Situations like these have others in the hemp industry calling for increased oversight and more regulation.
Documents show the complaint was filed with the North Carolina Department of Agriculture and Consumer Services (NCDA&CS) which then sent inspectors to the Terrys’ home in Raleigh on Feb. 4. Soon after, inspectors also visited Sugarleaf Labs in Conover, the processing facility that extracts the cannabidiol (CBD) oil Medicine Mama’s uses in its products.
According to Sugarleaf Labs president Tod Coles, the company uses third party lab analysis to insure its products are safe.
“The NCDA inspected our lab in Conover and the certificates of analysis for the oil we produce and found no deficiencies,” he said. No other incidents have been reported since the company was founded in 2016.
[Image: Handwritten state inspection report given to Jimmie Terry of Medicine Mama’s following the NCDA&CS inspection.]
This inspection report is from the commercial kitchen location, not the residence where CBD-infused food products were being made previously as may be implied.
Joe Reardon, Consumer Protection Assistant Commissioner in the NCDA&CS, says his department is not conducting inspections in Charlotte and Asheville and that some business owners are confusing regular inspections for food safety with inspections for CBD compliance. His department is not authorized to conduct CBD-related inspections at this time. They can, however, inspect a kitchen used to make food for sale whether it’s a commercial kitchen or in your home, and they can launch an investigation following a complaint.
What Happened at Medicine Mama’s?
Jimmie and Stephanie Terry launched Medicine Mama’s in July 2018. They were motivated at first by the need to treat Stephanie’s fibromyalgia — and then by numerous requests from friends and family to create formulas to treat the symptoms from which they were suffering.
Sourcing hemp from local farms and using full-spectrum oil made by Sugarleaf Labs, Medicine Mama’s makes and sells edibles, smokables and health and wellness products for people and pets. They deliver their products in a food truck and plan to open a storefront soon.
Following the complaint from the woman who reportedly suffered a stomach ache after taking a dose of Medicine Mama’s CBD oil, Anita MacMullan, Director of the NCDA&CS Food and Drug Division (NCDA) and Daniel Gains, Food Administrator — the top positions in that division — visited the couple on two separate occasions, at home and at their commercial kitchen workspace at The Kitchen Archive.
“They were really cool — they were polite,” says Jimmie Terry, noting that the inspections were scheduled, not surprises. “They were thorough, but they had to do their job.”
Reardon wants you to know that complaint follow ups are unannounced and that the first visit to the Terry home, where Medicine Mama’s products were being produced at the time, was unannounced. He says the couple then invited them to inspect the commercial kitchen they were transitioning into.
Jimmie Terry says the state collected some samples for testing at state labs. “Normally they only test for Delta-9 (THC), now they’re testing for CBD. We’re kinda like the guinea pig.”
Carolina Cannabis News has requested from NCDA&CS the testing results in addition to inspection reports from both companies and will update this story when those documents become available.
Although the Terrys recently signed a five-year lease on the commercial space, they were still preparing some of their offerings at home. There, inspectors discovered two dogs inside and two pigs outside.
Reardon says inspectors observed pigs inside of the house. Stephanie Terry made a statement on our Facebook Page that reads, in part, “If it makes you feel ANY better, the cops that also showed up unannounced at my House at 9am with Anita and Daniel, asked to meet our pigs which is why they were released into our house.” That is not what Jimmie Terry told us in a taped phone interview; he said only the family dogs were inside of the house during the inspection. We have asked the NCDA&CS if Mrs. Terry’s statement is accurate and will update this story when we hear back.
“They told us because we have pets,” says Jimmie Terry, “that to get into full compliance we would have to use the commercial kitchen 100 percent of the time.”
Despite the pets, the inspectors’ report stated: “No objectionable conditions observed regarding the manufacturing of human food.” They also noted that they collected three product labels to review and talked about “the importance of allergen labeling.”
When asked if the business would be allowed to continue selling CBD-infused foods going forward (Medicine Mama’s edibles menu includes brownies, gummies and hard candy), Terry said he didn’t think it would get to a point where he wouldn’t be able to sell his products. The company also sells topical CBD products.
“It’s not only going to mess with our business but it’s going to hurt other businesses,” he said of a purported “crackdown.” “I truly don’t think that’s the way it’s going to go.”
And in the event the state tells them something different?
“We’ll figure out a way,” Terry said. “We’re not going to give up.”
Both Medicine Mama’s and The Kitchen Archive are registered processors through the NCDA&CS Industrial Hemp Pilot Program.
Calls for Stricter Oversight
For some business owners in the hemp industry, the move toward more state oversight is hardly a surprise — and actually welcomed.
“We have encouraged the NCDA to begin providing reasonable regulations on hemp processors and have agreed to work with the department to assist in developing such regulations,” says Cole. “Sugarleaf supports North Carolina’s efforts to make sure all products are safe.”
In January, Hemp Magik owner Melissa Clark told Carolina Cannabis News that without some kind of regulation it would only be a matter of time before a consumer got sick. She was sure then that such an incident would hurt the industry.
