THE EFFECT OF CANNABIS COMPARED WITH ALCOHOL ON DRIVING

THE EFFECT OF CANNABIS COMPARED WITH ALCOHOL ON DRIVING

Nov 30, 2020 | Blog, Stoned Driving

This Study was released in 2010 but has very good information.

Abstract

The prevalence of both alcohol and cannabis use and the high morbidity associated with motor vehicle crashes has lead to a plethora of research on the link between the two. Drunk drivers are involved in 25% of motor vehicle fatalities, and many accidents involve drivers who test positive for cannabis. Cannabis and alcohol acutely impair several driving-related skills in a dose-related fashion, but the effects of cannabis vary more between individuals than they do with alcohol because of tolerance, differences in smoking technique, and different absorptions of Δ9-tetrahydrocannabinol (THC), the active ingredient in marijuana. Detrimental effects of cannabis use vary in a dose-related fashion, and are more pronounced with highly automatic driving functions than with more complex tasks that require conscious control, whereas with alcohol produces an opposite pattern of impairment. Because of both this and an increased awareness that they are impaired, marijuana smokers tend to compensate effectively while driving by utilizing a variety of behavioral strategies. Combining marijuana with alcohol eliminates the ability to use such strategies effectively, however, and results in impairment even at doses which would be insignificant were they of either drug alone. Epidemiological studies have been inconclusive regarding whether cannabis use causes an increased risk of accidents; in contrast, unanimity exists that alcohol use increases crash risk. Furthermore, the risk from driving under the influence of both alcohol and cannabis is greater than the risk of driving under the influence of either alone. Future research should focus on resolving contradictions posed by previous studies, and patients who smoke cannabis should be counseled to wait several hours before driving, and avoid combining the two drugs.

1. Introduction

Accidents are the fifth leading cause of death in the US; nearly half are motor vehicle accidents, which according to the Fatality Analysis Reporting System (FARS) killed 38,588 people in 2006 alone.1 Motor vehicle accidents are the nation’s leading cause of death in those under 30.2 The contribution of drugs of abuse to this accident rate has attracted increasing attention in recent years because of the dramatic increase in drug use. In 2002, the National Survey on Drug Use and Health (NSDUH) estimated that 22 million Americans—9.4% of the population—have a substance use or dependence problem. As marijuana is the most commonly used drug of abuse, having been tried by 40% of the population,3 and is also smoked most commonly in the age group that also has the most road traffic accidents, the contribution of marijuana smoking to road traffic accidents is of great concern to both governments and clinicians responsible for counseling patients with substance abuse problems. Moreover, given the paucity of data supporting marijuana’s acute toxicity, the most serious possible consequence of acute cannabis use is a road traffic accident from driving while intoxicated.4 The very high cost of crashes, both human and financial, underlines the importance of understanding the extent to which marijuana use contributes to such accidents. The purpose of this paper is to review the scientific evidence on the effects on driving while intoxicated with marijuana and contrast this with the effects of alcohol intoxication.

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2. Epidemiology of marijuana smoking and road traffic accidents

The rising prevalence of cannabis use, its increased availability and potency,5 lower prices, widespread social tolerance, and earlier age of onset of use have combined to increase the number of users and hence the number of people subject to cannabis use disorders.6 Peak initiation is at age 18, and ten years later, 8% of users are marijuana-dependent.7 Most cannabis use is intermittent and time-limited, however; users generally stop in their mid-to-late 20s, and only a small minority continue in daily use over a period of years.8

Young people also account for a disproportionate number of road traffic accidents. According to the National Center for Statistics and Analysis, the fatality rate for teenagers is four times that of drivers age 25 to 69, and drivers under age 25 account for a quarter of all traffic fatalities.9 Risk factors for having a fatal traffic accident include being a young man, having psychological characteristics such as thrill-seeking and overconfidence, driving at excessive speed, driving late at night, failing to wear a seatbelt, and lacking familiarity with the vehicle.10 The risk factors for adolescent marijuana use are somewhat overlapping—delinquency (vandalism, shoplifting, joyriding etc.), poor school performance, and substance use by self and peers.11

The National Highway Transportation Safety Administration (NHTSA) reported that in 25% of all motor vehicle crash fatalities, the driver had a blood alcohol concentration (BAC) of 0.01 g/dL (one eighth the legal limit) or greater, and in 21-year-old drivers, that figure rose to 39%.12 Drivers with a previous DWI (“Driving While Impaired”) conviction were responsible for 7.2% of all crashes involving alcohol.

