Hemp derivative faces uncertainty as FDA weighs regulations
Customers visiting Your CBD Store in Ormewood Park fear they are doing something illegal just by walking in the door.
“They come in whispering, ‘Am I on camera?’” said co-owner Khadijah Jones, who opened the store in August, one of more than 500 affiliates nationwide selling everything from tinctures placed under the tongue to pet products.
Consumers and some businesses have reason to be confused.
Products with cannabidiol, commonly referred to as CBD, have taken the market by storm this year, with retail sales topping $1 billion according to some estimates. Much is in the form of pills. But it is also increasingly mixed into hand cream and bath bombs, body butter and olive oil, coffee, tea and sparkling water.
Despite spotty scientific backing, aficionados tout it as a natural alternative to prescription medications, a magic bullet that eases not only anxiety but also pain, insomnia, seizures, addiction and eating disorders.
As CBD goes mainstream, though, questions remain not only about the safety and quality of products but also their legality.
CBD is derived from hemp, a cousin of the resurgent marijuana plant. As state and federal authorities legalize hemp and hash out the rules around marijuana, a cottage industry of related products is also up in the air.
The Food and Drug Administration said it is studying the safety of CBD products and will give an update – and potentially more regulations — in the coming weeks. To date, the FDA has only approved one CBD product: Epidolex, a medication for treating two rare forms of epilepsy. Beyond that, “it cannot conclude CBD is generally regarded as safe.”
As of now, businesses can sell CBD oils if they don’t make unsubstantiated health claims and products contain only trace amounts of THC, the compound that gives marijuana users their high. Authorities haven’t approved CBD being added to food and drinks — but also generally haven’t cracked down on businesses that do.
In November, the FDA sent warning letters to 15 companies across the country for illegally selling products containing CBD in ways that violate the Federal Food, Drug, and Cosmetic Act. That included Sunflora, Your CBD Store’s corporate owner, for selling human and animal foods containing CBD as well as marketing its SunMed products as a treatment or cure for health conditions such as cancer, diabetes and opioid addiction.
In a statement, Sunflora said it does not believe it is violating federal law but is taking the FDA’s concerns very seriously. “We are just as committed to public safety as the Federal Government,” it added.
Meanwhile, CBD’s fans keep growing.
Danielle Brunson, a 39-year-old Atlanta yoga instructor, turned to CBD in May to alleviate anxiety and depression.
“It is something new, and I was hopeful but wasn’t 100% sure it was going to make a change,” Brunson said.
Within days, Brunson said she saw significant improvement. Now she teaches a yoga class called “CBD & Chill.” She sticks to a brand that is tested by third parties, lists all ingredients and contains less than 0.3% THC – far less than the 15% or more often found in recreational marijuana.
Dr. Nora Volkow, director for the National Institute on Drug Abuse, believes some CBD claims are legitimate but others are hype. Research indicates it might help reduce seizures, anxiety and some types of pain, but also that high doses could harm the liver. The biggest danger from CBD is that patients will use it instead of other treatments proven to be beneficial, Volkow told The Atlanta Journal-Constitution in an interview earlier this year.
Georgia Department of Public Health spokeswoman Nancy Nydam said state food safety inspectors are trained to ask if restaurants and other establishments use unapproved additives like CBD and look for signs of CBD use. She said she is unaware of any fines but that some establishments have been told to stop using CBD.
With CBD in legal limbo, local businesses are acting differently depending on their appetite for risk.
Last year, Scotley Innis left his executive chef position at 5Church in Midtown to start a culinary business spotlighting Jamaican cuisine. When federal and Georgia state laws surrounding hemp loosened, he hoped it would spark more business for his fledgling company, particularly since his pop-up dinners featured CBD in the food.
Yet, soon after Gov. Kemp signed House Bill 213 to legalize local hemp farming, Georgia Department of Agriculture Commissioner Gary Black warned that CBD in food and drinks was still prohibited and remained “unlawful” nationwide. With the exception of preparing CBD-infused dishes for a pop-up held Nov. 12 in Atlanta, Innis has refrained from cooking with CBD and serving it to customers.
“I wouldn’t want to face any repercussions,” said Innis.
Others continue to at least dip their toes. In January, Cultured South founder and Golda Kombucha brewmaster Melanie Wade produced what may be the first CBD-infused beverage in Georgia. Since the debut of her grapefruit and rosemary kombucha, Wade has experimented with numerous other CBD-infused kombucha flavors, currently offering a couple on draft in Cultured South’s West End taproom.
