FDA has recently announced it is relaxing its enforcement of telemedicine for veterinarians under two federal provisions:  (1) when prescribing extralabel drug use; and (2) when prescribing medicate feed pursuant to the Veterinary Feed Directive.  Both generally require an initial physical examination of animals prior to such prescription.

FDA only enforces certain regulations governing a veterinarian’s relationship with its clients and patients.  As stated in a news release “Coronavirus (COVID-19) Update: FDA Helps Facilitate Veterinary Telemedicine During Pandemic,

The federal [veterinarian client patient relationship] VCPR definition requires that veterinarians physically examine animal patients and/or make medically appropriate and timely visits to the location where the animal(s) are kept. Therefore, the federal VCPR definition cannot be met solely through telemedicine.

Recognizing the importance of veterinary practice to animal and public health, FDA, provides the following examples of its proposed relaxed standards:

For example, the owner of a sick dog could share a video with a veterinarian. If necessary, the veterinarian could then prescribe a drug not approved for use in dogs or for that illness (extralabel use). As another example, a veterinarian could remotely examine and diagnose a group of food-producing animals with a skin disease, and then authorize the use of certain drugs in the animals’ feed.

Veterinarians, should be and are aware, that state law predominantly governs the practice of veterinarian medicine.  Therefore, a review of the current relevant state law statutes and regulations must also be considered when providing for animals in each particular state.  An easement on federal regulation does not preempt state veterinary practice laws.  That said, some states had previously introduced and adopted regulations permitting telemedicine as prescribed, and other states would likely take a reasonable approach to such care.

Practitioners should record the content of any telemedicine-provided examination and treatment, consistent with the standards of care in each state and practice area.

Despite myths perpetuated by animal activists, animal models remain critical to ensure that vaccines developed to prevent COVID 19 infections do not make those patients worse as a result of such treatment, as Dr. Fauci recently acknowledged during a briefing at the White House.

As also reported in Catching up to Coronavirus: Top 60 Treatments in Development,  “[m]ost of the therapy candidates for COVID-19 . . . were vaccines that are only in animal testing stages.”

Matthew R. Bailey, President, National Association for Biomedical Research, noting the criticality of animal research in halting the spread of coronavirus,  reported that “[two researchers at the University of Wisconsin-Madison just announced that they’ll ‘test medical countermeasures such as vaccines and therapeutics’ in nonhuman primates. They hope to discover how much of the coronavirus enters the body, where it infects the lungs, and how immune systems respond to it.”

Researchers and scientists throughout the United States are developing effective treatment models, first based on studies in genetically modified mice.  Such work is supported by the National Institutes of Health, and is a continuation of previous studies investigating the pathogenesis and treatment against other viruses, e.g., Nipah, Ebola and MERS, studied in rhesus macaques.

Such animal studies cannot be bypassed or replaced by computer simulation or organs on a chip.  COVID 19 causes multisystem infection that can only be adequately tested on entire organisms.  The current Phase I human vaccine trials underway in Seattle were preceded by testing in animal models:

The investigational vaccine was developed using a genetic platform called mRNA (messenger RNA). The investigational vaccine directs the body’s cells to express a virus protein that it is hoped will elicit a robust immune response. The mRNA-1273 vaccine has shown promise in animal models, and this is the first trial to examine it in humans.

There is no requirement for those opposed to the use of animal models in biomedical research to seek preventative or therapeutic treatment related to COVID 19 or other devastating human and animal illnesses, when such therapies were developed with animal heroes.   But such activists should not stand in the way of millions of others who accept the importance of the humane use of animal models and understand the rigors imposed on such researchers, who even without such mandates, would provide these animals with humane care while bred, raised and used throughout these critical life-saving endeavors.

