Category: Drug & Cosmetic Law

FDA Issues Warning Letters to 7 Dietary Supplement Companies for Drug Claims

  • On November 17, 2022, FDA posted warning letters to 7 companies for selling different dietary supplements with claims that caused the products to be “drugs” in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Under the FD&C Act, products intended to diagnose, cure, treat, mitigate, or prevent disease are drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements.

  • The claims were found on the 7 companies’ websites, social media pages, and/or Amazon or Walmart storefronts, and included a variety of statements regarding the products’ claimed abilities to cure, treat, mitigate, or prevent cardiovascular disease (or related conditions, such as atherosclerosis, stroke, or heart failure).  Six of the companies at issue sell a product(s) containing one or more dietary ingredients identified as Vitamin B3, red yeast rice, pine bark extract, EPA and DHA omega-3 fatty acids, magnesium, zinc, bergamot, Hawthorn berry, Hawthorn extract, Coleus forskohlii, hops, taurine, garlic powder, amino sulfonic acid, Co-Q-10, and/or octacosanol.  The seventh company does not list a dietary ingredient but identifies its product as a “glycocalyx regenerating product” and notes various “pathologies associated with impaired endothelial glycocalyx.”  As noted in the warning letters, FDA has not evaluated whether the unapproved products are effective for their intended use, the proper dosage, potential interaction with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.  Further, in addition to characterizing the products as unapproved “new drugs,” FDA’s letters note misbranding charges based on the impossibility of writing adequate directions for a layperson to use the products safely for the intended purpose of treating one more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.

  • FDA requested that the companies respond to the warning letters within 15 working days and describe how they will address the issues, or provide reasoning and substantiation as to why they believe the products are not in violation of the law.  Failure to adequately address could result in legal action, such as product seizure and/or injunction.

For more Biotech, Food and Drug Law news, click here to visit the National Law Review

© 2022 Keller and Heckman LLP

Colorado Legalizes Therapeutic Psychedelics – Now What?

Ten years after Coloradans voted for their state to be one of the first to legalize recreational cannabis, Colorado is again making history as the second state in the country to legalize therapeutic psychedelics for adults.

Colorado voters narrowly approved Proposition 122 with nearly 53% of the votes (as of the morning of November 14th 97% of the votes have been counted). Their vote thus enacted the Natural Medicine Health Act of 2022 (NMHA) which legalizes supervised or facilitated therapeutic sessions for adults twenty-one years and older using certain psychedelic plants and fungi. Click here for our initial takeaways and a high-level summary of key provisions of the NMHA.

Now that therapeutic psychedelics are legal in Colorado, what should be expected next? Below are key dates and next steps as Colorado navigates implementation of the NMHA.

  • The Colorado Department of Regulatory Agencies (DORA) must establish the Natural Medicine Advisory Board (Board) and appoint initial members to the Board by January 31, 2023. The Board must have 15 members who will be appointed by the Governor with the consent of the Colorado Senate. The primary role of the Board is to advise DORA as to implementation of the NMHA program.
  • By September 30, 2023, and annually thereafter, the Board must make recommendations to DORA on certain areas related to natural medicine, such as recommendations related to product safety, herm reduction, and cultural responsibility, training programs, educational and experiential qualifications for facilitators, regulatory considerations for each type of natural medicine and the rules to be promulgated by DORA.
  •  DORA has until January 1, 2024 to adopt rules and establish the qualifications, education and training requirements that facilitators must meet prior to providing natural medicine services to participants.
  • By September 30, 2024, DORA must adopt rules to implement the NMHA program and begin accepting applications for licensure of facilitators, healing centers, entities to test natural medicines, and any categories of licensure as determined by DORA.
  • Once applications are accepted, DORA must make decisions on licensure applications within 60 days of receiving an application.
  • From the launch of the NMHA program until June 1, 2026, “natural medicines” are limited to psilocybin and psilocyn. After June 1, 2026, upon recommendation by the Board, DORA may add one of more of the following to types of natural medicines that can be provided under the NMHA program: dimethyltryptamine, Ibogaine, and Mescaline (excluding peyote).

A notable takeaway and something to watch for in the forthcoming rules is a focus on social equity. Seemingly applying lessons learned from the rollout of the state’s cannabis program, the NMHA expressly requires DORA to prioritize equity and inclusivity as it establishes rules to implement the NMHA program. Specifically, DORA is required to adopt rules which: (i) establish procedures, policies and programs to ensure the NMHA program is equitable and inclusive; (ii) promote the licensing of and provision of natural medicine services to (a) persons from communities that have been disproportionally harmed by high rates of controlled substances (including cannabis); (b) persons who face barriers to access to health care; (c) persons who have traditional or indigenous history with natural medicines; and (d) persons who are veterans by, offering, at a minimum reduced fees for licensure and training, incentivizing the provision of natural medicine services at a reduced cost to low income individuals, and incentivizing geographic and cultural diversity in licensing and the provision of and availability of natural medicine services.

