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FDA: CBD oil not a dietary supplement

by DAVID COLE/dcole@cdapress.com
| August 19, 2015 9:00 PM

COEUR d'ALENE - Citing the legal gray area, at least one vapor smoke shop in Coeur d'Alene stopped selling liquids containing cannabidiol.

Others see cannabidiol, or CBD, as good for business and continue to make it available. But they are being cautious and checking with authorities to avoid trouble.

Meanwhile, the U.S. Food and Drug Administration concluded that CBD - which comes from cannabis - should not be sold as a dietary supplement.

"We've considered (ending sales), but we're going to go ahead with it," said Robert Gamble, who co-owns Best Ave. Vapor Store in Coeur d'Alene. "There's a lot of gray areas."

The shop, at 405 E. Best Ave., consulted with an attorney before continuing sales.

Chris Dosher, owner of CDA Vape, is no longer selling CBD products.

"I pulled all of the product out of the store until I can get more information from the legal side," Dosher said Tuesday. "I want to carry this product because it's helping people."

He said it provides pain relief and other medical benefits.

"My goal is to help these people get off prescription drugs," Dosher said. "The big pharmacy companies - that's who we should be pointing fingers at."

Todd Brewer, owner of Cheating Death Discount Vapor, contacted law enforcement before continuing sales.

"There's a lot of gray area," Brewer said, echoing comments made by others.

He offers multiple brands at his shop at 510 N. Fourth St.

He personally uses CBD for pain relief from gout.

"It seems like a miracle drug to me," Brewer said. "I'll stand up proud and look anybody in the eye and tell them it works for me."

Bo Sullivan Day, an owner of CBD products supplier Urban Wellness, said CBD derived from hemp is legal and falls under the definition of a dietary supplement.

"Basically marijuana and hemp are made up of the exact same stuff, but one has more (tetrahydrocannabinol or THC) and one has more CBD," Day said. "They off-balance each other - meaning you can't have high THC and high CBD. They share an amazing healing compound called CBD, but marijuana and hemp are not the same plant."

Urban Wellness gets its CBD products from CannaVest Corp., a manufacturer and distributor of hemp-derived CBD oil products.

CannaVest said on its website that there is a "strong legal argument" that production and distribution of CBD from hemp doesn't violate the Controlled Substances Act.

The company, with primary offices and facilities in Las Vegas and San Diego, said hemp has "little potential to produce high-content THC when pollinated."

CBD oil is a marijuana product to the federal Drug Enforcement Administration, no matter how low the concentration of THC. And marijuana is a Schedule 1 drug.

"If it's a controlled substance and it's not approved by FDA as a medicine, it isn't legal," said Rusty Payne, a spokesman for the DEA.

CBD is considered neither a dietary supplement nor an approved medicine by the FDA.

And since the FDA isn't regularly inspecting production of CBD products, consumers have to take the word of producers and sellers when it comes to quality of products and the levels of CBD they contain.

Gamble of Best Ave. Vapor and co-owner Brian Lux have tried to allay some concerns consumers might have about a lack of independent oversight of the products. They have provided an independent laboratory with CBD oil products from their store for testing, and they plan to pass the information on to customers.

The FDA is aware CBD products are sold on the Internet, marketed as available in all 50 states, and labeled as "hemp oil" that contains CBD, said Jeff Ventura, a spokesman for FDA.

And the agency is also aware that there is a growing public interest in CBD oils to treat childhood epilepsy, among other diseases, Ventura said.

"It is important, however, for patients and their caregivers to understand that these products have not been approved by the FDA, and those who choose to purchase these cannabidiol products cannot be assured by the FDA that they are safe or effective," he said.

The agency encourages people interested in experimental treatments such as cannabidiol to, if possible, gain access through clinical trials.

In February 2015, the FDA issued several warning letters to firms that market unapproved drugs, including some firms that claim their products contain CBD.

The FDA tested some of those products, and in some cases didn't find CBD.

"We understand that people have seen the benefits of (CBD), if the reports are true," said Payne, of the DEA. "But it's not legal under federal law."

Idaho law is no friendlier to CBD.

In April, Idaho Gov. Butch Otter vetoed a bill that would have given parents in the state the right to treat children with epilepsy with CBD.

Only legislators can change the laws on the national or state level, Payne said. Or the FDA can classify CBD as a medicine based on scientific research.

"They haven't done it with marijuana - they haven't done it with CBD," he said.