Photo of Nathalie Bougenies

Located in Harris Bricken's Portland office, Nathalie practices corporate law, intellectual property, real estate, and litigation, enabling her to assist companies with a wide range of legal and business challenges.

HEMP CBD FULL SPECTRUM HEMP FDA
… FULL SPECTRUM  HEMP?

In a recent post regarding the labeling requirements surrounding dietary supplements containing industrial hemp-derived CBD (“Hemp-CBD”), we alluded to a recent movement in the industry to rename Hemp-CBD products “full spectrum hemp.” We now take a closer look at the reasons behind this shift in nomenclature.

Part of the impetus behind this movement might be linked to a 2001 court decision pertaining to the status of lovastatin, a compound found in red yeast rice.

Although red yeast rice had been used for healing purposes for thousands of years, the isolated compound was approved by the FDA as a drug in the treatment of cholesterol. Despite the FDA approval, companies continued to sell and market lovastatin as a dietary supplement. One of these companies was Pharmanex. The FDA challenged the sale and marketing of Pharmanex’s product, Cholestin, and ultimately prevailed when Pharmanex challenged the FDA’s position in federal court.

The court held that the lovastatin found in Cholestin was not in its natural form (i.e., as naturally occurring in red yeast rice) because its manufacturer deliberately selected and used a method to produce specific levels of lovastatin that were greater than those naturally present in red yeast rice. In addition, the court determined that Cholestin was a drug because it was specifically marketed as the isolated lovastatin compound.

There may be some parallels between the case of red yeast rice and Hemp-CBD. Indeed, like red yeast rice, hemp and hemp extracts have been consumed for hundreds of years as food and for their medicinal value. Similar to red yeast rice, hemp contains hundreds of compounds, including CBD. And like lovastatin, CBD was recently approved by the FDA via a drug known as Epidiolex—although it is important to note that the CBD approved by the FDA as a drug is derived from the cannabis plant, not industrial hemp grown under an eligible state program, pursuant to the 2014 or 2018 Farm Bill.

Accordingly, if a Hemp-CBD product were to meet the standard laid forth by the court for red yeast rice (i.e., unadulterated full-spectrum hemp marketed as full spectrum hemp, not CBD), its manufacturer may be able to use the nomenclature “full spectrum hemp,” which might mitigate the risk of FDA enforcement action against Hemp-CBD products.

However, given the varieties of hemp strains, and the fact that each contain various levels of naturally occurring compounds, it might be challenging to specifically assess what constitutes “naturally occurring” levels of CBD. Nonetheless, “full spectrum” is generally understood to mean that all the natural constituents of the hemp plant are in product at the same percentages as they would be found in nature. Because advertising cannot be false or misleading, the nature of each product would be dispositive—i.e., whether or not the natural constituents are there in natural percentages—in determining whether those products might fall outside the scope of FDA scrutiny.

Accordingly, before manufacturers of Hemp-CBD products consider renaming their product “full spectrum hemp” they should consult with experienced attorneys to review their manufacturing process and determine whether switching from “CBD” to “full spectrum hemp” in labeling and marketing would be allowed and beneficial.

oregon cannabis interstate salesOnce again, Oregon is working on becoming a marijuana maverick. The Beaver State is on the verge of introducing a bill that would allow marijuana exports to other states by 2021.

In an attempt to tackle the oversupply crisis that has plagued Oregon the last few years, the Craft Cannabis Alliance, an Oregon-based membership association of cannabis and allied businesses, has spearheaded a campaign aimed at reintroducing the idea of exporting Oregon cannabis, a plan that was first proposed in 2017 by Senator Floyd Prozanski (D-Eugene).

The idea was memorialized in Senate Bill 1042, which would have permitted interstate transfers of cannabis products with adjacent legal states that complied with Oregon’s testing, packaging and labeling rules as well as any rules imposed by the receiving state. Although the original proposal died in the House last year, a lot has changed since then.

First, the popularity of marijuana among American adults has been on the rise. According to a 2017 Gallup survey, 64 percent of Americans favor the legalization of marijuana for recreational purposes.