In addition, DORA is prohibited from imposing unreasonable financial or logistical barriers that would prevent individuals with lower income from applying for a license and individuals are limited to having a financial interest in five healing centers. Currently, the definition of “individuals” does not include corporations. However, DORA could establish a rule which includes corporations in this limitation and would arguably level the playing field in this budding market.

We will continue to monitor developments and closely follow the rulemaking process as Colorado designs and implements this historical new program.

Article By Lauren P. Carboni of Foley & Lardner LLP

For more biotech, food, and drug legal news, click here to visit the National Law Review.

© 2022 Foley & Lardner LLP

Voters in Two States Approve Marijuana Ballot Initiatives on Election Day 2022

Voters in Maryland and Missouri approved laws to legalize recreational marijuana on Election Day 2022.  Recreational marijuana ballot initiatives did not pass in Arkansas, North Dakota and South Dakota.

Maryland

Maryland voters approved a state constitutional amendment that will allow the use of cannabis by anyone over the age of 21 on or after July 1, 2023, subject to the General Assembly passing legislation concerning the regulation, distribution, possession and taxation of marijuana.

Missouri

Missouri voters also approved an amendment to the state constitution.  The amendment addresses both medical marijuana and recreational marijuana.

The medical marijuana law will permit nurse practitioners to recommend medical marijuana use to their patients in addition to physicians.  It also will permit the use of “marijuana-infused products,” i.e., products that are infused, dipped, sprayed, coated or mixed with marijuana or marijuana extracts.  Those products may be vaporized or smoked, or may consist of edible products, ingestible products, topical products, suppositories, and “infused pre-rolls” (a type of consumable or smokable product).  Medical marijuana cards will be valid for three years.  While the medical marijuana law does not permit operation of a motor vehicle while under the influence of marijuana, the law is now revised to say that the arrest or conviction of a medical marijuana user will require evidence that the user was in actual physical control of the motor vehicle and may not rely solely on the presence of THC or THC metabolites in the person’s system.

The medical marijuana law still prohibits legal claims against employers based on an employer’s prohibition of being under the influence of marijuana while at work.  However, new provisions state that employers may not discriminate against medical marijuana users unless:  failure to do so would result in the loss of a monetary or licensing-related benefits under federal law, or unless the person was under the influence of marijuana on the employer’s premises or during work hours.

The constitutional amendment also permits the recreational use of marijuana by adults age 21 and older.  Employers are not required to permit or accommodate the use of marijuana at work or on the employer’s property.  Employers are permitted to take adverse employment actions if a person is working while under the influence of marijuana.

The law does not define the phrase “under the influence of marijuana” so it is unclear whether employers may rely on positive drug test results for marijuana to prove an employee was “under the influence.”

Finally, the new law will allow individuals who are serving prison sentences for certain crimes including possession of up to three pounds of marijuana to petition the sentencing court to vacate the sentence, order immediate release and expunge the government’s records.  There are additional provisions addressing expungement of criminal records for those who previously served prison sentences related to certain marijuana-related crimes.

The Missouri constitutional amendment will take effect thirty days after the election.

Employers in Maryland and Missouri should review their drug and alcohol policies to ensure compliance with these new laws.

Article By Kathryn J. Russo of Jackson Lewis P.C.

For more biotech, food, and drug law legal news, click here to visit the National Law Review.

Jackson Lewis P.C. © 2022

Presidential Pardon for Simple Marijuana Possession Leaves Out Many

Severe immigration consequences for certain non-U.S. citizens remain despite President Joe Biden’s pardon of all prior federal offenses for simple marijuana possession.

On October 6, 2022, President Biden took a major step toward the decriminalization of marijuana, pardoning all prior federal offenses for simple marijuana possession. Although this pardon will affect only approximately 6,500 individuals who were convicted of simple marijuana possession under federal law before October 6, 2022, it does not affect the much larger number of individuals who have been convicted of a marijuana possession offense under state law. To the disappointment of immigration advocates, the pardon does not benefit non-U.S. citizens who were not lawfully present in the United States at the time of their conviction, even if their conviction was under federal law.

