Brain Interfaces Bring Us Closer to a Life of the Mind

As we learn more about the human brain, we can begin to wonder if the rest of the body is necessary. Improved brain-machine interfaces are showing us how much can be accomplished by tapping directly into our thoughts.

While brainwaves can be read and interpreted through electrodes placed on the scalp, this method lacks the spatial detail of implanted electrodes. The recent action in practical thought-to-action science has taken place with direct physical connections.

For example, last summer brain researchers in Australia and the U.S. showed promising results by mounting electrodes on an expandable stent and threading it through blood vessels that lead to the brain. The sensors in the stent could sense when people’s brains signaled an intention to move, the sensors wirelessly sent this information to a computer which interpreted the signals. The interface allowed ALS patients to combine use of an eye tracker to move a cursor plus a thought-controlled click, making their communication faster and easier without surgery to implant electrodes.

Electrode-based therapy is still the gold standard, and Elon Musk’s company Neuralink has announced testing of a wireless implant that could provide a broadly useful direct interface between human brains and computers. Neuralink’s small implants include more than 1000 electrodes designed to send wireless signals to anything digital, like prosthetic hands or automotive controls.  According to a story in Wired last year, “The reason that excites neuroscientists is that right now their tools are relatively crude. The standard is the “Utah array,” a single chip with 64 electrodes on it. Just putting it in or taking it out can damage the tissue around it, and it’s not good at isolating single neurons or covering a large area … At the Neuralink presentation, Musk said that his prototype included sensors for motion, temperature, and pressure and 1,024 thin, flexible wires to pick up the electrical signals neurons put out while they’re neuron-ing.” Currently, this array can be wirelessly connected to a computer to learn to associate outbound signals with specific intentions.

Computer-aided brain-driven prosthetics have been improving by adding an element of touch feedback to the process.  Until recently, a person using a brain-computer interface would use visual cues to pick up objects with prosthetic arms. However, according to this week’s Ars Technica, researchers working with people paralyzed from the neck down added tactile feedback to the systems, allowing the test participants to drastically improve performance. The biggest improvements involved tasks requiring grasping an object. “While we may not always be consciously aware of them, touch and pressure play a major role in everything we do with our hands. By targeting the right area of the brain, the implant takes advantage of the systems the brain already has for managing this kind of sensory input.” As we understand more about these regions of the brain, the Brain/computer/ prosthetic interaction becomes easier and more efficient.

One of the most impressive recent achievements arrives this month out of Stanford and Brown Universities allowing a paralyzed person to type out about 90 characters per minute by imagining that he was writing the characters out by hand. This drastically beats the efficiency of earlier efforts that involve virtual keyboards and cursors. As noted by Wired, “there are other possible routes to getting characters out of the brain and onto the page. Somewhere in our writing thought process, we form the intention of using a specific character, and using an implant to track this intention could potentially work. . . Downstream of that intention, a decision is transmitted to the motor cortex, where it’s translated into actions. Again, there’s an intent stage, where the motor cortex determines it will form the letter (by typing or writing, for example), which is then translated into the specific muscle motions required to perform the action. These processes are much better understood, and they’re what the research team targeted for their new work.”

By placing implants in the premotor cortex, researchers were able to capture the base intentions of the thinker at an earlier, clearer stage than simply the intentions of movement to effectuate the underlying ideas. Conceptually, this is an interesting advance. We had been focused on tapping into the same neurons that allow a person to type a message, but we are finding that, if we can catch the thought before the brain has converted it into a specific physical action, then we can skip a step in the brain’s process and make the brain-computer interface much more efficient. It makes one wonder whether stripping the process back even further, capturing thoughts of entire words, rather than letters, would create further efficiencies.  Right now we can turn intentions toward physical action into the actions themselves.  But this is an advance toward capturing the initial desire before it can be processed further by the action portions of the brain.

As the Wired article stated, “the system shows a very significant speed boost compared to previous implant-driven systems, and the accuracy is quite good. The system also has the potential to be similar to touch-typing, in that a user doesn’t have to actually visually focus on letter production, allowing more normal interactions with the user’s surroundings.” So we proceed closer to the holy grail of brain-computer interface: allowing a person’s brain to drive direct actions without involving the rest of the body at all.

This would be a clear victory for those with bodily impairments, but it also would be an excellent step toward systems that allowed us to manage all parts of our world without needed a body to manipulate our environment.  We could speak to our home temperature control system or direct our automobile without touching anything. Arriving in the midst of a pandemic, the possibility of touchless control of our environments has a special allure. Maybe someday in the not-so-distant future, all we will need is an operational brain to be a fully functioning human.

Copyright © 2021 Womble Bond Dickinson (US) LLP All Rights Reserved.


For more articles on the human brain, visit the NLRBiotech, Food, Drug section

Voters in Five States Approve Marijuana Ballot Initiatives on Election Day

Voters in Arizona, Mississippi, Montana, New Jersey, and South Dakota approved laws to legalize marijuana on Election Day 2020. Recreational marijuana was approved in Arizona, Montana, and New Jersey, while Mississippi voters approved medical marijuana. South Dakota voters approved both medical and recreational marijuana ballot initiatives.