Second, Oregon’s supply has far exceeded local demands: the state is currently sitting on approximately 1.4 million pounds of marijuana that state and federal laws prohibit from selling outside state lines. This tremendous oversupply in Oregon has caused prices to crater, putting many licensed growers on precariously thin ice. Indeed, in 2018, the wholesale price of Oregon flower dropped from $3.90 per gram at the beginning of the year to $1.86 as of the end of the summer.

Third, interstate exporting has seen a growing support from lawmakers and local media.

So in theory, this idea should materialize; unfortunately, federal law remains in the way as we discussed last year.

Though the use and sale of recreational cannabis is currently legal in 10 states, the plant remains a Schedule I substance under the Controlled Substance Act (“CSA”). Specifically, Section 801 of the CSA provides that the distribution of controlled substances in “interstate commerce and foreign commerce” justifies federal control of said substances. federal guidance also expressly forbid the “diversion of marijuana from states where it is legal under state law in some form to other states.” Accordingly, federal law would put Oregon and other legal states engaged in such interstate transfers at great risk of federal enforcement actions and would most certainly compromise the cannabis exchange.

However, the passage of this idea into state law could arm the Beaver State with a big advantage. Specifically, the state would be able to start exporting its cannabis products the moment federal cannabis prohibition is lifted. Such strategic advantage would position Oregon as a leading marijuana exporter (assuming it can find some buyers) and would serve as an escape valve for the chronic oversupply issue.

For now, we must sit tight and see how the proposed bill, which has yet to be drafted, will be received by the Oregon legislature. We will keep you updated on this issue.

fda hemp cbd labeling
Get the inside AND the outside right.

There is no doubt that the enactment of the 2018 Farm Bill, which legalized industrial hemp by removing the crop from the Controlled Substance Act’s definition of “marijuana,” will lead to increased sales and growing opportunities for hemp-derived cannabidiol (“Hemp-CBD”) companies in the new year. In fact, we have already seen an uptick in new and current client inquiries, even in the past few weeks.

As we previously explained, however, there is little information provided by the Food and Drug Administration (“FDA”) about how Hemp-CBD products, including foods, dietary supplements, and cosmetics, should comply with the basic mandatory requirements imposed by the FDA. According to a report released by the Brightfield Group, we will need to wait another 18 to 24 months before the FDA makes a decision regarding the approval of Hemp-CBD products.

Until then, Hemp-CBD companies should handle these uncertainties and the lack of specificity regarding the legal status of Hemp-CBD by being extremely prudent when marketing their CBD products. To that end, we previously discussed the FDA labeling rules and regulations imposed on foods. We now turn to the marketing and labeling requirements imposed on dietary supplements.

For the last three years, the FDA has taken the position that CBD is excluded from the definition of “dietary supplement” under the Federal Food, Drug & Cosmetic Act (“FDCA”) because CBD is an active ingredient in FDA-approved drugs and was the subject of substantial clinical investigations before it was marketed as a dietary supplement.

In response to the federal agency’s position on CBD not qualifying as a dietary supplement, an increasing number of Hemp-CBD companies have embraced a change in nomenclature and have begun manufacturing products that contain hemp extracts standardized for total cannabinoid content rather than isolated CBD. Yet, aside from general legal risk, it is important to understand that the terminology “hemp extract” will not shelter a Hemp-CBD company from FDA enforcement should the concentrations of CBD present in the dietary supplement be disproportionate to their naturally occurring levels in the plant and/or in the levels occurring in traditional hemp extract preparations. (We will further discuss this issue in an upcoming post).

In addition to navigating the muddy waters surrounding the product’s nomenclature, Hemp-CBD companies that manufacture, package or distribute dietary supplements must also ensure that their labels contain the basic required components. Generally, a dietary supplement label must include:

  1. An Identity Statement: For example, “dietary supplement” or “botanical supplement”.
  2. A Net Quantity of Contents Statements: An accurate statement of the quantity of the content in weight, measure, or numerical count.
  3. An Ingredient Statement: A list of the product’s ingredients in descending order of predominance by weight in the product.
  4. A Responsibility Statement: The name and place of business of the manufacturer, packer, or distributor.
  5. A Nutrition Statement: Must appear by way of a prescribed format that provides detailed “Nutrition Facts” and “Supplement Facts” on the product.