Moreover, because marijuana is still listed as a Schedule I drug under the federal Controlled Substances Act:

  • Non-U.S. citizens can still be denied entry to the country for use of marijuana or for working or actively investing in the marijuana industry;

  • Immigration authorities may deny a non-U.S. citizen’s application for lawful permanent residence (green card) or naturalization on the ground that they have a conviction for a marijuana-related offense, an admission by the non-U.S. citizen that they have used marijuana in the past, or that they have worked or is actively investing in the marijuana industry; and

  • The Department of Homeland Security can still place individuals, including green card holders, into removal proceedings (deportation) as a result of marijuana-related offenses, unless the conviction was for simple possession of less than 30 grams.

In his order, President Biden urged governors to consider similar state law pardons for simple marijuana possession charges, which might affect many more individuals. President Biden has also asked the Department of Health and Human Services to consider changing the current Schedule I classification for marijuana. If one of these changes occurred, non-U.S. citizens would substantially benefit, as their state convictions for marijuana-related offenses might be pardoned, thus lowering the negative consequences for immigration purposes.

For now, however, non-U.S. citizens should still be wary of marijuana use, or working or investing in the marijuana industry, even in places in the United States or abroad where those activities are legal. While there may not be federal prosecutions for the use and possession of marijuana, there may be severe immigration consequences for non-U.S. citizens, because the use and possession of marijuana remains illegal in certain states.

Article By Carolina Guiral Cuervo of Jackson Lewis P.C.

Jackson Lewis P.C. © 2022

Biden’s Statement on Marijuana Reform: What Does it Mean?

While states continue moving to legalize cannabis, change has been slower to nonexistent at the federal level. That may have changed last week with President Biden’s statement on marijuana reform, announcing that he was pardoning citizens with federal convictions of simple possession of marijuana. He also directed an administrative review of how marijuana is scheduled under the Controlled Substances Act (CSA).

The cannabis industry has grown into a multibillion dollar industry with recreational use legalized in 19 states and medicinal use legalized in 18 states. In November, voters in five more states (Arkansas, Maryland, Missouri, North Dakota, and South Dakota) will decide whether to legalize recreational use marijuana. While the President’s statement likely represents the largest shift in federal marijuana policy in the last 50 years, significant questions still remain as to what changes will take place, when those changes will occur, and what it means for the cannabis industry.

A Review of Marijuana Scheduling

President Biden’s directive to review scheduling doesn’t change the current federal restriction on marijuana. In 1970, under the CSA, marijuana was categorized, alongside heroin and LSD, in the most prohibitive classification as a Schedule I drug. In the five-tier scheduling, Schedule I drugs are deemed to be “drugs with no currently accepted medical use and a high potential for abuse.”

Health and Human Services Secretary Xavier Becerra has indicated his agency will move “as quickly as we can but, at the end of the day science is going to take us to a solution.” The review of federal scheduling will be tasked to the Food and Drug Administration (FDA) which will conduct a scientific and medical analysis (including to determine currently accepted medical uses and potential for abuse) to make a recommendation on scheduling to the Drug Enforcement Agency (DEA). The CSA authorizes the DEA to move a drug to a lower schedule or remove it entirely. Moving as quickly as possible, the review process will take some time. Even with an administrative rescheduling review, the question remains as to what rescheduling would take place.  Would marijuana be moved to Schedule II (with cocaine, fentanyl, and methamphetamine) or Schedule III (with anabolic steroids) or removed from the CSA entirely?

Aside from the FDA evaluation and DEA rescheduling, Congress could also choose to enact legislation amending the CSA and removing marijuana from Schedule I. While the MORE Act was passed by the US House, the Senate has not yet seen sufficient support to pass legislation to remove marijuana’s Schedule I status.

Presidential Pardons

President Biden’s blanket pardon only impacts those people with federal (or Washington DC) convictions for simple marijuana possession. The impact of this pardon is modest as The White House estimates only 6,500 people will be affected by the decision. The President asked Attorney General Merrick Garland to develop and announce an application procedure for certificates of pardon for these individuals.

The vast majority of marijuana possession convictions are state-level convictions.

The vast majority of marijuana possession convictions are state-level convictions. The President also encouraged governors to offer pardons for state marijuana possession offenses. While he does not have the power to compel states to act, many states that have legalized marijuana have, in efforts to address social equity, already taken steps to remove old state marijuana possession convictions. Additionally, in an election year, several governors or gubernatorial candidates have already reacted to the President’s announcement. Those reactions “run the gamut” from complete support to concerns levied about drug abuse and rising crime.

