Category: Health

Can an Employer Implement a Nicotine-Free Hiring Policy?— It Depends on State Law (US)

Nicotine products are highly addictive and have been linked to a variety of serious health issues, including lung cancer and other respiratory illnesses.  In addition to the numerous health risks associated with nicotine use, there is also a causal connection between employee nicotine use and lower productivity in the workplace, as well as higher healthcare costs for employers.  In response to these issues, and in an effort to promote and empower a healthy workforce, more employers are enacting health-conscious workplace policies and anti-smoking/vaping initiatives.

In fact, over the last decade, employers—particularly hospitals and businesses in the medical field—have adopted anti-smoking/vaping policies in those states in which it is lawful to do so, with the goal of encouraging a more healthy work environment, as well as to increase worker productivity and reduce healthcare costs.  As the health risks associated with nicotine use become increasingly apparent (particularly with the recent wave of vaping-related illnesses), it is likely that more employers will consider their policies toward these important health issues. For example, on December 30, 2019, U-Haul International announced a new nicotine-free hiring policy that will go into effect in 21 states on February 1, 2020.  Although U-Haul subsidiaries operate in all 50 US states and 10 Canadian provinces, due to legal restrictions in some jurisdictions, the policy will be implemented only in the following 21 US states: Alabama, Alaska, Arizona, Arkansas, Delaware, Florida, Georgia, Hawaii, Idaho, Iowa, Kansas, Maryland, Massachusetts, Michigan, Nebraska, Pennsylvania, Texas, Utah, Vermont, Virginia, and Washington.  Prospective employees in those states will see statements regarding the nicotine-free hiring policy on application materials and will be questioned about nicotine use. Further, to be considered for employment in states where nicotine testing is allowed, applicants will be required to consent to submit to nicotine screening in the future.  U-Haul employees hired prior to February 1, 2020 will not be affected by the new policy.

U-Haul will be the first major company in its field to refuse to hire applicants who are nicotine users, and the new policy has caused some to question whether companies which, like U-Haul, are deeply invested in the well-being of their employees, are allowed to enact such policies.  The answer to that question depends on the jurisdiction in which the company operates.  Nicotine users are not a “protected class” under any federal anti-discrimination law, and thus state law governs this issue.  In each of the 21 states in which U-Haul companies will implement its policy, there are no laws that protect the rights of nicotine-users or prohibit employers from declining to hire applicants due to their engaging in otherwise lawful conduct outside the workplace.  Therefore, a policy refusing to hire nicotine users is perfectly legal in those jurisdictions, and employers in those states are free to enact nicotine-free hiring policies if they so choose.

However, employers who are considering implementing such nicotine-free hiring policies should tread carefully.  The rest of the 29 states where U-Haul subsidiaries are not implementing its policy (and the District of Columbia) have various anti-discrimination or employee privacy laws preventing employers from enacting such policies.  These states provide varying degrees of protection to employees.  For example, some states broadly forbid employers from discriminating against applicants or employees based on the use of “lawful products” or for “lawful conduct,” whereas other state laws specifically protect an applicant’s or employee’s right to smoke or use other tobacco products.  Although these states are generally more employee-friendly in this context, in some of these jurisdictions, employers can require smokers to pay higher health insurance premiums, so long as the additional amount reflects the actual differential cost to the employer.  Further, employers can still regulate and limit an employee’s on-site smoking, and can typically offer financial incentives for employees who participate in wellness programs to help them quit smoking.

Given the state-specific nuances associated with this issue, employers thinking about implementing a nicotine-free hiring policy should consult with an attorney before implementing such a policy to ensure it may lawfully do so.

© Copyright 2020 Squire Patton Boggs (US) LLP

For more on employers’ healthy-workplace initiatives, see the National Law Review Labor & Employment law section.

