Ensuring the Safety of Marijuana Edibles

Most all other edibles producers in California currently include nutrition labels on their products voluntarily.

What About HACCP?

According to the SFDPH, no edibles requiring refrigeration or hot-holding shall be manufactured for sale or distribution at a medical cannabis dispensary due to the potential for foodborne illness. Exemptions may be granted by the SFDPH on a case-by-case basis. For such exempted edible cannabis products, ice cream and other dairy products for example, SFDPH may require a Hazard Analysis and Critical Control Points (HACCP) plan.

At the federal level, marijuana remains classified as a Schedule I substance under the Controlled Substances Act, where Schedule I substances are considered to have a high potential for dependency and no accepted medical use, making distribution of marijuana a federal offense.

“Regardless of the state of origin of any medical marijuana products, edible or otherwise, such products are not allowed to be transported across any state lines,” Carella mentions. “There is absolutely no interstate commerce, so legally consumers are not supposed to move them across state lines even if they are moving from one state to another.”

Not surprisingly, to date, the U.S. FDA has not approved a marketing application for marijuana for any indication, including medical use.

That said, the FDA currently holds no jurisdiction or power over U.S. commercial edibles, which are allowed to be produced and sold in some states courtesy of specific state statues. Nonetheless, Auntie Dolores follows basically all of the food safety measures any food company would implement, Carella says. “We use a HACCP plan, even though our products don’t require refrigeration or hot-holding,” she boasts.

Intelligent Regulations, Please

“I don’t believe there should be any restrictions as to the types of products we make, be they temperature sensitive or otherwise,” Carella asserts. “We want regulations in California, but we want intelligent regulations. The current regulatory climate here does not inspire one to avoid purchasing edibles from the black market.”

With a staff of 20 people, including six to eight in production, Auntie Dolores operates out of two rented facilities in confidential locations, manufacturing more than 5,000 units of product per month. As an example, a canister 5 inches in diameter containing 30 sugar-free, low glycemic pretzels (in an inner zip lock bag) counts as one unit. “Each pretzel is designed to individually deliver an optimal dose of THC, with a full mg content of 120 mg THC per canister of pretzels,” Carella relates.

(By the way, Carella says most California landlords won’t rent space to an edibles producer. And because of the manufacturing sites being kept confidential, Carella adds that bioterrorism isn’t a main concern of her company.)

It’s a federal crime for cultivators in any state to sell cannabis plants or byproducts to buyers in other states, so all Auntie Dolores edibles are made with THC and cannabidiol (CBD) derived from cannabis grown in California. CBD is a non-psychoactive cannabinoid purported to provide anti-inflammatory and anti-anxiety benefits.

“The hemp-derived CBD that we use comes from the seed and stalk of plants that are cultivated in Europe,” Carella mentions.

Carella purchases cannabis plants and extracts from a local cooperative of growers. “We use a van to pick these materials up, and we have sales representatives and a distributor that pick up our finished products and deliver them to the dispensaries” she relates.

Auntie Dolores is actually part of this cooperative. “Anybody that touches the plant, from growers to manufacturers in our kitchen, to retailers and documented patients, are considered members of our cooperative,” Carella explains.

Product Testing

Legalization of medical cannabis has allowed the laboratory testing of medicinal cannabis products. Any testing of cannabis or cannabis products must be conducted at labs in the states where they are produced. “Some of the biggest potential contamination concerns during cultivation or extraction are pesticides, heavy metals, mycotoxin, and aflatoxins,” Carella says.