Mike Wright, general manager at Eddie’s Health Shoppe, explains what CBD oils are and how to find them on July 26, 2018. Knoxville News Sentinel
Is it legal? Maybe. But purveyors of CBD oil arenât afraid of prosecution â itâs available online, from health food stores, vape shops, even some Knoxville-area convenience stores.
And now itâs going mainstream, indeed upscale, with the mid-July opening of CBD American Shaman, at 150 Lovell Road.
âWe are more like a high-end salon,â said Todd Bliss, manager of the franchise location.
The store in The Shops at Lovell Road near Turkey Creek, wedged between Mountain Oak Vapors and Lennyâs Subs, is an open lounge area decorated in beige and wood tones. American Shaman is open 10 a.m. to 7 p.m. Monday through Saturday, and noon to 6 p.m. Sunday.
âWhat really makes us unique is we have gone mainstream. We are not in a head shop or vape shop,â Bliss said. âOur customers are generally older, and may not feel comfortable going in those places.â
He has younger customers too, but the target demographic is an older, female suburbanite with frequent pain.
âOur average customer is 60 years old,â Bliss said.
CBD is short for cannabidiol, a chemical found in the cannabis plant. Cannabis is the source for both marijuana, which also contains the high-producing chemical THC, and industrial hemp, which has very little THC. The CBD oil sold openly is made from hemp, but old and vague definitions make it unclear whether thatâs sufficiently different from marijuana to be legal.
It is legal under Tennessee state law, but recently officials at the Y-12 National Security Complex and U.S. Department of Energy facilities in Oak Ridge reiterated to about 10,000 employees and contractors that federal policy still treats CBD oil as a Schedule 1 drug. Thatâs in part, according to a Y-12 spokesman, because CBD oil can turn up on a urine test as marijuana.
Bliss said heâs never heard of a customer failing a drug test because of American Shamanâs CBD oil, but he also sells a product with zero THC for anyone whoâs concerned about it. American Shaman products have less than 0.3 percent THC, he said.
âOne of our marketing slogans is âHelp without the high,ââ Bliss said. âYou could drink all the inventory in here and you still wouldnât get high.â
American Shamanâs corporate website says its incoming supplies must be tested by the FDA, DEA and Homeland Security to make sure its THC content is âessentially nonexistent.â
A DEA statement on CBD, hemp and the 2014 federal âFarm Billâ said making and selling CBD oil breaks two federal laws: the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act. Despite its low level of THC, federal laws still legally classify CBD as marijuana; plus, the actual content of purported CBD products is unregulated, and therefore uncertain.
Itâs a public misconception that the 2014 bill generally legalized hemp and CBD, according to the statement; in fact, it only allowed universities and state agriculture departments to grow low-THC hemp for research, where state laws permit.
FDA Press Officer Michael Felberbaum referred to a Q&A on the agencyâs web page, headlined âFDA and marijuanaâ and last updated June 25, which acknowledgesÂ that âmarijuana or marijuana-derived productsâ are being used for conditions including AIDS-associated weight loss, epilepsy, neuropathic pain, multiple sclerosis, cancer and chemotherapy-induced nausea.
The agency has approved one drug containing cannabidiol, Epidiolex, for some childhood seizures; and for other conditions, three more drugs with synthetic compounds similar to THC. But the FDA maintains more clinical studies are needed on the effectiveness of âmarijuanaâ for anything.
It cautions against use of âuntested drugs,â especially for children and pregnant or nursing women.
Bliss said he wonât sell CBD oil to anyone under age 18.
âI wonât give it to a kid, but they (parents) can,â he said.
The 2014 farm bill, which referred to âindustrial hemp,â didnât change the FDAâs stance on drug research or marketing claims. The FDA has also concluded that CBD products donât fit the definition of âdietary supplements,â since itâs actively being investigated as a component in new drugs.
Itâs not legal to sell across state lines food to which THC or CBD has been added, the FDA maintains. But the agency is equivocal on its enforcement of CBD bans in dietary supplements and food additives, citing limited agency resources and the low relative threat to public health, as well as the opinion of law enforcement agencies.
