At his final hearing before a Senate appropriations subcommittee on Thursday, outgoing Food and Drug Administration (FDA) Commissioner Scott Gottlieb was again pressed on the agency’s plan to regulate hemp-derived CBD products.
Sen. Patrick Leahy (D-VT) voiced concerns about the “significant regulatory and enforcement uncertainty” surrounding marketing CBD, which has been raised at several hearings since industrial hemp and its derivatives were federally legalized under the 2018 Farm Bill. The senator asked Gottlieb how he thinks the FDA should use discretion in its enforcement efforts.
“We’re using enforcement discretion right now,” the commissioner said. “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider over-the-line claims.”
But what constitutes an “over-the-line” claim?
Gottlieb specified that people who are marketing CBD and “claiming that it can cure cancer or prevent Alzheimer’s disease” will be subject to enforcement action “because that can mislead a patient into forgoing otherwise effective therapy.”
“But there are products on the market right now that, given our enforcement priorities and our limited resources, we haven’t taken action against,” he said. “That’s not an invitation for people to continue marketing these products—we’re concerned about it—but we heard Congress loud and clear here.”
As Gottlieb has explained to lawmakers a number of times this year, part of the reason that regulating CBD products is especially complicated is that CBD currently exists as an approved drug in the form of the epilepsy medication Epidiolex, and is also “under substantial clinical investigation.”
“Even if it wasn’t an approved drug, because it was never previously in the food supply, we don’t have a clear route to allow this to be lawfully marketed short of promulgating new regulations,” he said.
That challenge will be taken up by an FDA working group comprised of “some of our most creative policymakers,” who will develop “potential legislative alternatives” to CBD regulation. In essence, Gottlieb has suggested that unless Congress passes a law that specifically targets CBD, it could take years for the FDA to enact CBD regulations.
“There is precedent for Congress legislating in the context of a single ingredient,” the commissioner told Sen. John Hoeven (R-ND) in a subsequent exchange. “You could, for example, contemplate a scheme here where Congress gave FDA authority to contemplate CBD as a food ingredient at certain concentrations and potency and purity and then have it exist separately as a drug product at a different concentration, different potency and purity.”
“Fish oil, for example, exists that way in the marketplace,” he said. “But fish oil, we didn’t need to come up with a legislative option to do that because it was previously in the food supply. CBD, obviously, it was not.”
A new report suggests that there should be no legal limit on how much THC can be in your body to consider someone impaired.
Former Governor Rick Snyder created a six-member Impaired Driving Safety Commission.
The board is made up of members of diverse backgrounds including reps from Michigan State Police, a medical marijuana patient, and doctors.
In its findings, the commission is suggesting to lawmakers not to set a measurable limit of THC.
“It’s not like alcohol at all,” Bruce Leach said.
Leach is a local criminal defense lawyer and practices law significantly on matters with marijuana.
Leach says he supports the commission’s decision.
“There is no direct correlation, and no science behind a set number of nanograms equals a certain amount impairment,” Leach said.
The commission found regular users respond differently than occasional users.
“There is a discrepancy of active THC and the long time frame for the metabolite to be in someone’s system. It is very difficult to tell what their level of impairment or intoxication may have been. The real test is how they were driving,” Leach said.
Michigan has a zero-tolerance drugged driving law.
The commission wanted to learn to see if active THC was the reason behind impairment.
Leach says the problem is THC can stay in your body for an extended period.
“Many hours or many days or weeks after someone actually ingested the product,” Leach said.
Studies show there can be behavioral effects when someone ingests cannabis.
The report shows the number of positive tests for cannabinoids in crash-involved drivers has more than doubled over a five-year time frame.
Leach says people need to consume responsibly.
“Me personally as well as everyone I know that I represent everybody wants the safest possible roads,” Leach said.
The report did also look at other states that legalized recreational and medical marihuana.
The plan which went into effect at midnight on Monday, use and possession of marijuana in small amounts in personal homes is not an offense.
Possession in public of amounts for personal use will result in a fine of about $275 for a first time offense and double for the second offense. A third offense within seven years will trigger a criminal investigation, or loss of driver’s or gun license.
Personal use is defined by the country’ Anti-Drug Authority as about 15 grams, though the reform legislation does not name a specific amount. Those with permission to possess cannabis for medical use must be able to present their license to police if confronted in public.
The plan was adopted in 2017 by Knesset after the recommendations of a panel set up by Public Security Minister Gilad Erdan. The reform legislation is temporary and will last three years, at which point the Knesset can decide to make it permanent.
