On Dec. 11, 2019, the Developmental and Reproductive Toxicant
of the California Office of Environmental Health Hazard Assessment will
meet to discuss whether delta-9-tetrahydrocannabinol (THC) should be
considered a development and reproductive toxicant that may cause
teratogenicity or birth defects.
If affirmed, THC will be added to the published list of more than 900
chemicals under the California Safe Drinking Water and Toxic Enforcement
Act of 1986 (Proposition 65) that are known to cause cancer, birth defects
and other reproductive harms. A company doing business in California with
products that contain THC would then be required to warn consumers, with a
clear and reasonable statement, that exposure to THC is known to the state
of California to cause birth defects or other reproductive harm.
What Is California Proposition 65?
Proposition 65 is a California regulation designed to reduce or eliminate
exposure to substances known to cause cancer and birth defects by requiring
notice of the same to the consumer. Under Proposition 65, consumer products
that contain such substances must include a “clear and reasonable” warning
of the risks and hazard prior to being sold or marketed to California
consumers. The warnings can be a simple and direct statement, such as “this
product contains a chemical known to the state of California to cause
cancer, birth defects and other reproductive harm.”
Although Proposition 65 currently contains more than 900 chemicals on the
published list, approximately 300 of them have safe-harbor-level status. If
a product contains a chemical exempted by a safe-harbor level, then the
product must include a warning only if the chemical in the product exceeds
the safe-harbor level. A safe harbor is a determination that exposure to
the chemical on the Proposition 65 list is not a risk if its presence in
the product is at or below the threshold amount.
Proposition 65 warnings can have significant effects on the marketplace,
including scaring off consumers and increasing liability for the
manufacturers, producers, packagers, importers, suppliers or distributors
of a product. Importantly, Proposition 65 contains a private right of
action under which consumers can bring a cause of action against companies
that violate Proposition 65, which gives the consumer the opportunity to
collect damages for any such violations.
How Does This Apply to CBD?
The Developmental and Reproductive Toxicant Identification Committee
(DARTIC) Dec. 11 meeting on THC could affect products marketed as
possessing THC, such as cannabidiol (CBD) products. In the meeting,
California Office of Environmental Health Hazard Assessment (OEHHA) will
present on the risks and science being considered in the decision-making
process and will solicit comments from the public. While the state of
California has not provided any science that suggests a strong link with
CBD causing cancer, CBD continues to be subject to scrutiny under
Proposition 65 because of its potential to cause reproductive harm as
evidenced through various scientific studies. The evidence DARTIC published
on the issue specifically references human and animal peer-reviewed studies
linking potential birth defects to CBD. See “Evidence on the Developmental
Toxicity of Cannabis (Marijuana) Smoke and Δ9-THC,” California Office of
Environmental Health Hazard Assessment, Oehha.ca.gov (Nov. 27, 2019).
CBD products have become increasingly popular among a wide demographic of
consumers because it is non-intoxicating and offers potential health
benefits. Because the legality of CBD products depends on the product
containing less than 0.3 percent of THC, the intoxicating effect of CBD on
users is presumed minimal. Therefore, many consumers believe they are not
ingesting THC, which is not always the case. Science suggests it is
possible for CBD products to contain trace amounts of THC.
Consequently, if DARTIC concludes that THC should be included on the
Proposition 65 published list, then the effect on manufacturers, producers,
packagers, importers, suppliers or distributors of CBD products could be
significant. Specifically, because DARTIC could also decide to promulgate a
safe-harbor level for CBD that no product could meet due to the minimal
amounts of THC present in the product, every product that contains CBD
would need to include a Proposition 65 warning.
Manufacturers of CBD products should pay close attention to the Dec. 11
meeting of DARTIC. Failure to provide the required warning on products that
contain threshold amounts of chemicals listed on the Proposition 65 list
could lead to potential litigation from plaintiffs attempting to enforce
the law. This litigation can be costly to defend and often results in
monetary settlements between the plaintiff and defendant. In the future, it
may be necessary for manufacturers to warn of the risks of CBD products if
those products will be sold in California.
DARTIC’s consideration of THC will begin Dec. 11.