For example, North Carolina Governor Roy Cooper and Attorney General Josh Stein have called for decriminalizing marijuana use and starting a review to expunge prior state convictions for simple possession. His comments mark the first time Governor Cooper has explicitly endorsed the decriminalization reform recommended by the Task Force for Racial Equity in Criminal Justice he convened in 2020.

Impact and Implications

Aside from the federal pardons, the true impact of last week’s statement on the cannabis industry remains to be seen. White House support may impact voters, governors, and candidates in states attempting to legalize marijuana at the state level. At a federal legislation level, White House support may impact stalled marijuana legislation such as the SAFE Banking Act, which would have significant impact on the cannabis industry by paving the way to greater access to financial institutions and services. While the cannabis industry continues to deal with the patchwork of state legalization and federal regulations, last week’s White House support marks a paradigm shift in a half-century federal policy on marijuana.

For more Food and Drug Law News, click here to visit the National Law Review

Copyright © 2022 Womble Bond Dickinson (US) LLP All Rights Reserved.

BREAKING NEWS: Biden to Pardon Federal Marijuana Possession Convictions

In a historic move, today, President Joe Biden announced a three-step program to bring broad changes to federal cannabis policy. As an initial step towards reform, President Biden will pardon all federal offenders convicted of simple marijuana possession. According to administration officials, the pardons will be issued through an administration process overseen by the Department of Justice. Those eligible for the pardons will receive documentation showing they were officially forgiven for their crime.

“No one should be in jail just for using or possessing marijuana,” Biden said in a video announcing his executive actions. “It’s legal in many states, and criminal records for marijuana possession have led to needless barriers to employment, housing, and educational opportunities. And that’s before you address the racial disparities around who suffers the consequences. While white and Black and brown people use marijuana at similar rates, Black and brown people are arrested, prosecuted, and convicted at disproportionate rates.”

“Too many lives have been upended because of our failed approach to marijuana. It’s time that we right these wrongs,” the President said.

As a second step in the program, Biden also encouraged Governors to take similar steps to pardon state simple cannabis possession charges.

And as the last step in this program, President Biden directed the Department of Health and Human Services and Attorney General Merrick Garland to “expeditiously” review the cannabis’s status as a Schedule I controlled drug pursuant to the federal Controlled Substances Act.

Article By Sarah A. K. Blitz and Whitney Hodges of Sheppard, Mullin, Richter & Hampton LLP

For more cannabis legal news, click here to visit the National Law Review.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

California Enacts Legal Protections for Cannabis Insurance Providers

Several cannabis-related bills were signed by California Governor Gavin Newsom on September 18, 2022, including Assembly Bill 2568 (AB 2568), which clarifies that it is not a crime for individuals and firms licensed by the California Department of Insurance (CDI) to provide insurance or related services to persons licensed to engage in commercial cannabis activities. Though the California Civil Code was amended in 2018 to clarify that cannabis is the legal object of a contract, and it has been tacitly understood that insurance contracts are legal in California, the intent of this new law is to remove any uncertainty and to encourage further growth of admitted insurance products for California cannabis businesses.

AB 2568 adds section 26261 to the California Business and Professions Code, which states in relevant part: “An individual or firm that is licensed by the Department of Insurance does not commit a crime under California law solely for providing insurance or related services to persons licensed to engage in commercial cannabis activity pursuant to this division.”

Intent of the Law

The California Assembly’s Committee on Insurance explained the intent behind AB 2568 in a report issued earlier this year:

“The hesitancy of insurance providers to provide insurance for commercial cannabis is attributed to risk, since cannabis is classified as a Schedule I substance under the Federal Controlled Substances Act. Therefore, much of the insurance available in California is from surplus lines. This does not align with the federal government’s longstanding determination that it is in the public’s interest for states to regulate their own insurance marketplaces. Further, the argument has been refuted in federal case law brought about in Green Earth Wellness Center v. Attain Specialty Insurance Company (2016), which established that federal classification of cannabis is not relevant in an insurance provider’s determination to write an insurance policy.

It is important that commercial cannabis businesses have multiple options for insurance as they pursue licensure. AB 2568 clarifies that writing insurance for commercial cannabis does not constitute a crime, since cannabis is part of a legal, regulated market in California. This clarity will provide assurances to admitted insurers that they will not be in violation of any regulations and encourage them to provide an insurance product.”

In addition, AB 2568 was strongly supported by CDI, which argued that “we must provide commercial cannabis businesses with multiple, affordable options for insurance as they pursue and maintain state licensure.” CDI supports AB 2568 in part to “promote reliable insurance coverage for all aspects of these cannabis businesses to ensure that these businesses can continue to flourish just like any other business in this state.”