As concerns about coronavirus continue to escalate, universities and colleges have taken advantage of spring break to protect students and staff from circulating virus, and many are planning on remote teaching for the rest of the semester.  For schools with students who remain at on campus residences and/or employees with service or emotional support animals, the following should be considered:

  1. People with service animals cannot be discriminated against, but they are required to provide for the care of their service animal, directly or through some other person.  If the disabled individual is infected and quarantined, s/he may be unable to care for that animal.  There should be plans for someone else to care for the service animal without exposure to the virus.  If the service animal can transmit the virus, even if only as a fomite, additional precautions must ensue.  The disabled person must be able to retain the services of that animal for the task(s) for which it has been trained, or an alternative must be considered.
  2. People with emotional support animals, that may not be afforded as significant protections as those with service animals, would likely benefit from the ability to keep that animal with them in the event they are quarantined, which can be a stressful situation.  The same concerns about disease spread to other people and the environment exist.
  3. The continuation of biomedical research with animal models may be disrupted by the inability to obtain adequate supplies, medications, feed, and/or bedding.  Since animals must be properly cared for, plans to provide alternate animal care staff should be considered in the event of infection in existing staff.

It is now increasingly evident that animals are critically important in testing of a potential vaccine against and treatment for COVID-19.  See, e.g., These Lab Animals Will Help Fight Coronavirus.  Continuing with this research is important for public health during this unprecedented pandemic.

There are many additional concerns about the potential transmission of the virus in a university setting.

As chair of the firm’s Animal Law Practice, I am available to answer any questions you have on this topic. Feel free to email me at Nhalpern@foxrothschild.com

As predicted, COVID-19 is spreading throughout the United States and globally.  State and Federal governmental agencies have implemented emergency response plans for highly contagious diseases, and businesses of all kinds are working to protect their employees and customers while maintaining business continuity if the coronavirus continues to spread.

Today, as we prepare for a new reality, albeit temporary, veterinary practices where animals in need of critical and preventive care should continue to be properly cared for by highly skilled, dedicated professionals.  As we hear that a pet may have tested positive for the virus in China, it is likely that companion animal practices may see an upsurge in demand from concerned pet owners, even though the CDC reports that, “[a]t this time, there is no evidence that companion animals including pets can be infected with or spread COVID-19.”  (COVID-19 is the strain of coronavirus spreading now).

Veterinarians should consider the following issues as human cases of COVID-19 continues to spread:

  1. Staff should be provided with a plan to minimize exposure from infected staff members or clients, including providing curbside services and admissions limited to emergency cases.
  2. Staff should be asked to stay home if exhibiting symptoms of infection.
  3. Plans to function with a reduced staff should be considered. If schools are closed, daycare may become an issue for staff members.
  4. Inventory medications and supplies that may become more difficult to purchase, depending on the manufacturer and/or distributor.
  5. Obtain sampling and testing equipment that may be needed to respond to requests from owners concerned about their pets. If demand for human testing makes this impossible, provide clients with information from CDC and other animal health officials about the low likelihood of the spread of this virus between pets and people.

Here are some facts about potential reverse zoonosis to keep in mind.  (Zoonosis is the spread of disease from animals to humans; reverse zoonosis is the spread from people to animals).

  1. Like other viruses, dogs and other animals in close contact with infected people, may be exposed to and inhale the virus, but may not become infected. A test that simply identifies a virus on a swab does not mean that the animal was infected, particularly in the absence of clinical signs of disease, assuming that the diagnostic test is approved for use in animals, and was performed in a competent, accredited laboratory.
  2. Dogs can be infected with a respiratory form of coronavirus, but, historically, it was different from the human form of the virus. They can also be infected with an enteric form that causes diarrhea. Veterinary diagnostic laboratories can test for coronavirus in dogs.
  3. Practice good hygiene around your pet (and everywhere else). The CDC has comprehensive guidance about “staying safe and healthy around animals, including pets.”

The AVMA has been advocating to address potential mandatory closures of veterinary practices along with other facilities where the public may co-mingle, and has published a COVID-19 resources website.

