World Health Organization Expert Committee Calls For Changes In Cannabis’ International Classification

The World Health Organization’s (WHO) Expert Committee on Drug Dependence have proposed amending the classification of cannabis under international law.

According to reporting in the British Medical Journal, the WHO policy reversal “takes account of the growing evidence for the medical applications of the drug,” and marks the first time that the agency has reviewed its stance on cannabis in nearly 60 years.

The recommended changes, outlined in a letter by WHO Director-General Dr. Tedros Adhanom Ghebreyesus and reported on by NORML, call for cannabis to be removed from Schedule IV of the 1961 Single Convention on Narcotic Drugs. Schedule IV is the most restrictive classification under the treaty. Instead, the committee advises that whole-plant cannabis and THC be designated as Schedule I controlled substances under international law.

“The current [international] scheduling of cannabis is as strict as that for heroin,” the BMJ summarizes. “[T]he Committee believes that keeping cannabis at that level of control would severely restrict access to and research on potential therapies derived from the plant.”

In a separate recommendation, the Committee reiterated its 2017 request that preparations containing “pure cannabidiol … and not more than 0.2 percent of delta-9-tetrahydrocannabinol” no longer be scheduled within the international drug conventions.

The Committee’s policy recommendations now await action from the 53 participating members states of the United Nation’s Commission on Narcotic Drugs. The Commission is anticipated to vote on the issue in March.

In October, NORML delivered over 10,000 public comments to the US Food and Drug Administration urging the agency to recommend that WHO reschedule cannabis internationally.

The post World Health Organization Expert Committee Calls For Changes In Cannabis’ International Classification appeared first on TheJointBlog.

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Exporting CBD Food Just Got Harder: The European Union Makes a Move

We’ve been writing a lot on this blog about the regulation and sale of cannabidiol (“CBD”) products at the state and federal levels. The United States is not the only international actor, however, that is concerned with regulating the sale of CBD products, including CBD-infused foods. The European Food Safety Authority (“EFSA”), the European equivalent of the U.S. Food and Drug Administration (“FDA”), recently changed guidance on cannabinoids, declaring that all new food products infused with the plant or its derivatives should receive a pre-market approval under the European Union “novel food” regulation.

Regulation 2015/2283, which is the latest food regulation adopted by the European Parliament and the European Union (“EU”), defines “novel food” as “food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of the Member States to the Union.”

The EU Novel Food Catalogue entry for CBD, which contains a non-exhaustive list of ingredients that inform member nations on whether a product will need an authorization under the Novel Food Regulation, now refers to a broader class of “cannabinoids” and provides that:

Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.

This new EFSA guidance drastically expands the categories of cannabinoids that would require pre-market approval–note, however, that hemp seeds, flour and seed oil remain permitted–and it suggests that CBD-infused food could be off the European market for some time. Generally, it takes 3 years for an ingredient to gain novel food status.

A handful of European countries such as Spain, Italy, and Austria have already taken enforcement actions against CBD products on the basis of being “novel foods.” As such, it seems likely that these EU member nations will adopt the new EFSA guidance and continue their efforts in regulating CBD-infused foods as “new foods.”

The EU or its affiliates are expected to provide further guidance on this issue; however, due to administrative procedures and time required for adequate data collection, such publication won’t likely be released until 2020.

This new EFSA guidance will further complicate U.S. CBD companies’ ability to export their products overseas. In addition to potential international law violations, CBD companies run the risk of FDA and Customs and Border Protection (“Customs”) enforcement actions. The FDA has yet to release guidelines on shipping CBD products to other countries; however, the main FDA inquiry for the purpose of exporting CBD would likely be whether the CBD products were adulterated or mislabeled due to the fact that they were not manufactured or labeled in compliance with the target country’s law. Another risk in exporting CBD products is that Customs agents may not have a sophisticated understanding of the difference between hemp and marijuana, as demonstrated in recent state enforcement actions. If such confusion were to occur, Customs would likely seize the CBD shipment and potentially involve the Drug and Enforcement Administration.

In light of those regulatory changes, CBD companies should remain informed on domestic and international shipping laws and consult with experienced lawyers to assess the risks of exporting their products overseas.