Health Law Section Report – September-December 2019

  • On September 16, 2019, at 51 N.J.R. 1462(a), the Department of Human Services, Division of Medical Assistance and Health Services, published an adoption of a correction to an error in the text of the definition of “nurse delegation” in the definitions set forth in N.J.A.C. 10:60-1.2. During the comment period, Disability Rights New Jersey (DRNJ) submitted a comment pertaining to the definition of nurse delegation. As part of the comment, DRNJ requested DMAHS to add “pursuant to N.J.A.C. 13:37-6.2” after “selected nursing tasks” to clarify what selected nursing tasks referred to (see Comment 16). DMAHS agreed to the change; however, in making the addition upon adoption, DMAHS inadvertently added the cross-reference as “N.J.A.C. 10:37-6.2.” The adoption corrects the error and inputs pursuant to N.J.A.C. 13:37-6.2.
  • On October 7, 2019, at 51 N.J.R. 1493(a), the Department of Human Services, Division of Medical Assistance and Health Services, published a rule proposal for a new chapter, N.J.A.C. 10:52B, to implement The County Option Hospital Fee Pilot Program. The purpose of the pilot program is to increase financial resources through the Medicaid/NJ FamilyCare program to support local hospitals in providing necessary services to low-income residents. The pilot program shall be in effect for a period of five years from April 30, 2019 and will end on April 30, 2024.
  • On October 7, 2019, at 51 N.J.R 1514(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners, adopted an amendment to the athletic trainer continuing legal education requirement at N.J.A.C. 13:35-10.21, to require one credit in topics concerning prescription opioid drugs, including the risks and signs of opioid abuse, addiction, and diversion, commencing with the biennial renewal period beginning on February 1, 2019.
  • On October 7, 2019, at 51 N.J.R 1546(a), the Commissioner of the Department of Health published a notice of petition for rulemaking submitted by the New Jersey Hospital Association to make certain amendments to N.J.A.C. 8:43G Hospital Licensing Standards, Subchapter 14 Infection Control, N.J.A.C. 8:43G-14.9, Sepsis protocols, as recommended by CMS and the Surviving Sepsis Campaign, known as Sepsis-1.
  • On October 21, 2019 at 51 N.J.R. 1568(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Physical Therapy Examiners, published a proposal to amend rules for supervision of licensed physical therapy assistants to clarify the record keeping regulations (N.J.A.C. 13:39A-7.2 and 7.3) in a manner that in the event patient records are maintained on computer recordkeeping systems that do not permit a supervising licensed physical therapist to sign a licensed physical therapist assistant’s notes, the supervising licensed physical therapist will be able to enter a separate note in the record indicating that he or she reviewed the licensed physical therapist assistant’s notes or the plan of care with the physical therapist assistant. This is meant to avoid a de facto dual signature requirement.
  • On November 4, 2019 at 51 N.J.R. 1597(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners proposed amendments to its existing rules concerning graduate medical education programs in order to update the eligibility requirements for graduates of international medical schools who seek licensure or authorization to engage in the practice of medicine as residents. The proposed amendments would replace outdated restrictions on graduates of international medical schools pursuing licensure or authorization in New Jersey and allow the Board to rely on recognized accrediting bodies for international medical schools that adhere to standards substantially similar to the bodies that accredit domestic medical schools. By expanding eligibility, the proposed amendments may positively affect the supply of physicians practicing in the State. The proposal seeks to amend N.J.A.C. 13:35-1.5, 3.11, and 3.11A.
  • On November 4, 2019 at 51 N.J.R. 1600(a) the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee (Committee) proposes new rules to effectuate the provisions of the telemedicine and telehealth statute for licensed audiologists and/or speech-language pathologists. The proposed new rules would be codified at N.J.A.C. 13:44C-11.
  • On November 18, 2019, at 51 N.J.R. 1638(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Dentistry, proposed amendments, repeals, and new rules to: 1) implement new laws; 2) update rules, terminology, citations, website addresses, and the names of the licensure examinations; and 3) clarify and codify current standards of practice and licensure and registration requirements. The rulemaking reflects updates related to statutory changes, additions to enhance the safety of patients receiving dental services and those working in the profession, and identifies continuing education courses that must be completed in each renewal period. In response to adverse incident reports and news articles from across the country, the Board is proposing amendments to the sedation rules to enhance the safety of patients receiving dental services. Because the Board is seeing incidents of trained individuals achieving a deeper level of sedation than intended, the Board wants to provide more guidance to the regulated community as to what is expected so as to enhance patient safety. See N.J.A.C. 13:30. Comments due January 17, 2020.