In comparison, the percentage of road traffic accidents in which one driver tested positive for marijuana ranges from 6% to 32%.13, 14 In one study, 9.7% of cannabis smokers reported having driven under the influence in the previous year; those who did drove while intoxicated an average of 8.1 times during the year.15 Among those who seek treatment for cannabis problems, more than 50% report having driven while “stoned” at least once in the previous year.16, 17

3. Studies relevant to marijuana and smoking

Three types of studies are generally performed to help assess the risk that smoking marijuana may increase the probability of having a fatal traffic accident. The first are cognitive studies that measure the effects of smoking marijuana on cognitive processes that are considered to be integral to safe driving. The second are experimental studies on the collision risk of people under the influence of marijuana. The third are descriptive and analytic epidemiological studies on the relationship between cannabis use and accidents, usually performed through drug testing of injured drivers.

3.1 Cognitive studies

Attentiveness, vigilance, perception of time and speed, and use of acquired knowledge are all affected by marijuana;18–21 in fact, a meta-analysis of 60 studies concluded that marijuana causes impairment in every performance area that can reasonably be connected with safe driving of a vehicle, such as tracking, motor coordination, visual functions, and particularly complex tasks that require divided attention,22 although studies on marijuana’s effects on reaction time have been contradictory.23 Similar conclusions have been reached by other reviewers.2 Worse still, marijuana and alcohol, when used together, have additive or even multiplicative effects on impairment.24 Consequently, on the basis of cognitive studies, it seems reasonable to propose that smoking marijuana may increase the risk of having a fatal traffic accident.

Alcohol at 0.75 g/kg (slightly less than four standard drinks) causes high levels of impairment in psychomotor performance and medium-to-high levels of impairment in such tasks as critical flicker fusion and short-term memory.25 Alcohol impairs pursuit tracking, divided attention, signal detection, hazard perception,26–28 reaction time, attention, concentration, and hand-eye coordination.29, 30

Alcohol also reduces the perceived negative consequences of risk-taking,31 which can increase willingness to take risks after drinking,32 the amount of risk-taking behavior while driving, even at low alcohol doses,33 and the incidence of road traffic accidents while driving drunk.34, 35 However, there is considerable variability in the effects that alcohol can have on people—the same dose may have different effects not only on different individuals, but also in the same individual on different occasions, because of other factors such as gender, body mass index, age, drinking habits, time of day, stomach contents, genetics, stage of the menstrual cycle, and environmental factors.36

3.2 Experimental research (driving and simulator studies)

Experimental research measures the potential risk of an accident using a driving simulator or driving course.

3.2.1 Studies that do not show impairment

Surprisingly, given the alarming results of cognitive studies, most marijuana-intoxicated drivers show only modest impairments on actual road tests.37, 38 Experienced smokers who drive on a set course show almost no functional impairment under the influence of marijuana, except when it is combined with alcohol.39

Many investigators have suggested that the reason why marijuana does not result in an increased crash rate in laboratory tests despite demonstrable neurophysiologic impairments is that, unlike drivers under the influence of alcohol, who tend to underestimate their degree of impairment, marijuana users tend to overestimate their impairment, and consequently employ compensatory strategies. Cannabis users perceive their driving under the influence as impaired and more cautious,40 and given a dose of 7 mg THC (about a third of a joint), drivers rated themselves as impaired even though their driving performance was not; in contrast, at a BAC 0.04% (slightly less than two “standard drinks” of a can of beer or small 5 oz. glass of wine; half the legal limit in most US states), driving performance was impaired even though drivers rated themselves as unimpaired.41 Binge drinkers are particularly likely to rate themselves as unimpaired, possibly because they tend to become less sedated by high doses of alcohol.42