For more on cannabis and international law, check out the following:

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Beyond the Crackdown: New York Classifies Hemp-CBD as a Dietary Supplement (Part Two)

Home of “dietary supplement” CBD.

This post is part two of two on how New York is regulating CBD.

On Monday, I wrote about the New York City Department of Health’s (“DOH”) recent crackdown on Hemp-CBD in food and how it was consistent with the New York State Department of Agriculture’s (“Department”) FAQs on hemp-derived CBD (“Hemp CBD”). In summary, the Department’s FAQs state that any Hemp-CBD product sold in New York state must be labeled and manufactured as a dietary supplement. Today’s post focuses on the Department’s Template CBD Processor Research Partner Agreement (“CBD Agreement”) which elaborates on the dietary supplement classification.

The CBD Agreement is a research contract between Hemp-CBD processors, referred to as “Research Partners” in the Agreement, and the Department. Its provisions would not bind other actors including Hemp-CBD sellers or Hemp-CBD processors legally operating in other states. However, the CBD Agreement does shed light on what the Department is going to require for Hemp-CBD.

Research Partners cannot process or sell Hemp-CBD as food. A Research Partner must also obtain written approval from the Department if it intends to sell or distribute Hemp-CBD dietary supplements in a form other than “pill, capsule, caplet, tablet, tinctures, droplets or elixir, chewable, or isolate form[.]”

The CBD Agreement expands on how Research Partners, or CBD processors in other states hoping to sell products in New York, can comply with FDA’s dietary supplement standards:

For the purposes of this Research Agreement, products and production methods used shall comply with FDA law, regulation and guidance concerning dietary supplements with respect to the standards for: personnel, facilities, production, process control systems, quality control measures, record retention, packaging, holding and distribution, supply chain management, recalls, returns, complaints and training associated with dietary supplements.

The dietary supplement standards are in addition to THC testing for CBD products. Hemp-CBD intended to be consumed or absorbed into the human body must also be tested under New York’s medical marijuana program for “cannabinoid profile, solvents, pesticides, heavy metals, bacteria and molds.”

The CBD requirements requires that Research Partners must also provide a serving size and applicable warning on the label. According to the CBD Agreement, CBD products shall also include the following information:

  • The list of all pharmacological active ingredients, including and not limited to THC, CBD, and other cannabinoid content over .05%;
  • The CBD product must set forth the servings per bottle/package, the amount of CBD in milligrams per serving and the total CBD content, in milligrams per package, and the maximum recommended daily amount;
  • The list of all solvents (pesticides) used in the cultivation/extraction process;
  • The manufacture date and source;
  • The batch number;
  • The product expiration date, and
  • The following warning, along with an appropriate warning to consult with a physician concerning the product use:

“This product is neither reviewed nor approved by the State of New York; and has not been analyzed by the FDA. There is limited information on the effects of using this product. Keep out of reach of children.”

The CBD agreement also covers reporting, approved extraction methods, and sourcing hemp. According to the CBD Agreement, the Department may eventually require registration from entities selling Hemp-CBD.

Recently, I wrote about the FDA’s stated position is that Hemp-CBD is not a dietary supplement. As such, the Department’s position is contrary to the FDA’s. The following language in the CBD Agreement requires Research Partners to acknowledge the FDA’s position:

The Research Partner represents that it has sought whatever legal or other advice it believes to be appropriate and is not relying upon the Department’s approval of its research proposal or any other statement or conduct by the Department in connection with the Research Partner’s evaluation of any legal or other risk to which the Research Partner may be exposed in undertaking the project, including, without limitation, the FDA’s position with respect to CBD and dietary supplements.

For CBD Processors in New York, the CBD Agreement must be carefully observed. For CBD Processors operating in other states who wish to sell products in New York, the Department’s position makes things a little more complicated. For example, the FDA has different standards for cosmetic products. CBD Processors may want to argue that they are selling a CBD cosmetic not a dietary supplement. However, if that CBD cosmetic is sold in New York, it must be labeled as a dietary supplement. This may mean that the CBD cosmetic distributor may need to avoid New York or adopt labeling and manufacturing requirements as if the product was a dietary supplement.