Medical Marijuana

  1. Mississippi – Mississippi Ballot Measure 1 passed, with 68% voting “yes” and 32% voting “no.” Ballot Measure 1 asked voters to generally cast a vote for “either measure” Initiative 65 or Alternative 65A, or against both measures. Voters who cast a vote for “either measure” were then required to cast an additional vote for their preferred measure. Mississippi voters passed Initiative 65 with 74% voting for it and 23% voting for Alternative 65A.*

Initiative 65 allows the medical use of marijuana by patients who suffer from qualifying medical conditions. Qualified medical marijuana patients may possess up to 2.5 ounces of medical marijuana. The new law does not permit a qualifying patient to be “subject to criminal or civil sanctions for the use of medical marijuana.” However, it does not require “accommodation for the use of medical marijuana or require any on-site use of medical marijuana” in any place of employment. It also does not affect any “existing drug testing laws, regulations, or rules.”

The Mississippi State Department of Health has the authority to implement, administer, and enforce the law. It is required to issue final rules and regulations regarding medical marijuana by July 1, 2021. The Department must begin issuing medical marijuana identification cards and treatment center licenses no later than August 15, 2021.

  1. South Dakota – South Dakota’s Initiated Measure 26 passed, with 69% voting “yes” and 31% voting “no.” The new law allows the medical use of marijuana by patients who suffer from a debilitating medical condition. Medical marijuana card holders may possess up to three ounces of marijuana and cultivate marijuana plants. The law goes into effect July 1, 2021, but it may take up to a year before medical marijuana is available in the state.

Under the new law, medical marijuana cardholders are entitled to “all the same rights under state and local laws” as the person would be afforded if they were prescribed a pharmaceutical medication as it pertains to: (1) any interaction with a person’s employer; (2) drug testing by a person’s employer; and (3) drug testing required by any state or local law, agency, or government official.

The new law requires the South Dakota Department of Health to issue regulations regarding medical marijuana within 120 days after the law goes into effect (October 29, 2021) and to begin issuing registry identification cards to qualifying patients within 140 days after the law goes into effect (November 18, 2021).

The new law does not apply to employers to the extent it would conflict with the employer’s obligations under federal law or regulation or if it would disqualify an employer from a monetary or licensing-related benefit under federal law or regulation.

Although employers may discipline employees for ingesting marijuana in the workplace or for working while under the influence of marijuana, employers may not consider a qualifying patient to be under the influence of marijuana solely because of the presence of metabolites or components of marijuana that appear in “insufficient concentration to cause impairment.” Employers in South Dakota should take note of this language because there is no universally accepted concentration of marijuana that proves “impairment.”

Recreational Marijuana

  1. Arizona – The Smart and Safe Arizona Act passed with nearly 60% voting “yes” and 40% voting “no.” Under the Smart and Safe Arizona Act, individuals 21 years of age or older may lawfully use and purchase less than one ounce of marijuana (except, not more than five grams may be in the form of marijuana concentrate) and may cultivate up to six marijuana plants for personal use at the individuals’ primary residence (subject to certain restrictions). The new law does not include a delayed effective date, but it will likely be several months before Arizonans can purchase recreational marijuana.

The new law requires the Arizona Department of Health Services to begin accepting applications for marijuana establishment licenses from “early applicants” beginning January 19, 2021 through March 9, 2021. Licenses will be issued to qualified applicants within 60 days of receiving an application.

The new law does not restrict the rights of employers to “maintain a drug-and-alcohol free workplace” or prevent employers from having workplace policies “restricting the use of marijuana by employees or prospective employees.” It also does not require employers to “allow or accommodate the use, consumption, possession, transfer, display, transportation sale or cultivation of marijuana in a place of employment,” nor does it restrict employers from prohibiting or regulating marijuana use that occurs on or in their properties.

Arizona passed the Arizona Medical Marijuana Act in 2010, prohibiting employers from discriminating against medical marijuana patients. The recreational marijuana law expressly states that is it not intended to limit any privilege or right of a qualifying patient under the Arizona Medical Marijuana Act.

  1. Montana – Montana’s Initiative 90 and Constitutional Initiative 118 both passed with approximately 57% voting “yes” and 43% voting “no” for Initiative 90.  Effective January 1, 2021, individuals age 21 or older may possess, use, or transport one ounce or less of marijuana, and grow up to four mature marijuana plans and four seedlings on the grounds of a private residence. The Montana Constitution provides that a person 18 years of age or older is an adult for all purposes, except that a different legal age may be established for purchasing, consuming, or possessing alcoholic beverages. Effective October 1, 2021, the Montana Constitution will similarly permit a different legal age (i.e., 21 years of age or older) to be established for the purchase, consumption, or possession of marijuana.

Certain provisions of the new law go into effect on October 1, 2021, which is the deadline for the Department of Revenue to issue rules and regulations related to licensure of adult-use marijuana providers and dispensaries. The Department must begin accepting applications from dispensaries, providers, and manufacturers on or before January 1, 2022. However, for the first 12 months, the Department will only accept such applications from providers and dispensaries licensed under Montana’s medical marijuana statute.

