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I think its can help youBlasting air at up to 185 mph, leaf blowers can whip up hazardous particles and contaminants from the ground at speeds greater than a Category 5 hurricane, sending them long distances.Epidemiological studies have long recognized the harm these particles — including hydrocarbons from gasoline, animal droppings, spores, fungi, pollens, pesticides and herbicides, fertilizers, brake-lining dust and tire residue and heavy metals — cause to people's respiratory systems, according to Bay Area Air Quality Management District reports.Exposure to particulate matter is rarely, if ever, cited as the cause of death in a coroner's report when someone dies of a heart attack or stroke or lung disease, a 2012 district study noted. "However, epidemiological studies indicate that exposure to particulate matter is an important contributing factor in hundreds, perhaps thousands, of deaths in the Bay Area each year."The district has called particulate matter "the air pollutant that poses by far the greatest health risk to Bay Area residents."The average adult inhales 450 cubic centimeters (roughly one pint) of air per breath, which includes 1 million to 10 million tiny particles with each breath."But that figure can spike to much higher levels in close proximity to high-volume roadways or other major outdoor emission sources," the district's "Bay Area 2010 Clean Air Plan" noted.The contribution of leaf blowers to air pollution isn't to be underestimated. About 5 pounds of particulate matter per leaf blower per hour are swept into the air and take hours to settle, according to a widely cited leaf-blower pollution report by the Orange County, California grand jury in 1999.An Air District program aimed at replacing up to 50,000 leaf blowers and 10,000 lawn mowers by 2020 would reduce the most dangerous small-particle emissions (sized 2.5 and 10 microns) by 0.12 tons (240 pounds) per day, according to the 2010 Clean Air Plan.Fine particles measuring 2.5 microns and coarser material measuring 10 microns are more readily absorbed into the lungs. The smaller 2.5-micron particles are associated with hazardous organic compounds and heavy metals, according to the U.S. Environmental Protection Agency (E.P.A.). Particles measuring 10 microns are typically composed of smoke, dirt, dust, mold, spores and pollen.Particulates in the 2.5-micron range can migrate many hundreds of miles and stay the air for days or weeks; 10-micron particles can travel up to 30 miles and stay aloft for hours, according the U.S. E.P.A.Besides what they kick up off the ground, gas-powered leaf blowers themselves emit specific pollutants the State of California has identified as of concern: hydrocarbons from both burned and unburned fuel, which combine with other gases to form ozone; carbon monoxide; and toxic contaminants such as benzene, 1,3-butadiene, acetaldehyde and formaldehyde, according to a widely quoted 2000 California Environmental Protection Agency Air Resources Board report.The Air Quality District in 2010 estimated there were approximately 258,000 two-stroke leaf blowers in the Bay Area, which generate significantly more air pollution than four-stroke engines.Testing in 2011 by the vehicle reviewer New Cars, Used Cars, Car Reviews and Pricing | Edmunds showed just how dirty leaf blowers remain, even 11 years after new emission standards for blowers went into effect.Pitting leaf blowers against a Ford F-150 SVT Raptor crew cab, the leaf blowers were the big dogs when it came to spewing non-methane hydrocarbons, oxides of nitrogen and carbon monoxide — the three pollutants that the EPA and the California Air Resources Board find most concerning.The two-stroke blower generated 23 times the carbon monoxide and nearly 300 times more non-methane hydrocarbons as the truck."To equate the hydrocarbon emissions of about a half-hour of yard work with this two-stroke leaf blower, you'd have to drive a Raptor for 3,887 miles, or the distance from northern Texas to Anchorage, Alaska," the article noted.Officials from local lung-health organizations said the contribution of leaf blowers to pollution can't be ignored."It should be of great concern," said Lynn Smith, interim executive director of Breathe California of the Bay Area, also noting the huge discrepancy between leaf blower and car emissions.Various arguments have been made by some environmental groups that blowers should be entirely banned in favor of a return to old-fashioned brooms and rakes.A 1999 study by the University of California Riverside and San Joaquin Valley Unified Air Pollution Control District, the first of its kind, attempted to quantify the differences. Leaf blowers produced about 30 milligrams per square meter of 2.5-micron-sized particulates and 80 mg per square meter of 10-micron particles.The results were similar for push brooms used on a concrete surface, probably because of the smoother surface, the researchers found. But using a push broom on asphalt produced no 2.5-micron particles and only 20 mg in the 10-micron range.And raking on either surface produced no particulates in either range, the study found.The California Landscape Contractors Association, however, disputes the allegations of the air pollution caused by leaf blowers, calling concerns over air emissions "spurious," according to a 1999 letter from its board of directors that was confirmed as current on July 20."Properly used leaf blowers do not raise inordinate amounts of dust. Rule 403 of the South Coast Air Quality Management District states that 'a person shall not cause or allow the emissions of fugitive dust from any active operation, open storage pile, or disturbed surface area such that the presence of such dust remains visible in the atmosphere beyond the property line of the emission source.' Blower users can and should follow this rule," the letter states.In addition to arguing that emissions standards from the California Air Resources Board implemented in 2000 would significantly reduce emissions from handheld equipment, the association pointed to the intermittent use of blowers."Portable lawn and garden equipment contributes only 0.8 percent of all U.S. VOC (volatile organic compound) emissions, 0.6 percent of carbon monoxide emissions, and no nitrogen oxide emissions."Debates over air pollution aside, there's also noise — perhaps the most evident pollution caused by leaf blowers. The City of Palo Alto requires leaf blowers to emit no more than 65 decibels, when measured from 50 