In a separate analysis, the California Senate Committee on Insurance inquired as to whether the bill would achieve the intended result of expanding insurance options for cannabis businesses. It concluded:

“This bill expressly states a protection under California Law for CDI licensees. This protection has been implied since the legalization of recreational cannabis in 2016, and in that same year a federal court gave a nod to insurers that writing cannabis [insurance] is permissible, but only one admitted company has fully waded into the market. On the one hand, insurers are famously risk averse, so this express statement of state law may go a long way for some to take the risk to sell cannabis coverage. But, federal illegality of cannabis could always be the larger barrier to entry for some companies than what the state laws say.”

The Senate report concludes that more study is needed to “consider additional efforts to effectuate the stated goal of growing the domestic market for cannabis insurance.”

Analysis

AB 2568 does not materially change existing California law since providing insurance services to properly licensed California businesses has been legal under state law since at least 2018. The bill, however, is meant to remove any lingering doubt on the topic and to encourage more insurance service providers to enter the market.

As we have previously reported, it is reasonable to conclude that the risk-benefit calculus has adequately shifted to justify entrance into the cannabis market without an unreasonable fear of prosecution. This certainly is true for the insurance industry.

Congress continues to prohibit the Department of Justice and other federal agencies from spending money to prosecute conduct that complies with state medical marijuana laws. Federal law enforcement, meanwhile, has not initiated any prosecution against a plant-touching or ancillary business involved in either adult-use cannabis or medical marijuana where the underlying marijuana business activity was compliant with state law and there was no other independent violation of law.

Despite this favorable outlook, it must be acknowledged that, without a change to the status quo, some degree of theoretical legal risk remains present for any plant-touching or ancillary business in the marijuana industry. Any decision to provide insurance-related services to the cannabis industry must be based on a well-informed understanding of the legal risks and the very challenging operating environment for state-licensed cannabis companies.

For more Food and Drug Legal news, click here to visit the National Law Review.

© 2022 Wilson Elser

In One Day, California Governor Signs Into Law Ten Cannabis Bills, Including Authorization for Interstate Commerce

Acting in one fell swoop, on September 18, 2022, California Governor Gavin Newsom signed 10 cannabis-related legislative bills into law. These bills, which touch on issues that run the gamut of the cannabis industry, are intended to “strengthen California’s cannabis laws, expand the legal cannabis market and redress the harms of cannabis prohibition.” Senate Bill 1326 is the most widely recognized bill of the group, and authorizes the Governor the power to sign cannabis trade agreements with other states where cannabis is legal. Other bills address employment protection, labelling, use of cannabis in veterinary medicine and taxation. In his press release, Governor Newsom said: “For too many Californians, the promise of cannabis legalization remains out of reach. These measures build on the important strides our state has made toward this goal, but much work remains to build an equitable, safe and sustainable legal cannabis industry.”

Still before Governor Newsom for his signature is SB 1496, which would implement a series of changes to the state’s cannabis tax policy, including authorizing regulators to extend the deadline for tax payments by cannabis businesses located in areas affected by an emergency proclamation by the Governor.

Below is a discussion of the cannabis-centric Senate and Assembly bills adopted during the 2022 Legislative session.

SB 1326 – Cannabis: Interstate Agreements

SB 1326 adds Chapter 25 to the Business and Professions Code and allows for interstate cannabis commerce from California to and from other states that recognize the legality of cannabis cultivation, production, distribution and/or possession. While seemingly revolutionary, SB 1326 is contingent on an official assurance that the activity would not result in federal enforcement action against California – meaning, most likely, that this bill cannot be utilized until cannabis is federally decriminalized.

Historically, California is an industry leader in product quality and innovation, and this bill, according to SB 1326’s author, Senator Anna Caballero, “provides a relief valve for the oversupply of cannabis, an opportunity to grow California’s brand and market share, support job creation, and gives the state a competitive advantage as federal policy develops…SB 1326 is an essential step to ensure that California can fully capitalize on, and remain a leader in, the forthcoming national cannabis market. Furthermore, SB 1326 would allow California to use its own labor, environmental, and product quality standards be adopted in other states.”

SB 1186– Medicinal Cannabis Patients’ Right of Access Act

SB 1186 prohibits a local jurisdiction from adopting or enforcing any regulation that prohibits the delivery of a medicinal cannabis retail sale to medicinal cannabis patients or their primary caregivers by medicinal cannabis businesses, or that has the effect of prohibiting such delivery. The bill’s author, Senator Scott Weiner, states this bill is a victory for seniors living with chronic illness, and will both improve patient access and help fill voids throughout the state where no cannabis license types have been authorized.