Though it may be hard to comply with the Department’s regulations, the FAQs and CBD Agreement at least provide guidance. If you want to sell Hemp-CBD in New York, it must be sold as a dietary supplement, at least for now.

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Legislation to Legalize Marijuana Passed by New Mexico Committee

Legislation that would legalize marijuana for everyone 21 and older has been passed by a key House committee in New Mexico.

The House Health and Human Services Committee passed House Bill 356 by a vote of 5 to 2, with all of the “Yes” votes coming from Democrats.

“Prohibition simply does not work, and the country is coming to the realization of that”, said Representative Antonio Maestas, one of the bill’s sponsors.

The measure would allow those 21 and older to possess and grow personal amounts of marijuana. They would be authorized to purchase the plant from a licensed retail outlet.

The proposal would establish a 19% tax on recreational marijuana sales. The tax revenue would be split between law enforcement, health and research programs, and city and county governments. The measure would also allow for the expungement of past charges that would become legal if it’s passed.

The proposal must now be passed by the full House of Represents and then Senate before it can be sent to Gov. Michelle Lujan Grisham for consideration. Govewrnor Grisham has said she would support a legalization law under certain conditions, such as having strong safeguards to prevent children from obtaining cannabis.

For the full text of House Bill 356, click here.

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Beyond the Crackdown: New York Classifies Hemp-CBD as a Dietary Supplement (Part One)

Home of “dietary supplement” CBD.

This post is part one of two on how the State of New York is regulating CBD.

Last week, New York City’s Department of Health (“DOH”) quarantined a number of edible products that contained hemp-derived CBD (“Hemp-CBD”) and announced that Hemp-CBD would not be allowed in food products in the City. Eater first broke the story, but the crackdown made national news with the Wall Street Journal, the New York Times, NBC, and Fox all publishing stories on the event. It is unsurprising that the DOH action drew such coverage. CBD is massively popular, New York City is the largest city in the United States, and the story is compelling because the DOH actually sent out agents to quarantine products, rather than simply issuing a statement. It seems to be this last point that garnered national attention based on the relative lack of coverage of a very similar story a few months ago.

On December 18, 2018, shortly before the signing of the 2018 Farm Bill, the New York State Department of Agriculture and Markets (the “Department”) issued a series of frequently asked questions (“FAQs“) and a CBD Processor Template Agreement (“CBD Agreement“) that were both focused on Hemp-CBD. Unlike the DOH, the Department did not take any enforcement action. Coverage of the FAQs and the CBD Agreement was sparse. Now that New York City is taking action, it’s time to dig into the state’s position on Hemp-CBD.

The Department oversees New York’s industrial hemp program, which was promulgated under the 2014 Farm Bill. Rather than issuing licenses or permits, the Department enters into research agreements with individuals and companies who wish to process hemp into commercial products. The Department uses a number of template agreements available online. The CBD Agreement applies to processors who wish to create Hemp-CBD products intended for human consumption.

The FAQs and the CBD Agreement make it clear that the Department is intending to treat Hemp-CBD as a dietary supplement. The FAQs state that an individual cannot “sell any item for human consumption that has CBD as an ingredient unless” the two following standards are met:

  1. The item is produced under the rigorous dietary-supplement standards described in the CBD Agreement; and
  2. The item is properly labeled and packaged for sale pursuant to FDA regulations for dietary supplements.

The FAQs elaborate on its dietary supplement standard:

What is the difference between a dietary supplement and a food product?

No product for human consumption that has CBD added to it can be labeled and marketed as a food. All extracted CBD and CBD products must be manufactured pursuant to FDA dietary supplement standards and must be labeled and marketed as a dietary supplement[.]

What are “dietary-supplement standards” or “dietary supplement GMP”?

The FDA sets three levels of Good Manufacturing Practices (GMPs): one GMP standard for foods, a more rigorous GMP standard for dietary supplements, and an extremely rigorous GMP for pharmaceuticals. Products listing CBD as an ingredient must be manufactured pursuant to the dietary-supplement standards. The dietary supplement GMPs are federal, and are described here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=111

This section is titled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” Any product for human consumption that lists CBD as an ingredient must be manufactured pursuant to these dietary-supplement standards.