The new law does not impose restrictions on employers. It states that is may not be construed to: (1) require an employer to permit or accommodate recreational marijuana use (or any other conduct permitted by the law) in any workplace or on the employer’s property; (2) prohibit an employer from disciplining an employee for violation of a workplace drug policy or for working while intoxicated by marijuana; (3) prevent an employer from declining to hire, discharging, or otherwise taking adverse action against an individual with respect to hire, tenure, terms, conditions, or privileges of employment because of the individual’s violation of a workplace drug policy or intoxication by marijuana while working.

Montana has had a medical marijuana law since 2004.

  1. New Jersey – New Jersey’s Question 1 passed with 67% voting “yes” and only 33% voting “no.” Effective January 1, 2021, the New Jersey Constitution will be amended to legalize recreational use of marijuana for adults ages 21 and older. The constitutional amendment provides for the Cannabis Regulatory Commission to regulate recreational marijuana and subjects all retail sales of recreational marijuana products to state sales tax.

The Cannabis Regulatory Commission and New Jersey lawmakers will address the regulatory issues that will determine the amount individuals can possess legally, the requirements for operating dispensaries for sale of cannabis, and taxation by state and local authorities. This process is expected to take up to approximately one year.

New Jersey has approved the use of medical marijuana since 2013. Under 2019 amendments to the Jake Honig Compassionate Use Act, employers are not permitted to discriminate against those who use cannabis for medical reasons.

  1. South Dakota – South Dakota’s Constitutional Amendment A passed with 53% voting “yes” and 47% voting “no.” Effective July 1, 2021, the new law permits individuals 21 years of age or older to possess and use one ounce or less of marijuana and to grow up to six marijuana plants on the grounds of a private residence.

No later than April 1, 2022, the South Dakota Department of Revenue is required to issue rules and regulations related to the commercial sale, cultivation, and testing of marijuana. The new law also directs the legislature to pass laws regulating the cultivation, processing, and sale of hemp and medical marijuana by April 1, 2022.

The new law does not require employers to permit or accommodate conduct authorized by it. It also does not affect an employer’s ability to restrict the use of marijuana by employees.

Next Steps

Employers should review their drug and alcohol policies – especially drug and alcohol testing policies – for compliance with applicable state laws.

While marijuana remains a Schedule I drug under the federal Controlled Substances Act, the trend in the courts over the last three years is to disregard marijuana’s status under federal law and to enforce state laws instead (with the exception of federally regulated employees such as those regulated by the U.S. Department of Transportation).

Employers must be familiar with the marijuana laws in the states where they operate before taking employment actions against those who use marijuana.


Jackson Lewis P.C. © 2020
For more articles on marijuana legalization, visit the National Law Review Biotech, Food, Drug section.

Japan Announces Process for Adding “Existing Substances” to PL

The Japanese Ministry of Health, Labour and Welfare (MHLW) has published a request for nominations for “existing substances” be included on the Positive List (PL) of “synthetic resins” for food-contact materials (FCMs) with corresponding submission forms. “Existing substances” include those marketed or used for food-contact utensils, containers and packages (UCP) in Japan prior to the effective date for the PL (i.e., June 1, 2020).  The deadline for filing such nominations is October 30, 2020.

For additional information on the PL system for “synthetic resins” that was MHLW published on April 28, 2020, see the PackagingLaw.com article, A Move to Mandatory: Japan Finalizes its Positive List for “Synthetic Resins”.)

As a component of MHLW’s process for nominating “existing substances,” the Ministry requires that companies include an attestation that such substances were marketed or used in food-contact UCP prior to June 1, 2020.  Submission forms are provided for each of the following materials:

  1. Base polymers (Plastics and Coatings);
  2. Minor monomers polymerized with base polymers; and
  3. Additives (including coating agents).

Additional information, including links to application form and submission instructions, is available here.


© 2020 Keller and Heckman LLP
For more articles on packaging law, visit the National Law Review Biotech, Food, Drug section.

BRAG Biobased Products Blog

USDA Requests Input On HBIIP

On January 16, 2020, the U.S. Department of Agriculture (USDA) announced the issuance of a Request for Information (RFI) to assist with the creation of its new program called Higher Blends Infrastructure Incentive Program (HBIIP). A USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. Requesting feedback from all interested parties, this RFI solicits information on options for fuel ethanol and biodiesel infrastructure, innovation, products, technology, and data derived from all HBIIP processes and/or science that drive economic growth, promote health, and increase public benefit. With an approaching deadline for comment submissions by January 30, 2020, thus far, only three parties have submitted comments to USDA.

DOE Announces Launch Of The 2020 Tibbetts Awards Program

On January 21, 2020, the U.S. Department of Energy’s (DOE) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Programs Office announced the launch of the U.S. Small Business Administration’s (SBA) Tibbetts Awards. The Tibbetts Awards recognize companies, organizations, and individuals exemplifying the best of the best in the SBIR and STTR programs. Named after the founder of the SBIR program, Roland Tibbetts, the awards also help DOE to document the economic, technical, and societal benefits from SBIR/STTR funding. Nominees can consist of an individual, a company, or an organization that promotes the mission and goals of the SBIR/STTR programs. The mission and goals include:

  • Stimulation of technological innovation;
  • Work with small businesses to meet federal development needs;
  • Encouragement of diverse participation in innovation and entrepreneurship;
  • Increase of private sector commercialization of innovations derived research and development (R&D); and
  • Foster technology transfer through cooperative R&D between small businesses and research institutions.