Planning for emergencies and disasters should be one of many management tools in veterinary practices.  Veterinarians are trained to deal with infectious, contagious diseases and are well-equipped to help manage this current outbreak.  As a former animal health official in New Jersey (the State Veterinarian) part of my responsibility was to protect the livestock, poultry and aquaculture in the state from the spread of highly contagious diseases, draft and implement emergency response plans in coordination with other state, local and federal agencies and with all stakeholders and impacted businesses.  New Jersey is no stranger to disaster and emergency response, having responded to the most devastating terrorist attack on our country, the anthrax attacks, Hurricane Floyd and Super Storm Sandy.  As before, using the tools and resources described herein, we are armed to survive the COVID-19 storm.

Since we first published “FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs,” a number of impacted stakeholders have been expressing concern about the intended and unintentional consequences of FDA’s current approach.

First, as a result of widespread concern about the proposed guidelines, FDA will be extending the time to comment, previously scheduled to close on February 18, 2020.

According to the American Veterinary Medical Association (AVMA),

[t]he FDA agreed Friday to allow an additional 120 days for public review and commenting on its latest proposal to regulate compounding. Granting a request made by the AVMA on February 3, FDA officials announced they would receive comments on draft Guidance for Industry (GFI) #256, Compounding Animal Drugs from Bulk Drug Substances, until June 17.

As reported by Wedgewood Pharmacy, one of the largest compounding pharmacies in the United States, serving more than 40,000 prescribers of compounded medications, “Veterinarians Report That FDA’s Proposed Guidance Will Have a Significant Negative Impact on Animal Patients.

According to Wedgewood, “a coalition of the largest pharmacies serving veterinarians and animal patients in the U.S. commissioned the study. The survey results, including thousands of comments by veterinary professionals, are available at MyMedsMatter.com.”

The survey reports on the responses of 1,849 veterinary professionals in the U.S., 78% of whom practice in small businesses with four or fewer veterinarians; 70% of respondents treat primarily companion animals. For 99.4% of those responding, having access to compounded medications when they are necessary in their medical judgement is important.

By grossly limiting, if not eliminating entirely, veterinarians’ use of bulk substances in compounded medications, many are concerned about their ability to provide adequate medical care for species for which FDA-approved drugs are not available, e.g., exotic, wild and zoo animals, animals involved in biomedical research.

In a letter to FDA from the AVMA, dated Feb 3, 2020, AVMA requested clarification about several sections in the Guidance, including: articles used for euthanasia and depopulation of food-producing animals; the use of compounded medications for the immobilization of “animals in zoos, wildlife rehabilitation clinics, and other similar settings [which are] . . . required not only to address animal safety and suffering, but also for human safety when caring for animals,” and use of large-volume parenterals, amongst other concerns.

On the other hand, the Animal Health Institute, a trade association representing the companies that develop and produce animal medicines, published an article on January 30, 2020 in support of FDA’s proposed guidance titled, “Animal Drug Compounding Guidance Will Protect Veterinarians and their Patients,” stating,

The animal health industry supports the use of compounding to address the medical needs of animal patients.  We do not support the ability of compounders to act like manufacturers and put patient health at risk.  This guidance document from FDA defines the difference between the two and we believe it should be finalized.

Undoubtedly, there will more news we will share about FDA’s Guidance #256.

Veterinarians in New Jersey are hereby notified of amendments to existing regulations governing continuing veterinary educational requirements and supervision of veterinary students in training by state licensees.

First, continuing veterinary education (CVE) requirements have been amended to require one credit hour of CVE “in topics concerning prescription opioid drugs, including the risks and signs of opioid abuse, additional, and diversion,” beginning with the biennial renewal period beginning on June 30, 2019.  N.J.A.C. 13:44-4.10 (b)(3).

There was no discussion in the proposed rule — to which no comments were received — about the merits or intent of the proposed amendments.  Also unclear, is who would be qualified to provide such CVE, which presumably relates to addiction by humans – either veterinary clients diverting opioids prescribed for their pets, or veterinary staff.  Perhaps this is an example where, under the “One Health” banner, physicians could help educate veterinarian for the benefit of people and pets.  And notably, there will be a presentation on this topic at the NJVMA 2020 Veterinary Education Conference.

