Challenging Proposed Regulations for Lack of Necessity

One way to challenge California’s proposed medical cannabis regulations is to argue that the record of rule making fails to establish the need for a particular regulation.

California Government Code § 11349(a) defines necessity in the context of proposed regulations:
“‘Necessity’ means the record of the rulemaking proceeding demonstrates by substantial evidence the need for a regulation to effectuate the purpose of the statute, court decision, or other provision of law that the regulation implements, interprets, or makes specific, taking into account the totality of the record. For purposes of this standard, evidence includes, but is not limited to, facts, studies, and expert opinion.”

In other words, if the record of the rule making proceeding fails to show, by substantial evidence, the need for a particular regulation, that regulation is susceptible to a necessity challenge.

For an example of a proposed California medical cannabis regulation which may be susceptible to a necessity challenge, the manufacturing ISOR does little to establish the necessity of the categorical prohibition on cannabis-infused caffeine products set forth in proposed Section 40300. The ISOR states:

“The recommendation that caffeine not be allowed as an additive comes from the FDA determination that caffeine (stimulant) in certain alcoholic (depressant) beverages is an “unsafe food additive” due to the unpredictable negative effects of the two substances. The mixing of stimulants with depressants may lead to dangerous cardiac events. A similar lack of definitive information exists as well for the safety of caffeine as an additive to cannabis.”

The ISOR cites no facts, studies, or expert opinions to establish the necessity of the ban on caffeine, and the record of the rule making proceeding at this juncture appears insufficient to establish by substantial evidence the necessity of a categorical prohibition on caffeine.

You can easily find Section 40300 of the regulations proposed by the Office of Manufactured Cannabis Safety as well as the corresponding ISOR on the Regulations page of the Law Offices of Omar Figueroa web site:

The California Office of Administrative Law has a very informative web site collecting written decisions disapproving of agency regulatory actions.  These decision identify proposed regulations which were rejected as defective. An example of a recent Disapproval Decision is the disapproval of the Department of Alcoholic Beverage Control’s proposed regulatory action for “failure to comply with the “necessity” and “clarity” standards of Government Code section 11349.1 and failure to follow all required procedures under the California Administrative Procedure Act (APA).”


The above information is provided for informational purposes only and is not intended as legal advice.  Please contact a lawyer for legal counsel.

If you would like legal assistance in advocating for changes to the proposed regulations, please get in touch with us at (707) 829-0215 or at (415) 489-0420.