AB 1646 – Cannabis Packaging: Beverages.

AB 1646 authorizes cannabis beverages to be packaged in containers of any material that are clear or any color.

AB 1706 – Cannabis Crimes: Resentencing.

If an eligible cannabis conviction was not challenged by July 1, 2020, AB 1706 requires the California court system to process record sealing and other forms of relief for such convictions by March 1, 2023. AB 1706 also requires the Department of Justice to complete an update of the State’s summary criminal history information database, and ensure that inaccurate state summary criminal history is not reported. The Department of Justice is also required to conduct an awareness campaign so that individuals that may be impacted by this process become aware of methods to verify updates to their criminal history. The bill would make a conviction, arrest, or other proceeding that has been sealed pursuant to these provisions deemed never to have occurred.

AB 1885 – Cannabis & Cannabis Products: Animals: Veterinary Medicine

AB 1885 expands the purpose of the comprehensive system established by Medicinal and Adult-Use Cannabis Regulation and Safety Act (MAUCRSA) to include the control and regulation of the cultivation, distribution, transport, storage, manufacturing, processing, and sale of cannabis products intended for use on, or consumption by, animals. The bill makes various related revisions to the definitions under MAUCRSA, would exclude livestock and food animals, as specified, from the definition of “animal,” for these purposes, and would specify that cannabis concentrate and edible cannabis products are not considered processed pet foods as defined under the Pure Pet Food Act of 1969.

AB 1885 would also prohibit the Veterinary Medical Board within the Department of Consumer Affairs from disciplining a veterinarian who recommends the use of cannabis on an animal for potential therapeutic effect or health supplementation purposes, unless the veterinarian is employed by or has an agreement with a cannabis licensee. Under this bill, the Veterinary Medical Board is required to adopt guidelines, by January 1, 2024, for veterinarians to follow when recommending cannabis within the veterinarian-client-patient relationship, and would require the Veterinary Medical Board to post the guidelines on its internet website.

Lastly, AB 1885 would require that cannabis products intended for animals comply with additional concentration and other standards adopted by regulation. These regulations must be promulgated no later than July 1, 2025, and would prohibit the marketing or sale of those products before the regulations take effect.

AB 1894 – Integrated Cannabis Vaporizer: Packaging, Labeling, Advertisement, & Marketing

AB 1894 requires the advertisement and marketing of a cannabis cartridge and an integrated cannabis vaporizer to prominently display a specified message to properly dispose of a cannabis cartridge and an integrated cannabis vaporizer as hazardous waste. This bill also prohibits the package, label, advertisement, and marketing from indicating that the cannabis cartridge or integrated cannabis vaporizer is disposable or implying that it may be thrown in the trash or recycling streams.

AB 2210 – Cannabis: State Temporary Event Licenses: Venues Licensed by the Department of Alcoholic Beverage Control: Unsold Inventory

AB 2210 prohibits Department of Cannabis Control (DCC) from denying an application for a state temporary event license solely on the basis that there is a license issued pursuant to the Alcoholic Beverage Control Act for the proposed premises of the event. It also prohibits the Department of Alcoholic Beverage Control from taking disciplinary action against a person licensed pursuant to the Alcoholic Beverage Control Act on the basis of a state temporary event license issued by the DCC to a licensee that utilizes the same premises.

AB 2210 requires all on- and off-sale privileges of alcoholic beverages at the venue to be suspended for the day of the event until 6 a.m. on the day after the event has ended, and would prohibit all alcohol consumption on the venue premises for the day of the event, until 6 a.m. on the day after the event has ended. All inventory of cannabis or cannabis products to be sold by a state temporary event license to be transported to and from the temporary event by a licensed distributor or licensed microbusiness. A state temporary event licensee, upon completion or cessation of the temporary event, is authorized to reconcile unsold inventory of cannabis or cannabis products and return it to the licensee’s retail premises.

AB 2188 – Discrimination in Employment: Use of Cannabis[1]

AB 2188 makes it unlawful for an employer to discriminate against a person in hiring, termination, or any term or condition of employment, or otherwise penalize a person” solely because of off-duty, off-site cannabis use. The bill will also eliminate employment-based THC testing, with exceptions for certain positions, such as federal employees or those working in the building and construction trades. AB 2188 does not preempt state or federal laws requiring applicants or employees to be tested for controlled substances as a condition of employment, receiving federal funding or federal licensing-related benefits, or entering into a federal contract.