In the regulation there is also no discussion of or direction to veterinarians who may suspect opioid abuse, addiction or diversion in or from their clients (or staff for that matter).  Perhaps further amendments are needed to protect veterinarians if reporting such suspicious conduct in light of the overarching requirements for veterinarians to maintain confidentiality of veterinary medical records.

Another amendment receiving no public comment was adopted by the Division of Consumer Affairs, State Board of Veterinary Medical Examiners on October 30, 2019, effective on Feb. 3, 2020.  This amendment requires a veterinarian who is supervising a veterinary student in their practice to: (1) notify the veterinary board of the intent to supervise; (2) obtain certain information from the student’s veterinary school; (3) notify the patient’s owner that the student is not a licensee and maintain that information in the patient record.  See, N.J.A.C. 14:44-4.13.

With the increase in veterinary schools relying on training of veterinary students in private practices, veterinarians should understand what liabilities they be exposed to when agreeing to supervise veterinary students and other volunteers.  See, e.g., Wodohodsky v. Hall, 573 S.W.3d 645 (Mo. Ct. App. 2019), transfer denied (Mar. 29, 2019), reh’g and/or transfer denied (Mar. 29, 2019), transfer denied (June 4, 2019) (affirming verdict against veterinarian in action veterinary student brought “against veterinarian and farm operators for negligent supervision” in which student was hurt on the farm and the court found “sufficient evidence established the existence of a common law duty on the part of veterinarian to exercise ordinary care in supervising veterinary student.”)

Veterinarians should consult with an attorney and their insurance carrier about any potential exposure to liability.

In 2008, the Department of Justice (“the DOJ”), Civil Rights Division, published a Notice of Proposed Rulemaking seeking to amend the regulations which enforce the ADA’s prohibition of discrimination in public accommodations.[1] As part of the proposed changes, the DOJ wished to clarify the obligations of public accommodations regarding the use of service animals by persons with disabilities.[2]

According to the DOJ, the need for clarification was brought about by a large number of complaints from individuals with service animals concerned that covered entities were confused regarding the full scope of their duty to accommodate service animals.[3] Another concerning trend in need of correction was the growing use of wild, exotic, and untrained animals as supposed service animals.[4] In response to these concerns, the DOJ proposed defining “service animal” to include dogs and other “common domestic animals.”[5] The proposed rule specifically carved out of the definition “wild animals (including nonhuman primates born in captivity), reptiles, rabbits, farm animals (including horses, miniature horses, ponies, pigs, and goats), ferrets, amphibians, and rodents.”[6]

The DOJ explained this proposed change was necessary because of a growing concern among commentators who suggested that “limiting the number of allowable species would help stop erosion of the public’s trust, which results in reduced access for many individuals with disabilities despite the fact that they use trained service animals that adhere to high behavioral standards.”[7] In other words, an overly broad definition of service animal had resulted in public backlash with the practical effect of facilities turning away individuals with disabilities, which was the opposite intent of the ADA and its regulations.

The public reacted strongly to this proposed change with a stalwart defense of one category of animals specifically marked for exclusion from the definition of service animals. While commentators acknowledged the wisdom of excluding primates, reptiles, and other concerning animals, a strong case was made for inclusion of miniature horses as service animals.[8] One commentator pointed out that miniature horses had “proven to be very effective and well-received by the public both domestically and abroad in Europe.”[9] The American Association of the Deaf-Blind opined that miniature horses served “not only as seeing eye guides but as support for balance problems. For these deaf-blind people, guide dogs are not strong enough to give them something to hang on to when they stumble, wobble, or lose their balance.”[10] The Disability Rights Education and Defense fund likewise noted, “Miniature horses have been used as service animals by the disability community for some time, particularly the blind community. Miniature horses are able to be trained to do work or perform tasks for people with disabilities, can be housebroken, and are a viable option for those who are allergic to dogs or who would like a service animal with a longer lifespan.”[11] The Washington State Human Rights Commission argued that miniature horses “should also be allowed for those with balance issues or allergies to dogs.”[12] One commentator told the story of his blind friend who experienced deep grief from the loss of two guide dogs to old age. The commentator’s friend subsequently decided to train a miniature horse due to their long life expectancy and found she had received, what she called, “A Guide for Life.”[13]