A Charlotte native, Clark worked as an elementary and special needs teacher for 20 years, mostly in Ohio. She moved back to the Tar Heel State five years ago, as she put it, “inspired by the natural beauty and all the hippies.”
Clark said she first got into CBD products to help her dog Luna who was suffering from severe seizures. Nothing on the market at the time helped. The full-spectrum oil she created did.
To make the transition from teaching to processing, Clark worked briefly at another hemp product company in North Carolina, but says she couldn’t in good conscience sell their products. Then, following what she describes as a fair amount of research and training, she started Hemp Magik out of her house. Later, she transitioned to a small lab, and in October 2018 opened a 1,200-square foot cGMP (Current Good Manufacturing Practices) lab space in Woodfin.
“This plant really is magic,” Clark said. “It helps with everything. I make stronger products at the same price point [as others with less milligrams and cannabinoids] and people really feel the effect.”
[Image: N.C. state Rep. Brian Turner (D-Dist 116) at Hemp Magik. Photo by Grant Baldwin.]
Story continues after videos.
[Video: Rep. Turner discusses the North Carolina hemp industry, the N.C. General Assembly Cannabis Caucus and upcoming cannabis reform legislation following a tour of Hemp Magik’s processing facilities. Jan. 23, 2019.]
[Video: N.C. state Rep. John Ager (D-Dist. 115), himself a farmer, toured Hemp Magik’s CBD processing facility in Asheville with Rep. Turner on Jan. 23, 2019. Afterward he spoke to Carolina Cannabis News about what he learned, the NCGA Cannabis Caucus and more.]
While passionate about the need for stricter oversight and regulation, with regard to the recent “crackdown” and potential loss of business for her and other companies, Clark is concerned about what the ultimate plan will be. “The biggest pharmaceutical companies have plans for how to own the market,” she said. “I feel bad for all these dispensaries. I don’t know what’s going to happen.”
For her part, Clark said she has never used a CBD isolate in her products and has been prepared for a crackdown on those that do since her company’s inception. But in order to follow U.S. Food and Drug Administration (FDA) and NCDA&CS recommendations regarding dietary supplements, Clark has pulled some of her products and put off plans to create gummies, inhalers and pain patches.
[Image: Melissa Clark, owner of Hemp Magik. Jan. 23, 2019. Photo by Grant Baldwin.]
Committed to creating the purest, safest, and most effective products, Clark tests the concentrated extract she makes to ensure it’s free of anything potentially harmful to the people that trust her with their health and well-being. She employs a sales staff with medical backgrounds to help people understand the possible effects of drug interactions when consuming her hemp products.
Clark advocates a push to make all processors cGMP certified. She also calls for farmers to grow under GAP (Good Agricultural Practices) certification, and stresses the urgent need for the N.C. General Assembly “to pass a bill that establishes a criteria for growing, manufacturing and dispensing that protects all of us.”
She recently voluntarily hosted two N.C. legislators for a tour of her lab. “I just wanted to show them what people in the industry are up to and talk about the need for standards,” she said. “I want my Made in Asheville stamp to be a good thing.”
Current Regulation and the “Crackdown”
“We are taking an educate before regulate stance with industry,” Reardon continued. “We know they may not be aware of the state laws regarding the addition of a drug to a food product. However, we reserve the right to be more assertive, as other states have been, if we need to be in the future. Our main concern is consumer health and safety with any product that falls under our regulatory authority.
NCDA&CS also sent a letter on Feb. 11 to North Carolina businesses that create CBD-infused foods and beverages as well as supplements containing CBD. The letter states, in part, “It is a prohibited act … to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved” by the U.S. Food and Drug Administration (FDA).
The letter is signed by Anita MacMullan, Director of the NCDA&CS Food and Drug Division; one of the inspectors who visited Medicine Mama’s.
The letter, which is expected to be delivered to all hemp and CBD processors in North Carolina this week, goes on to say that a CBD isolate is the active ingredient in new drug Epidiolex, which treats epilepsy and has been approved by the FDA. As such, it is not legal to be used as a dietary supplement.
Officials say they are just advising companies regarding the FDA’s stance and that neither fines or penalties will be imposed at this time. That is subject to change.
Tinctures of full-spectrum CBD oil and topicals fall outside of the FDA’s Dec. 20 directive, issued immediately following the signing of the 2018 farm bill. The NCDA&CS is deferring to the FDA on the issue.
Reardon says all CBD extracts are included in this prohibition. In this instance, the descriptor “full-spectrum” doesn’t matter — tinctures for use as topicals are not prohibited. It’s extracted CBD for use as supplements or as additions to food, drink and dog food that are banned.
Below is an interactive copy of the NCDA&SC draft letter, issued to media last week. If you have trouble reading it, click here.
In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act.
Neither the NCDA&CS letter nor the FDA memo distinguished between CBD isolate and full-spectrum CBD (which also includes cannabinoids like CBN and CBG, terpenes and trace amounts of THC) or broad-spectrum CBD (similar to full-spectrum, sans THC.)
In January, the World Health Organization recommended to the United Nations that CBD be completely descheduled and that high-THC cannabis be reclassified to a less restrictive classification under international treaty.