  • On November 18, 2019, at 51 N.J.R. 1664(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Acupuncture Examining Board (Board) proposed to amend N.J.A.C. 13:35-9.20 to require licensed acupuncturists to hold current certification in cardiopulmonary resuscitation (CPR), first aid, and the use of an automated external defibrillator (AED) as part of continuing education required to renew licensure. The certification must be from the American Heart Association, or a substantially similar course approved by the American Red Cross, National Safety Council, Coyne First Aid, Inc., American Safety and Health Institute, EMP International Inc., or EMS Safety Services Inc. In recognition of the hours required to obtain the certification, the Board proposes to reduce the number of required continuing education hours from 30 to 26. The Board is changing the total credits that could be obtained by certain methods to reflect that half of the total required hours will be 13 rather than 15. The Board also proposes to allow licensees who complete more than the continuing education hours required to renew licensure to apply those additional hours to the immediately succeeding biennial license renewal period. See N.J.A.C. 13:35-9.20.
  • On November 18, 2019, at 51 N.J.R. 1666(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Massage and Bodywork Therapy proposed amendments that would require applicants for licensure and licensed massage and bodywork therapists to physically attend CPR, first aid, and use of an automated external defibrillator (AED) courses, would require licensed massage and bodywork therapists to complete continuing education in laws and rules pertinent to the practice of massage and bodywork therapy, and would end recognition of continuing education courses provided by schools, colleges, or universities. See N.J.A.C. 13:37A-2.1, 2.2, 2.3, 4.1, and 4.2.
  • On November 18, 2019, at 51 N.J.R. 1674(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board Of Marriage And Family Therapy Examiners, Art Therapists Advisory Committee adopted new rules at N.J.A.C. 13:34D requiring licensure of art therapists and providing rules governing licensed art therapists. The new rules require licensed art therapists to preserve the confidentiality of information obtained from a client in the course of professional treatment unless disclosure is required by Federal law and requires an art therapist whose client has explicitly waived the art therapist-client confidentiality privilege to release client information to a third-party payor whose benefit plan is qualified under the Federal Employee Retirement Income Security Act (ERISA). In addition, the new regulations provide that failure to comply with Federal laws related to the practice of art therapy will be deemed professional misconduct. See N.J.A.C. 13:34D.
  • On November 18, 2019, 51 N.J.R. 1688(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Massage and Bodywork Therapy readopted rules with amendments, adopted repeals and new rules regarding licensure, reinstatement and reporting of misconduct, record keeping and business registration. See N.J.A.C. 3:37A.
  • On November 18, 2019, 51 N.J.R. 1691(a), the Department of Law and Public Safety, Division of Consumer Affairs, Orthotics and Prosthetics Board adopted a new rule regarding the abandonment of license applications due to incomplete information on the application or a one year lapse in submission of information requested by the Board. See N.J.A.C. 13:44H-3.5A.
  • On November 18, 2019, 51 N.J.R. 1691(b), the Department of Law and Public Safety, Division of Consumer Affairs, Orthotics and Prosthetics Board adopted a new rule to implement the telemedicine statute and to permit the use of telemedicine and telehealth by licensed orthotist, orthotist assistant, pedorthist, prosthetist, prosthetist assistant, prosthetist-orthotist, or prosthetist-orthotist assistant. See N.J.A.C. 13:44H-11.
  • On December 2, 2019, at 51 N.J.R. 1761(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board Of Marriage And Family Therapy Examiners, Alcohol & Drug Counselor Committee adopted amendments to the rules regarding who may provide clinical supervision to interns and counselors. See N.J.A.C. 13:34C-6.2, 6.2A, and 6.3.
  • On December 2, 2019, at 51 N.J.R. 1806(a), the Commissioner of the Department of Health published a notice of action on rulemaking by announcing that more time is required for deliberating on the adoption of new sepsis protocols for hospitals, as proposed on October 7, 2019 at 51 N.J.R 1546(a).
  • On December 16, 2019, at 51 N.J.R. 1841(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners proposed an amendment and new rule recognizing the provisions of the Compact privileges that would require physical therapists and physical therapist assistants working in New Jersey, under Compact privileges, to comply with Board rules, except for those governing credentialing of applicants, license renewal, and continuing education. The proposed amendment and new rule require those seeking to work in New Jersey, pursuant to Compact privileges, to pass the State jurisprudence examination and to pay the Compact privilege fee ($40).
  • On December 16, 2019, at 51 N.J.R. 1849(ab), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments to the rules regarding continuing medical education that would permit up to 10 hours volunteer medical service to uninsured low income patients to count towards the required CME requirement. See N.J.A.C. 13:35-6.15.