This awareness of impairment has behavioral consequences. Several reviews of driving and simulator studies have concluded that marijuana use by drivers is likely to result in decreased speed and fewer attempts to overtake, as well as increased “following distance”. The opposite is true of alcohol.43 One review of eight driving simulator studies and seven on-road studies44 found that cannabis use was associated with either poor lane control41, 45–48 or slower driving that successfully maintained lane control.49–51 In seven of ten studies cited, cannabis use was associated with a decrease in driving speed despite explicit instructions to maintain a particular speed, whereas under the influence of alcohol, subjects consistently drove faster. Two simulator studies showed that the tendency to overtake was decreased with cannabis use but increased with alcohol.52, 53 One simulator study and two on-road studies examining car-following behavior concluded that cannabis smokers tend to increase the distance between themselves and the car in front of them.41, 45 Other studies have found no adverse effects of marijuana use on sign detection,49 a sudden lane-changing task,43 or the detection of and response to hazardous events.48

3.2.2 Studies that show impairment

Not all deficits can be compensated for through the use of behavioral strategies, however. Both alcohol and marijuana use increase reaction time and the number of incorrect responses to emergencies.43 Drivers under the influence of marijuana were not able to compensate for standard deviation of lateral position (SDLP, a measure of staying within lane), which increased with increasing doses of THC. This is a measure that is not subject to conscious compensatory mechanisms in the way that other aspects of driving are. Other studies have found poorer monitoring of the speedometer under the influence of marijuana,54 increased decision time when passing,52 increased time needed to brake when a light suddenly changes,55 and increased time to respond to a changing light45, 56 or sudden sound.57 Drivers also crashed more frequently into a sudden obstacle on a high dose of marijuana, although this did not happen at a low dose.45

Meta-analyses of over 120 studies have found that in general, the higher the estimated concentration of THC in blood, the greater the driving impairment, but that more frequent users of marijuana show less impairment than infrequent users at the same dose, either because of physiological tolerance or learned compensatory behavior. Maximal impairment is found 20 to 40 minutes after smoking, but the impairment has vanished 2.5 hours later, at least in those who smoke 18 mg THC or less (the dose often used experimentally to duplicate a single joint).58, 59

With increasing doses of alcohol, however, there is general dose-dependent lowering of both sustained attention and overall attentional capacity, with consequently more concentration paid to the main component of a complex skill (steering, for example), and less and less attention paid to secondary tasks (such as speed or driving skill). Functional imaging on the effects of increasing doses of alcohol up to a BAC of 0.08% in simulated driving has demonstrated that orbitofrontal areas (subsuming judgment) and motor areas are affected first, then cerebellar areas controlling coordination show functional deterioration, and finally, at high doses, global cognitive networks and simulated driving performance are impaired.60

Interestingly, three reports indicate that chronic marijuana smokers are less susceptible to impairment from alcohol on some measures compared with nonsmokers or infrequent smokers. As far back as 1970, Reese Jones noticed that alcohol’s effects were diminished in heavy cannabis smokers.61 A subsequent study showed that regular cannabis smokers demonstrate less of a decrement in peripheral signal detection under the influence of alcohol than do infrequent users,62 and a later study still found that regular cannabis users given alcohol alone showed less of a decrement in tracking accuracy and dizziness ratings than infrequent users given the same alcohol dose.63 The reason for this is unclear, but is hypothesized to result from either pharmacological or behavioral cross-tolerance between marijuana and alcohol.

3.2.3 Summary of experimental studies

It appears that cannabis use may impair some driving skills (automatic functions such as tracking) at smoked doses as low as 6.25 mg (a third of a joint), but different skills (complex functions that require conscious control) are not impaired until higher doses, and cannabis users tend to compensate effectively for their deficits by driving more carefully. Unexpected events are still difficult to handle under the influence of marijuana, however, and the combination of low-dose alcohol and low-dose cannabis causes much more impairment than either drug used alone.48, 64, 65 Alcohol appears to impair tasks requiring cognitive control more than it does automatic functions, whereas marijuana at a comparable dose impairs automatic functions more than those requiring cognitive control. Together, the effects on impairment are additive and may even be synergistic. Chronic marijuana smokers are less impaired by both alcohol and marijuana than would be expected, however.

3.3 Epidemiologicalstudies

One weakness of driving studies is that subjects are aware of being observed and assessed, so such studies are generally a better measure of what drivers are capable of doing rather than what they actually do. Epidemiological studies attempt to assess the actual risk that a driver may cause an accident under the influence of a drug, relative to that of a sober person driving under similar conditions. The relative risk is expressed in the form of an “odds ratio” (OR), which is the multiplier for the increased accident risk from driving under the influence of marijuana. Two approaches are taken. The first is culpability studies, which classify drivers who have crashed according to their degree of responsibility for the crash, then compare drug use in each category. If there is greater use of the drug in those culpable for crashes, then the drug is judged to be responsible for a greater crash risk. The second is case control studies. We will discuss both in turn.