AB 2568 – Cannabis: Insurance Providers.

AB 2568 provides it is not a crime for individuals and firms to provide insurance and related services to persons licensed to engage in commercial cannabis activity.

AB 2925 – California Cannabis Tax Fund: Spending Reports.

AB 2925 requires that the State Department of Health Care Services submit reports to the legislature, starting no later than July 10, 2023, that accounts for cannabis tax revenue that has been distributed to the Youth Education, Prevention, Early Intervention and Treatment Account, as required under MAUCRSA.

For more Biotech, Food, & Drug Law news, click here to visit the National Law Review.

FOOTNOTES

[1] AB 2188 is discussed in further detail here.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

DOT Proposes New Guidance For Medical Examiners To Address CBD Use By Commercial Motor Vehicle Drivers

The U.S. Department of Transportation, Federal Motor Carrier Safety Administration (FMCSA) published a proposed draft Medical Examiner’s Handbook (MEH), including updates to the Medical Advisory Criteria, in the Federal Register on August 16, 2022.  The FMCSA’s regulations provide the basic driver physical qualification standards for commercial motor vehicle (CMV) drivers, in 49 CFR 391.41 through 391.49. DOT Medical Examiners currently make physical qualification determinations on a case-by-case basis and may consider guidance to assist with making those determinations.

FMCSA stated that the goal of the updated MEH and related Medical Advisory Criteria is to provide information about regulatory requirements and guidance for Medical Examiners to consider when making physical qualification determinations in conjunction with established best medical practices. The revised Medical Advisory Criteria, in addition to being included in the MEH, would also be published in Appendix A to 49 CFR part 391. The final version of the criteria would be identical in both publications. FMCSA is proposing to update both the MEH and Medical Advisory Criteria and seeks public comment on these documents until September 30, 2022.  The draft MEH may be viewed here.

Use of CBD with 0.3% THC or Less Is Not Automatically Disqualifying

Under FMCSA regulation 49 CFR 391.41(b)(12)(i), CMV drivers are not permitted to be physically qualified when using Schedule I drugs under any circumstances. The federal Controlled Substances Act lists marijuana, including marijuana extracts containing greater than 0.3% delta-9-tetrahydrocannabinol (THC), as Schedule I drugs and substances. A driver who uses marijuana cannot be physically qualified even if marijuana is legal in the State where the driver resides for recreational or medical use.

However, under current federal law cannabidiol (CBD) products containing less than 0.3% THC are not considered Schedule I substances; therefore, their use by a CMV driver is not grounds to automatically preclude physical qualification of the driver under §391.41(b)(12)(i).

FMCSA emphasized that the U.S. Food and Drug Administration (FDA) does not currently determine or certify the levels of THC in products that contain CBD, so there is no federal oversight to ensure that the labels on CBD products that claim to contain less than 0.3% of THC are accurate. Therefore, drivers who use these products are doing so at their own risk.

FMCSA now proposes that each driver should be evaluated on a case-by-case basis and encourages Medical Examiners to take a comprehensive approach to medical certification and to consider any additional relevant health information or evaluations that may objectively support the medical certification decision. Medical Examiners may request that drivers obtain and provide the results of a non-DOT drug test during the medical certification process, if it is deemed to be helpful in determining whether a driver is using a prohibited substance, such as a CBD product that contains more than 0.3% THC.

This guidance does not impact FMCSA’s drug and alcohol testing regulations.  Use of a CBD product does not excuse a positive marijuana drug test result.

Use of Suboxone and Similar Drugs Is Not Automatically Disqualifying

FMCSA received a large number of inquiries related to Suboxone (a Schedule III drug under federal law, meaning that it has a lower potential for abuse than Schedule I and II drugs).  Treatment with Suboxone and other drugs that contain buprenorphine and naloxone, as well as methadone, are not identified in the FMCSA regulations as precluding medical certification for operating a CMV. FMCSA relies on the Medical Examiner to evaluate and determine whether a driver treated with Suboxone singularly or in combination with other medications should be issued a medical certificate. The Medical Examiner should obtain the opinion of the prescribing licensed medical practitioner who is familiar with the driver’s health history as to whether treatment with Suboxone will or will not adversely affect the driver’s ability to safely operate a CMV. The final medical certification determination, however, rests with the Medical Examiner who is familiar with the duties, responsibilities, and physical and mental demands of CMV driving and non-driving tasks.

Article By Kathryn J. Russo of Jackson Lewis P.C.