© 2020 Giordano, Halleran & Ciesla, P.C. All Rights Reserved

For more health care developments in New Jersey and other states, see the National Law Review Health Law & Managed Care section.

 

Five Suggestions for Elder Care If You or Your Elderly Parents Have “One Foot on the Banana Peel”

Shana and I recently had a new client, “Jane,” that came to see us because she was concerned about her elderly parents. Both are in their 90s and although they are still living independently, she is noticing both a physical and cognitive decline in both.  She described them as having “one foot on the banana peel,” recognizing that they are one fall or illness away from no longer being able to maintain their current lifestyle.

As with many of our clients, they are resistant to making any changes and she is worried about what will happen. Jane lives a distance from her parents, works full time, and has her own teenage children. She came to us for assistance in understanding what she can do to help them. Here are five suggestions we made for her:

1. Changes to Powers of Attorney and Health Care Proxy

Jane’s parents’ existing legal documents have each other as primary agents and neither is able to act in that capacity. Jane is handling their bill paying and taking them to MD appointments and it will be easier for her to continue this role with the appropriate legal documents naming her as the primary agent.

2. Financial Planning

Jane’s parents have limited liquid assets and own their home. Their monthly income does not cover their expenses, so they are drawing from those assets every month. This plan will not work long term if either needs to hire a caregiver to help them at home due to the high cost. We helped Jane to understand the realities of paying for care and the limited coverage of Medicare. We also explained the criteria for Medicaid eligibility, the application process and the problem with using Medicaid to pay for home care. We stressed the importance of Jane and her parents exploring alternative living situations that may better meet their needs while they still had funds and ensuring that they found a facility that would allow them to spend down to Medicaid when their funds are exhausted.

3. Home Evaluation

Jane’s parents live in a bi-level home with stairs to enter and Jane is very concerned about their safety. We recommended a home evaluation to determine what modifications can be done to the home to make it safer. These modifications can be simple such as a tub bench, so they don’t have to step over the tub to get into the shower or more complex such as a stairlift or emergency alert system.

4. Medication Management

Jane’s parents have multiple medical conditions and each takes many medications. They often forget to take their medications or take them incorrectly. This is a very serious issue and often leads to unnecessary hospitalization which can precipitate a downward spiral. We discussed a variety of options, including a visiting nurse and an automatic medication dispenser.

5. Take a Deep Breath

As with all our clients, Jane loves her parents and wants what is best for them. However, her vision of what is best for them doesn’t necessarily coincide with their vision. As a caregiver-child myself, I can very much relate to her frustration of having a clear idea of what will improve an elderly parent’s quality and/or quantity of life and having that parent refuse to make a change. Sometimes small changes are acceptable and they can make a difference and prolong stability. But very often the best we can do is to plan for the emergency and know we have done the best we can.

©2020, Norris McLaughlin & Marcus, P.A., All Rights Reserved

For more on caring for elderly relations, see the National Law Review Family Law, Divorce & Custody type-of-law section.

FDA Works to Find Source of Multi-State Outbreak of E. coli Infections

On November 20, the Centers for Disease Control and Prevention (CDC), in conjunction with the Food and Drug Administration (FDA) and several state agencies, announced that it is currently investigating an outbreak of Shiga toxin-producing E. coli (STEC) O157:H7 infections that has so far impacted at least 17 people across 8 states. The first reported illnesses date back to September 24, 2019. Investigators are looking into a branded chicken Caesar salad as a potential source, after the Maryland Department of Health (MDH) identified E. coli O157 in an unopened package. However, MDH is still conducting a whole genome sequencing (WGS) analysis to determine if it is closely related genetically to the E. coli identified in this outbreak.

As previously reported on this blog, in January 2019, FDA’s Food Safety and Inspection Service (FSIS) transitioned to using only WGS for Shiga toxin-producing E. coli (STEC) in an effort to update its analytical methods to the state of the art. The method of WGS determines the order of all of the DNA building blocks (nucleotides) in an organism’s entire genome in a single laboratory process, and a comparison of the DNA sequence of an isolated bacterial pathogen to the sequences from other samples in a DNA database can pinpoint the source of a foodborne disease outbreak.

