Tuesday 20 December 2016

Marijuana & Massage: Are CBD Pain-Relief Products Caught Up in New DEA Rule?

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gavel and marijuana leaf

At a Glance

  • Topical products derived from cannabis are used by many people to effect pain relief.
  • The DEA has issued a new rule that established a drug code for extracts of all forms of cannabis, which includes hemp-derived extracts.
  • This new rule does not reclassify cannabis extracts into a new drug schedule.
  • Hemp has less than 0.3 percent THC and doesn’t get people high like marijuana does.
  • In some states, the cultivation and distribution of hemp-derived products is legal. In other states, it is not.

DEA Issues New Code for Extract

Cannabidiol (CBD) personal-care products include topical products such as patches, salves and oils, and are created from hemp, a cousin to marijuana. Some massage therapists, chiropractors and the general public have embraced CBD products for pain relief.

Now, many people in the cannabis industry are scrambling to interpret a new rule issued by the Drug Enforcement Administration (DEA) on Dec. 14 titled “Establishment of a New Drug Code for Marihuana Extract”—and to determine if it could affect manufacturers and distributors of hemp-derived products. The rule is scheduled to take effect Jan 13, 2017.

What has resulted is curiosity on the part of some hemp advocates regarding whether or not the new code will have an effect on the CBD industry.

What is seems to come down to is whether a CBD product is ingested or applied topically.
DEA spokesperson Russ Baer told MASSAGE Magazine that CBD lotions, topical ointments and patches are exempt from controls under the Controlled Substances Act, while edible hemp-derived products are not.

Increased Vigilance?

Plants of the genus Cannabis include both hemp and marijuana. Industrial hemp contains less than 0.3 percent THC; therefore, CBD oil derived from hemp seeds does not effect the high commonly associated with marijuana, while CBD oil derived from marijuana seeds contains an appreciable amount of THC.

According to the Office of the Federal Register, a new Administration Controlled Substances Code Number was created for marijuana extract in order to better allow quantities of extract material to be tracked apart from quantities of marijuana, and therefore help in complying with international drug control treaties.

The action taken by the DEA was to amend the Code of Federal Regulations related to food and drugs, to include a new subparagraph that creates a new code, 7350, pertinent to CBD extracts. Until now the DEA had used code 7360 for marijuana, or cannabis, and everything derived from it.

Some cannabis advocates say that with this change, the DEA is signaling increased vigilance over interstate hemp-product distribution, while Baer indicated the code change was more along the lines of administrative housekeeping meant to better reflect the activities of scientific research.

“Some attorneys are interpreting it as, ‘This is DEA sending up a red flag’ regarding whether it’s legal to move hemp across state lines or not,” Deputy Director of the National Cannabis Industry Association Taylor West told MASSAGE Magazine.

It’s possible that due to this rule, hemp-derived product distributors could be in violation of federal law when shipping such products across state lines, West said—but whether or not all those distributors were actually in compliance with federal law before now is not clear either.

“Certainly lots of people have made that case [for compliance], but I would not consider that to be a 100-percent accepted theory,” West said.

What is known is that in the 24 states that are in compliance with Section 7606 of the Agricultural Act of 2014, also known as the Farm Bill, it is legal to grow and distribute hemp, because that section “defines hemp as distinct from marijuana and does not treat it as a controlled substance when grown under a compliant state program,” according to a Dec. 14 press release published by the Hemp Industries Association.cannabis word cloud

Lack of Clarity

Despite laws on the books pertaining specifically to hemp products, there has been a lack of clarity among the public, the media and even hemp advocates about whether hemp-derived CBD products for pain relief fall under the Controlled Substances Act that lists marijuana as a Schedule I drug—a class that also includes LSD and heroin; therefore, many companies have operated under the belief that hemp-derived CBD products were not under the controlled substances act, West added, “and they have been moving products across state lines and selling them in nonregulated areas.”

However, official sources say all forms of cannabis, including hemp, have always been included under Schedule I. For example, the Industrial Hemp Facts published by the Kentucky Department of Agriculture—Kentucky being one of the states that is in compliance with Section 7606 of the federal Farm Bill—reads, “Under the current U.S. drug policy, all cannabis varieties, including hemp, are considered Schedule I controlled substances under the Controlled Substances Act.”

Yet, in recent years, various governmental entities have acknowledged the differences between hemp and marijuana, and have legislated accordingly.