This dietary supplement classification applies to any “product that is a combination of ready-to-eat food with additional CBD infusions or CBD extracts, such as CBD chocolate syrup or CBD soda or CBD-infused frosting drizzled cookies.” The FAQs also apply to CBD-Hemp from other states: “products made from industrial hemp that are sold in NYS must meet NYS standards, regardless of where the product is processed or manufactured.”

It should be noted that the Department acknowledges that its jurisdiction over Hemp-CBD is limited. For example, the Department does not require businesses to apply to the Department to add pre-manufactured Hemp-CBD to another product such as a topical or to develop products using CBD is sourced from another state. There is also no requirement to obtain any authorization from the Department to sell Hemp-CBD products. However, if the product is sold anywhere in New York State, it must comply with dietary supplement standards.

You can agree or disagree with the New York City DOH’s decision to start quarantining CBD in food, however, it does seem to be consistent with the Department’s guidance. The Department is a state agency and the DOH is a city agency so DOH’s decision may be a show of deference to the Department.

Later this week, I’ll analyze the CBD Agreement and how it provides additional insight into the state’s position on Hemp-CBD.

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Hawaii Committee Unanimously Approves Bill to Legalize Marijuana

Legislation to legalize marijuana for everyone 21 and older has been unanimously passed by its initial committee in Hawaii’s Legislature.

Hawaii Senate Bill 686 was introduced by Senator Kalani English (D) along with 11 cosponsors. According to its official summary, the measure “Legalizes the personal use, possession, and sale of marijuana in a specified quantity” and “Requires licensing to operate marijuana establishments”.

The measure sets the possession limit at one ounce. It would also allow for the personal cultivation of six marijuana plants, up to three of which can be mature. In addition, the measure establishes a licensed and regulated system of marijuana businesses.

The measure will now moves towards a vote by the full House of Representatives. Passage in the House will send it to the Senate. If also passed by the Senate, it will be sent to Governor David Ige for consideration.

For the full text of Senate Bill 686, click here.

The post Hawaii Committee Unanimously Approves Bill to Legalize Marijuana appeared first on TheJointBlog.

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State Crackdowns Against CBD Products Have Begun

Earlier this year, the Food and Drug Administration (“FDA”) began seizing various cannabidiol (“CBD”) products from store shelves. These enforcement actions reflected the implementation of the agency’s position that CBD, regardless of the source from which it is derived, cannot be lawfully sold for human consumption.

A few states, including states that have adopted industrial hemp pilot research programs under the 2014 Farm Bill, now seem to have embraced this FDA position by banning certain CBD-infused products from local stores.

Last Friday, several New York restaurants, bakeries, and bars were forced to stop selling CBD-infused foods and drinks. Officials with the New York City Department of Health confiscated those products, marking them as “embargoed.” The embargo process consists of identifying, itemizing and removing products. The Department has yet to issue a public statement or to provide further information on these actions, but it appears that state health inspectors explained to the affected business owners that CBD could not be used as a “food additive”.

This argument was similar to that used by the Maine Department of Health and Human Services (“DHHS”). Earlier last week, Maine health authorities began notifying businesses that they were required to remove all CBD-infused foods, tinctures, and capsules from their shelves. Relying on an internal report by the state Attorney General’s Office, which concluded that CBD could not be used in mass-market food until Maine’s hemp pilot program receives federal approval pursuant to the 2018 Farm Bill, the Maine DHHS determined that CBD was an unapproved food additive that the FDA does not recognize as safe.

Section 201(s) of the Food, Drug, and Cosmetic Act (“FD&C Act”) defines “food additive” to encompass any substance that may reasonably be expected to directly or indirectly affect or become part of a food. Until a food additive is tested and reveals to be safe for its intended use, it is deemed unsafe. A food additive is considered safe if there is a reasonable certainty in the minds of competent scientists that a substance is not harmful under its intended use and condition. If a food additive is added to a food prior to FDA approval, its presence renders the food adulterated and subject to enforcement action.