The DOJ was ultimately convinced by these and other commenters into recognizing properly trained, appropriately sized, miniature horses as service animals in their final rule announced on September 15, 2010.[14] The DOJ stated the following points contributed to their decision:

  1. Proven Effective. Miniature horses already had a long history providing assistance to persons with disabilities.
  2. Allergies. Miniature horses constituted a viable alternatives to dogs for individuals with dog allergies.
  3. Religious Concerns. Miniature horses could service those whose religious beliefs preclude the use of dogs.[15]
  4. Longer Life/Strength. A strong factor in favor of miniature horses is their longer life span and strength in comparison to dogs. Specifically, miniature horses can provide service for more than 25 years while dogs can provide service for approximately seven years, and, because of their strength, miniature horses can provide services that dogs cannot provide. Accordingly, use of miniature horses reduces the cost involved to retire, replace, and train replacement service animals.
  5. Training Methods. Similar to dogs, miniature horses can be trained through behavioral reinforcement to be “housebroken.”
  6. Variety of Services. The rulemakers noted miniature horses are not one specific breed, but are derived from several breeds, with distinct characteristics that produce animals suited to a variety of service animal work. The horses generally range in height from 24 inches to 34 inches measured to the withers, or shoulders, and generally weigh between 70 and 100 pounds. These characteristics are similar to those of large breed dogs, such as Labrador Retrievers, Great Danes, and Mastiffs. According to information provided by an organization that trains service horses, miniature horses can be trained to provide a wide array of services to their handlers, primarily guiding individuals who are blind or have low vision, pulling wheelchairs, providing stability and balance for individuals with disabilities that impair the ability to walk, and supplying leverage that enables a person with a mobility disability to get up after a fall. According to one commenter, miniature horses are particularly effective for large stature individuals. The animal can be trained to stand (and in some cases, lie down) at the handler’s feet in venues where space is at a premium, such as assembly areas or inside some vehicles that provide public transportation. Some individuals with disabilities have even traveled by train and have flown commercially with their miniature horses.[16]

These points, in contrast to the lack of utility of other animals proposed exclusion, lifted miniature horses out of disfavor and into recognition as viable service animals. The example of the miniature horse highlights the important role public commentators serve in the rulemaking process.

[1] Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities, 73 FR 34508-01, (June 17, 2008)

[2] Id. at 34516.

[3] Id. at 34515.

[4] Id. at 34516.

[5] Id. at 34520.

[6] Id. at 34521.

[7] Id. at 34516

[8] Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities, 75 FR 56236-01 (September 15, 2010) (“Commenters asserted that certain species of animals (e.g., reptiles) cannot be trained to do work or perform tasks, so these animals would not be covered.”)

[9] DOJ-CRT-2008-0015-0906 (Steven Jacquez).

[10] DOJ-CRT-2008-0015-2670 (American Association of the Deaf-Blind).

[11] DOJ-CRT-2008-0015-2753 (Disability Rights Education and Defense Fund).

[12] DOJ-CRT-2008-0015-2693 (Washington State Human Rights Commission).

[13] DOJ-CRT-2008-0015-1752 (D. Vaughn).

[14] Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities, 75 FR 56272 (September 15, 2010).

[15] https://www.huffpost.com/entry/whats-up-with-muslims-and_b_1144819

[16] Id.

I was honored to join colleagues and clients at the 2020 Aviation Symposium the Firm sponsored in Tysons Corner from February 4 through February 6, 2020.

Symposium topics included:

  • What about the Lion Air and Ethiopian Airlines accidents should concern you?
  • An update on emotional support and service animals
  • Structuring and conducting an effective emergency drill
  • Working with first responders
  • A decade of evolution in the Federal Family Assistance Plan
  • The changing faces of the NTSB and FAA
  • The effect of FAA reorganizations on oversight, monitoring and surveillance
  • Recent developments involving disruptive passengers
  • The C-Suite and Crises: Managing the message and handling bad news, internally and externally.