Each component must appear in the correct format, or the product will be considered misbranded and subject to FDA enforcement action, unless an exemption applies.

Lastly, Hemp-CBD companies must refrain from making claims that their dietary supplement prevents, diagnoses, treats or cures serious diseases, such as cancer. The FDA deems any product containing a health claim as a drug for human use and must go through the FDA drug approval process before it is marketed in the U.S.

As this post highlights, the marketing and labeling rules surrounding CBD, or more accurately, hemp extract dietary supplements are incredibly complex and nuanced. Also, given the lack of precise FDA guidelines regarding Hemp-CBD products, companies in this space should consult with attorneys who specialize in federal regulations to discuss the potential liability of introducing their product into interstate commerce and ensure the legally defensible marketing of their products.

international law WHO UN cannabisLast Friday, December 7, the World Health Organization (“WHO”) Expert Committee on Drug Dependence (“ECDD”), was scheduled to make a recommendation about the international legal status of cannabis. The WHO is a “specialized agency” of the United Nations, and the ECCD is a WHO committee consisting of experts in the field of drugs and medicines, that assesses the health risks and benefits of the use of psychoactive substances. Alas, the ECDD announced it would temporarily withhold the results of the assessment until January, declaring it needed additional time “for clearance reasons.”

Earlier this year, the ECDD released a preliminary report (“Pre-Review”) on the effects of the plant, which concluded that cannabis is a “relatively safe drug.” The Pre-Review also revealed that cannabinoids (“CBD”) offer numerous therapeutic benefits, including reduction of pain, promotion of sleep, and improvement of motor function for individuals affected by Parkinson’s disease. As a result, the ECDD made the recommendation to the United Nations Commission on Narcotic Drugs (“CND”), that pure CBD not be scheduled under any international drug treaty.

The Pre-Review results gave us and other reform advocates great hope that a more in-depth review would take place before the ECDD makes a final recommendation to U.N. Secretary António Guterres. Comprehensive scientific data on the effects and benefits of cannabis are hard to find. Indeed, the current status of cannabis as a strictly prohibited substance has forced researchers who wish to study the plant to overcome additional hurdles that do not exist for the study of other drugs. To this end, U.S. Surgeon General Jerome Adams declared last week that the federal government should evaluate how it classifies the drug because the restrictive scheduling hinders research.

Just as we need to look at criminal justice laws, rules and regulations, we need to look at health laws, rules and regulations, and that includes the scheduling system.”

This statement by one of the key officials of the Trump administration highlights a shift in the U.S. federal government’s strict position on the prohibition of cannabis. As we previously discussed, the federal government has repeatedly cited to obligations under international treaties to perpetuate the current ban on cannabis and its derivatives. Back in May, the Food and Drug Administration (“FDA”) concluded that CBD should be descheduled but felt forced to recommend rescheduling the plant to Schedule V of the Controlled Substance Act to comply with international treaties to which the U.S is a party. Nonetheless, the FDA specified that if treaty obligations were to no longer require control of CBD that its recommendation would need to be promptly revisited.

Accordingly, the potential recommendation by the ECDD to remove cannabis from international control would create wide-ranging implications for the global effort to legalize the plant, including in the U.S. But for now, we must wait patiently for the ECDD’s recommendation to the CND, which is scheduled to be discussed and to go up for a vote in March 2019. The delay is frustrating, although we are encouraged to see that the U.N. continues to take a hard look at cannabis. Sit tight.

marijuana bank fincen
Slowly but surely, it’s happening for canna businesses.

According to a recent report from the U.S. Treasury Department’s Financial Crime Enforcement Network (“FinCEN”), a growing number of financial institutions are willing to work with cannabis businesses. As of September 30, 375 banks and 111 credit unions were managing marijuana business accounts.

These numbers reveal a steady growth in the number of financial providers willing to engage with the cannabis industry, despite its federal illegality. The report confirms what our cannabis business lawyers have observed over the past few years in Washington and Oregon: namely, most of our licensed cannabis business clients in those states are banked, and it isn’t as hard as it used to be to acquire a basic merchant account. (California is a different story.)