3.3.1 Culpability studies

3.3.1.1 Studies that do not show culpability

Some reviewers have concluded that there is no evidence that cannabis alone increases the risk of culpability for crashes, and may actually reduce risk.66 Drummer’s review of blood samples of traffic fatalities in Australia found that drivers testing positive for marijuana were actually less likely to have been judged responsible for the accident.67 Several other studies have found no increase in crash risk with cannabis.68–70 Williams’ California study of 440 male traffic accident deaths found that while alcohol use was related to crash culpability, cannabis use was not.71 Terhune’s study of 1882 motor vehicle deaths calculated an OR of 0.7 for cannabis use, 7.4 for alcohol use, and 8.4 for cannabis and alcohol use combined.68 Lowenstein and Koziol-McLain’s study of 414 injured drivers admitted to a Colorado E/R found an OR of 1.1, indicating that marijuana use was not associated with increased crash responsibility.72 Drummer’s later and more extensive ten-year study of 3400 traffic fatalities in three Australian states found that drivers with blood THC levels less than 5 ng/mL, and those with only carboxy-THC present (THC-COOH, a metabolite that is excreted in the urine for weeks and is thus more likely to indicate past use than current use), had an OR of 1.0, but those with serum levels greater than 5 ng/mL had an OR of 6.6, the same as that for a BAC of 0.15%. In all 30 cases in this study in which one driver had a serum level of THC greater than 10 ng/mL, that driver was judged to have been responsible for the accident. When marijuana was combined with alcohol, the risk was higher still.73 A later reanalysis of the same data that adjusted for the age and sex of the fatalities found that OR of crashing for cannabis use alone dropped to 0.6 (not significantly different from 1.0), versus 7.6 for alcohol.66 Laumon’s study of 10,748 French motor vehicle fatalities found that although rates of alcohol and cannabis intoxication were similar (nearly 3%), ten times as many crashes were associated with alcohol as with cannabis; however, investigators noted a dose-dependent effect on OR with increasing THC serum levels, confirming Drummer’s observation by calculating an OR of 4.72 for THC levels greater than 5 ng/mL.74 Longo’s large, well-known study of hospitalized injured drivers in South Australia showed few adverse effects of cannabis on crash risk, although there was a slightly increased risk of crashing with higher THC concentrations and a slightly lower risk with lower concentrations.75

What 5 ng/mL means in terms of actual impairment is hard to calculate, as THC levels in the blood peak quickly following inhalation then decrease rapidly according to complex pharmacokinetics, making it almost impossible to extrapolate backwards from the concentration of THC at the time of the blood test to the concentration at the time of the traffic accident. Some insight can be gained from Jones’ study of 1276 Swedish motorists arrested for DUI with blood tests positive for THC alone, which revealed an average THC blood level of 3.6 ng/mL at the time of testing.76 A similar Swiss study of 440 DUI suspects who also were positive for only THC found average blood concentrations of 5.0 ng/mL at the time of testing, indicating that a residual level of 5 ng/mL does appear to correlate with observable driving impairment earlier.77 The Swedish study also found that, of the 291 DUI arrestees who were positive for both THC and alcohol, the average THC blood level was only 2.3 ng/mL, again suggesting that lower levels of THC, when combined with alcohol, are sufficient to cause obvious impairment.76

Methodological problems often can make culpability studies hard to interpret, however. Since no study has ever shown an increased risk of road accidents among frequent marijuana smokers who are not intoxicated at the time that they drive, a positive urine test that measures levels of the long-lasting metabolite carboxy-THC but not the active ingredient THC is insufficient to classify a driver as intoxicated, as such a measure will include in the marijuana group unimpaired people who have smoked only in the past and thus artificially depress the OR.78 The Colorado study that found that marijuana use was not associated with increased crash responsibility used urine toxicology to assess drug use, so likely suffered from this limitation.72 Sampling delays in excess of an hour can cause an underestimation of THC concentration in the blood of injured drivers who test positive for marijuana, possibly explaining Longo and others’ failure to find adverse effects.