Nominations are open through February 21, 2020, and can be submitted via this website.

EU Funds Project To Develop Biobased Ropes For Aquaculture

On January 17, 2020, the European Union (EU) announced a new innovative project called BIOGEARS that will be funded under the European Maritime and Fisheries Fund (EMFF). The project focuses on the development of biobased gear solutions for the creation of an eco-friendly offshore aquaculture sector using a multitrophic approach and new biobased value chains. With the aim to address the gap of biobased ropes for offshore aquaculture, which is currently manufactured with 100 percent non-recyclable plastics, BIOGEARS will create a biobased value chain under the EU Bioeconomy Strategy framework. The European Bioeconomy Strategy aims to accelerate the deployment of a sustainable and circular European bioeconomy to maximize its contribution towards the 2030 Agenda and its Sustainable Development Goals (SDG), as well as the Paris Agreement. With the goal of increasing aquaculture marketable products, BIOGEARS uses an Integrated Multi-Trophic Aquaculture (IMTA) approach by integrating seaweed with mussel production. The BIOGEARS project’s intention is to develop biobased ropes that are tough, durable, and fit-for-purpose while still able to biodegrade in shorter time and managed by local composting facilities.

As part of the project, all project partners will participate in a BLUE LAB to enhance cooperation and enable tracking of innovation of the new biobased materials developed. Project coordinator, Leire Arantzamendi, expressed her hopes of boosting more eco-friendly mussel and seaweed production stating that BIOGEARS “will generate three rope prototypes with a highly reduced carbon footprint along the value chain.” The project will focus on the Atlantic Basin.


©2020 Bergeson & Campbell, P.C.

For more developments in the Biotech sphere, see the National Law Review Biotech, Food & Drug law section.

New Joint Website on Agricultural Biotechnology Products Launched by EPA, USDA, and FDA

On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products.  This “one-stop-shop” website was created under the direction of Executive Order (EO) “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.”

EPA regulates biotechnology-based pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and residues from such pesticides under the Federal Food, Drug and Cosmetic Act (FFDCA).  EPA also regulates under the Toxic Substances Control Act (TSCA) certain new microorganisms that are not subject to regulation under other statutes.  USDA regulates certain new biotechnology products under the Plant Protection Act (PPA), including agricultural crops that have been modified to be resistant to conventional pesticides.  FDA regulates the safety of human and animal foods produced using biotechnology, including genetically modified agricultural crops and animals, and the safety of drugs and human biologics produced with biotechnology, under the FFDCA.

The website, The Unified Website for Biotechnology Regulation, describes the federal review process for biotechnology products, outline’s each agency’s role in regulating biotechnology products, and allows users to submit questions to the three agencies.  EPA Administrator Andrew Wheeler states that the new website “will help provide regulatory certainty and clarity to our nation’s farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and break down barriers for these biotechnology products in the marketplace.”

Commentary

In recent years, a number of Non-Governmental Organizations (NGO) have raised concerns regarding the risks from products that have been genetically modified using biotechnology, including agricultural crops that have been genetically modified to improve pesticide or disease resistance, and agricultural animals that have been genetically modified to enhance food production.  In some instances, farmers have also expressed concern that crops with novel traits may exchange genetic information with other plant strains or species.  Implicit in all of this criticism is a presumption that the agencies with regulatory jurisdiction over these novel organisms have not adequately prevented or mitigated the risks associated with biotechnology.

In contrast, proponents of biotechnology have complained that regulatory requirements imposed by the responsible agencies have stifled useful innovation and have requested relief from regulatory requirements that they contend have impeded or slowed introduction of new products of agricultural biotechnology.  The Executive Order that underlies the new website seeks to streamline the administrative process for introducing novel agricultural products without increasing potential risks of biotechnology.

Additional information on how EPA regulates biotechnology products is available here.


©2020 Bergeson & Campbell, P.C.

For more on biotech, see the National Law Review Biotech, Food & Drug lawpage.

CMS’s Request for Information Provides Additional Signal That AI Will Revolutionize Healthcare

On October 22, 2019, the Centers for Medicare and Medicaid Services (“CMS”) issued a Request for Information (“RFI”) to obtain input on how CMS can utilize Artificial Intelligence (“AI”) and other new technologies to improve its operations.  CMS’ objectives to leverage AI chiefly include identifying and preventing fraud, waste, and abuse.  The RFI specifically states CMS’ aim “to ensure proper claims payment, reduce provider burden, and overall, conduct program integrity activities in a more efficient manner.”  The RFI follows last month’s White House Summit on Artificial Intelligence in Government, where over 175 government leaders and industry experts gathered to discuss how the Federal government can adopt AI “to achieve its mission and improve services to the American people.”

Advances in AI technologies have made the possibility of automated fraud detection at exponentially greater speed and scale a reality. A 2018 study by consulting firm McKinsey & Company estimated that machine learning could help US health insurance companies reduce fraud, waste, and abuse by $20-30 billion.  Indeed, in 2018 alone, improper payments accounted for roughly $31 billion of Medicare’s net costs. CMS is now looking to AI to prevent improper payments, rather than the current “pay and chase” approach to detection.