feet away.The Occupational Safety and Health Administration (OSHA) has determined that decibel levels above 85 cause permanent hearing loss. The World Health Organization recommends a general outdoor noise level of 55 decibels or less and 45 or less for sleeping restfully.Excessive noise has been implicated in higher heart-attack rates, gastrointestinal disturbances, sleep problems, social discord and psychological problems, according to the U.S. E.P.A.Ironically, metal rakes aren't much quieter, though the sound is less constant: The City of Palo Alto noted in a 2005 report that metal rakes used on concrete can generate 58-60 decibels at 50 feet.When it comes to encouraging gardeners to forego their gas-powered machines, one air quality district in southern California has had significant success with its leaf blower exchange. The South Coast Air Quality Management District, which covers Orange County, urban Los Angeles, San Bernardino and Riverside, has held a leaf blower buy-back program since 2006 for professional gardeners. In that time, the district has put more than 12,000 reduced-noise and lower-emissions leaf blowers in the hands of professional gardeners.The agency distributes about 1,500 new leaf blowers annually, said spokesman Sam Atwood."According to the E.P.A., a commercial blower emits 93 pounds per year of air pollutants. Multiplied out times 12,000, the units we have distributed have reduced 500 tons of pollutants since 2006," he said.So far, the district has distributed cleaner blowers manufactured by the company Stihl. The company has supplied trainings at the exchanges. Operators learn to use the blower like a broom, rolling the debris from one area to another where it can be collected, rather than blasting it in a cloud of dust, he said.The district helped support the development of backpack electric leaf blowers, which are just now becoming commercially available, he said. Atwood said the district hopes that it will get at least one proposal this year for a truly zero-emission, battery-powered leaf blower as part of its request for proposals."In demos, they seem to work very well, equal at least to a gas-powered blower. But it's a little premature to say how they will compare in the field to their gasoline counterparts," he said.For its part, the Bay Area Air Quality Management District is running a program to fund the purchase of new, battery-powered, zero-emission electric lawn and garden equipment in exchange for gasoline-powered lawn and garden equipment. The program is currently only operating in Alameda and Contra Costa counties, however.2nd PART:yes,its harmfulThe use of leaf blowers is harmful to our community as they emit a disturbing sound, pose multiple hazards to the health of the individuals in our community, and are harmful to the environment. They are an unnecessary tool as the same task can be completed with a broom and rake with no adverse effects to the community. Leaf blowers use fossil fuel in place of human effort and muscle, at the expense of our environment. Leaf blowers should be banned within the limits of Monrovia to protect the health and wellbeing of our community.The narrow frequency bandwidth of the noise emitted by leaf blowers, the whine, the pitch, is a particularly disturbing sound. The sounds these machines make regularly provoke people to rage. The constant use and over-use of leaf blowers reduces the productivity of our citizens (many people work at home), disturb sleeping infants and children, and they cause rise in blood pressure, adrenaline, heart rate and nervous stress.The World Health Organization recommends noise levels of 55 decibels or less, 45 decibels to meet sleep criteria. A leaf blower generally measures at least 70-75 decibels at 50 feel away and far higher at close range.The United States Environmental Protection Agency (EPA) has found that noise levels over 75 decibels can cause hearing loss and are harmful to human health.According to the California Air Resources Board the types of air pollutants emitted when using a gasoline-powered leaf blower for half an hour are equivalent to those emitted from 440 miles of automobile travel at 30mph average speed. Compared to an average large car, one hour of operation of a leaf blower emits 498 times as much hydrocarbons, 49 times as much particulate matter and 26 times as much carbon monoxide.A Grand Jury convened on the subject of leaf blowers in San Luis Obispo County, CA concluded that:"Considering the evidence... the health hazards citizens are exposed to from two-cycle leaf blowers outweigh the possible benefit they provide." The Grand Jury went on to recommend that all cities within that county initiate a phase out of leaf blowers.Dr Barry Boyd, an oncologist at our own Greenwich Hospital, testified to the Town of Greenwich Board of Health in 2005 that:Air pollution connected with leaf blowers worries him. He believes gasoline powered engines are the reason CT is the number one state in the country in incidences of breast cancer. He stated that one leaf blower, in one hour, pollutes the same amount as 40 cars idling on a lawn. "Connecticut has one of the highest rates of cancer," he said. "It is critical that we eliminate pollution from gasoline-powered engines where we can. Summertime is when Connecticut air is most polluted. A summertime ban on leaf blowers makes sense to me," he told the members.Every doctor affiliated with the Mt. Sinai Children's Environmental Health Center in New York City signed a letter submitted on April 22, 2010 by the Mt. Sinai Hospital supporting proposed restrictions on leaf blowers in Eastchester, NY. The Mt. Sinai team of doctors stated that:"Leaf blowers pose multiple hazards to human health. Children are the most susceptible members of our population to these hazards because they breathe more air per pound of body weight per day than adults and thus inhale more of any pollutants that are thrown into the air by this equipment. Children's vulnerability to the health effects of this equipment is further magnified by the fact that they are passing through the stages of early development, and thus their lungs, ears, eyes, and other organ systems are inherently more sensitive to environmental hazards than the organs of adults."The doctors went on to elaborate in great detail the specific hazards associated with leaf blowers, emphasizing the categories of: airborne pollutants, noise, and eye hazards.The American Lung Association of New York State submitted a letter in 2008 which "commends the towns and