Israel had already increased the number of doctors who can write prescriptions for medical cannabis, removed limits on the number of marijuana growers, made cannabis available at public pharmacies, and made it possible to receive medical cannabis with just a doctor’s prescription.
The new marijuana reform does not apply to soldiers, minors, or those with a criminal record. Minors will, however, be directed to rehabilitation programs as opposed to entering the criminal justice system.
Michigan officials are informing citizens that food and drinks with CBD oil aren’t legal yet. CBD is the new thing in the health alternative market.
After Proposal 1 passed in Michigan which legalized adult-use marijuana and industrial hemp as well as the 2018 U.S. Farm Bill which legalized hemp nationwide there has been a rise of products made with CBD.
“The whole scheme is fascinating. It doesn’t make the subject matter into an illegality,” said Michael Komorn, a lawyer and president of the Michigan Medical Marijuana Association. “It’s a not a crime, it’s a regulatory fine. You won’t get arrested, but it may prevent you from getting a license to do that in the future.”
Michigan’s Department of Agriculture and Rural Development is waiting on the federal government to write its hemp program regulations before it comes up with its own rule set — and that won’t happen until 2020.
“It won’t be until 2020 until a state government can have a state plan for raising industrial hemp in their state,” said James Averill, deputy director for MDARD.
However, a mechanism in the 2014 Farm Bill that allows farmers to grow industrial hemp by working with universities or with state departments of agriculture — and Averill said Michigan is considering a way to help farmers plant hemp sooner rather than later.
“For putting seed in the ground this year — we have to work off the 2014 Farm Bill and that is a conversation that we’re continuing to have with the administration,” Averill said.
Previously, U.S. Drug Enforcement Administration requirements made the state’s direct involvement to authorize hemp farmers difficult. The 2018 Farm Bill changed that, Averill said.
LARA RELEASE 3/29/19
Michigan Offers Guidance on CBD and Industrial Hemp
March 29, 2019 – The Bureau of Marijuana Regulation (BMR) and the Michigan Dept of Agriculture & Rural Development (MDARD) issued joint guidance today regarding CBD (cannabidiol) and industrial hemp.
From the Bureau of Marijuana Regulation:
CBD products produced from marijuana will not be regulated as marijuana if the THC content is below 0.3%.
Edible marijuana products containing CBD made by licensed processors may only be produced using CBD obtained from regulated sources. Currently, these regulated sources include state of Michigan licensed growers or processors under the MMFLA.
BMR is in the process of writing administrative rules under the MMFLA and MRTMA to determine the methods for industrial hemp grown under the Industrial Hemp Research and Development Act to be transferred to licensed marijuana facilities. Until the administrative rules are written, there is no authorized method for licensed facilities to obtain industrial hemp.
Only facilities licensed by the Bureau of Marijuana Regulation (BMR) under the MMFLA can commercially grow, process, and sell marijuana and marijuana products.
BMR does not regulate marijuana or marijuana products grown or produced by registered qualifying patients or designated primary caregivers under the MMMA or individuals over 21 for personal use under the MRTMA.
From the Michigan Department of Agriculture and Rural Development:
Any product derived from industrial hemp with a THC concentration above 0.3% is classified as marijuana and regulated under the laws that apply to those products through the Michigan Department of Licensing and Regulatory Affairs.
Products derived from industrial hemp, including CBD oil, fall under several different categories. Any substances that will be added to food or drink or marketed as dietary supplements must first be approved by the U.S. Food and Drug Administration for that intended use. At this time, the FDA has not approved CBD for use in food or drink or as a dietary supplement. Therefore, it’s currently illegal to add CBD into food products or drinks or sell it as dietary supplements.
GRAS (Generally Regarded As Safe) is a list of substances that the FDA considers safe to add to food. Hulled hemp seeds, hemp seed protein and hemp seed oil are considered GRAS, as of 12/20/18. CBD is currently not considered GRAS, as of 3/29/19. In Michigan, any food production falls under the Michigan Food Law and the licensing requirements within the law.
Growing industrial hemp will require a license from the Michigan Department of Agriculture and Rural Development (MDARD). MDARD is in the process of developing a licensing program for growers to meet the requirements of both state and federal laws to allow interstate commerce of the plants.
Definitions
Marihuana (legal term) or Marijuana (common term): the plant Cannabis sativa L. with delta-9-THC concentrations above 0.3%. Includes products made from the marijuana plant, but excludes stalks, products made from the stalks, and some products made from seeds.