Alcohol levels, which have linear pharmacokinetics, are easier to back-calculate to the time of the accident, and are consistently linked with increased culpability in crashes.71, 75 Moreover, whereas CNS levels of alcohol, which moves easily throughout the body with little difference in concentration between compartments, can be approximated with a good degree of accuracy through measuring blood or breath levels, the same is not true of THC, which is highly lipophilic and concentrates preferentially in adipose tissue. Consequently, experimental studies have shown that functional impairment (which reaches a maximum an hour after smoking) lags behind THC blood level (which peaks within minutes and decreases rapidly thereafter).79 (Figure 1) This makes it much harder to generate blood level versus impairment curves for marijuana than it is for alcohol.

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R. Andrew Sewell, MD,James Poling, PhD, and Mehmet Sofuoglu, MD, PhDAuthor informationCopyright and License informationDisclaimerThe publisher’s final edited version of this article is available at Am J AddictSee other articles in PMC that cite the published article.

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The FDA recognizes the opportunities that cannabis and CBD

The FDA recognizes the opportunities that cannabis and CBD

Apr 19, 2020 | Blog

There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.

Consumer Information

FDA Communications

Regulatory Resources

Questions and Answers

Below are a number of frequently asked questions and answers on this topic.

  1. What are cannabis and marijuana?
  2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?
  3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?
  4. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?
  5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?
  6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?
  7. Has the agency received any adverse event reports associated with cannabis use for medical conditions?
  8. Is it legal for me to sell CBD products?
  9. Can THC or CBD products be sold as dietary supplements?
  10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
  11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?
  12. Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?
  13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
  14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?
  15. Can I import or export cannabis-containing or cannabis-derived products?
  16. What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?
  17. Does the FDA object to the clinical investigation of cannabis for medical use?
  18. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?
  19. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?
  20. Does the FDA have concerns about administering a cannabis product to children?
  21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?
  22. What does the FDA think about making CBD available to children with epilepsy?
  23. What should I do if my child eats something containing cannabis?
  24. I’ve seen cannabis products being marketed for pets. Are they safe?
  25. Can hemp be added to animal food?
  26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?

1. What are cannabis and marijuana?

A. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”) [21 U.S.C. 802(16)]. “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use of the plant in the United States.

2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?

A.  At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.

The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.

3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?

A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.

FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.

The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.

4. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?

A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug.  Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review.  CBD was not an ingredient considered under the OTC drug review.  An unapproved new drug cannot be distributed or sold in interstate commerce.

FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases. 

Unlike drugs approved by FDA, products that have not been subject to FDA review as part of the drug approval process have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns.

The agency has and will continue to monitor the marketplace and take action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and that are being marketed for therapeutic uses for which they are not approved. At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.  The Center for Drug Evaluation and Research (CDER) is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process (see Question #16).

5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?

A. FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.

To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. The agency has, however, approved one cannabis-derived and three cannabis-related drug products (see Question #2).

FDA relies on applicants and scientific investigators to conduct research. The agency’s role, as laid out in the FD&C Act, is to review data submitted to the FDA in an application for approval to ensure that the drug product meets the statutory standards for approval.

The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry:  Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products.  The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA).

6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?

A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.

7. Has the agency received any adverse event reports associated with cannabis use for medical conditions?

A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects.

Information from adverse event reports regarding cannabis use is extremely limited; FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.

8. Is it legal for me to sell CBD products?

A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.

We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.

9. Can THC or CBD products be sold as dietary supplements?

A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.

FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue.  Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

When a substance is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in the agency’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the FD&C Act. To date, no such regulation has been issued for any substance.

Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements.  However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products.  For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]).  Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling.  A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).

Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.

10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?

A. No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]).  To date, no such regulation has been issued for any substance.

Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of 301(ll), and therefore might be able to be added to food.  For example, as discussed in Question #12, certain hemp seed ingredients can be legally marketed in human food. However, all food ingredients must comply with all applicable laws and regulations.  For example, by statute, any substance intentionally added to food is a food additive, and therefore subject to premarket review and approval by FDA, unless the substance is generally recognized as safe (GRAS) by qualified experts under the conditions of its intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]). Aside from the three hemp seed ingredients mentioned in Question #12, no other cannabis or cannabis-derived ingredients have been the subject of a food additive petition, an evaluated GRAS notification, or have otherwise been approved for use in food by FDA.  Food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the food additive and GRAS processes.