villages across the Lower Hudson Valley that took a positive step to protect lung health by passing leaf blower ordinances."June Kaminski, MSN, PhD candidate, studied leaf blowers and published an article entitled "Leaf Blowers Threaten Health." Dr Kaminiski discovered that: "theparticulates spewn into the air by leaf blowers contribute to and aggravate respiratory and allergy problems, as well as add a significant amount of pollution. They also dry and destroy the fragile top soil, hurting the environment." She found that "if landscape contractors [operating leaf blowers] are not protecting their ears with earplugs or earmuffs, they are routinely exosing their ears to sounds above 85 decibels--the level experts agree may threaten hearing over a period of time."Steve Zien, a professional landscaper and Executive Director of Biological Urban Gardening Services (BUGS), an international membership organization of primarily professional landscapers, states:BUGS has opposed the use of leaf blowers for many years for a variety of reasons. There are many hidden costs when utilizing blowers regularly. The leaf blower is perhaps the most over-used and inappropriately used landscape tool. Autumn's tremendous amout of organic debris that requires collection might be considered appropriate use of this tool. However, the weekly routine of blowing abuses the soil and damages landscape plants while the noise creates ill will from neighbors and clients alike.The landscape maintenance industry should join BUGS and take a positive approach to blower bans. Old fahsioned leaf raking can be a renewed service that their business could provide. It could be used as a selling point: no noise and environmentally sound too! Approach it right and they could charge the client an appropriate fee for this service, especially if blowers are banned. This could even become a major selling point for some companies. It could lead to business growth and the hiring of more personnel to mee the demand. Environmentally sound landscapers should be able to turn this kind of legislation into a positive for their businesses, making it work to their benefit.Noise and auditory damageGasoline powered leaf blowers create noise levels of 90-100 decibels at close range, and exceed the EPA's recommended maximum noise level of 80 decibels even at 50 feet. Many Santa Rosa residents in the high density neighborhoods regularly endure the noise of neighbors leaf blowers from less than 50 feet away! Repeated and/or sustained exposure to high noise levels damages the nerve endings in the ears and contributes to loss of hearing and deafness. Children are particularly vulnerable. Doctors at the Mt. Sinai Children's Environmental Health Center have documented the harmful health impact of leaf blowers on children, and have written letters in support of the leaf blower ban we are seeking.The World Health Organization recommends ambient noise levels of 55 decibels or less (Environmental Health Criteria 12: WHO).Noise and mental/emotional distressThe narrow frequency bandwidth of the noise emitted by leaf blowers, the whine, the pitch, is a particularly disturbing sound. The sounds these machines make regularly provoke people to rage. The constant use and over-use of leaf blowers reduces the productivity of our citizens (many people work at home), disturb sleeping infants and children, and they cause rise in blood pressure, adrenaline, heart rate and nervous stress. To put it mildly, they drive people crazy.Noise also degrades our quality of life. It reduces communication. It interferes with our ability to enjoy being outdoors, or taking walks, or working or playing in our own backyards. It is an uncivil and selfish act to subject one's neighbors to a half hour or hour of deafening noise every week in order to have a pristine lawn area.Worker safety and OSHAThe noise levels experienced by the operators of leaf blowers, are dangerous to their ears and can cause permanent hearing loss. The Occupational Health and Safety Act (OSHA) requires hearing protection for any workers using equipment that generates noise over 85 dB. According to the World Health Organization (WHO) "there is an increasing predictable risk" of hearing damage from noise above 75 dB. According to the American Academy of Otolaryngology, half the wearers of hearing protectors do not get the expected benefit, due to improper fit or failure to wear them continuously. And many workers do not even wear protection at all. Not surprisingly, there is evidence of unusually high levels of hearing loss in landscape workers. Using leaf blowers commercially may violate OSHA.Breathing the particulate matter stirred up by and the emissions from the leaf blowers is also detrimental to worker health. Many landscape workers in Greenwich are operating leaf blowers a large part of every day, with undeniable adverse effect on their hearing and their lungs.Air pollution and emissions: carcinogensLeaf blowers contribute to smog and ozone pollution, a problem particularly in the warm months (which is the season we are seeking to ban their use). The inefficient two stroke engine on a leaf blower often releases as much as 25% of its raw, unburned gasoline in its exhaust, according to studies by the Air Resources Board of the CA EPA. The exhaust contains unacceptable levels of harmful hydrocarbons and oxides of nitrogen, both pollutants which contribute to smog and other health problems.Reducing the use of leaf blowers helps reduce levels of ozone, carbon monoxide, and fine particulate matter as regulated by the Clean Air Act. When the City of Los Angeles reduced the number of leaf blowers operating in the LA area by 1,500 it was estimated to eliminate up to 14 tons of harmful emissions annually.Among the substances blown into the air and respired are heavy metals, pesticides, and other carcinogenic substances. In addition, the exhaust from the two stroke engine also contains benzene and other carcinogens.Dr. Barry Boyd, a Greenwich Hospital oncologist has informed the member of the Greenwich Board of Health that:Air pollution connected with leaf blowers worries him. He believes gasoline powered engines are the reason CT is the number one state in the country in incidences of breast cancer. He stated that one leaf blower, in one hour, pollutes the same amount as 40 cars idling on a lawn. "Connecticut has one of the highest rates of cancer," he said. "It is critical that we eliminate pollution from gasoline-powered engines where we can. Summertime is when Connecticut air is most