In California, for example, the California Industrial Hemp Farming Act, passed in 2013, revised the definition of marijuana to exclude industrial hemp, and defined industrial hemp as a “fiber or oilseed crop, or both,” that contains less than 0.3 percent of THC and that is intended to be used for fiber or oil derived from the stalks or seeds.

Then in 2014, President Obama signed into law the Farm Bill, which included an amendment to legalize hemp cultivation for research-related purposes.

Yet, just as medical- and recreational-marijuana laws vary from state to state, so too do laws applying to the cultivation of hemp. While some states have approved hemp-cultivation laws, in 20 states and the District of Columbia, cultivation of hemp is illegal.

One thing is clear: As a growing number of U.S. states legalize marijuana for medical or recreational use, the number of people in the general population who are turning to marijuana and its more sedate cousin, hemp, is growing as well.

Even with the lack of consistent regulation, CBD products are big business. According to the Hemp Business Journal CBD Report, by the year 2020 the CBD market will increase by 30 percent to $2.1 billion, with $450 million of that derived from hemp-based sources.

Glossary of Terms

  • Cannabis: the genus of plant to which both marijuana and hemp belong.
  • Cannabinoid: chemical compounds found in cannabis plants; there are more than 100 active cannabinoids in cannabis.
  • THC: a cannabinoid that has psychotropic effects.
  • Cannabidiol: a cannabinoid that has pain-relieving and other effects, minus the psychotropic effects of THC.
  • Marijuana: a cannabis plant bred for a high THC content.
  • Hemp: a cannabis plant containing less than 0.3 percent THC.

cbd products for pain relief

The New Code

According to Baer, the DEA uses a four-digit code for any controlled substance for the purpose of registration, “so whether you are a manufacturer, importer-exporter, or a researcher, anyone that’s handling a controlled substance, you complete that DEA form with a drug code.

“The establishment of the marijuana extract code allows us to process these applications more efficiently and give priority to researchers that are wanting to do medical scientific research on extracts,” he added.

Further, Baer provided input into an article titled “New DEA rule on extracts, CBD causes commotion in cannabis industry,” written by a reporter with The Cannabist online publication. In his email to The Cannabist, Baer said, “We have not changed any control status with this Federal Register Notice … Everything remains schedule I, so no other provisions of the law (registration, security requirements, research protocols, etc.) change. Companies will simple [sic] use a new code for extracts.”

National Hemp Association Assistant Director Alli Cloyd told MASSAGE Magazine she would tell CBD-product manufacturers and users, “Don’t be worried at this point.”

CBD Clinic co-founder David Goldsmith shared Cloyd’s view; he said as soon as his company’s staff heard about the new code, they immediately spoke with legal counsel and were told the code will not have an impact on the hemp industry.

He told MASSAGE Magazine that once the DEA posted the code change on its website, “this got picked up by people in the media who took it as something entirely new and a new threat, when in fact it really isn’t that.”

CBD Products for Pain: Wait and See

Meanwhile, what does all this mean for the companies manufacturing and distributing CBD products, including topical products such as patches, salves and oils intended for pain relief?

According to Goldsmith, CBD topical companies should not be worried by this code change; they should only be be worried if they are making medical claims for which the Food and Drug Administration (FDA) could come after them.

“If you have a CBD topical and all it says is ‘CBD topical for skin,’ that’s not a medical claim,” he said. “You can’t distribute a product that makes medical claims if it doesn’t have an FDA-approved component.”

Others suggest a wait-and-see approach, tempered with caution.

Companies need to realize they have already been operating in a somewhat gray area, West said, “and if you have been told by attorneys that it is not a gray area, they may not be doing you the best service—which is not to say these businesses should not be taking this risk, but they should understand there is a risk involved.”

Of Baer’s statement to The Cannabist, West said Baer seemed to be implying that the DEA is not planning to go out of its way to target CBD companies that are producing hemp-derived CBD products and selling them, “but you can weigh that against the fact that one of the express [DEA] priorities is to prevent interstate commerce of marijuana products, so now you could be opened up to risk that wasn’t as stark before.”

Hemp advocates are ready to fight back should the code change threaten the manufacture and distribution of CBD products.

“DEA has stated that CBD is a controlled substance previously,” stated a Dec. 15 press release from the Hemp Industries Association. “HIA strongly disagrees with the DEA position and is ready to take action to defend should DEA take any action to block the production, processing or sale of hemp under Sec. 7606 [of the Farm Bill].”

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