11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?

A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.

The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer PainExternal Link Disclaimer )

12. Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?

A. In December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil.  FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for the uses described in the notices, provided they comply with all other requirements. These GRAS notices related only to the use of these ingredients in human food. To date, FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food (see Question #25).

Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”

The GRAS conclusions can apply to ingredients for human food marketed by other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.

These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.

13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?

A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”

Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).

If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. (See Question #3 for more information about drugs.) 

FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.

14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?

A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

15. Can I import or export cannabis-containing or cannabis-derived products?

A. General information about the import/export of drug products regulated by FDA can be found online here. The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the controlled substance laws and regulations in the U.S. and, as such, should be consulted with respect to any regulations/requirements they may have regarding the import or export of products containing cannabis. Please see here for information about importing or exporting food ingredients.

Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).

Research and Expanded Access

16. What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?

A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.

As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.

Conducting clinical research using cannabis-related substances that are scheduled by the DEA often involves interactions with several federal agencies. This includes: a registration administered by the DEA; obtaining the cannabis for research from NIDA, within the National Institutes of Health, or another DEA-registered source; and review by the FDA of the IND or INAD application and research protocol. Additionally:

  • For a Schedule I controlled substance under the CSA, DEA provides researchers with investigator and protocol registrations and has Schedule I-level security requirements at the site cannabis will be studied.
  • NIDA provides research-grade cannabis for scientific study. The agency is responsible for overseeing the cultivation of cannabis for medical research and has contracted with the University of Mississippi to grow cannabis for research at a secure facility. Cannabis of varying potencies and compositions is available. DEA also may allow additional growers to register with the DEA to produce and distribute cannabis for research purposes.
  • Researchers work with the FDA and submit an IND application to the appropriate division in the Office of New Drugs in CDER depending on the therapeutic indication. Based on the results obtained in studies conducted at the IND stage, sponsors may submit a marketing application for formal approval of the drug.

17. Does the FDA object to the clinical investigation of cannabis for medical use?

A. No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis. The FDA supports the conduct of that research by:

  1. Providing information on the process needed to conduct clinical research using cannabis.
  2. Providing information on the specific requirements needed to develop a drug that is derived from a plant such as cannabis. In December 2016, the FDA updated its Guidance for Industry: Botanical Drug Development, which provides sponsors with guidance on submitting IND applications for botanical drug products.
  3. Providing specific support for investigators interested in conducting clinical research using cannabis and its constituents as a part of the IND process through meetings and regular interactions throughout the drug development process.
  4. Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Research’s Small Business and Industry Assistance group.

18. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?

A. Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available.  Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations.

19. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?

A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions.  Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.

Children and Pregnant/Lactating Women

20. Does the FDA have concerns about administering a cannabis product to children?

A. We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds, and will continue to work with companies interested in bringing safe, effective, and quality products to market. With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult.

21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?  

A. The FDA is aware that there are potential adverse health effects with use of cannabis products containing THC in pregnant or lactating women. Published scientific literature reports potential adverse effects of cannabis use in pregnant women, including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, neonatal intensive care unit (NICU) admission, and stillbirth. [1, 2, 3] Based on published animal research, there are also concerns that use of cannabis during pregnancy may negatively impact fetal brain development.  [4, 5, 6 ] The American College of Obstetricians and Gynecologists (ACOG) recommends that women who are pregnant or contemplating pregnancy should be encouraged to discontinue cannabis use. In addition, ACOG notes that there are insufficient data to evaluate the effects of cannabis use on breastfed infants; therefore, cannabis use is discouraged when breastfeeding. [7] Pregnant and lactating women should talk with a health care provider about the potential adverse health effects of cannabis use.

22. What does the FDA think about making CBD available to children with epilepsy?

A. The FDA has approved Epidiolex, which contains a purified form of the drug substance CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. That means the FDA has concluded that this particular drug product is safe and effective for its intended use. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring cannabis-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

23. What should I do if my child eats something containing cannabis?

A. With the exception of products such as the hemp seed ingredients discussed in Question #12, which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis and cannabis-containing products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. If the parent or caregiver has a reasonable suspicion that the child accidentally ingested products containing cannabis, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.