CMS currently relies on its records system to detect fraud. Currently, humans remain the predominant detectors of fraud in the CMS system. This has resulted in inefficient detection capabilities, and these traditional fraud detection approaches have been decreasingly successful in light of the changing health care landscape.  This problem is particularly prevalent as CMS transitions to value-based payment arrangements.  In a recent blog post, CMS Administrator, Seema Verma, revealed that reliance on humans to detect fraud resulted in reviews of less than one-percent of medical records associated with items and services billed to Medicare.  This lack of scale and speed arguably allows many improper payments to go undetected.

Fortunately, AI manufacturers and developers have been leveraging AI to detect fraud for some time in various industries. For example, the financial and insurance industries already leverage AI to detect fraudulent patterns. However, leveraging AI technology involves more than simply obtaining the technology. Before AI can be used for fraud detection, the time-consuming process of amassing large quantities of high quality, interoperable data must occur. Further, AI algorithms need to be optimized through iterative human quality reviews. Finally, testing the accuracy of the trained AI is crucial before it can be relied upon in a production system.

In the RFI, CMS poses many questions to AI vendors, healthcare providers and suppliers that likely would be addressed by regulation.  Before the Federal government relies on AI to detect fraud, CMS must gain assurances that AI technologies will not return inaccurate or incorrect outputs that could negatively impact providers and patients. One key question raised involves how to assess the effectiveness of AI technology and how to measure and maintain its accuracy. The answer to this question should factor heavily into the risk calculation of CMS using AI in its fraud detection activities. Interestingly, companies seeking to automate revenue cycle management processes using AI have to grapple with the same concerns.  Without adequate compliance mechanisms in place around the development, implementation and use of AI tools for these purposes, companies could be subject to high risk of legal liability under Federal False Claims Act or similar fraud and abuse laws and regulations.

In addition to fraud detection, the RFI is seeking advice as to whether new technology could help CMS identify “potentially problematic affiliations” in terms of business ownership and registration.  Similarly, CMS is interested to gain feedback on whether AI and machine learning could speed up current expensive and time-consuming Medicare claim review processes and Medicare Advantage audits.

It is likely that this RFI is one of many signals that AI will revolutionize how healthcare is covered and paid for moving forward.  We encourage you to weigh in on this on-going debate to help shape this new world.

Comments are due to CMS by November 20, 2019.


©2019 Epstein Becker & Green, P.C. All rights reserved.

For more CMS activities, see the National Law Review Health Law & Managed Care page.

Ubers of the Future will Monitor Your Vital Signs

Uber has announced that it is considering developing self-driving cars that monitor passengers’ vital signs by asking the passengers how they feel during the ride, in order to provide a stress-free and satisfying trip. This concept was outlined in a patent filed by the company in July 2019. Uber envisions passengers connecting their own health-monitoring devices (e.g., smart watches, activity trackers, heart monitors, etc.) to the vehicle to measure the passenger’s reactions. The vehicle would then synthesize the information, along with other measurements that are taken by the car itself (e.g., thermometers, vehicle speed sensors, driving logs, infrared cameras, microphones, etc.). This type of biometric monitoring could potentially allow the vehicle to assess whether it might be going too fast, getting too close to another vehicle on the road, or applying the brakes too hard.  The goal is to use artificial intelligence to create a more ‘satisfying’ experience for the riders in the autonomous vehicle.

This proposed technology presents yet another way that ride-sharing companies such as Uber can collect more data from their passengers. Of course, passengers would have the choice about whether to use this feature, but this is another consideration for passengers in this data-driven industry.


Copyright © 2019 Robinson & Cole LLP. All rights reserved.

For more about self-driving cars, see the National Law Review Communications, Media & Internet law page.

Mississippi Sued Over Plant-Based, Cell-Based, and Insect-Based Meat Labeling Law

Like countless other states, earlier this year, Mississippi passed SB 2922, which stipulates that cell-based, plant-based, or insect-based foods cannot be labeled as “meat” or “a meat food product” (e.g., “hamburgers,” “hot dogs,” “sausages,” “jerky”, etc.). Specifically, SB 2922 amended Section 75-35-15(4) of the Mississippi Code to state “[a] food product that contains cultured animal tissue produced from animal cell cultures outside of the organism from which it is derived shall not be labeled as meat or a meat food product. A plant-based or insect-based food product shall not be labeled as meat or a meat food-product.” Such products still run afoul of the law even if the labels include claims like “100% vegan,” “plant-based,” or “meatless.”

SB 2922 came into effect on July 1, 2019. On that same day, vegan “meat” producer, Upton’s Naturals Co. and the Plant Based Foods Association (PBFA) filed suit in federal court against Mississippi’s Governor and Commissioner of the Department of Agriculture and Commerce arguing that the label restrictions violate their First Amendment right to free speech, among other claims. Upton’s and PBFA are seeking a declaratory judgment that SB 2922 violates the First and Fourteenth Amendments to the U.S. Constitution, a preliminary injunction prohibiting enforcement of SB 2922 throughout the duration of the litigation, a permanent injunction, and an award of nominal damages in the amount of $1.00.

