Designing Awesome Edibles – Clark Howell LLP

Happy New Year!

Hope you had some rest and are feeling refreshed to start this new decade
together! Thank you for choosing us as your guides on the Green Frontier. As
new hills and valleys and crossings come into view, it’s a privilege and honor to
see you succeed in this dynamic and challenging landscape.

With the start of the new year, we are given a new decade and a new opportunity
to make California legal cannabis what it can and should be. Of course, regulatory
complexity persists and legislative changes and tax increases continue to create
challenges. But that hasn’t stopped you and it won’t stop us from continuing to
help you navigate unchartered territory. Let’s keep moving forward.

The General

January 1 – Two New Rules

As we head into January, there is so much in the pipeline. The legislature reconvened this week with several important issues on the table for policymakers, including tax reform, vaping, and continuing to refine the B2B supply chain. And two important new rules went into effect as of January 1:

New cultivation and excise tax rates and
CR Packaging required for all products before retail.

The Specific

Edibles Refresher

Are you designing a new edible this year? Or doubling down on the awesome product you already make? If so, there is more to consider than simply the CDPH regulations. Indeed, even as edibles are still a controlled substance at the federal level, there are relevant and applicable federal regulations to consider.

Health Claims

Do not make claims that your product cures any disease, ailment or otherwise relieves pain or anxiety. Such statements may be considered misleading or unsubstantiated by the regulators. Check out this warning letter for examples of language the FDA considers problematic. We have recently noticed an uptick in cease and desist letters sent by the FDA to California hemp businesses making “misleading” or “unsubstantiated” health claims.

The California Department of Public Health is responsible for enforcing these rules for cannabis manufacturers. The language characterized as “problematic” by the FDA offers cautionary guidance about what to avoid in your marketing or advertising materials.

PROP 65 WARNINGS: ALL EDIBLES, NEW RULE

All products containing THC (NEW) and/or Beta-Myrcene must include the Proposition 65 on-product warning for reproductive harm, cancer or both. Refer to our previous bulletin (sent on December 23) for more information.

FDA APPROVED INGREDIENTS ONLY

FDA Approved Ingredients ONLY. All ingredients and components of edibles (other than cannabis) must be permitted by the United States Food and Drug Administration (FDA) for use in food or food manufacturing by either:

(A) being specified in the list of Substances Added to Food in the United States, available at this link or;
(B) by being Generally Recognized as Safe (GRAS) under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (codified in 21 U.S.C 321(s) and 21 U.S.C. 348).

No booster additives. Additionally, edibles cannot contain any non-cannabinoid additive that would increase potency, toxicity, or addictive potential, or that would create an unsafe combination with other psychoactive substances. Prohibited additives include nicotine and caffeine unless the caffeine is naturally occurring (as it is in coffee, tea, or chocolate).

No commercial candy. Don’t take a commercially available candy or snack food item and simply apply concentrate or extract to create an infused version. You can make something way better anyway! For example, an infused Oreo cookie would be prohibited, but the cookie may be allowed as
an ingredient under certain conditions (detailed in CDPH Regulation, Section 40300).

PACKAGING & LABELING

CR PACKAGING REQUIRED 1/1/2020
Remember that as of the start of 2020, the child-resistant package requirement can no longer be met through the use of a child-resistant exit bag at retail. The product itself must be in child-resistant packaging.

OPAQUE & CR
Edible packaging must be opaque and child-resistant for the life of the product.

CR WHEN OPENED?
A package containing more than one serving is not required to be child-resistant if each individual serving is packaged in child resistant
packaging.

NO PHOTO
Don’t include a picture of the edible on the package label.

“CANNABIS-INFUSED”
The primary panel should include the words “cannabis-infused” just above the product identity and in a larger text size.

NAME OF MANUFACTURER.
Don’t forget to include the name of the licensed manufacturer, a contact number or website address, and all other
informational panel requirements specified in Section 40408 of CDPH regulations.

KEY TERMS

EDIBLE CANNABIS PRODUCT

“Edible cannabis product” means a cannabis product intended to be used orally, in whole or in part, for human consumption. Under CDPH regulation, “edible cannabis product” includes cannabis products that dissolve or disintegrate in the mouth, but does not include cannabis concentrates such as extracts, vape cartridges, tinctures, and inhaled products.”

Examples: gummies, chocolates, and sublinguals.

ORALLY-CONSUMED CONCENTRATE

“Orally-consumed concentrate” means a cannabis concentrate that is intended to be consumed by mouth and is not otherwise an edible cannabis product.

Examples: tinctures, capsules, and tablets.

TABLET

“Tablet” means a solid preparation containing a single serving of THC or another cannabinoid that is intended to be swallowed whole, and that is not formulated to be chewable, dispersible, effervescent, orally disintegrating, used as a suspension, or consumed in a manner other than swallowed whole, and that does not contain any added natural or artificial flavor or sweetener.

This email is provided as informational only and does not constitute legal advice.

If you have any questions about compassionate use donations, please contact your attorney directly or call our main line at 877-257-2442.

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