polluted. A summertime ban on leaf blowers makes sense to me," he told the members.Particulate matterLeaf blowers are a large contributor to particulate matter in our air, especially in summer, when particulate pollution is at its worst. The high velocity jets in leaf blowers blow into the air many unwanted and toxic elements. Various pollutants include dust, salt, lead, arsenic, mercury and other heavy metals, pesticides, fertilizers, fungicides, rodentides, herbicides, fungi, dirt, ash, mold, spores and fecal matter. Approximately 5 pounds of particulate matter per leaf blower per hour are blown into the air and can take hours and even days to settle. These particulates aggravate allergies. They also contribute to cardiac conditions such as arrhythimia and can cause heart attacks. Moreover, they contribute to pulmonary diseases such as bronchitis. Please visit EPA's web site about the health impacts of particulate matter: www.epa.gov/air/particlepollution.A Grand Jury in the Superior Court of California issued findings about the toxicity of leaf blowers and the health hazards associated with them. Contact us for a link to this study.Spread of pulmonary disease, asthma, and allergiesThe dust, pollen, spores and other particulate matter spread by leaf blowers exacerbates asthma, emphysema, and allergies. Children and the elderly are the most vulnerable segments of the population and are particularly impacted by the use, and abuse, of leaf blowers in our community. Nine doctors from the Mt. Sinai Children's Environmental Health Center wrote a letter supporting other town's restrictions on leaf blowers because of these and other health concerns. Contact us for a link to this study.Among the particulates thrown into the air by leaf blowers are dried fertilizers, and fecal and urinary matter of animals, including mice and other rodents. These substances have been linked to the spread of various respiratory diseases.Destruction of gardens and landscapes through compaction, dessication and loss of topsoilLeaf blowers blow a concentrated stream of hot air onto plants at 200 mph--higher speed and force than a hurricane. As professional landscaper Steve Zien says: "wind speeds in excess of 180 mph are currently blasting landscapes throughout [the country]. Leaves are ripped from branches, new growth and developing flowers are damaged and precious topsoil is blown away. Nurseries and Extension Agents are receiving more plant samples from gardeners indicating a tornado or hurricane devastated their landscape plants."Winds stress the fragile living material of plants, causing dehydration, burned leaves, and the suspension of photosynthesis and other natural plant functions. Overall growth is also slowed. Natural openings in the leaves that allow for the exchange of oxygen and carbon dioxide are sealed shut. Disease spores laying dormant on the soil or fallen debris are blown back onto plants where a little moisture can renew their cycle of infestation and damage. Blowers effectively distribute disease spores, weed seeds and insect eggs through the landscape and onto neighboring landscapes.Blowers create a disposal problem. Most landscapers do not compost their debris; they put it into sanitary landfill which are being rapidly filled to capacity. The organic material is a gardeners best friend and should remain on site to be recycled back into the landscape.Another hidden cost of leaf blowers is that they deprive flowers, shrubs, and trees of live-giving mulch. Without this natural blanket, erosion, water evaporation and the spread of disease all become problems. Mulch, when not blown away, creates a favorable growing environment for plants and beneficial organisms both above and below ground while adding nutrients to the plants' root zone. When mulch is removed to the compost and renewed annually many soil borne diseases are kept to a minimum.Disturbance of small mammals, birds, and insects, and their habitatNoise, toxic fumes, and hot air blown at hurricane force are all taking a toll on animals and birds in our landscapes. Even beneficial insects like earthworms and bees are being damaged by the assault of the leaf blowers most yards in Greenwich are subjected to. Nests and other habitat are disturbed; animals and birds are driven away by noise. Pollen, sap, and other natural plant substances are desiccated or simply sent airborne. Every living creature in the range of a leaf blower is harmfully impacted.Non-point source water pollutionAnother problem is the common practice of many landscapers to blow debris into the street, or into a neighboring property. When it is pushed into the street it often clogs storm drains and gutters, contributing to inefficient functioning of these drains and to increased flooding and erosion. At other times, the debris enters the drains and moves toxins and other unwanted material into our creeks, rivers and ultimately Long Island Sound, creating a significant new source of non-point source water pollution.The City of Santa Monica, CA forbids the use of leaf blowers because it recognizes the link between the toxic substances, including heavy metals and chemicals, which are pushed into gutters by leaf blowers and which end up in the already polluted Pacific Ocean and the rivers and bays that connect with it in the Santa Monica area.Overall carbon footprint and energy usageLeaf blowers accomplish collection of material inefficiently. They use fossil fuel in place of human effort and muscle, at the expense of our environment. Their two stroke engines use gasoline exceptionally inefficiently, spewing 25% of it unburned into the air through their emissions. Why use an engine to do what your arms can do more efficiently and with no harmful effects to humans, animals, or the environment? Americans are increasing in obesity and becoming more and more sedentary, in part because we no longer do even the simple and rewarding tasks, or tending our own gardens, cutting our grass ourselves, or raking autumn leaves.A University study showed that Americans spill 17 million gallons of gasoline per year refilling lawn mowers, leaf blowers, chain saws and other lawn and garden equipment. That's more than the 1989 Exxon Valdez oil spill in Alaska. Every time a leaf blower is refilled, toxic fumes called Volatile Organic Compounds (VOCs) can be released into the air. Spilling and overfilling equipment can also result in the release of VOCs. When VOCs react with the sun, ground-level ozone or smog is produced. Ozone can affect not only the lungs, but many other organs and systems of the body. Children, the elderly, and people with chronic illness are the most susceptible. Gasoline spilt on lawns can seep into the groundwater and waterways, affecting drinking water and polluting rivers, lakes, and oceans.