I addressed the increasingly problematic issues involving the identification of legitimate service animals in the face of the increasing designation of their pets as emotional support animals, during the session titled “Disruptive/Disgruntled Passengers, Miniature Horses, Emotional Support Parakeets and Other Issues.”

The U.S. Department of Transportation has recently published proposed amendments to the regulation of service animals on flights.

As reported by DOT, the regulations would:

Define a service animal as a dog that is individually trained to do work or perform tasks for the benefit of a person with a disability;

No longer consider an emotional support animal to be a service animal;

Consider a psychiatric service animal to be a service animal and require the same training and treatment of psychiatric service animals as other service animals;

Allow airlines to require forms developed by DOT attesting to a service animal’s good behavior, certifying the service animal’s good health, and if taking a long flight attesting that the service animal has the ability to either not relieve itself, or can relieve itself in a sanitary manner;

Allow airlines to require passengers with a disability who are traveling with a service animal to check-in at the airport one hour prior to the travel time required for the general public to ensure sufficient time to process the service animal documentation and observe the animal;

Require airlines to promptly check-in passengers with service animals who are subject to an advanced check-in process;

Allow airlines to limit the number of service animals traveling with a single passenger with a disability to two service animals;

Allow airlines to require a service animal to fit within its handler’s foot space on the aircraft;

Continue to allow airlines to require that service animals be harnessed, leashed, tethered, or otherwise under the control of its handler;

Continue to allow airlines to refuse transportation to service animals that exhibit aggressive behavior and that pose a direct threat to the health or safety of others; and

Continue to prohibit airlines from refusing to transport a service animal solely on the basis of breed.

It would appear that miniature horses would not be permitted on flights as service animals, which is inconsistent with the American for Disability Act.  As explained in a blog to be published shortly, “A Brief History of Miniature Horses and the ADA,” those individuals who rely on mini-horses are likely to object to their exclusion from flights.  I would caution, however, whether any miniature horse could safely exist a plane during an emergent landing, for example when egress on a plane’s emergency chute/slide is required.  As any horse owner or veterinarian knows, horses do not sit down.  If a horse cannot safely exist a plane in an emergency, perhaps that is a sufficient reason to prohibit it from flying in the first place.

There are other concerns about the DOT proposed rule, including what appears to be discriminatory requirements for disabled passengers that seemingly conflict with the intent, if not the language of the ADA, to prohibit such discrimination.

That said, the intent to limit the abuse of false claims that a pet is a service or emotional support animals are overdue, and hopefully the regulation can be further amended as needed to comply with provisions enacted to benefit those with disabilities under the ADA.

Last month, I listened to a podcast interviewing the owner of Straight Arrow, the parent company that produces Mane and Tail and Cowboy Magic products. As a lifelong horse owner (including several grey horses that love mud), I cannot remember a time when I did not have a Mane and Tail and/or Cowboy Magic product in my tack room. The interview took place after the podcasters toured the Cowboy Magic manufacturing facility, which, according to the podcast interview, is a state of the art facility which adheres to strict quality assurances. When listening to the details of how their products are manufactured, I realized that many animal owners may not know what regulatory standards apply to the manufacturing of pet grooming products.

According to the FDA, the “animal counterpart of a cosmetic is commonly referred to as a ‘grooming aid.’” See FDA, Animal Products FDA Regulates, available at https://www.fda.gov/animal-veterinary/resources-you/animal-products-fda-regulates (hereinafter, “FDA Guidelines”). The FDA is only empowered to regulate cosmetics that pertain to human use:

The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

21 U.S.C. § 321(i). Therefore standard animal grooming products do not fall within the control of the FDA. See FDA Guidelines. However, if animal grooming products are also made for human use, if the products are intended for any therapeutic purpose, or if the products are intended to affect the structure or function of the animal, they are subject to FDA regulation as a new animal drug. Id. Thus, a product like Mane and Tail, which is marketed for human use as well as animal use, is subject to FDA regulations.

