California Proposes Medical Marijuana Manufacturing Regs
CDPH is proposing each label include a listing of all ingredients in descending order; the amount of sugar, sodium, and fat per serving; and a cannabis product symbol. The proposal will prohibit labels from making any claims of health or other physical benefit.
The California Department of Public Health's Office of Manufactured Cannabis Safety has released proposed medical cannabis manufacturing regulations for public comment and has scheduled two public hearings in June about them.
A summary of the regulations indicates the department intends to set THC limits: CDPH has proposed to limit edible products to no more than 10 mg of THC per serving and 100 mg of THC per package and also proposes to limit other products (tinctures, capsules, topicals, etc.) to no more than 1,000 mg of THC per package.
Comments may be submitted by mail to: California Department of Public Health, Office of Regulations, 1415 L Street, Ste. 500, Sacramento CA 95814, by fax to 916-440-5747, or by email to email@example.com. The public hearings will be held:
- June 8, 2017, 10 a.m., 50 D Street, Room 410A/410B, Santa Rosa, CA 95404
- June 13, 10 a.m., 1350 Front Street, Auditorium, San Diego, CA 92101
The summary says in addition to Type 6 (non-volatile solvent and/or mechanical extractions) and Type 7 (volatile solvent extractions), CDPH is proposing two additional types of manufacturing licenses: a Type P license for businesses that will only package and/or label another manufacturer's products and a Type N license for businesses that only conduct infusions (e.g. create edibles, topicals, or other products using extracts from another manufacturer) and/or packaging and labeling their own products. A facility will receive a single license based on the activities it is conducting.
For publicly traded companies, the CEO and any person or entity with ownership interest of 5 percent or more is defined as an owner in the proposed regulations. For all other entity structures, any person or entity with ownership interest of 20 percent or more or any person who participates in the direction, control, or management of the cannabis business is considered to be an owner. All owners must disclose their spouse (or any other person who has a community property interest), including identifying information.
CDPH proposes that offenses related to the adulteration or misbranding of food, drugs, or dietary supplements will be considered substantially related and can be used as a basis for denial of an application. Except for specified convictions related to use of or sale to minors, prior controlled substances convictions will not be considered substantially related offenses.
The regulations address product packaging: In addition to statutory requirements (not attractive to children and tamper-proof), CDPH is proposing to prohibit packaging from resembling traditionally available food packages; require packaging to be resealable if it includes more than one serving; and require edible
products to be packaged in opaque packages. CDPH also proposes to require all manufactured products to be packaged in their final form prior to release to a distributor.
Besides the statutory requirements (not attractive to individuals under age 21, mandated warning statements, THC content), CDPH is proposing each label include a listing of all ingredients in descending order; the amount of sugar, sodium, and fat per serving; and a cannabis product symbol. The proposal will prohibit labels from making any claims of health or other physical benefit. CDPH also proposes to clarify what is considered "attractive to individuals under age 21," proposing that labels not be allowed to feature cartoons, images popularly used to advertise to individuals under age 21, or imitations of candy packaging or labeling.
The regulations include a one-time license application processing fee of $1,000 and annual license fees that will be scaled according to the gross annual revenue of the licensed premises, with the highest fee, $50,000, for those with gross annual revenue above $5 million. The fees are intended to cover operational costs, database development, track-and-trace program, and repayments to the General Fund.