Industrial Hemp: the plant Cannabis sativa L. with delta-9-THC concentrations below 0.3%. Includes products made from the industrial hemp plant.
CBD (Cannabidiol): a substance derived from cannabis plants that does not have psychoactive effects.
Michigan officials are informing citizens that food and drinks with CBD oil aren’t legal yet. CBD is the new thing in the health alternative market.
After Proposal 1 passed in Michigan which legalized adult-use marijuana and industrial hemp as well as the 2018 U.S. Farm Bill which legalized hemp nationwide there has been a rise of products made with CBD.
“The whole scheme is fascinating. It doesn’t make the subject matter into an illegality,” said Michael Komorn, a lawyer and president of the Michigan Medical Marijuana Association. “It’s a not a crime, it’s a regulatory fine. You won’t get arrested, but it may prevent you from getting a license to do that in the future.”
Michigan’s Department of Agriculture and Rural Development is waiting on the federal government to write its hemp program regulations before it comes up with its own rule set — and that won’t happen until 2020.
“It won’t be until 2020 until a state government can have a state plan for raising industrial hemp in their state,” said James Averill, deputy director for MDARD.
However, a mechanism in the 2014 Farm Bill that allows farmers to grow industrial hemp by working with universities or with state departments of agriculture — and Averill said Michigan is considering a way to help farmers plant hemp sooner rather than later.
“For putting seed in the ground this year — we have to work off the 2014 Farm Bill and that is a conversation that we’re continuing to have with the administration,” Averill said.
Previously, U.S. Drug Enforcement Administration requirements made the state’s direct involvement to authorize hemp farmers difficult. The 2018 Farm Bill changed that, Averill said.
LARA RELEASE 3/29/19
Michigan Offers Guidance on CBD and Industrial Hemp
March 29, 2019 – The Bureau of Marijuana Regulation (BMR) and the Michigan Dept of Agriculture & Rural Development (MDARD) issued joint guidance today regarding CBD (cannabidiol) and industrial hemp.
From the Bureau of Marijuana Regulation:
CBD products produced from marijuana will not be regulated as marijuana if the THC content is below 0.3%.
Edible marijuana products containing CBD made by licensed processors may only be produced using CBD obtained from regulated sources. Currently, these regulated sources include state of Michigan licensed growers or processors under the MMFLA.
BMR is in the process of writing administrative rules under the MMFLA and MRTMA to determine the methods for industrial hemp grown under the Industrial Hemp Research and Development Act to be transferred to licensed marijuana facilities. Until the administrative rules are written, there is no authorized method for licensed facilities to obtain industrial hemp.
Only facilities licensed by the Bureau of Marijuana Regulation (BMR) under the MMFLA can commercially grow, process, and sell marijuana and marijuana products.
BMR does not regulate marijuana or marijuana products grown or produced by registered qualifying patients or designated primary caregivers under the MMMA or individuals over 21 for personal use under the MRTMA.
From the Michigan Department of Agriculture and Rural Development:
Any product derived from industrial hemp with a THC concentration above 0.3% is classified as marijuana and regulated under the laws that apply to those products through the Michigan Department of Licensing and Regulatory Affairs.
Products derived from industrial hemp, including CBD oil, fall under several different categories. Any substances that will be added to food or drink or marketed as dietary supplements must first be approved by the U.S. Food and Drug Administration for that intended use. At this time, the FDA has not approved CBD for use in food or drink or as a dietary supplement. Therefore, it’s currently illegal to add CBD into food products or drinks or sell it as dietary supplements.
GRAS (Generally Regarded As Safe) is a list of substances that the FDA considers safe to add to food. Hulled hemp seeds, hemp seed protein and hemp seed oil are considered GRAS, as of 12/20/18. CBD is currently not considered GRAS, as of 3/29/19. In Michigan, any food production falls under the Michigan Food Law and the licensing requirements within the law.
Growing industrial hemp will require a license from the Michigan Department of Agriculture and Rural Development (MDARD). MDARD is in the process of developing a licensing program for growers to meet the requirements of both state and federal laws to allow interstate commerce of the plants.
Definitions
Marihuana (legal term) or Marijuana (common term): the plant Cannabis sativa L. with delta-9-THC concentrations above 0.3%. Includes products made from the marijuana plant, but excludes stalks, products made from the stalks, and some products made from seeds.
Industrial Hemp: the plant Cannabis sativa L. with delta-9-THC concentrations below 0.3%. Includes products made from the industrial hemp plant.