Can you do CBD and Affexor?The real questions are:(1) Are there interactions between CBD, Effexor, and other medicines you're taking(2) Are there serious side effects associated with CBD(3) Are there serious problems associated with over-the-counter CBD products(4) Are your reactions to CBD -- good or bad -- likely to be the same as everyone else's(5) Is there any evidence that CBD will be beneficial to people with depression and related mental disorders(6) If you decide to try CBD oil ….(1) Are there interactions between CBD, Effexor, and other medicines you're takingDrug Interaction Report - Drugs.comThat’s according to what is known, so far, about the interactions of effexor and CBD, based on the standard assays using a couple of liver enzymes.However, one of the very serious problems that has been identified with CBD is its potential for interacting with numerous, commonly-prescribed drugs and over-the-counter medicines. Anyone who is using or considering using CBD should download Brown & Winterstein (2019), and check all of the drugs you're taking (including OTC medicines such as acetaminophen and ibuprofen) against the tables of drug-drug interactions in the paper.Brown JD, Winterstein AG. Potential Adverse Drug Events and Drug–Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Journal of clinical medicine. 2019 Jul;8(7):989..(2) Are there serious side effects associated with CBDOnly epilepsy, cancer-related pain, and multiple sclerosis are recognized by any international federal agencies as indications for CBD. Products include Sativex (nabiximols), an oromucosal spray containing CBD plus THC, and Epidiolex, an oral solution containing a plant-derived, pharmaceutical-grade isolated CBD.Sativex is not yet approved in the United States but is available in some other countries for the treatment of spasticity related to multiple sclerosis. Epidiolex recently received FDA approval for treating the rare, treatment-resistant seizure disorders, Lennox-Gastaut and Dravet syndromes.The FDA has very stringent requirements for proving that a product is safe and effective for use in treating a given disorder, or even treating a given symptom in patients with a specific disorder. Other than Epidiolex for treatment-resistant seizure disorders, the FDA has not approved any other CBD products for the diagnosis, cure, mitigation, treatment, or prevention of any other disease.Now that Epidiolex is approved, it is likely that off-label prescriptions will increase. It is even more likely that non-prescription CBD products will be assumed to be completely innocuous by the general public.It is essential that physicians and patients understand that CBD, like any other medication, is not appropriate for every individual or every disease and that it has side effects that are not negligible and must be considered prior to use.During its review of the request for approval for Epidiolex, the FDA identified certain serious safety risks, including the potential for liver injury. These are risks that can be managed when an FDA-approved CBD drug product given for an FDA-approved application is taken under medical supervision, but it is less clear how these risks might be managed when CBD is used more widely, and not in accordance with FDA-approved labeling. Most studies on humans have involved very few patients and durations as short as a single exposure. Only one clinical study on any application for any disorder has lasted longer than four months, i.e., a multicenter, open-label Epidiolex study, which was conducted for one year in patients with epilepsy. Additional studies are needed to analyze long-term safety effects in humans to establish toxicologic parameters.In fact, even when Epidiolex is being considered for FDA-approved applications, a careful case-to-case evaluation on the risk/benefit balance must be made. The studies submitted to gain FDA approval showed that many severe adverse effects are possible (see below). However, in the most serious cases of treatment-resistant epilepsy in children, repetitive infantile seizures can cause severe developmental, cognitive, and motor impairment. These may be more detrimental than the adverse effects and possible neurodevelopmental implications of CBD; hence, CBD may be a therapeutic option in these cases.And even though Epidiolex has been approved for the treatment of rare epilepsy syndromes, the FDA has required GW Pharmaceuticals, the UK-based company that markets it, to conduct extensive postmarketing studies to assess significant remaining concerns, such as a known serious risk of liver injury, to assess a signal of a serious risk of increased serum creatinine, and to identify the following unexpected serious risks: adverse maternal, fetal, or infant outcomes resulting from the use of Epidiolex; adverse effects of the 7-COOH metabolite on embryofetal development or pre- and postnatal growth and development; and the carcinogenic potential of cannabidiol or its 7-COOH metabolite. Moreover, the FDA has determined that only a clinical trial (rather than a nonclinical or observational study) will be sufficient to identify an unexpected serious risk of drug-drug interactions or QT interval prolongation, to include new clinical trials on the effects of Epidiolex on the pharmacokinetics of caffeine, of a sensitive CYP2B6 substrate, of a sensitive CYP2C9 substrate, of a sensitive UGT1A9 substrate, and of a sensitive UGTB7 substrate in healthy volunteers; and to submit the complete results for ongoing drug-drug interaction trials to evaluate the effects of a strong CYP2C19 inhibitor, a strong CYP3A inhibitor, and rifampin on the pharmacokinetics of Epidiolex in healthy volunteers. Finally, the FDA requires a thorough QT trial at the maximum tolerable dose of Epidiolex that is feasible (e.g., dosing in the fed state). There are numerous reporting requirements, which include a report on the status of any study or clinical trial otherwise undertaken to investigate a safety issue, submitted with the annual reports. Postmarketing surveillance for liver toxicity after exposure to Epidiolex is required. The FDA notes that they expect continued cooperation to resolve any problems that may be identified.Letter from the Food and Drug Administration to GW Research, Ltd, NDA 210365 approval, dated 