The recent outbreak follows a similar outbreak of E. coli 0157:H7 from 2018 that was ultimately traced to romaine lettuce. The 2018 outbreak included 62 cases from 16 states and the District of Columbia, and prompted FDA to issue recommendations for leafy greens growing operations as well as a partnership between FDA and leafy greens stakeholders in Arizona to enhance food safety. Subsequent research from the U.S. Department of Agriculture’s Agricultural Marketing Service found that pest flies were a potential vector in the spread of the E. coli O157:H7 and contamination of leafy greens.

© 2019 Keller and Heckman LLP

For more in food safety, see the National Law Review Biotech, Food & Drug law page.

PTSD Compensation for First Responders without Associated Physical Injury Revisited by Ohio Legislature in New House Bill

With the recent proliferation of mass shootings and other deadly incidents, several states have taken on the issue of allowing mental and/or emotional impairments caused by post-traumatic stress disorder (PTSD) to be a compensable workers’ compensation condition for first responders without the requirement of a physical injury.

In June 2019, House Bill 80, the budget bill for the Ohio Bureau of Workers’ Compensation, included such a proposal. After the bill passed the House, the Senate stripped the policy provisions on the mental-only diagnosis issue out of the proposed budget. Senate leaders indicated while there may be a reason for a special circumstance, it should be studied and debated separately from the workers’ compensation budget. In July 2019, leadership vowed to consider the legislation later in the year.

True to their word, the issue was revived in September 2019 by Representative Thomas Patton. House Bill 308 reintroduced the issue of PTSD coverage for first responders exposed to traumatic events in the course and scope of their employment. Two hearings on the bill have already occurred, most recently on Oct. 22, 2019. Proponent testimony was offered by several organizations and individuals. The statements reiterated concerns first responders are not able to pursue avenues for compensation under the law set forth by the Supreme Court of Ohio in Armstrong v. John R. Jurgensen Co. Interestingly, one of the organizations offering proponent testimony was the Ohio State Medical Association.

The business community remains opposed to any legislation that would allow for a “mental-mental” avenue for claimants. Rob Brundrett, director of public policy for the Ohio Manufacturers Association, provided testimony on House Bill 80 earlier this summer. Beyond merely the increased cost to employers, if a mental-only diagnosis were allowed, Mr. Brundrett noted the potential expansion of workers’ compensation beyond first responders could be required.

“If we erode the physical-injury requirement for peace offers, firefighters, and emergency medical workers, it may be difficult to justify not doing the same for other professionals who seek equal treatment,” Mr. Brundrett said in his testimony.

How such a proposal would be funded is also a concern of employers. Mr. Brundrett, who is closely following House Bill 308, has indicated that several discussions in the Senate have occurred in recent weeks on a potential bill that would provide PTSD coverage for first responders outside of the Bureau of Workers’ Compensation system. This proposal would, of course, be the preference of the business community.

While passage of this issue in the past has been unsuccessful, the August 2019 mass shooting in Dayton and its impact on first responders may result in this bill moving through the legislature. Dinsmore’s workers’ compensation group will continue to monitor this bill, as its passage would have a profound impact on employers.

If you wish to see the proponent testimony and follow the bill, you can obtain more information here.

© 2019 Dinsmore & Shohl LLP. All rights reserved.

For more on mental health, see the National Law Review Health Law & Managed Care page.

FDA Toughens Enforcement of Homeopathic Products

FDA recently announced that it was taking two significant actions with respect to products marketed as homeopathic drugs, suggesting that increased enforcement related to these products is imminent. Homeopathy is a form of alternative medicine that is based on the idea that illnesses and their symptoms can be treated by small doses of ingredients that produce similar symptoms in healthy people.

First, the Agency has withdrawn Compliance Policy Guide (CPG) Sec. 400.400, entitled “Conditions Under Which Homeopathic Drugs May be Marketed.” The CPG was issued in 1988 and described an enforcement policy that permitted unapproved homeopathic drugs to be marketed if certain conditions related to labeling, ingredients, manufacturing, and other considerations were met. In withdrawing the CPG, the Agency observed that products that seemed to meet the criteria described in the CPG nonetheless caused or could have caused serious harm.