Because the FDA has yet to approve CBD as a food additive, is it accurate that Hemp-CBD products, particularly edibles and infused drinks, would be deemed unsafe under the FD&C Act.

Although the state health authorities embargoed CBD edibles and other CBD products used for human consumption, they told affected business owners that they could continue selling CBD products that “could be smoked, vaped, worn as a patch or applied as lotion.” This is because cosmetics and smokable products are subject to less onerous FDA regulations than foods and dietary supplements. Nevertheless, this is all likely to change because the FDA will undoubtedly release a plan to regulate Hemp-CBD products soon.

These recent enforcement actions in places like New York and Maine threaten to spook this fast-growing industry and should remind industry players that business and legal considerations surrounding the sale of Hemp-CBD products are in a constant state of flux.

We will continue to monitor this issue and update you on other states CBD enforcement actions. Until then, don’t hesitate to contact our offices for additional information on the legal status of state and federal Hemp-CBD law and policy.

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Washington Cannabis: The Proposed Hemp Overhaul is Here

In light of the recent federal legalization of industrial hemp, Washington lawmakers are taking a hard look at the state’s hemp program. Senators Bob Hasegawa (D) of Beacon Hill, Steve Conway (D) of Tacoma, and Karen Keiser (D) of Kent recently introducing Senate Bill 5719. The stated purpose of SB 5719 is as follows:

Authorize the growing of hemp as a legal, agricultural activity in this state. Hemp is an agricultural product that may be legally grown, produced, processed, possessed, transferred, commercially sold, and traded. Hemp and hemp products produced in accordance with this chapter may be transferred and sold within the state, outside of this state, and internationally. Nothing in this chapter is intended to prevent or restrain commerce in this state involving hemp or hemp products produced lawfully under the laws of another state or country.”

The bill requires Washington comply with the 2018 Farm Bill, which removed industrial hemp from the federal Controlled Substances Act, and which provides for state-and tribe-level programs for the cultivation of industrial hemp. As such, the Washington State Department of Agriculture (“WSDA”) would need to submit a plan to US Department of Agriculture (“USDA”) pursuant to the 2018 Farm Bill. The plan must address licensing, THC testing, enforcement, and a host of other topics required under federal law.

It’s too early to tell whether SB 5719 will ultimately become law, but it’s worth keeping an eye on at this point (and will be covered in our upcoming free CBD Webinar on February 21 at 12:00 PST). Here are some of the key provisions:

Food and Hemp

SB 5719 would repeal Washington’s Industrial Hemp Research Program (RCW 15.120 et seq.) completely. This program was created under the 2014 Farm Bill, which was fairly light on details and limited to hemp cultivation for “research” purposes. Washington’s hemp program is fairly limited and has never really taken off like it has in Colorado, Kentucky, and Oregon. Washington’s hemp law is also confusing thanks to RCW 15.120.020 which prohibits the “production of any part of industrial hemp, except seed, as food, extract, oil, cake, concentrate, resin, or other preparation for topical use, oral consumption, or inhalation by humans[.]” This provision only refers to the production of hemp, not the sale of hemp products, including widely popular hemp-derived CBD (“Hemp-CBD”) products. However, it has also stunted the retail sale of hemp products intended for human consumption under the idea that if it’s illegal to produce hemp for human consumption it is also legal to sell hemp products for human consumption. This would no longer be an issue if SB 5719 passes. However, SB 5719 does come with some ambiguity.

Under, SB 5719 “CBD and CBD products derived from hemp are considered a food product that must be tested and treated in accordance with other agricultural crop derived food products for human and animal consumption.” This could lead to confusion. For example, a Hemp-CBD topical cream would still have to be “tested and treated” as food. That is inconsistent with FDA regulation which treats food and cosmetics differently. Additionally, what does it mean to “treat” something as food? I read it to refer to things like manufacturing, labeling, and storing Hemp-CBD, but I could be wrong.