Pets and other Animals

24. I’ve seen cannabis products being marketed for pets. Are they safe?

A. FDA is aware of some cannabis products being marketed as animal health products. We want to stress that FDA has not approved cannabis for any use in animals, and the agency cannot ensure the safety or effectiveness of these products. For these reasons, FDA cautions pet-owners against the use of such products and recommends that you talk with your veterinarian about appropriate treatment options for your pet.

Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.

If you have concerns that your pet is suffering adverse effects from ingesting cannabis or any substance containing cannabis, consult your veterinarian, local animal emergency hospital or an animal poison control center immediately.

While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting cannabis, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal drug or for how to report an adverse event or problem with a pet food.

25. Can hemp be added to animal food?

A. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)].  In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food.  At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food. Learn more about animal food ingredient submissions here.

With respect to products labeled to contain “hemp” that may also contain THC or CBD, as mentioned above it is a prohibited act under section 301(ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added.

26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?

A. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), permits veterinarians to prescribe extralabel uses of approved human and animal drugs for animals under certain conditions. Extralabel use must comply with all the provisions of AMDUCA and its implementing regulation at 21 CFR § 530. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.

In addition, under 21 CFR 530.20, extralabel use of an approved human drug in a food-producing animal is not permitted if an animal drug approved for use in food-producing animals can be used in an extralabel manner for the use. In addition, under 21 CFR 530.20(b)(2), if scientific information on the human food safety aspect of the use of the approved human drug in food-producing animals is not available, the veterinarian must take appropriate measures to ensure that the animal and its food products will not enter the human food supply.
For more information on extralabel use of FDA approved drugs in animals, see Extralabel Use of FDA Approved Drugs In Animals.

[1] Gray, et al. Identifying Prenatal Cannabis Exposure and Effects of Concurrent Tobacco Exposure on Neonatal Growth. Clinical Chemistry. 2010; 56(9): 1442-1450.

[2] Gunn, et al. Prenatal Exposure to cannabis and maternal and child health outcomes: a systematic review and meta-analysis. BMJ Open. 2016; 6:e009986.

[3] Hayatbakhsh, et al.  Birth Outcomes associated with cannabis use before and during pregnancy.  Pediatric Research. 2012; 71 (2): 215-219.

[4] Silva, et al. Prenatal tetrahydrocannabinol (THC) alters cognitive function and amphetamine response from weaning to adulthood in the rat. Neurotoxicol and Teratol 2012; 34(1): 63-71. 

[5] Trezza, et al. Effects of perinatal exposure to delta-9-tetrahydrocannabinol on the emotional reactivity of the offspring: a longitudinal behavioral study in Wistar rats. Psychopharmacology (Berl) 2008; 198(4): 529-537.

[6] Campolongo, et al. Perinatal exposure to delta-9-tetrahydrocannabinol causes enduring cognitive deficits associated with alteration of cortical gene expression and neurotransmission in rats. Addict Biol 2007; 12(3-4): 485–495.

[7] ACOG Committee Opinion: Marijuana Use During Pregnancy and LactationExternal Link Disclaimer 

Content current as of:

03/11/2020

IRS report predicts national rise in cannabis industry tax audits.

IRS report predicts national rise in cannabis industry tax audits.

Apr 6, 2020 | News

A recently released report from a branch of the U.S. Treasury Department states the Internal Revenue Service is preparing to launch an increase in marijuana industry audits nationwide, However, it also offers a possible way for marijuana companies to skirt federal taxes.

The IRS is closely monitoring the marijuana industry and intends to target companies that have failed to pay their full federal tax obligations.The agency has plans to enforce the collection of those taxes.

The report – written by the Treasury Inspector General for Tax Administration (TIGTA) – found there are likely hundreds of millions of dollars in unpaid taxes owed by the marijuana industry under Section 280E of the Internal Revenue Code, which prohibits standard business deductions by companies that traffic in federally illegal drugs, including marijuana.

26 U.S. Code § 280E.Expenditures in connection with the illegal sale of drugs

No deduction or credit shall be allowed for any amount paid or incurred during the taxable year in carrying on any trade or business if such trade or business (or the activities which comprise such trade or business) consists of trafficking in controlled substances (within the meaning of schedule I and II of the Controlled Substances Act) which is prohibited by Federal law or the law of any State in which such trade or business is conducted.