Second, the Agency has revised its draft guidance entitled “Drug Products Labeled as Homeopathic.” The revised draft guidance describes enforcement priorities for homeopathic drugs marketed without required approval. According to the revised draft guidance, these priorities include:

•Products with reports of injury that, after evaluation, raise potential safety concerns.  For example, MedWatch reports on other information submitted to the Agency can indicate or signal a potential association between the product and an adverse event, medication errors, or other safety issues.

•Products that contain or purport to contain ingredients associated with potentially significant safety concerns. For example, potentially significant safety concerns are raised by products that contain or purport to contain:

– An infectious agent with the potential to be pathogenic;

– A controlled substance, as defined in the Controlled Substances Act, 21 U.S.C. 812;

– Multiple ingredients that, when used in combination, could result in possible interactions, synergistic effects, or additive effects of the various ingredients; and,

– Ingredients that pose a risk of toxic, or other adverse effects, particularly when the ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C), or are not adequately controlled in the manufacturing process.

  • Products for routes of administration other than oral and topical. . . .
  • Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases or conditions. . . .
  • Products for vulnerable populations. . . .
  • Products with significant quality issues. . . .

The revised draft guidance stresses that “nothing in the FD&C Act exempts homeopathic drug products from any of the requirements related to approval, adulteration, or misbranding, including labeling requirements.” It further emphasizes that “any homeopathic drug product that is being marketed illegally is subject to FDA enforcement at any time.”

©2019 Greenberg Traurig, LLP. All rights reserved.

For more FDA regulations, see the National Law Review Biotech, Food & Drug law page.

Cannabis Coming to the Northeast? Governors of NY, NJ, CT and PA Adopt “Core Principles” to Implement Adult-Use Legislation.

On October 17, 2019, Governor Cuomo of New York, Governor Lamont of Connecticut, Governor Murphy of New Jersey and Governor Wolf of Pennsylvania co-hosted the first Cannabis Regulation and Vaping Summit to create a set of uniform principles each state can implement through its adult-use legislation to standardize regulations across the region.

The summit resulted in an agreed-to set of core principles for rolling out adult-use legislation, including (1) market regulation and empowerment, (2) public health, (3) public safety and enforcement, and (4) vaping best practices. Also attending the summit were representatives from Rhode Island, Massachusetts and Colorado.

Market Regulation and Empowerment

When creating adult-use legislation and regulation, the states will implement agreed-to guidelines to set cannabis tax structures and to ensure that social justice initiatives are key components of the legislation. The guidelines discussed include:

  • Implementing social equity initiatives to ensure industry access to those disproportionately impacted by the war on drugs
  • Maintaining awareness of the need to ensure a fair and competitive market by deploying strategies such as limiting the number of licenses or license types
  • Implementing a similar overall tax structure for cannabis products between the four states
  • Providing guidance to open up banking to the industry
  • Implementing meaningful social justice reform such as expediting expungements or pardons and waiving associated fees.

Public Health

Concerned that decreasing production costs might lead to inexpensive high-potency products, the four governors agreed to standardized product safety and testing requirements and impose restrictive advertising requirements to ensure youth are not targeted. These principles include:

  • Prohibiting advertising and product forms that target minors
  • Restricting advertising to audiences that are for the most part over the age of 21
  • Banning adverting and products that appeal to youth, such as flavored cannabis products
  • Restricting cannabis sales to purchasers over the age of 21
  • Collecting and sharing cannabis use data to better understand public health outcomes
  • Limiting the cannabis possession amount and limiting the overall THC content of products to discourage over-consumption and accidental overdose.

Public Safety and Enforcement

To help ensure highway safety and improve options for testing cannabis impairment in the field, the states agreed to the following guidelines:

  • Uniform treatment of drug recognition expert evidence
  • Uniform standard for blood or saliva tests
  • Training for drug recognition experts
  • Methods for sharing information on suspected “bad actions” in legal markets
  • Law enforcement strategies to police the illicit market.

Vaping Best Practices

The states agreed to principles to regulate the entire vaping industry, including vapes containing nicotine, CBD and THC. Using the following guidelines, the states will share strategies and solutions for investigating illicit THC vape pens and regulating filler oils and carrier fluids:

  • Banning or regulating the sale of flavored vapes to reduce use among youth
  • Implementing vape product safety standards for nicotine and cannabinoids that include diluents, excipients and cutting agents
  • Regulating temperature control for vape heating mechanisms
  • Increasing enforcement actions to prevent sale to minors.