Mississippi’s Department of Agriculture and Commerce, along with the state’s cattle and poultry associations, supported the state law. Indeed, in response to the lawsuit, the Department said it has a “duty and obligation to enforce the law” and that it wanted to ensure the consumer has “clear information on the meat and non-meat products they purchase.” However, supporters of the lawsuit, like the Good Food Institute, argued that “Mississippi is acting as word police” and that the law is a “slippery slope” that could open the door to restrictive labeling.

© 2019 Keller and Heckman LLP
For more on food regulation & labeling, see the National Law Review Biotech, Food & Drug law page.

Your Next Hamburger Could Be “Slaughter-Free”

In the face of an ever-increasing global population set to surpass 9 billion by 2050, agriculture and science have converged to create sustainable, innovative solutions to food production. Cellular agriculture is perhaps the most cutting edge of them all.

Producing meat, poultry and seafood through cellular agriculture promises to revolutionize the way we think about, grow and consume food. When rolled out to consumers in the coming years, these products are expected to have the same nutrition profile and organoleptic properties as their conventionally sourced counterparts.  Organoleptic properties refer to the sensory aspects of food, including taste, sight, smell, and touch.

What is Cellular Agriculture?

Cellular agriculture refers to the production of agricultural products from cell cultures. Through cellular agriculture, meat, poultry, and fish can be produced ex vivo, or grown outside the animal. The finished product – commonly referred to as cultured, clean or cell-based meat – replicates the characteristics of muscle harvested from food-producing animals.

How Are Cell-Cultured Foods Made?

The production process is quite complex and varies across producers. At a high level, there are four core elements to production: (1) cell cultures, (2) scaffolds, (3) media and (4) bioreactor (cultivator).

Cells are obtained from food-producing animals, healthy at the time of biopsy. The cells are subsequently separated and transferred in a sterile environment and placed in a bioreactor also referred to as a cultivator. Once placed in the cultivator, the cell cultures are fed nutrients referred to as media. Media is a mixture of ingredients that works as a food source for cell lines. The cultivator controls food supply inputs and temperature, the cells are continuously monitored, and once the meat is cultivated, meat tissues are harvested and stored under appropriate conditions. See Figure 1, below (P.D. Edelman, D.C. McFarland, V.A. Mironov, and J.G. Matheny. Tissue Engineering. May 2005).

Scaling Up Production

Product development efforts are well underway across the globe. In 2016, for example, San Francisco-based Memphis Meats unveiled the first meatball produced with clean meat technology. In late 2018, Aleph Farms debuted the very first cell-cultured steak. Significant investments from Tyson Foods’ venture capital arm Tyson Ventures, Cargill, Bill Gates and Richard Branson — among others — are driving innovation in the field and helping startups to reduce costs and scale up production.

Cell-based meat could hit supermarket shelves within the next 5 years. Before that happens, stakeholders must confront a number of questions. Among those – Who will be the key regulators? How will the regulators work to ensure product safety? And will consumers actually want to eat hamburgers, chicken nuggets and fish fillets produced in such a novel way and perhaps pay a premium to do so?

The Regulatory Conversation

Cellular agriculture came to life in 2018 – from Capitol Hill to the halls of the FDA and USDA. Given the novelty of the production process, the regulators engaged stakeholders to think through an appropriate regulatory pathway for meat, poultry and seafood produced from cell cultures.

A recently issued Memorandum of Understanding (March 7, 2019) outlines the U.S. government’s current thinking regarding a proposed pathway for cell-based meat and poultry. The MOU provides that the FDA and USDA will jointly regulate human food produced using cell culture technology derived from cell lines of USDA-amenable species. In other words, cell-based meat and poultry will be subject to joint FDA-USDA oversight. Seafood products will generally be subject to FDA oversight (except in limited instances where the species is considered to be USDA-amenable, e.g., catfish). This builds on existing precedent as current American food law places the production and processing of meat and poultry under USDA jurisdiction. FDA regulates regulates all seafood except for Siluriformes (catfish) which fall under USDA oversight.

So what will joint regulation look like? The MOU indicates that the FDA will oversee cell collection, cell banks, and cell growth and differentiation. Oversight then shifts to the USDA during the cell harvest stage. USDA’s core tasks will be inspection and labeling. Upon harvest, USDA will conduct inspection activities at cell-based food processing facilities. This means that any establishment engaged in the business of processing harvested USDA-amenable, cell-based foods will need to obtain a federal grant of inspection from the USDA and all such foods will need to bear a USDA mark of inspection.

Many critical questions core to developing a functioning regulatory review process remain to be answered: How will the FDA and USDA initiate their respective application processes, how long will it take to obtain premarket approval, and what will inspections of production facilities look like? Further, how should these products be labeled? The devil will be in the details.

Regulators are currently reviewing comments submitted to the FDA and USDA following two public meetings: (1) An FDA meeting held on July 12, 2018 focused on safety considerations and (2) A joint FDA-USDA meeting held on October 23 and 24, 2018 focused on potential hazards and labeling.

Safety Considerations & Potential Hazards

Regulators are focused on working with stakeholders to:

  • Consider and develop appropriate controls for potential hazards that may arise during all stages of production, i.e., culturing and harvesting, processing, and packaging.
  • Understand the safety profile of the cell culture media used to produce cell-based foods.
  • Leverage best practices from the traditional meat, poultry and seafood production context, as well as the biomedical arena as appropriate, to ensure that meat and poultry produced by way of cellular agriculture are safe and wholesome.
  • Consider how these products will compare to traditionally produced meat and poultry from a compositional, nutritional and organoleptic standpoint.

