2024 Regulatory Update Part 2: What We Are Watching In the CBD and Hemp Pet Products Sector

As in the past, we are monitoring proposed state and federal legislation, as well as any FDA and AAFCO discussions and/or research which may lead to pet food labeling changes and regulatory requirements for the sale of products containing cannabidiol (CBD).

Research

 
March 5, 2024: National Animal Supplement Council (NASC) Announces
Publication of Landmark Safety Study of Cannabidiol Products in Healthy Dogs

The National Animal Supplement Council (NASC) today announced that Frontiers in
Veterinary Science (Front. Vet. Sci.) has published results from the first-of-its-kind
peer-reviewed safety study of cannabidiol products in healthy dogs. In the study,
different cannabinoids were well tolerated in healthy male and female dogs when dosed for 90 consecutive days with a 14-day recovery period. Based on the results of this study, other published studies, and data from extensive post-market surveillance, hemp-derived cannabinoids are well tolerated in healthy dogs at a dose of 5mg/kg of body weight per day and do not pose significant risk to dogs in long-term use. “These data demonstrate that different cannabidiols are safe for long-term use in healthy dogs when given at the dose studied,” said Bill Bookout, NASC President. “With safety studies, no matter how well controlled or meticulously defined, it is impossible to account for everything that can occur when a product is commercialized. That is why this safety study includes not only data from a well-designed study protocol, but also 10 years of post-market surveillance data from the NASC Adverse Event Reporting Database (NAERS®), which is the most advanced monitoring system in the world for these types of products given to companion animals. No other study that we are aware of is as comprehensive and includes both data sets.”  

https://www.businesswire.com/news/home/20240305878251/en/National-Animal-Supplement-Council-Announces-Publication-of-Landmark-Safety-Study-of-Cannabidiol-Products-in-Healthy-Dogs
(Business Wire)

FDA Action

As we reported in our last regulatory update on the topic, in January 2023 the United States Food and Drug Administration (FDA) announced its position that that existing regulatory frameworks for foods and dietary supplements are not appropriate to manage the risks of cannabidiol (CBD) and that a new regulatory path forward therefore is necessary. The FDA reiterated its position during an April 11, 2024 hearing before the House Oversight and Accountability Committee. At the hearing, FDA Commissioner Dr. Robert Califf acknowledged the FDA’s recognition that consumers want access to these products and restated its intention (as announced in January 2023) “to work with Congress on a new regulatory pathway that would provide access, safeguards, and oversight over products containing CBD in ways that existing pathways cannot.” He also stated that:

[u]nder the Federal Food, Drug, & Cosmetic Act, any substance, including
CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive. The use of CBD raises safety concerns, especially with long-term use. Studies have shown evidence of liver toxicity, interactions with certain medications and possible harm to the male reproductive system. Accordingly, FDA has concluded that a new regulatory regime is needed, which could encourage better information to inform consumers about their choices. In the meantime, FDA continues to assess the evolving information base and build awareness for Americans.

https://oversight.house.gov/wp-content/uploads/2024/04/FDA-House-Oversight-and-Accountability-Testimony.pdf
(pp. 7-8)(footnotes omitted)

Warning Letters

As we have noted in prior regulatory updates, over the past several years FDA has issued several warning letters to firms that market cannabis-derived products, including cannabidiol (CBD) and delta-8 tetrahydrocannabinol (delta-8 THC) products. So far in 2024 the FDA has issued warning letters to at least six companies illegally selling unapproved products containing CBD and/or delta-8 THC in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act). At least one of these companies appears to market pet products, although it is not clear as to whether the FDA’s letter is aimed at such products.

Legislative Action

Federal

As we previously reported, two pieces of legislation aimed at creating possible pathways to the regulation of CBD products were introduced in the United States House of Representatives in March of 2023.

The “CBD Product Safety and Standardization Act of 2023” (HR 1628) would authorize the regulation of interstate commerce with respect to food containing cannabidiol derived from hemp and would direct the FDA to regulate CBD as the agency would for other food ingredients, setting requirements for quality and labeling, among other areas.