New York will aim to pass adult-use legislation during the 2020 legislative session, which begins in January. It is expected that Governor Cuomo will include a cannabis plan in his budget proposal, as he did last year.

© 2019 Wilson Elser

For more cannabis regulation, see the National Law Review Biotech, Food & Drug Law page.

FDA Recommends New Warnings for Breast Implants Alleged to Cause Cancer

On October 24, 2019, the United States Food and Drug Administration (“FDA”) issued a draft guidance addressing textured breast implants that have been linked to breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL”).”

Part of that guidance recommends a Black Box Warning, the most serious level of warning, in the device’s labeling to help ensure women receive and understand information regarding the serious risks of textured breast implants. Part of that warning should include:

  • breast implants are not lifetime devices;

  • the chances of developing complications increase the longer a patient has the implant, and additional surgery may be required to address the complications; and

  • breast implants have been associated with the risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and may be associated with systemic symptoms (like fatigue or joint pain).

Additionally, the draft guidance recommends that textured breast implant manufacturers include a patient decision checklist at the end of a patient informational booklet or brochure. A patient decision checklist gives patients the opportunity to acknowledge individual risks of textured breast implants and can be used to help guide discussion during a patient’s consultation with a surgeon. The proposed checklist specifically addresses the risk of BIA-ALCL.

Finally, the FDA confirmed that it is coordinating with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation, to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology, which collects data from patients with a confirmed diagnosis of BIA-ALCL. The FDA contends that this will contribute to a better understanding of textured breast implants and BIA-ALCL, as well as improve FDA communication updates to the public regarding textured breast implants and BIA-ALCL.

COPYRIGHT © 2019, STARK & STARK

For more FDA medical device regulation, see the National Law Review Products Liability law page.

Vaping Businesses Catch a Bad Rap: The Recent Ban of ALL Vaping Products in Massachusetts Unfairly Prejudices the Vape Industry and Vape Consumers

Massachusetts has taken a drastic and abrupt step by banning the sale of all vaping products, nicotine and THC, within its state borders for the next four months. This drastic and sweeping prohibition against vaping products will have far-reaching economic consequences for many small businesses that make up the bulk of this new and burgeoning industry. The root cause of the recent vaping-related illnesses appears to be the result of illicit and unregulated THC cartridges from the black market.

Reports and Causes

Dr. Michael Siegal, a professor at Boston University’s School of Public Health, recently stated: “Given the fact that close to 90% of the cases and 100% of the deaths for which products have been reported are associated with marijuana vaping, it is inexcusable that the CDC [Centers for Disease Control and Prevention] fails to distinguish between the products being vaped.” The communications from CDC also have failed to distinguish between vaping oil-based e-liquids − which were used in the illicit THC cartridges that have given rise to multiple arrests in Arizona and Wisconsin and cause lipoid pneumonia − and the water/alcohol-based e-liquids that are used in virtually all e-cigarettes. More troubling is the fact that the media largely has overlooked that the manufacturers of nicotine-containing e-liquids filed their ingredient lists with the FDA years ago.

On September 27, 2019, the CDC released the following information:

  • There are 805 lung injury cases reported from 46 states and 1 U.S. territory. Twelve deaths have been confirmed in 10 states.
  • CDC has received sex and age data on 771 patients.
    • About 69% of patients are male.
    • Nearly two thirds (62%) of patients are 18 to 34 years old; with 22% of patients between 18 and 21.
    • Sixteen percent of patients are under 18 years of age.
  • All reported patients have a history of e-cigarette product use or vaping.
  • The latest findings from the investigation into lung injuries associated with e-cigarette use or vaping suggest products containing THC play a role in the outbreak.
    • CDC has received data on substances used in e-cigarettes or vaping products in the 30 days prior to symptom onset among 514 patients:
      • About 77% reported using THC-containing products; 36% reported exclusive use of THC-containing products.
      • About 57% reported using nicotine-containing products; 16% reported exclusive use of nicotine-containing products.