Nationwide, though, most financial services providers have been reluctant to serve the marijuana industry for years, fearing the federal cannabis prohibition would trigger liability under money laundering laws. Earlier this year, many concluded that banks would refuse to associate with cannabis businesses following the decision by then-U.S. Attorney General Jeff Sessions to retract policy protections for licensed marijuana businesses from federal interference. However, the latest FinCEN report reveals that those fears were mostly speculative.

The American Bankers Association, which recently conducted a survey on the issues faced by banks that are serving cannabis businesses, is advocating for greater legal clarity to banks operating in states where recreational and medical cannabis has been legalized. Indeed, the guidelines currently used by the financial services industry are those published in 2014 by the FinCEN and could use an update given the continued ascendance of marijuana reform.

Several key officials of the Trump administration have also expressed the need to clarify cannabis banking issues. For instance, Treasury Secretary Steven Mnuchin stated in congressional testimony that he wants businesses operating in states where marijuana is legal to be able to store their profits in banks.

I assure you that we don’t want bags of cash … We do want to find a solution to make sure that businesses that have large access to cash have a way to get them into a depository institution for it to be safe.”

In June, Federal Deposit Insurance Corporation Chariwoman Jelena McWilliams explained that she instructed her staff to consider ways to address the banking issues, but that the agency’s hands were “somewhat tied” until federal law legalizes cannabis.

Support for clarification and for fixing marijuana banking problems also comes from the states. A few months ago, a coalition of the top financial regulators located in thirteen states asked Congress to take action to protect banks working with the cannabis industry.

In their letter, the regulators wrote:

It is incumbent on Congress to resolve the conflict between state cannabis programs and federal statutes that effectively create unnecessary risk for banks seeking to operate in this space without the looming threat of civil actions, forfeiture of assets, reputational risk, and criminal penalties.”

Finally, back in June, a bipartisan group of twelve governors urged lawmakers to pass the Strengthening the Tenth Amendment Entrusting States (“STATES”) Act, which proposed to amend the Controlled Substance Act to exempt state-legal marijuana activities.

This growing support for permanent protections of banks that serve cannabis businesses is a promising sign that legal reform is on its way. The newly formed Democratic House has expressed a strong desire to move cannabis legislation, including banking issues, in the new year. Only time will tell whether the Republican-controlled Senate will allow it.

cbd label copyright trademark
Start from scratch to avoid infringement issues.

We previously discussed the need for manufacturers of CBD-infused foods and beverages (“Manufacturers”) to comply with the Food and Drug Administration labeling rules. However, such requirements are only one of many issues Manufacturers should worry about. Indeed, Manufacturers should also ensure: 1) that their name as well as their logo/design are not infringing on those of another; and 2) that they hold the right to the Trademarks they intend to display on their labels. This post provides a brief overview of the steps Manufacturers should take to shield themselves from infringement claims.

Trademark and/or Logo Infringement

As we explained before, trademarks are words, phrases, symbols or designs (i.e., logos) that identify the source of a product and help distinguish that product from that of competitors. The very best way to protect your trademark is to register it at the state or federal level.

Logos may also be protected under copyright law. Copyright law protects literary, musical, graphic, or other artistic forms in which an author expresses intellectual concepts. Thus, logos that are adequately original and ornate have a strong chance of being copyright protected, even without registration—though it is in the Manufacturer’s best interest to register its Logo with the U.S. Copyright Office, see why here.

Choosing branding that will not infringe the trademark and/or copyright rights of another is a critical step in developing a sound marketing strategy. Infringing will not only result in paying substantial damages to the pre-existing brand owner, it will also lead to massive rebranding costs: Think of all those printed labels a Manufacturer will need to throw away and the products they will need to pull off the shelves.

Therefore, before they start printing their labels (and ideally, before they start marketing altogether), Manufacturers should do their due diligence and conduct comprehensive searches with the U.S. Patent and Trademark Office and the U.S. Copyright Office to ensure that no one has already registered a similar trademark and/or logo.

Ownership of Logo

Some Manufacturers whose labels we reviewed hired a graphic designer to develop their logo, yet, few entered into a written independent contractor agreement (“Agreement”).

This Agreement is a contract between two parties, in this case a Manufacturer and a graphic designer, for a specific service or project (i.e., the development of a logo). It clearly provides why the graphic designer was hired and stipulates that he or she is not an employee of the Manufacturer for legal and tax purposes.