Based on our conversations with cell-based meat producers, it is clear that in many cases the production process for cell-based foods will likely not be vertically integrated. That is, each step in the production process could be an end point — i.e., the collection, characterization and qualification of cell-lines could be conducted by Company A; Company B could then grow the meat in a cultivator (bioreactor) with media supplied by Company C; Company D could, in turn, market the meat once harvested at Company B. Hazards could conceivably emerge at each step, and especially during the transportation phase. Thus, regulators and producers will need to consider those transitions and outline where hazard control responsibilities begin and end and how best the FDA and/or USDA should go about verifying compliance.

Labeling

As of this writing, no set nomenclature has been settled upon for meat, poultry or seafood produced through cellular agriculture.

The labeling of cell-based meat and poultry is a hot button issue that came to the forefront in February 2018. That month, the United States Cattlemen’s Association (USCA) filed a petition with USDA’s Food Safety and Inspection Service (FSIS) requesting that USDA undertake rule-making on beef labeling to clarify the difference between beef derived from cattle and “beef” products created through cell culture technology. To date, the USDA has received over 6,100 comments on this petition.

Cell-based meat and conventional agriculture stakeholders have expressed a range of views. Among conventional animal agriculture interests, some contend that terms such as “meat” and “beef” should not be used to describe products produced through cellular agriculture. Others have expressed some openness to using “meaty” terms provided that the labeling clearly indicates how the product was produced. In this regard, some commenters called for the establishment of standards of identity for cell-cultured foods to distinguish them from their conventionally produced counterparts.

At a recent industry meeting and in recent industry trade press, USDA has indicated that the Agency is strongly considering proposing such standards of identity within the next 12 months.

© 2019 Foley & Lardner LLP
Learn more about food production on the National Law Review Biotech, Food and Drug page.

CBD Risk Management

Advising companies on CBD (cannabidiol) risk management is made challenging by the rapid pace of developments and frequent confusion caused by often false or misleading online information. This article attempts to provide a concise analysis of critical CBD legal and risk management issues.

Do Not Conflate “Legality” under the 2018 Farm Bill with U.S. Food and Drug Laws

The 2018 Farm Bill, which was signed in to law in December 2018, exempts hemp and hemp-derived products, including hemp-derived CBD, from the Controlled Substances Act (CSA). In the lead-up to passage of the Farm Bill, there was widespread confusion in the public as to the extent of the “legality” of hemp-derived CBD, with many commentators and even some legal experts conflating legality under the CSA with legality under the Food Drug and Cosmetics Act (FDCA) and state food and drug laws. This confusion prompted former FDA Commissioner Scott Gottlieb to issue a public statement clarifying that Congress had explicitly preserved the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FDCA, regardless of whether they are derived from cannabis or hemp. 

Identify How the CBD Product Will Be Defined under the FDCA

A product containing a cannabinoid could be considered a drug, food, food additive, dietary supplement or cosmetic depending on how the product is marketed and sold. How aggressively these products are policed by FDA and state agencies depends on the nature of the product and how it is defined under the FDCA and state law.

CBD as “Food” or “Dietary Supplement”

FDA’s position since at least 2015 is that certain cannabinoids, including CBD, are impermissible additives that adulterate food and dietary supplements for both humans and animals. Under the FDCA’s drug exclusion rule, once a substance that was never previously in the food supply is (1) an active ingredient of an approved drug product or (2) an active ingredient of a product in clinical trials that have been made public, a food or supplement containing that substance cannot be shipped in interstate commerce. FDA has cited Epidiolex® as an example of a clinical investigation regarding CBD that has been made public. Epidiolex was approved by FDA in June 2018 for treatment of childhood seizures associated with two rare forms of epilepsy. FDA has therefore concluded that CBD products are in fact drugs and require FDA approval under the FDCA. The new drug-approval process is exorbitantly expensive; in 2016, the Journal of Health Economics estimated the average cost per approved drug at well over $1 billion.

CBD as a “Cosmetic”

Cosmetics are generally less heavily regulated by FDA than food or drugs, and until recently the agency has remained silent on the use of CBD in cosmetic products. On April 2, 2019, FDA provided much-needed insight, stating that although certain cosmetic ingredients are prohibited or restricted by regulation, “currently that is not the case for any cannabis or cannabis-derived ingredients.” However, FDA warned that no ingredient − including cannabis-derived ingredients – can be used in a cosmetic if “it causes the product to be adulterated or misbranded.” A cosmetic may be considered adulterated “if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling.” FDA cautions that a product may be considered both a cosmetic and a drug, even if it affects the appearance, if it is “intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease.”

Several large national retailers, including CVS, Walgreens and Rite-Aid, recently announced they will begin selling CBD-infused cosmetics in certain stores.