When customers inquire, Wade said she explains her CBD-infused kombucha uses hemp oil extracted from a hemp plant and that her drink contains no THC. Posted behind the bar is a certificate of analysis.
“I don’t want to come off as a business owner carelessly doing this,” said Wade. “We’re doing it in the most legit way I know.”
Kegs of CBD-infused Golda kombucha can also be found in other area restaurants and bars, including Cypress Street Pint and Plate in Midtown, the Lost Druid Brewery and the Beer Growler in Avondale Estates, Citizen Soul in Alpharetta and some Taco Mac locations.
But Wade has held off on offering the product in cans for retail sales.
That is in contrast to Kill Cliff, an Atlanta-based beverage company ramping up production of its portfolio of canned CBD drinks. Kill Cliff launched its first flavor, Orange Kush, in July and rolled out two more flavors last month. The drinks are sold on its website and at stores like Gold’s Gym in Texas and California.
Kill Cliff currently only manufactures in Georgia. But to keep up with demand, including shipping 60,000 12-packs early next month, it plans to produce CBD beverages in three states next year.
“It’s turned out to be an explosive business for us,” said Chief Operating Officer John Timar, adding he believes the company adheres to all guidelines governing the sale of hemp-derived products.
Analysts at New York-based investment bank Cowen & Co estimate the U.S. market for CBD products could reach $16 billion in retail sales by 2025, a marked jump from between $600 million and $2 billion last year. Cowen also found nearly 7% of 2,500 people polled earlier this year had used CBD.
The FDA will have the most say in how CBD will be regulated in the future. Even though last year’s Farm Bill legalized hemp under federal law, removing it from the Controlled Substances Act, it preserved the agency’s oversight of products derived from cannabis.
Whitt Steineker, a Birmingham, Ala.-based attorney who advises clients on cannabis laws, said the FDA could go in two directions. It could move gradually towards a regulatory regime where CBD is regulated but also allowed in foods and drinks. Or, if it believes it lacks the resources to regulate an industry that has “demonstrated a willingness to bend the rules,” as he puts it, the FDA might dramatically step up enforcement action.
The FDA, Steineker added, is looking at the ubiquity of CBD and a possible scenario where you could have someone “who wakes up and brushes her teeth with CBD toothpaste, uses CBD mouthwash and puts CBD in her eggs and has a month’s worth of CBD before her second cup of coffee.”
Other government branches will also have input. The Department of Agriculture is working on federal rules for hemp production. Locally, the Georgia Department of Agriculture is responsible for ensuring that hemp products processed in Georgia do not exceed 0.3% THC.
In the meantime, Atlanta shoppers aren’t having much difficulty finding someone to sell them CBD as products continue to proliferate.
Behind the register at Higher Standards in Ponce City Market was a glass case filled with a selection of CBD products from brand names such as Bloom Farms, Mary’s Medicinals, Lord Jones and Social CBD.
Naomi Walker, assistant store manager, brought out trays with assorted products and sat with customers on a comfortable couch. She invited them to smear lotion on their hands and apply menthol CBD muscle rubs. She also advised consumers to stick with brands tested by third parties and track how they feel before and after using the products.
“After they leave, some people are more aware,” Walker said. “And some come in, realize where they are, and run.”
What is CBD?
CBD is short for cannabidiol, one of more than 80 known chemical compounds (cannabinoids) found in the cannabis plant. It is derived from hemp, a cannabis plant with 0.3% or less of tetrahydrocannabinol, or THC, the psychoactive substance found in marijuana. Cannabis oil used for medical purposes, known as medical marijuana, can have up to 5% THC. In states where marijuana is fully legal, THC levels have jumped as high as 17-28% in some plants.
With so many CBD products on the market, the terminology can also be confusing. Here are some of the most common terms and their meanings:
CBD Hemp Extract: The general term for CBD extracted from the leaves, flowers and stalks of the hemp plant.
Hemp seed oil: Taken from the seed of the plant, this has no CBD but does have high levels of omega 3 and 6.
Full Spectrum Hemp Extract: Typically taken from the whole plant this contains CBD and other cannabinoids. It may contain trace amounts of THC but it cannot be above the legal limit of 0.3%.
Broad Spectrum Hemp Extract: Includes a range of cannabinoids including CBD but not THC.
CBD Isolate: Contains only pure CBD with all other cannabinoids removed.
Sources: The Atlanta-Journal Constitution; Higher Standards Atlanta
Here are some examples of CBD products being sold in Atlanta:
Lord Jones candy
Mary’s Nutritionals capsules
SunFlora body lotion
SunMed topical cream
SunMed water soluble CBD
SunMed soft gel capsules
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