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Supreme People’s Court Upholds China’s First Patent Linkage Ruling – Decision Released

On August 28, 2022, 知识产权那点事 published the first patent linkage decision from the Supreme People’s Court (SPC). The SPC upheld the Beijing IP Court ruling that Wenzhou Haihe Pharmaceutical Co., Ltd.’s application for marketing authorization for a generic form of “Aidecalcidol Soft Capsule” did not fall within scope of protection of the relevant patent. China’s patent linkage system prevents marketing authorization for a generic prior to the expiration of the patent term on the branded equivalent unless the Beijing IP Court or the China National Intellectual Property Administration (CNIPA) rules that the generic does not fall within the scope of the relevant patent rights or is invalid.

On November 10, 2021, the Beijing IP Court announced that the plaintiff of the case, Chugai Pharmaceutical Co., Ltd., a subsidiary of Roche, claimed that it was the patentee as well as the holder of the marketing license for the patented drug “Aidecalcidol Soft Capsule”, and the patent involved in the drug was CN 2005800098777.6 entitled “ED-71 preparation.” The plaintiff discovered that the defendant Wenzhou Haihe Pharmaceutical Co., Ltd. had applied to the National Medical Products Administration (NMPA) for a generic drug marketing license application named “Aidecalcidol Soft Capsule”. The public information on the Chinese listed drug patent information registration platform showed that the defendant had made a 4.2 category statement regarding the generic drug (the generic drugs do not fall into the scope of protection of the related patents). Therefore, the plaintiff filed a drug patent linkage lawsuit with the Beijing Intellectual Property Court in accordance with the provisions of Article 76 of the Amended Patent Law, requesting the court to confirm that the generic drug “Aidecalcidol Soft Capsule” that the defendant applied for registration fell into the scope the rights of Patent No. 2005800098777.6 enjoyed by the plaintiff.

 

The Beijing IP Court held:

The technical solution used by the generic drug involved is neither the same nor equivalent to the technical solution of claim 1 of the involved patent, so the technical solution does not fall within the protection scope of claim 1 of the involved patent. Since claims 2-6 are dependent claims of claim 1, if the technical solution of the generic drug involved does not fall within the protection scope of claim 1, it also does not fall within the protection scope of claims 2-6. Accordingly, the plaintiff’s claim that the involved generic drug falls within the protection scope of claims 1-6 of the involved patent cannot be established, and the court will not support it.

In the decision, the Supreme People’s Court stated there were two key points:

1. In the process of drug marketing review and approval, disputes arising from the patent rights related to the drug to be registered between the drug marketing license applicant and the relevant patentee or interested parties are only one type of the related patent rights between the two parties – often referred to as drug patent link disputes. For chemical generic drugs, the drug regulatory department of the State Council conducts drug marketing review and approval based on the application materials of the generic drug applicant, and decides whether to suspend the approval of the relevant drugs according to the effective judgment made by the people’s court [or the China National Intellectual Property Administration] on such disputes within the prescribed time limit. Therefore, when judging whether the technical solution of a generic drug falls within the scope of patent protection, in principle, it should be compared and judged on the basis of the application materials of the generic drug applicant. If the technical solution actually implemented by the generic drug applicant is inconsistent with the declared technical solution, it shall bear legal responsibility in accordance with the relevant laws and regulations on drug supervision and administration; if the patentee or interested party believes that the technical solution actually implemented by the generic drug applicant constitutes infringement, a separate lawsuit for patent infringement may also be filed. Therefore, whether the technical solution actually implemented by a generic drug applicant is the same as the application materials is generally not within the scope of examination to confirm that the dispute falls within the scope of patent protection.

2. The court of second instance held that both the donation [to the public] rule and the estoppel rule can constitute a restriction on the application of the principle of equivalence, both of which aim to achieve a reasonable balance between equitably protecting the interests of the patentee and safeguarding the interests of the public. If the conditions for limiting the application of the principle of equivalence are met, there is usually no need to judge whether the two features constitute similar means, functions, and effects, and whether those skilled in the art can conceptualize them without creative work. In this case, since Haihe Company claimed the application of the estoppel rule by virtue of the amendment of the claims by Chugai Pharmaceutical Co., Ltd., and claimed the application of the donation rule by the patent text as the result of the amendment, the court of second instance first rendered a judgment on whether the rules on estoppel should be applied on the basis of the amendment of the claims by the patentee.

The case numbers are:

北京知识产权法院（2021）京73民初1438号民事判决书

最高人民法院（2022）最高法知民终905号民事判决书

The full text of the decision courtesy of 知识产权那点事 is available here (Chinese only).

Article By Aaron Wininger of Schwegman, Lundberg & Woessner, P.A.

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