In addition to requiring the graphic designer to carry insurance and to hold any mandatory professional licenses under state and federal laws, the Agreement states that the designer assigns his or her rights in the work product to the Manufacturer. In other words, the logo becomes the sole ownership of the Manufacturer even if its author is the graphic designer (under copyright law, the author of a creative work is automatically the owner of the work, absent any arrangement to the contrary).

Consequently, an Agreement will ensure that the Manufacturer has the right to freely use the logo, including entering into licensing agreements and relying on their logo as a valuable asset.

With the growing popularity of CBD-infused foods and beverages, Manufacturers are eager to enter the market and tend to rush through the marketing process, running the risk of incurring significant recall and rebranding costs. To avoid such financial burden, Manufacturers should consult with experienced CBD business attorneys who can review their product labels and ensured that their branding is indeed theirs to use.

oregon marijuana OLCC report
Pretty good report for licensed Oregon producers.

On Monday, the Oregon Liquor Control Commission (“OLCC”) released results of enforcement inspections of recreational marijuana producers, which indicate that the majority of inspected licensees are in compliance with Oregon laws and the OLCC rules.

“Operation Good Harvest” was a saturation compliance effort that focused on Oregon’s fall 2018 legal outdoor cannabis harvest. OLCC inspectors were in the field for the past two months and conducted 354 inspections across the state, with an emphasis on southern Oregon, a hotbed of marijuana production, accounting for more than a third of the recreational marijuana licenses in the state.

The OLCC inspected a total of 354 outdoor producer licensees and found that 259, or 73 percent of them did not have any “deficiencies” nor were they likely to commit potential violations. Of the 95 licensees with deficiencies, 41 have potential violations that could lead to the cancellations of their license, which roughly represents 12 percent of the outdoor producer facilities inspected. A more comprehensive overview of the inspection results is as follows:

Region

Inspections Licensees with Deficiencies Compliance Rate

Possible License Cancellations

Statewide

354

95

73%

41

Bend

11

5

55%

2

Eugene

44

9 44%

5

Medford

167

43 74%

22

Portland Metro

102

33 68%

11

Salem

30

5

83%

1

The inspections reflect our agency’s effort to prevent diversion from Oregon’s legal cannabis market, and we’ll continue compliance activity across all license categories to maintain the well-regulated market that Oregonians expect”, declared Steve Marks, OLCC Executive Director.

The results of Operation Good Harvest demonstrate that the OLCC continues to take steps to corral Oregon’s overproduction of marijuana by taking a tougher stance on rule violations by licensees. (For some background on this administrative policy progression, we have recently written about OLCC’s recent “tightening up”, from application scrutiny through dealing with non-compliance.)

The result of Operation Good Harvest also seems to reinforce the fact that the surplus of marijuana in our state does not generally emanate from cannabis grown and produced by OLCC licensees, despite earlier reports to the contrary. Instead, illegal export tends to stem from unlicensed grows and from poorly regulated, quasi-commercial systems like the Oregon Medical Marijuana Program.

As far as the violations actually turned up by OLCC inspections in Operation Good Harvest, the most common deficiencies pertained to issues with cameras and surveillance coverage. Other common violations included:

  • Data in the Cannabis Tracking System (METRC) not matching plants or product found on the licensed premises;
  • Marijuana plants not tagged and entered into METRC;
  • Failure to provide the OLCC with harvest notification information;
  • Making unapproved alterations to the licensed premises; and
  • Using scales not approved by the Oregon Department of Agriculture.

The agency is currently investigating licensees for alleged violations and will decide how to charge these license holders once its investigations are complete. Any licensees whose license will be revoked will be entitled to challenge the OLCC charges through the State of Oregon’s Administrative Hearings process However, the final decision on any charges will be made by the OLCC Commission.

Operation Good Harvest produced promising results, showing that Oregon continues to be a leader in regulating cannabis, and that this nascent industry is slowly but surely finding its equilibrium.

industrial hemp cannabis farm bill

Just two weeks after Speaker of the House Paul Ryan expressed public support for the legalization of industrial hemp, Senate Majority Leader Mitch McConnell is now guaranteeing that the 2018 Farm Bill will include the industrial hemp legalization provision once the House and the Senate solve their difference regarding this issue.