06/25/2018When considering trying CBD for other patients and/or indications, the most important consideration is whether or not there is sufficient scientific data that CBD is efficacious in treating a given disease or condition. The field is changing rapidly, but proof of efficacy is currently limited to CBD as an anti-epileptic. Factors that could contribute to CBD efficacy and/or adverse events in patients with other disorders include CBD potency, amount and frequency of use, route of administration (vaporized, transdermal, oral), concurrent use of other drugs (both legal and illicit), drug-drug interactions, and any co-morbidities. Route of administration can have a huge impact on the bioavailability and pharmacokinetics of the active ingredients. The considerable variability in CBD formulations (tablets, oromucosal spray, oral capsules, oral solutions, vaporized cannabis plant material, powder in oil, and CBD-THC products), and the wide CBD dose range (18- 1500 mg) will have unknown effects on CBD efficacy and adverse events. Research is still needed on larger cohorts of patients, and on the impact of long-term exposure to CBD on genotoxicity and cytotoxicity, hormones, and the immune system. The effects of CBD on special populations (e.g., the elderly, those with neurological disorders, children, adolescents, and pregnant and lactating women) are unknown.Notice that some people have thoughts about suicide while taking CBD, and anyone who has depression, any mood disorder, suicidal thoughts or actions, or drug or alcohol addiction should talk with an experienced doctor (e.g., psychiatrist) before taking CBD. (You should be under the care of an experienced psychiatrist who is knowledgeable about cannabinoids when and if you do decide to try it. And I'd suggest you check into getting an off-label prescription for Epidiolex, since that is the only CBD product that is well-characterized and manufactured under good manufacturing practices (GMP) and is subject to regulations governing labeling, purity, and reliability.)Cannabidiol Uses, Side Effects & Warnings - Drugs.comMany other adverse effects have been reported. For a review on the adverse effects of CBD reported in studies on humans and in clinical trials, as well as those found in animals, see Huestis et al 2019. Please note most of the studies on humans have involved very short treatments; ergo, little to nothing is known about chronic adverse effects that develop over time.Huestis MA, Solimini R, Pichini S, Pacifici R, Carlier J, Busardò FP. Cannabidiol Adverse Effects and Toxicity. Current neuropharmacology. 2019 Oct 1;17(10):974-89.Something that is rarely mentioned in papers on cannabinoids in general and cannabidiol in particular is that the cytochrome P450 enzymes (CYPs) that are involved in drug metabolism in the liver/gut are also found in the brain, where they are responsible for the metabolism of endogenous substrates such as neurosteroids, monoaminergic neurotransmitters, vitamins, arachidonic acid, cholesterol, and bile acids, as well as exogenous substrates (e.g., xenobiotics, dietary components, and pollutants), and can be inhibited or induced in vivo, independently of hepatic CYP enzyme involvement.In contrast to the liver and gut, each region of the brain differs in cellular composition, cell density, and function, and, as a result, the expression of CYP isoforms varies from location to location within the brain. Moreover, although the hepatic and brain CYP isoforms are broadly identical, significant functional differences can occur.And ... CYP isoforms in the brain may affect susceptibility to mental and neurodegenerative diseases and may contribute to their pathophysiology. In addition, they can modify the therapeutic effects of psychoactive drugs at the place of their target action in the brain, where the drugs can act by affecting the metabolism of endogenous substrates. See, e.g.:Ghosh C, Hossain M, Solanki J, et al. Pathophysiological implications of neurovascular P450 in brain disorders. Drug Discov Today. 2016;21:1609–1619.Haduch A, Daniel WA. The engagement of brain cytochrome P450 in the metabolism of endogenous neuroactive substrates: a possible role in mental disorders. Drug metabolism reviews. 2018 Oct 2;50(4):415-29..(3) Are there serious problems associated with over-the-counter CBD productsIf you’re thinking about buying CBD oil products that are not FDA-approved (i.e., anything other than Epidiolex), you need to be aware that there are serious and well-founded concerns about their safety. CBD products are rarely manufactured under good manufacturing practices (GMP) and are not subject to regulations governing labeling, purity, and reliability. In other words, currently, there is no guarantee of consistency between products, or even between different lots produced by the same manufacturer.Many CBD oil products have far less CBD than their labels claim. Some have far more. One study published in JAMA analyzed 84 CBD-infused products, produced by 31 different companies, that were sold online as medical products. Of these, only 31% of the products had a CBD content that that corresponded with the label (within 10%). Another 26% of the products contained significantly less CBD than labeled -- some tested negative for any trace of CBD. And 43% contained significantly more CBD than on the label, sometimes enough to make you sick. Despite being promoted as THC-free, some products also contained unacceptable amounts of THC, at levels that may produce intoxication or impairment, especially among children. In fact, some are deliberately made to contain enough THC to make you high, although their manufacturers don't disclose that fact.When it comes to figuring out how much of a given CBD oil product to consume, the user has no idea what effective dose s/he's getting -- irrespective of the claimed contents of the product. For one thing, CBD is known for its high intra- and inter-subject absorption variability in humans. CBD products may be consumed by smoking, vaporization, buccal spray or ingested orally in the form of soft gels, oil drops, or foods such as cookies. The absorption of CBD administered by these routes is limited and erratic, and results in highly variable pharmacodynamic and pharmacokinetic profiles. The poor aqueous solubility and extensive first-pass metabolism are thought to be the main reasons for the limited bioavailability from orally ingested products. Furthermore, an effect of food (i.e., food/fat-dependent absorption) on CBD bioavailability has been reported. Food intake was found to increase area under the curve (AUC) and maximum plasma concentration (Cmax), as well as time to reach maximum plasma concentration (Tmax) (delayed absorption). Note that the "food" here may refer not only to the food in edible CBD products such as cookies, but also to non-CBD foods consumed before, with, or after consumption of CBD oil. See, e.g.:Knaub K, Sartorius T, Dharsono T, Wacker R, Wilhelm M, Schön C. A Novel Self-Emulsifying Drug Delivery System (SEDDS) Based on VESIsorb® Formulation Technology Improving the Oral Bioavailability of Cannabidiol in Healthy Subjects. Molecules. 