Licensing and Seeds

The WSDA would issue hemp producer licenses. Current hemp licensees could transfer into Washington’s new program once it’s up and running. Hemp producers will only be allowed to use seeds listed in SB 5719 or approved by the WSDA. The bill also contains a clever provision that distinguishes seed varieties based on THC percentage. Certain seed “cultivar” (i.e., “a variation of the plant Cannabis sativa L. that has been developed through cultivation by selective breeding”) will be exempt from THC testing. WSDA will have the authority to approve seed cultivar and determine whether THC testing is required. Cultivar that were brought into Washington state before January 1, 2022 so long as “the state has planting, growth, and stability records covering at least three years.”

Even though seeds will be regulated fairly robustly, SB 5719 does not indicate the need for seed-to-sale traceability as the WSDA will not be responsible for determining whether a hemp product was derived from an approved hemp cultivar.

Regulatory Authority

Though SB 5719 is a major overhaul, WSDA would still have authority over hemp in the Evergreen State. Both marijuana and hemp are ways to describe cannabis so it’s natural to wonder what is the LCB’s role in regulating hemp under SB 5719? SB 5719 specifically states that “all rules relating to hemp, including any testing of hemp, are outside the control of the [LCB].” However, the WSDA is mandated to consult with the LCB to establish rules and policies to prevent cross pollination between marijuana and hemp crops. In the event that a documented cross-pollination erupts between two farms growing hemp or marijuana, the farm operating first will be the victor. This first-in-time law would give marijuana farmers a massive upper-hand, at least initially, as Washington’s marijuana program is older and much larger than the hemp program. The WSDA and state lawmakers will undertake a task force for determining the need for crop insurance.

Bottom line

SB 5719, if passed in its current form, would drastically change Washington’s hemp laws. Like the 2018 Farm Bill, it’s a much more commercial friendly scheme. If you agree or disagree with the current version of SB 5719, you can submit comments here.

If SB 5719 becomes law, it will take effect immediately. Given that there are several time-sensitive provisions in the bill, it makes sense to start planning now. We’ll keep an eye on this and other hemp-bills in Washington and other states.

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Study: Marijuana Consumption Linked to Increased Sperm Count

Men who have consumed marijuana have higher sperm counts than those who have never used it, according to a new study published in the February 6th issue of the journal Human Reproduction.

This longitudinal study “included 662 subfertile men enrolled at the Massachusetts General Hospital Fertility Center between 2000 and 2017.” The men “provided a total of 1143 semen samples; 317 men also provided blood samples in which we measured reproductive hormones.”

Researchers found that “Men who had ever smoked marijuana had higher sperm concentration and count and lower serum FSH [follicle stimulating hormone] concentrations than men who had never smoked marijuana; no differences were observed between current and past marijuana smokers.”

The following is the method researchers used to come to this conclusion:

Use of marijuana and other drugs was self-reported at baseline. Standard protocols were followed for measuring semen quality, sex hormones and DNA integrity. We used linear mixed effect models with a random intercept to evaluate the associations of self-reported marijuana smoking at enrolment with semen parameters from subsequently collected samples, and linear regression models for sperm DNA integrity and serum reproductive hormones, while adjusting for confounders including smoking and cocaine use.
Below are the main results of the study:
Men who had ever smoked marijuana (N = 365) had significantly higher sperm concentration (62.7 (95% confidence interval: 56.0, 70.3) million/mL) than men who had never smoked marijuana (N = 297) (45.4 (38.6, 53.3) million/mL) after adjusting for potential confounders (P = 0.0003). There were no significant differences in sperm concentration between current (N = 74) (59.5 (47.3, 74.8) million/mL) and past marijuana smokers (N = 291) (63.5 (56.1, 72.0) million/mL; P = 0.60). A similar pattern was observed for total sperm count. Furthermore, the adjusted prevalence of sperm concentration and total sperm motility below WHO reference values among marijuana smokers was less than half that of never marijuana smokers. Marijuana smokers had significantly lower follicle stimulating hormone (FSH) concentrations than never marijuana smokers (−16% (−27%, −4%)) and there were no significant differences between current and past marijuana smokers (P = 0.53). Marijuana smoking was not associated with other semen parameters, with markers of sperm DNA integrity or with reproductive hormones other than FSH. Chance findings cannot be excluded due to the multiple comparisons.

For more information on this study, click here.

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