosage and purity.   This is what the public is entitled to have -- clean, pure, safe, appropriate dosages for modern medicine.  We are already seeing the disaster of the lies that vaping is safe.  Hundreds of people -- mostly young people because they are typically the people who vape -- are hospitalized and now several reported deaths.  They are vaping nicotine AND THC or a combination of them.   The data is already there that this is an alarmingly dangerous activity.   Vaping is one of the delivery tools for medical cannabis --- ban vaping devices as an unregulated medical device.https://freebeacon.com/issues/colorado-doctor-sounds-alarm-on-marijuana-legalization/Randall said the state government has not only ignored scientific findings about marijuanas effects to push sales, but failed in the regulatory responsibility it promised would accompany legalization. The surgeon generals report noted that marijuana use during pregnancy is linked to adverse outcomes, including lower birth weight. A recent study of Colorado dispensaries found that 69 percent recommended women use marijuana anyway, with some actually discouraging mothers from telling their doctors about their drug use.Randall pointed to other commonly cited effects of legalization, including a historic increase in homelessness and a growing population of chronic, marijuana-dependent users. All of these, she suggested, have gone unreported in spite of the toll they are taking on her community.The glittering image of post-legalization Coloradowith billions in tax revenue and a happy populaceruns up against the uncomfortable reality of poor regulation and patients dangerously misguided about the risks and benefits of marijuana use. ---I am a concerned citizen and asking for the FDA to help save our nation from the clearly known problems from failed cannabis legalization.    You have been issuing warnings about inappropriate therapies/treatments from CBD products, but everywhere I look, there is now CBD, under the guise of hemp in products.  I took a cannabis in science  medicine course so I could find the benefits, but the reality is that the literature supporting any of these claims is paltry at best.   I work in an ED.  I see the side effects of this industry (on a daily basis).  The harms of THC are profound.  It is sad when I can look at a 15 y/o with cannabis induced hyperemesis and know that this will keep happening.  There are now case reports of deaths related to this.  https://onlinelibrary.wiley.com/doi/abs/10.1111/1556-4029.13819https://journals.lww.com/ajg/Fulltext/2016/10001/Cases_of_Death_Secondary_to_Cannabinoid.2217.aspxThis has become one of the most frequent diagnoses seen in the ED on a consistent basis.  As you know, in addition to CHS, there are numerous other harms.  We have not done enough to protect our teens/young adults from the false advertising that is occurring all the time.Please contact me for questions Dr. Sharpless prepared testimony to the US Congress is linked below with several statements noted for their importance. I note that Dr. Sharpless has called the vaping issues an epidemic of youth use of ENDS products -- surely the rise of youth consuming illicit cannabis IS AN EVEN LARGER NATIONAL EPIDEMIC!  I am not at all dismissing the crisis of youth vaping THC, CBD, and/or nicotine products or ENDS but rather that if vaping among children and young people qualifies as an epidemic than most certainly the broader consumption of THC and CBD products qualifies for an even large concern of an epidemic.   If this qualifies for the FDA to exercise its emergency powers through the Emergency Operations unit of the FDA than this call to action --- yes, action by the FDA itself --- should be mobilized regarding the cannabis epidemic of children, youth, young adults, and all society consuming cannabis products.   With crime up, hospitalizations up,  emergency room visits up,  neglected children cases up, traffic deaths from cannabis impaired drivers is up,  children being given cannabis by parents is up -- than surely this should qualify for the FDA to place this crisis with the Emergency Operations unit of the FDA.The FDA has authorized the sale of vaping devices for tobacco products (nicotine).  It would appear that this was approved without adequate scientific evidence as to the safety of a nicotine delivery devise but, be that as may be,  the vaping devises have not been approved to vape THC nor CBD products.  Thus any sales of a vaping device for the vaping of THC and/or CBD or combined with nicotine would appear to be a violation of federal law and such transactions would appear to be outside the FDA regulated approval of vaping devises for nicotine products. As noted in the testimony,  the FDA would consider the sale of an altered vaping devise .... if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act. Because many of the products associated with cases contain THC oils, we have engaged the DEA to help with our investigation....   To be clear the pursuit of criminal behavior should be if anyone is selling an unapproved usage of a vaping devise (ie FDA has regulated it only for nicotine consumption) for a drug under the FDA authority i.e.CBD and/or THC then upon a criminal investigation, charges should be brought, and prosecuted working with the DEA and the US Department of Justice.   In fact, it should not just be for personal profit but if anyone is manufacturing and/or distributing vaping devises that are done for the consumption of CBD and/or THC drugs that are under the FDA regulations as controlled drugs that there should be prosecutions of such cases.   The purpose of the FDA is to provide oversight and enforcement of products and devices to protect the public health and safety. The FDA needs to invoke emergency protocols to address the cannabis epidemic in the USA that includes the vaping crisis but all forms of cannabis consumption as well.   States have placed vaping of medical cannabis into their state constitutions by a grossly uninformed voting public, and into state law by uninformed state legislatures.   September 25, 2019    Acting Commissioner of Food and Drugs - Food and Drug Administration Norman E. Ned Sharpless MDhttps://www.fda.gov/news-events/press-announcements/remarks-prepared-testimony-us-house-energy-and-commerce-subcommittee-fda-regulation-electronicSecond, FDAs ongoing efforts to address an epidemic of youth use of ENDS products; including the Administrations recent announcement about our intention to issue a policy that would address ongoing marketing of flavored ENDS products.Working with state partners, FDA and CDC have been investigating an outbreak of severe lung injury associated with the use of vaping products. Most cases have reported recent use of vaping products containing THC, the psychoactive ingredient in marijuana. Although these cases seem similar, it is not clear if they have a common cause, or if they have differing pathogenesis with similar presentation. The investigation has not identified any specific substance or product that is linked to all cases.Let me outline the main components of our investigation. FDAs Office of Emergency Operations has activated an Incident Management Group to coordinate across the agency and works alongside CDCs Incident Management System.But to be clear, if we determine that someone is manufacturing or distributing illicit, adulterated vaping products that caused illness and death for personal profit, we would consider that to be a criminal act. Because many of the products associated with cases contain THC oils, we have engaged the DEA to help with our investigation.