If there’s a Farm Bill, it’ll be in there, I guarantee that,” McConnell told reporters last Friday.

(To watch McConnell’s hemp legalization guarantee, go to 13:15 into this video clip).

As we have discussed at length, the House and the Senate versions of the bill differ in that the House version is silent on the legalization of industrial hemp whereas the Senate version, which was introduced by the Senate Majority Leader himself, would remove the crop from the definition of “marijuana” under the Controlled Substance Act, and instead treat hemp like a standard agricultural crop. Indeed, although industrial hemp and marijuana are the same species, hemp contains a negligible amount of tetrahydrocannabinol (“THC”), the psychoactive compound that gives its users a high.

In justifying his support of the legalization of the crop, McConnell stressed the immense value and versatility of industrial hemp. In addition, McConnell declared that he became aware of the international implications of hemp legalization during his visits of hemp processors this past year and explained that major foreign investors have expressed interest in the hemp business, signaling the crop’s tremendous potential.

I don’t want to overstate this—I don’t know if it’s going to be the next tobacco or not—but I do think it has a lot of potential. And as all of you already know, in terms of food and medicine but also car parts…it’s an extraordinary plant.”

According to the Senate Majority Leader, once legalized, industrial hemp will be “lightly regulated” by the U.S. Department of Agriculture. In addition, there will be no more federal involvement except for the issuance of crop insurances to hemp farmers—which is one of the most significant provisions included in the Senate version of the bill. Instead, industrial hemp would be regulated by local law enforcement, pursuant to the state program under which hemp farmers would be registered.

Although McConnell acknowledged that a provision pertaining to work requirements for food stamp recipients had caused delays in the enactment of the 2018 Farm Bill, he declared that the enactment of the bill will be one of his top priorities when Congress reconvenes for a lame-duck session.

The continuing public support for the legalization of industrial hemp by conservative Congressional leaders strongly suggests that the enactment of the 2018 Farm Bill is imminent, which is fantastic news!

label CBD hemp oregon FDA
Start from scratch with your CBD product labels.

Since the beginning of the year, our firm has received a growing number of inquiries related to the labeling of cannabinoids (“CBD”)-infused foods. This legal issue is particularly confusing given the fact that the U.S. Food and Drug Administration (“FDA”) has yet to provide clear guidance for this category of products. This post aims to shed some light on the matter by addressing some of the requirements with which manufacturers and distributors of CBD-infused foods, specifically those derived from industrial hemp, must comply in Oregon.

Unlike the State of Indiana, which recently adopted the most stringent labeling rules for hemp-derived CBD products, Oregon opted to defer to the labeling rules promulgated by the FDA.

The Fair Packaging and Labeling Act (“FPL”) directs the FDA to issue regulations requiring that all “consumer commodities” be labeled to disclose net contents, identity of commodity, and the name and place of business of the products’ manufacturer, packer or distributor. Specifically, the FDA rules aim to ensure that foods sold in the United States are safe, wholesome and properly labeled.

The FDA rules provide two ways to label packages and containers:

  1. Place all label statements on the front label panel (also known as the “principal display panel” or “PDP”), which is the portion of the package label that is most likely to be seen by the consumer at the time of purchase (i.e., the front of the package or container); or
  2. Place certain statements on the PDP and others on the information panel, which is the label panel immediately to the right of the PDP, as seen by the consumer facing the product.

Although the FDA gives you the option of placing all label statements on the PDP or split them between the PDP and the information panel, you must ensure that the following label statements appear on the PDP:

  • The statement of identity or name the food as commonly known or used (e., chocolate, pasta); and
  • The net quantity statement or amount of product.

Due to the FDA’s ambiguous position on CBD, manufacturers and distributors should refrain from using the term “CBD” in their statement of identity and should favor instead the term “industrial hemp-infused.” (If you have been on Amazon lately, you will notice that everyone has moved over from the “CBD” to “industrial hemp” terminology.) Note also that the FDA rules impose strict font sizes and methods to accurately determine the weight of your product. Make sure you comply!