A “new animal drug” is “any drug intended for use in animals other than man, including any drug intended for use in animal feed” but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggested in the labeling of the drug. See 21 U.S.C. § 321(v); see also FDA, New Animal Drug Applications, available at https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications. New animal drugs may not be sold until they are approved or conditionally approved by the FDA’s Center for Veterinary Medicine.

Thus, the answer as to what standards apply to the production of animal grooming products is, like most things in the law: it depends. A pet shampoo that merely claims to make the fur soft and shiny is unlikely to be subject to FDA regulations, whereas a shampoo that claims to prevent anemia or illness caused by fleas or ticks would be subject to FDA regulations and EPA regulations (governing all pet pesticide treatments). Of course, pet grooming products must still comply with packaging and labeling requirements governed by FTC and state consumer protection laws, and any claims about the efficacy of the product must be substantiated by competent and reliable scientific evidence.

We are available if you need advice related to any animal products you are manufacturing, distributing or selling.

Here is a glimpse into what happened at the tail end (ha!) of the 2018-2019 New Jersey Legislative Session.

Homes for Animal Heroes

The Homes for Animal Heroes bill, S 2826, made it over the final hurdle on the last day of this legislative session in New Jersey, passing 75-0 in the Assembly on January 13, 2020.  It had previously passed in the Senate so is now headed to the Governor’s desk.

The bill will require an institution of higher education, and research institutions that contract with colleges and universities to use cats and dogs for educational, research, or scientific purposes to provide such animals for adoption, when the cat or dog is no longer needed for educational, research, or scientific purposes, after determining that the health of the cat or dog renders it suitable for adoption.

While this is the practice of these research institutions in the State and much of the country, this law codifies this practice.

As reported in a press release published on Insider NJ,

‘New Jersey’s biomedical research community, including our nationally-renowned research universities and partners within the state’s life sciences companies, are pleased to see the Legislature recognize the importance of ensuring permanent homes for retired research animals – our animal heroes,’ said Tom Leach, executive director of the New Jersey Association for Biomedical Research. ‘We thank Assemblywoman Vainieri Huttle and the late Senator Anthony R. Bucco for their leadership in sponsoring this important legislation and working with all stakeholders to ensure we continue to find forever homes with the best interests of the animals in mind.’

Equine Stabling Tax Exempt

Another animal-related bill that made it through the legislative process, A1045 “clarifies the sales tax collection responsibilities of horse-boarding businesses in New Jersey by providing an exemption from tax for the lease or rental of certain stable stalls and charges for horse boarding and certain other related services.”

The bill provides that boarding, stabling, keeping, and feeding horses and other domestic equids are non-taxable services.

Proposed Bill on Animal Use in Cosmetic Testing

A bill just introduced on January 9, 2020, S4348 would prohibit the sale of cosmetic products that have been tested on animals.  Like similar bills passed in other states, this bill includes numerous exemptions, if:

(1)   The animal test is required by a federal or State regulatory authority and:

(a)   the ingredient that requires an animal test is in wide use and cannot be replaced by another ingredient,

(b)   a specific human health problem is associated with the ingredient and the need to conduct an animal test on the ingredient is justified and supported by a research protocol, and

(c)   there is no non-animal test that is accepted by the relevant federal or State regulatory authority as a means to gather the relevant data;

(2)   The animal test is conducted to comply with a requirement of a foreign regulatory authority, if no evidence derived from the test is relied upon to substantiate the safety of the cosmetic pursuant to federal or State regulations; or

(3)   The animal test is conducted on a product or ingredient subject to the requirements of chapter V of the federal “Food, Drug, and Cosmetic Act,” 21 U.S.C. s.351 et seq.

[and]

to cosmetics that were sold in the State or tested on animals prior to January 1, 2020, even if the cosmetic is manufactured after that date.

Like the bills known as “Moose’s Law” and “Desmond’s Law” previously discussed, S4348 will likely be re-introduced in the 2020-2021 Legislative Session.