The “Hemp and Hemp-Derived CBD Consumer Protection and Market
Stabilization Act of 2023” (HR 1629) would make hemp, cannabidiol derived from hemp, and other hemp-derived products lawful for use as a dietary supplement unless otherwise directed by the FDA.

As of the date of this update, both bills remain in the Health subcommittee of the House Committee on Energy and Commerce.

To access HR 1628, click here:
https://www.congress.gov/bill/118th-congress/house-bill/1628/all-info
To access HR 1629, click here:
https://www.congress.gov/bill/118th-congress/house-bill/1629/all-info

On July 20, 2023 a bill was reintroduced in the United States Senate called the “Hemp Access and Consumer Safety Act” (Senate Bill 2451). The Hemp Access and Consumer Safety Act would:

●  Give hemp-derived CBD products an opportunity to lawfully be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act;
●  Prioritize consumer safety, requiring manufacturers to comply with all
existing federal regulations for the products that contain CBD; and
●  Ensure that these products are properly labeled.

After its introduction, the bill was referred to the Committee on Health, Education, Labor, and Pensions, where it remains.
To access SB 2451, click here:
https://www.congress.gov/bill/118th-congress/senate-bill/2451/all-info

State

New York Assembly Bill 6435 (substituted for its companion, Senate Bill 6326) would amend the definition of “commercial feed” to provide that commercial feed may include the addition of hemp seed or hemp seed products for use as feed or for mixing in feed for a pet, specialty pet, horse, or camelid. This bill ultimately passed both chambers only to be vetoed by Governor Kathy Hochul on December 8, 2023.

Various state legislatures introduced bills aimed at regulating hemp or CBD products this session. Introduced in February, Iowa House Bill 2605 (formerly House Study Bill 665) was signed into law on May 17 of this year. The bill will provide for the regulation of hemp and hemp products, providing penalties, and making penalties applicable.

Also introduced in February of this year, Oklahoma Senate Bill 635 would require
registration of hemp-derived cannabinoid products. The bill has passed one chamber and remains in House committee. Massachusetts Senate Bill 2579 (currently in the Senate Ways and Means committee) would relate to legislation “to promote the growing and use of hemp and hemp products.” It was introduced on January 31, 2024 and replaces Senate Bill 40, House Bill 90 and House Bill 93. New Jersey Assembly Bill 1890 (carryover of Assembly Bill 5198 and Senate Bill 3470) was introduced in January and would require registration and regulation of certain hemp-derived cannabinoids manufactured and sold in the State. Introduced in March, South Carolina Senate Bill 1214 would regulate the sale and distribution of products containing hemp-derived cannabinoid.

Hawaii Senate Bill 651 (carried over from the 2023 session) would amend
the definition of “hemp product” to exclude delta-8-tetrahydrocannabinol and would prohibit the sale of food products and hemp products containing delta-8-tetrahydrocannabinol. The bill also would allow the sale of food products infused withcannabinoid, hemp extract, hemp derivatives, or other hemp products, as well
as the sale of hemp leaves and hemp floral material. The law would require the
identity statement used for labeling or advertising of hemp products to clearly
identify the hemp’s place of origin. That bill remains in the Senate Health and
Human Services Committee.

Illinois House Bill 4293 and Senate Bill 3926 were both introduced earlier this
year; both bills would create the Hemp Consumer Products Act. The bills set forth
provisions aimed at definitions; prohibitions and compliance; applications and
licensing for hemp consumer product processors; requirements for licensees;
registration of hemp consumer CBD products; requirements of hemp consumer CBD products; packaging and labeling of hemp consumer CBD products; testing
requirements; marketing and sale of hemp consumer CBD products; penalties; and the administration and enforcement of the Act and rulemaking, including emergency rulemaking, among other matters, HB4293 passed both chambers and was re-referred to the House Rules Committee. SB3926 remains in the Senate Assignments Committee.