2019 Jan;24(16):2967.CBD products are not as innocuous as most people believe. In fact, in the first nine months of 2019, US poison control centers had managed 1,256 cases related to CBD overdoses. See:Cannabidiol (CBD). National Poison Data System, American Association of Poison Control Centers, accessed November 18, 2019.Some CBD products contain synthetic cannabinoids and other psychoactive constituents, even though they'd been advertised as being "100 percent natural CBD extracts." See:Psychoactive Adulterants Identified In Some Liquid CBD Products. December 2018In 2018, the US Army Public Health Center released a public health alert after 93 soldiers and Marines experienced serious side effects from vaping CBD oil products, including palpitations, headaches, vomiting, disorientation, mood swings and seizures, with 60 hospitalizations and two deaths. See:Army: 2 deaths, 60 hospitalizations blamed on vaping oils. CBS News, February 2018.Report: Many Commercially Marketed CBD Products Tainted with Psychoactive Adulterants. September 19, 2019Recent studies have concluded that the majority of commercially available CBD products are contaminated with toxic compounds. For example, one study tested over 240 CBD-infused products. Their analysis determined that 70 percent of the products were found to be "highly contaminated with heavy metals like lead and arsenic, herbicides like glyphosate and a host of other contaminants including pesticides." See, e.g.:Report: Majority Of Commercially Available CBD Products "Contaminated" With Heavy Metals. May 23, 2019Some contaminants are intentionally added to CBD oil products in order to increase yield, weight, or potency (e.g., pesticides, metal particles, synthetic cannabinoids), but others, such as heavy metals, molds, bacteria, and aflatoxins, enter the Cannabis plant unintentionally. Cannabis plants cannot (yet) be grown and processed under conditions aseptic enough to meet pharmaceutical standards, while infection risks are well documented in the medical literature and can be harmful or even fatal to seriously ill patients. See:Hazekamp A. Evaluating the effects of gamma-irradiation for decontamination of medicinal cannabis. Frontiers in pharmacology. 2016 Apr 27;7:108.While I was researching the problems with "over-the-counter" CBD products (including those sold by Amazon and major drug store chains), I found dozens of articles from news media throughout the country on tests they had requested on products that could be obtained locally, to see if the problem existed in their locations. I didn't find a single one that didn't confirm problems with contamination, false labeling, and inconsistent CBD content..(4) Are your reactions to CBD -- good or bad -- likely to be the same as everyone else'sNo.There are two sources for information on whether CBD is beneficial for a given disorder, i.e., reviews/testimonials, and scientific studies in humans. (Animal models might not have any correlation to what happens in humans.)Relying on reviews and testimonials is very risky. You never know who actually wrote them, or why. Studies have found that reviews and testimonials for any type of product or service are often faked, given in return for free products, or posted because the seller is a friend.This Is Why You Should Not Trust Online ReviewsFor $2 a Star, a Retailer Gets 5-Star ReviewsAnd there are many ways to get paid for writing reviews -- of companies, as well as products -- and you often have no idea money is changing hands:45 Ways to Get Paid to Write ReviewsErgo, aside from the studies published in scientific journals, there is no reliable way to determine how helpful or harmful CBD products may be.Plus, it is well established that there are significant inter-individual differences in CBD pharmacokinetics and pharmacodynamics -- which may be especially important with regard to depression and risk for suicide. For example, CBD is metabolized by CYP2C19, and CYP2C19 is one of the two major cytochrome P450 polymorphisms (having different structures and activities) whose gene variations can cause abolished, reduced, normal or increased enzyme expression translating into the poor (PM), intermediate (IM), extensive (EM) and ultrarapid (UM) metabolizer phenotypes. CYP2C19 has broad substrate specificity and metabolizes many different classes of psychotropic drugs, including selective serotonin-reuptake inhibitors, tricyclic antidepressants such as amitriptyline, benzodiazepines such as diazepam, and the anticonvulsant drug mephenytoin. Increasing evidence suggest that the polymorphic CYP2C19 has endogenous functions in the development and regulation of specific neuronal pathways, translating into inter-individual differences in cognition and risk for depression and suicide. Enzyme-coding gene polymorphisms determine metabolic rates of a large number of psychotropic drugs modifying their concentrations at the site of action and can predict a need for adjustments in dosage. The prevalence of isoforms can be quite variable, with inter-individual and inter-ethnic differences dictating the rate of metabolism of different P450 substrates. CYP2C19 "poor metabolizers" can range from as few as 3-5% of a given ethnic population to as many as 79%. See, e.g.:Ingelman-Sundberg M, Persson A, Jukic MM. Polymorphic expression of CYP2C19 and CYP2D6 in the developing and adult human brain causing variability in cognition, risk for depression and suicide: the search for the endogenous substrates. Pharmacogenomics. 2014 Nov;15(15):1841-4.Yarlagadda A, Rosenblatt KP, Clayton AH. Single nucleotide polymorphisms and the central nervous system: potential biomarkers in identifying suicide risk. Innovations in clinical neuroscience. 