While some policy makers appear to be confused over the cause of the recent reports of lung disease, there is no coincidence that the recent use of vitamin E acetate and possibly other unapproved thickening agents by the illicit THC manufacturers caused the public health crisis that prompted Massachusetts’s ban of all vapor products. One should ask whether it makes sense that vaping nicotine e-liquids, which have been available since at least 2007, would suddenly cause lipoid pneumonia lung disease (which is a rare condition that occurs when fat particles enter the lung) disproportionately in white males with an average age of 19.

Impact of the Ban

The abrupt action of Massachusetts resembles the witch hunts of that former colony’s past. With a single stroke of a pen on an emergency order from Governor Charlie Baker, Massachusetts has foreclosed the right of its citizens to their freedom of choice, denying them the right to an arguably safer alternative to smoking cigarettes, and caused far-reaching economic harm to many small businesses that manufacture and sell vaping products. Such an action will surely cause many bankruptcies, as these legal businesses can no longer afford to pay rent or buy products made and/or sold by other U.S. companies, pay salaries to employees, or pay taxes to Massachusetts and the federal government.

The economic impact of the vaping industry in the United States in 2018 was almost $24 billion, which means that the impromptu actions of Massachusetts will likely cause a reversing trend and cast a negative shadow over a legitimate and safe industry. The broad scope of the ban smacks of an unconstitutional taking of property without due process. Many affected businesses will have difficulty surviving without four months of revenue, which is why national trade organizations such as The Vapor Technology Association and others are considering legal options.

Call for International Forum on Safety and Health Benefits

Unfortunately, as the witch hunts continue, consumers will not be safer. Any person who was vaping legal nicotine containing e-liquids rather than smoking combustible cigarettes will have to make the choice to return to smoking combustible cigarettes or buy a black market e-liquid product. Citizens of Massachusetts who legally use THC through vaping for medicinal purposes also will be affected by the ban. Since all the data shows the lung disease breakouts were overwhelmingly caused by illicit THC cartridges made with vitamin E acetate or other unregulated thickening agents, the public health ban on legitimate products only increases the black market demand and the risk of illicit THC cartridges finding their way back into the hands of consumers, in addition to creating a black market for nicotine e-liquids while the CDC warns consumers not to buy these products off the street

The manufacturers of both nicotine-containing e-liquids and THC-containing products support meaningful regulation so health problems caused by illicit manufacturers can be prevented. A sensible public health strategy devised by the federal government likely could have prevented many of these illnesses and deaths by stopping unregulated illicit-market THC vape products from getting into the hands of consumers. But the voices of science and good public policy are falling on deaf ears while legitimate small businesses are being harmed and consumer choices for legitimate products are being eliminated.

One can only hope that Massachusetts reconsiders this ban and that other states do not follow this type of overreaching prohibition. Public policy regulators should discuss these issues in an international forum such as The E-Cigarette Summit, where the public health benefits experienced by the UK and other countries as well as the detailed facts of the recent cases of lung disease can be debated before businesses are closed. Until then, the black market profits while legal small businesses are “vaporized.”

© 2019 Wilson Elser

For more on vaping regulation, see the National Law Review Products Liability page.

U.S. Dealing with Several Hepatitis A Outbreaks, Including One Due to Food Worker Infection

Public health officials in Mendham, New Jersey are dealing with a relatively rare instance of a foodborne hepatitis A outbreak due to an ill food handler.  The employee has been linked to illnesses in 27 people, with 1 death reported.

According to the Centers for Disease Control and Prevention, foodborne outbreaks of hepatitis A are not common in the U.S.  CDC does not recommend that all food service workers receive routine vaccination against hepatitis A—except in areas with an active community-wide outbreak and where state and local health authorities (or private employers) indicate that vaccination would be cost-effective.

There are hepatitis A outbreaks in Alabama and Nevada where infected food handlers have been identified but where illnesses have not been traced to such workers.  Twenty-five counties in Alabama are reporting cases of hepatitis A in an outbreak that has been ongoing since September 2018, including among food workers; officials are urging food handlers in that area to get vaccinated.  Officials in Las Vegas, which also has an ongoing outbreak with 86 cases and one death, have warned customers who purchased non-prepackaged foods at a 7-Eleven store where a worked tested positive for hepatitis A to be on the lookout for symptoms.

CDC’s hepatitis A surveillance is updated through 2016.  Thus, it is not yet clear whether the 2019 cases reflect a marked increase in the incidence of hepatitis A in the U.S.

© 2019 Keller and Heckman LLP