Definition of Controlled Substance Schedules

Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules. An updated and complete list of the schedules is published annually in Title 21 Code of Federal Regulations (C.F.R.) §§1308.11 through 1308.15. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused. Some examples of the drugs in each schedule are listed below.

Schedule I Controlled Substances

Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.

Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine (“Ecstasy”).

Schedule II/IIN Controlled Substances (2/2N)

Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.

Examples of Schedule II narcotics include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®, Percocet®), and fentanyl (Sublimaze®, Duragesic®).  Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone.

Examples of Schedule IIN stimulants include: amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®).

Other Schedule II substances include: amobarbital, glutethimide, and pentobarbital.

Farmington Hills, MI-based Attorney Michael Komorn who has represented the medical marijuana businesses and recreational cannabis licensing and legal defense stated “Here they come like we knew they would… so now is the time to prepare.”

Recent Posts

Nevada to introduce first banking system for the cannabis industry.

Nevada to introduce first banking system for the cannabis industry.

Jul 23, 2019 | Blog

Nevada to introduce the nation’s first banking system for the cannabis industry.

The dispensary businesses are targeted for burglaries and robberies for the cash they keep around to pay overhead and employees.

Motivated by their gaming sector, officials would allow marijuana businesses to deal in electronic tokens and chips.

“We really want to deal with the public safety issue. That much cash in the hands of that many people, it’s just dangerous. It’s an attractive target,” said Nevada state Treasurer Zach Conine, who pushed for the program.

Cannabis businesses operate on a cash basis due to banks and other financial institutions having refused to do business with them citing federal laws of the Schedule 1 drug.

Nevada has to make sure they get theirs and not let that cash slip through the system.  Hopefully it will be used for making Nevada a better place for families and not for idiocracy.

Attorney Michael Komorn stated “The time has come for the legitimacy of cannabis and hemp industries to be accepted and allowed to operate as taxpayers and invest in the community. If you are thinking of growing hemp or starting a cannabis business you will require legal guidance…that’s what we do“.

Recent Posts

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Michigan Released Emergency Recreational Marijuana Rules For Establishments

Michigan Released Emergency Recreational Marijuana Rules For Establishments

Jul 3, 2019 | Blog

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The release of the rules is intended to give local governments time to decide whether they want to ban adult-use marijuana businesses before the state Marijuana Regulatory Agency begins accepting business license applications. The emergency rules expire in six months.

“It provides clarity on the state’s approach on establishing the regulatory program and doing so in a way that is consistent as possible with the standards in the medical market that exist now, and doing so in a way that provides adequate time for municipalities to evaluate what we put in the rules and to make a determination on how the municipality wants to approach this new market before we start taking applications,” said agency Director Andrew Brisbo

Read the more here at MLive

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The rules outline how the new adult-use market will function and how the business license application process will work. It is also how the recreational and medical marijuana industries will interact.

The release of the rules is intended to give local governments time to decide whether they want to ban adult-use marijuana businesses before the state Marijuana Regulatory Agency begins accepting business license applications. The emergency rules expire in six months.

“It provides clarity on the state’s approach on establishing the regulatory program and doing so in a way that is consistent as possible with the standards in the medical market that exist now, and doing so in a way that provides adequate time for municipalities to evaluate what we put in the rules and to make a determination on how the municipality wants to approach this new market before we start taking applications,” said agency Director Andrew Brisbo

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Recreational marijuana smoking lounges, festivals and home delivery are soon to be allowed in Michigan. They are defined under a set of emergency rules state officials released.

These rules have defined the launch of the recreational cannabis market in Michigan. The release was signed Tuesday by Governor Gretchen Whitmer.

The rules outline how the new adult-use market will function and how the business license application process will work. It is also how the recreational and medical marijuana industries will interact.

The release of the rules is intended to give local governments time to decide whether they want to ban adult-use marijuana businesses before the state Marijuana Regulatory Agency begins accepting business license applications. The emergency rules expire in six months.

“It provides clarity on the state’s approach on establishing the regulatory program and doing so in a way that is consistent as possible with the standards in the medical market that exist now, and doing so in a way that provides adequate time for municipalities to evaluate what we put in the rules and to make a determination on how the municipality wants to approach this new market before we start taking applications,” said agency Director Andrew Brisbo

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