For several years the FDA has sent warning letters to firms marketing âunapproved new drugs that allegedly contain cannabidiol (CBD).â
âAs part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain,â said an FDA website notice. âIt is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease.â
Letters went to 18 companies in 12 states; none were in Tennessee, and Kansas-based American Shaman was not on the list.
As a product of the marijuana plant, CBD oil is still classified as a Schedule 1 drug, said Barbara Carreno, DEA public affairs officer. But because of the FDAâs approval of Epidiolex, the DEA is taking 90 days to consider downgrading CBD to a lower classification, she said. That period ends Sept. 24.
Just the medication could be downgraded, or CBD could be in general â not full legalization, but a lesser penalty, Carreno said.
The approved prescription medications with synthetic THC were rated as Schedule 3 or 4 drugs, she said; those include steroids, Hydrocodone, many sedatives and the mildest opioids.
But for enforcement actions, CBD oil is not a high priority for the DEA, which has only 700 investigators to oversee manufacture and legal distribution of controlled substances, Carreno said.
Due to a 2004 Ninth Circuit Court of Appeals injunction, the DEA no longer enforces the controlled-substance regulation which bans human consumption of products derived from cannabis plants, according to a May 22, 2018, internal agency directive.
âProducts and materials that are made from the cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA,â the directive says. âSuch products may accordingly be sold and otherwise distributed throughout the United States without restriction under the CSA or its implementing regulations. The mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA; the dispositive question is whether the substance falls within the CSA definition of marijuana.â
That applies to imports as well.
American Shaman, based in Kansas, has been in business for more than three years. It has nearly 100 retail stores nationwide, and many more small dealers via phone and mail. This is its first retail franchise in Tennessee, but Bliss said it wonât be alone for long: he plans to open another in Bearden Hill within 90 days. After that, the franchise-holder is looking at locations in Halls, Fountain City, and on the University of Tennesseeâs campus, Bliss said.
âA lot of college kids take it for anxiety and depression,â he said.
Bliss sells CBD oil to customers with chronic pain, anxiety, diabetes and other conditions. Some pain patients are sent by doctors or pharmacists, he said.
âThe medical community is aware that CBD can help certain people with certain things,â Bliss said. âWe donât make medical claims, but it has helped a lot of people.â
He sells a water-soluble oil, to be placed under the tongue or drunk with water; capsules; gummies and candy; tea; vape fluid; and âequine ointmentâ topical cream â literally designed for horses, but usable on humans too, Bliss said. Most prices run from $20 to $80.
Thereâs also a body lotion for skin conditions, and treats or food additives for animals: cats, dogs or horses with pain or anxiety, he said.
The FDA warns against giving marijuana products to pets, but doesnât cite any reports of adverse effects from them.
âHowever, adverse events from accidental ingestion are well-documented in scientific literature,â the agency says, again referring to high-THC marijuana.
What makes American Shaman different from other CBD oil makers is a proprietary process that breaks its molecules down into nanoparticles, increasing its absorption rate into the body from 10 percent to nearly 100, Bliss said.
American Shamanâs hemp comes from Norway, and is processed at the companyâs Kansas headquarters, Bliss said. He also sells regular CBD oil â not treated with American Shamanâs proprietary process â but not much of it, because of the regular oilâs lower absorption rate, he said.
Of American Shamanâs special version, the fastest-acting products are the water-soluble oil, vape fluid or ointment, from which customers can feel effects within 10 minutes, Bliss said.
He offers free samples of the oil or ointment for use in the shop.
âYou can try it before you buy it,â Bliss said.
A June 25 statement from FDA Commissioner Scott Gottlieb called for careful, rigorous research on CBD oil, and denounced some purveyorsâ claims.
âThe FDA has taken recent actions against companies distributing unapproved CBD products,â Gottlieb wrote. âThese products have been marketed in a variety of formulations, such as oil drops, capsules, syrups, teas, and topical lotions and creams. These companies have claimed that various CBD products could be used to treat or cure serious diseases such as cancer with no scientific evidence to support such claims. Weâll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims. Weâre especially concerned when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits.â
Read or Share this story: https://knoxne.ws/2OTWq9a