CBD (Cannabidiol): a substance derived from cannabis plants that does not have psychoactive effects.
The resolution of Marijuana product access to patients from the LARA Medical Marihuana Licensing Board Meeting in Lansing, Michigan.
At a regularly scheduled meeting of the Medical Marihuana Licensing Board (Board), convened in Lansing, Michigan, the following resolution was adopted.
WHEREAS:
The Board is established within the Department of Licensing and Regulatory Affairs (Department) under the Medical Marihuana Facilities Licensing Act, 2016 PA 281 (Act), with the general responsibility to implement the Act; and The Board’s duties include granting or denying each application for a state operating license, providing for the levy and collection of fines for a violation of the Act or rules and providing oversight of marijuana facilities through the Board’s inspectors, agents, and auditors for the purpose of conducting investigations into the operation of marijuana facilities as the Board considers necessary and proper to ensure compliance with the Act and rules and to protect the overall safety, security and integrity of the operation of marijuana facilities; and
The Board’s powers include the authority to investigate alleged violations of the Act or rules, take appropriate disciplinary action against a licensee, and take disciplinary action as the Board considers appropriate to prevent practices that violate the Act or rules, and take any other reasonable or appropriate action to enforce the Act or rules; and
THEREFORE:
IT IS RESOLVED that the Board will not take disciplinary action against an applicant in the following circumstances: • For an Applicant temporarily operating: o For the time period ending March 31,2019: • The applicant temporarily operates a proposed marihuana facility that would otherwise require a license if either of the following apply:
• The applicant’s proposed facility is within a municipality that adopted an ordinance before December 15, 2017 but is pending adoption of an ordinance under the Act, or • The applicant’s proposed facility is within a municipality that has adopted an ordinance before December 15, 2017. • The applicant notifies the Department within 1 business day of becoming aware of any adverse reaction to a marijuana product sold or transferred, and • For purposes of this resolution only, the applicant applied for a license no later than February 15, 2018. o An applicant that does not comply with this resolution shall cease and desist operation and may be subject to penalties and sanctions, and o An applicant that is temporarily operating is not guaranteed a license.
IT IS FURTHER RESOLVED that the Board will not take disciplinary action against a licensee in the following circumstances: • For a licensed Provisioning Center: o For the time period ending March 31,2019: • The licensee obtains marijuana products from a registered primary caregiver (caregiver), and • The licensee obtains patient consent on a form provided by the Department prior to selling any marijuana products that have not been tested in full compliance with the law and administrative rules, and • The licensee enters all inventory into the statewide monitoring system immediately upon receipt from a caregiver, and • The licensee, before any sale or transfer, must verify, and confirm with government issued photo identification, with the statewide monitoring system that a patient or primary caregiver holds a valid registry identification card, and • The licensee enters all sales in the statewide monitoring system, and • The licensee determines sales will not exceed daily purchasing limits, and
• The licensee shall notify the Department within 1 business day of becoming aware of any adverse reaction to a marijuana product sold or transferred. o For the time period beginning April 1, 2019 and until such time as the Department publishes an advisory bulletin notifying all licensees that the effect of this resolution has been terminated: • The licensee obtains marijuana products only from a licensed grower or licensed processor, and • The licensee obtains patient consent on a form provided by the Department prior to selling any marijuana products obtained from a caregiver prior to April 1, 2019 that have not been tested in full compliance with the law and administrative rules, and • The licensee enters all inventory into the statewide monitoring system immediately upon receipt, and • The licensee, before any sale or transfer, must verify, and confirm with government issued photo identification, with the statewide monitoring system that a patient or primary caregiver holds a valid registry identification card, and • The licensee enters all sales in the statewide monitoring system, and • The licensee determines sales will not exceed daily purchasing limits, and • The licensee notifies the Department within 1 business day of becoming aware of any adverse reaction to a marijuana product sold or transferred. • For a licensed Grower or licensed Processor: o Until such time as the Department publishes an advisory bulletin notifying all licensees that the effect of this resolution has been terminated: • The licensee obtains marijuana products from caregivers, and • The licensee enters all inventory into the statewide monitoring system immediately upon receipt, and • The licensee only transfers marijuana products that have been tested in full compliance with the law and administrative rules, and • The licensee tags or packages all inventory that has been identified in the statewide monitoring system, and • The licensee transfers marijuana products by means of a secured transporter, except where exempted under the Act, and • The licensee notifies the Department within 1 business day of becoming aware of any adverse reaction to a marijuana product sold or transferred.