2017 May;14(5-6):21.There are many more biomolecules involved in a given individual’s response to cannabinoid treatment than just those involved in metabolism in the liver and gut (which are the basis for predictions on websites such as Drugs.com | Prescription Drug Information, Interactions & Side Effects), and we’re only beginning to get a handle on this. Studies on pharmacogenetics indicate that a given individual's response to cannabinoid treatment may be affected by the striking degree of polymorphism (having different structures and activities) in the proteins produced by genes involved in the action, metabolism, and transport of CBD and other cannabinoids. These include, e.g., genes encoding receptors (CNR1, CNR2, TRPV1, GPR55, OPRM1, and GABRA2), transporters and action (ABCB1, ABCG2, SLC6A4, and COMT), and biotransformation, biosynthesis, and bioactivation proteins encoded by CYP3A4, CYP2C19, CYP2C9, CYP2A6, CYP1A1, COMT, FAAH, COX2, ABHD6, and ABHD12 genes, and biomolecules associated with cannabinoid-related cellular processes encoded by MAPK14 and NGR1. See, e.g.:Rambaran KA, Chu M, Johnson TB, Alzghari SK. The Current Landscape of Marijuana and Pharmacogenetics. Cureus. 2017 Jul;9(7).For details on just the G protein-coupled receptors, see:Thompson MD, Cole DE, Capra V, Siminovitch KA, Rovati GE, Burnham WM, Rana BK. Pharmacogenetics of the G protein-coupled receptors. In Pharmacogenomics in Drug Discovery and Development 2014 (pp. 189-242). Humana Press, New York, NY..(5) Is there any evidence that CBD will be beneficial to people with depression and related mental disordersDespite all the glowing testimonials on the benefits of CBD for all sorts of disorders, there actually is very little data that supports these claims. Given public interest in CBD oil, there have been many recent clinical studies on its potential therapeutic effects for a wide variety of disorders. However, reviews and meta-analyses published as recently as April 2019 concluded that clinical studies conducted to date do not support the popular uses of CBD oil for depression, anxiety disorder, insomnia, Parkinson disease, schizophrenia, cancer palliation and treatment, chronic pain and spasticity, or inflammation.The most recent review and meta-analysis on cannabinoids for the treatment of mental disorders and their symptoms was published in October 2019. It, like those before, also concluded that there is scarce evidence to suggest that cannabinoids improve depressive disorders and symptoms, anxiety disorders, attention-deficit hyperactivity disorder, Tourette syndrome, post-traumatic stress disorder, or psychosis, and that high-quality studies directly examining the effect of cannabinoids on treating mental disorders are needed. In warning clinicians about this (since they often are not up-to-speed on the latest research), Peter Roy-Byrne, Editor-in-Chief, New England Journal of Medicine Journal Watch Psychiatry, said of this study:"An analysis of mostly low-quality studies of pharmaceutical-grade cannabinoids shows no evidence of benefit but does not acknowledge the wealth of evidence showing harmful effects."Cannabis legalization in multiple states has resulted in self-directed use for various medical conditions. These authors reviewed 83 studies (40 randomized, controlled trials [RCTs]) of medical cannabinoids."Most studies focused on treatment with largely pharmaceutical-grade tetrahydrocannabinol (THC), cannabidiol (CBD), or their combination (e.g., nabilone, nabiximols, dronabinol); few studies focused on medicinal plant-based marijuana, and very few investigated CBD specifically. Meta-analysis was used for RCTs; narrative synthesis was used for observational studies. In most depression and anxiety studies, the psychiatric condition was secondary to a medical condition. No consistent evidence of benefit was found for psychosis, depression, anxiety, post-traumatic stress disorder (PTSD), Tourette syndrome, or attention-deficit/hyperactivity disorder. Studies were not of high quality."Comment: Although most studies in this review concerned pharmaceutical-grade THC/CBD, most individuals therapeutically using cannabinoids consume plant-based medicinal cannabis. The authors identified no good-quality studies of CBD alone, where the jury is still out. In the National Academy of Sciences' review in 2017 of the effects of cannabis (typically, marijuana used for therapeutic purposes) on mental health conditions ( https://viajwat.ch/33QKsV5 ), adverse effects were found in individuals with psychosis, bipolar illness, social anxiety, and PTSD; while the effects on depression were neutral, the observed increases in suicidal ideation and attempt suggested that depressed patients using cannabis are also at risk for adverse effects. These findings were similar to the American Psychiatric Association's 2018 statement on cannabis use in mental disorders ( https://viajwat.ch/33SP2C3 ) and to two recent studies focused on addictive disorders (NEJM JW Psychiatry Nov 15 2019; [e-pub] and Depress Anxiety 2019; 36:1072 and Drug Alcohol Depend 2019; 205:107642). Together, all these earlier publications imply that by failing to include information on these adverse effects, the conclusions of the current review — and media coverage of it — do not go far enough." [Emphasis added]Roy-Byrne R. Cannabinoids: Not Recommended for Treatment of Mental Disorders. NEJM JW Psychiatry November 15, 2019..(6) If you decide to try CBD oil …Cannabis products are widely used by cancer patients, but a survey revealed that very few of them notify their doctors that they do. That is extremely foolish -- the doctors are flying blind. If you do decide to try CBD oil, notify your doctors when you start yourself on a product, when you change the dosage, when you change your source, and when you discontinue it.Make any changes in medications (adding, deleting, or changing dosages), whether prescription or OTC, one at a time. If you make multiple changes simultaneously and your symptoms change, you won't have any idea which treatment was responsible for the change.Keep a journal of all symptoms and all factors that might affect your symptoms -- injuries, infections, stresses of all sorts, even weather extremes -- and also keep track of all treatments, whether prescription, OTC, or nutritional supplements, as well as CBD oil. This is invaluable in helping you figure out if a given treatment is having any effect, positive or negative. You think you'll remember, but trust me, you won't!And remember, adverse effects can be chronic as well as acute. You may gradually develop an adverse reaction to the CBD weeks or even months after you start on it. (That's another extremely important reason to keep a journal!)