In addition to the statement of identity and the net quantity statement, labels will have to provide:

  • The Manufacturer/Distributor Information.
  • Ingredients List: Each ingredient must be listed in descending order of predominance (i.e., heaviest to lightest).
  • Nutrition Labeling, unless you qualify for an exemption, such as the “manufactured by small businesses” exemption which applies to companies that refrain from making nutritional claims and generate $50,000 or less in annual sales.
  • Serving Size.

Lastly, manufacturers and distributors should abstain from making any health claims in fear of being investigated by the FDA which treats products with labels containing health claims as drugs, not food (see here and here more information on this issue). Sometimes, “health claims” can be a fine line, so you should assume that the FDA is going to take a restrictive view of what you can and cannot say.

Although the FDA does not impose a pre-approval process of food labels, manufacturers and distributors of CBD-infused foods should have their labels reviewed by an attorney before they enter the market. Relying on attorneys who are well-versed on the issue of CBD law will ensures compliance with the FDA rules, but also help manufactures and distributors avoid wasting money on reprinting labels and marketing materials.

hemp cbd paul ryan farm bill
There’s been quite a bit of it lately on hemp and CBD.

Earlier this week, Speaker of the House Paul Ryan announced his support to end federal cannabidiol (“CBD”) prohibition and expressed strong support for the uses of industrial hemp. To view the video of Ryan’s comments, go here at the 21:15 mark.

For any newbies out there, CBD is one of the many chemical compounds in a class called “cannabinoids” that naturally occur in cannabis plants. “[CBD] has proven to work,” Ryan said, specifying that it “helps reduce seizures.” Indeed, the Food and Drug Administration (“FDA”) approved Epidiolex back in August, which is G.W. Pharma’s oral CBD solution for the treatment of seizure associated with Lennox-Gastraut and Dravet syndrome. The FDA approval prompted the Drug Enforcement Administration to reschedule all FDA-approved drugs containing cannabis-derived CBD with no more than 0.1 percent THC under Schedule V of the Controlled Substance Act (“CSA”).

The Speaker, who is not running for reelection and is retiring from Congress at the end of the year, shared that his mother-in-law used a synthetic form of cannabinoids when she was dying from melanoma and ovarian cancer.

Ryan also jumped on the opportunity to speak in favor of industrial hemp when responding to a medical marijuana question from a rally attendee who husband had succumbed to cancer. “And by the way, there’s a lot of industrial uses for hemp that I understand from talking to Mitch McConnell is a big deal to Kentucky agriculture,” he said. “And we’re all in favor of that as well.” Ryan is not going as far as John Boehner, a recent House Speaker who is currently sitting on an advisory board for a for-profit marijuana company, but his take is welcome news to us.

The Speaker’s endorsement of industrial hemp comes at a decisive time. As we previously discussed, Congressional leaders are still attempting to reconcile the House and the Senate versions of the 2018 Farm Bill. The Senate version, which was introduced and championed by Senate Majority Leader Mitch McConnell, would legalize hemp by removing the crop from the CSA definition of marijuana. The House version, however, is silent on this issue, and thus would afford meager protection for the crop. With Paul Ryan’s public support for ending federal CBD prohibition, however, it seems more likely that the House would approve the hemp language found in the Senate bill.

This is not the first time that Ryan has expressed support for the legalization of CBD and industrial hemp. Back in 2015, the speaker co-sponsored a bill with Rep. Scott Perry (R-PA) that sought to remove industrial hemp and CBD-infused products containing less than 0.3 percent THC from the definition of marijuana under the CSA.

It is still important to note, however, that the Speaker’s endorsement of CBD does not extend to the full legalization of marijuana, even for medical uses. “There’s no THC in that oil. That is not medical marijuana,” he declared. But of course, Ryan’s statement is inaccurate given that most CBD products contain small amounts of the psychoactive cannabis compound.

Nonetheless, proponents of industrial hemp and CBD should be pleased by this latest and encouraging development. The public support for the legalization of the crop and of marijuana’s non-psychoactive cousin by one of the most powerful Congressional leaders reveals a shift in the minds of conservatives and suggests the likely passage of the much anticipated 2018 Farm Bill. Stay tuned!