FDA Currently Uses “Enforcement Discretion”

Other than issuing letters to companies that sell CBD-infused oils and food products warning them to refrain from making impermissible health claims, FDA has to date taken no other visible enforcement action in that regard. Former FDA Commissioner Scott Gottlieb recently testified before a Senate appropriations subcommittee that “we are using enforcement discretion right now,” and that “I will take enforcement action against CBD products that are on the market if manufacturers are making what I consider over the line claims.” This would certainly include the egregious health claims at issue in the recent warning letters, such as that CBD can cure cancer or prevent Alzheimer’s disease. Gottlieb nevertheless acknowledged that FDA has not taken action against numerous products on the market given its enforcement priorities and limited resources. He cautioned, however, that FDA’s lack of enforcement is “not an invitation for people to continue marketing these products.”

State Enforcement of CBD

Authorities in several states have stepped up enforcement actions, including unannounced inspections and CBD product embargos ordered by authorities in California, New York, Texas and other states. Several states and cities, including California, Maine, North Carolina, Ohio and New York City, have banned CBD-infused food products under state and local laws.

Notwithstanding this state-led crackdown, certain states are working to provide greater legal access to CBD products under state law. Lawmakers in California and Texas, for example, are working on bipartisan legislation to allow sales of CBD products in those states, notwithstanding FDA’s prohibition.

CBD’s Pathway to Legality

As a result of significant pressure by industry groups and members of Congress, FDA has signaled a willingness to consider a potential easing of restrictions on CBD. On April 2, 2019, FDA issued a press release that announced new steps for advancing the potential regulatory pathways for CBD products. The press release explains that FDA primarily is concerned that permitting widespread commercial availability of CBD products negatively impacts research that may otherwise be performed to support regulatory approval through FDA’s drug review process. Similarly, FDA does not want to incentivize patients to forgo appropriate medical treatment by substituting unapproved products for FDA-approved medicines. Also of concern is the potential for liver injury and cumulative exposure to CBD if accessed by consumers across a range of products.

Notwithstanding the intense pressure on FDA to fast-track the CBD approval process, without congressional action that exempts CBD from FDA’s regular rulemaking process, it is likely that the approval process for use of CBD in foods or supplements will take years. In Gottlieb’s recent Senate testimony, he explained that “we don’t have a clear route to allow [CBD] to be lawfully marketed short of promulgating new regulations.” He noted, however, that there is precedent for Congress to issue legislation in the context of a single ingredient, similar to prior legislation for human growth hormone. Gottlieb also has appeared to embrace the idea of legislation that classifies CBD according to defined concentration levels, whereby CBD would be classified as a dietary supplement up to a defined concentration threshold, above which it would be considered a pharmaceutical drug. This is similar to the way fish oil has been regulated.

A public hearing scheduled to take place on May 31, 2019, will cover a range of CBD-related topics, including (1) health and safety, (2) manufacturing and product quality and (3) marketing/labeling/sales. FDA is encouraging public comments and participation at the hearing.

Acting FDA Commissioner Ned Sharpless is now leading the agency. Some have expressed concern over how Sharpless will approach CBD because he is a former cancer drug researcher who has less experience with the dietary supplement and food regulation side of FDA’s mandate. According to a recent interview with former associate FDA Commissioner Peter Pitts, Sharpless is expected to manage the process already in place with respect to CBD for the time being.  How much attention Sharpless will give to CBD issues in the future “depends on the priorities and the new commissioner’s stomach for battle.”

CBD Risk Management … in the Meantime

Until the legal pathway for CBD is clear, companies that market most CBD products must tread carefully. Some, such as the large national retailers that recently announced the sale of CBD products, are focused on safer cosmetic products. Others choose to market and sell CBD-infused foods and supplements based on a higher appetite for risk and a “safety in numbers” assessment in the face of no visible FDA enforcement.

No matter how a company chooses to participate in the CBD industry, it must be counseled on FDA regulatory risk based on the product type in addition to the risks of marketing and selling CBD products on a state-by-state basis. Because the legality of CBD products varies widely by state and is changing so rapidly, providing accurate counsel can be a challenge. In addition, CBD product labels must be carefully reviewed for compliance under both federal and state law. Some states have specific and onerous labeling requirements for CBD products.

Although many companies tend to downplay the risk and potential financial severity of regulatory enforcement by federal or state agencies when it comes to CBD, they ignore at their own peril the risk presented by potential civil tort exposure. CBD products may be considered adulterated, contaminated or mislabeled under federal and state law. This may give rise to financially ruinous lawsuits, including consumer class actions or competitor suits that allege false advertising or unfair competition under state consumer protection statutes. It is essential for every CBD company to have a solid grasp of both the CBD regulatory risks and the unfair competition laws to fairly compete in the new CBD marketplace, and to avoid unwittingly being named as a defendant in an expensive and potentially company-ending lawsuit.

To this end, it also is important for any company that markets and sells CBD products to conduct an insurance coverage review with an attorney and broker that understand the nuances of the CBD insurance market. With passage of the 2018 Farm Bill, insurance coverage for hemp-derived products, including CBD, is expanding rapidly. Problematic endorsements and exclusions remain, however, with respect to limitations on coverage as a result of regulatory penalties, product seizures, resulting business interruption and tort damages premised on violations of law.

Most importantly, CBD risk management requires constant education and vigilance to stay abreast of an area of the law changing more rapidly than any other in recent history.

 

© 2019 Wilson Elser
This post was written by Ian A. Stewart of Wilson Elser. 
Read more on marijuana and CBD policy on the National Law Review’s Biotech page.