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Washington State Regulates CBD Additives as Used in Marijuana Products

cannabis washington lcb marijuana

Earlier this year, the Washington Legislature passed House Bill 2334 (the “Bill”) into law. The Bill allows licensed marijuana producers and processors to use cannabidiol (CBD) from a source not licensed by the Washington State Liquor and Cannabis Board (LCB). The Bill defines a “CBD product” as “any product containing or consisting of cannabidiol” and would permit the use of CBD products from unlicensed sources so long as the CBD product has a THC level of 0.3 percent or less on a dry weight basis and has been lab tested. The Bill essentially allows Washington processors to add CBD from industrial hemp derived in other states into Washington marijuana products.

Washington’s regulated cannabis market is a closed loop that works on the principle that no marijuana comes in and none goes out. Everything sold in a licensed retail store is grown by licensed producer and processed into products like oils and edible by a licensed processor.

Start ramping up ahead of December 1.

On October 31, the LCB enacted new regulations in light of the Bill. These new rules impose some additional requirements and restrictions with regards to CBD derived from sources outside of Washington’s framework. The LCB will not allow the addition of CBD to useable marijuana flower. That means CBD additives will be limited to edibles, oils, tinctures, and other products that are derived from marijuana. Licensees will have to enter CBD products into the LCB’s traceability system, keep the records up-to-date, and the additives labeled. And licensees must also keep CBD additives quarantined from other marijuana until the CBD additives have gone through lab testing.

The LCB already requires that all marijuana and marijuana products undergo lab testing. WAC 314-55-102. CBD additives will go through additional testing under these new regulations. CBD additives that do not pass testing cannot be added to marijuana products.

In addition to the THC threshold, outside CBD must be tested for contaminants and toxins by the same accredited labs that test other marijuana and marijuana products in Washington. Licensees must submit samples of CBD additives to accredited labs. The samples must be representative of the entire product and must be one percent of the product as packaged by the manufacturer but no less that two grams. The samples must be collected in a sanitary manner, meaning the person collecting the samples must wash her hands, wear gloves, and use sanitary utensils and storage devices. Samples must be labeled with an unique identifier number, the trade name of the lab receiving the sample, the license number and tradename of the licensee, the date the sample was collected and the weight of the sample.

The CBD additives must be tested for THC to ensure that the product contains less than 0.3 percent. The additives are also tested to determine/verify the levels of THC and CBD. CBD additives must be tested for pesticides, heavy metals, residual solvents, microbiological matter, and mycotoxin.

For any questions on these new rules, give us a call. The new rules take effect December 1, 2018.

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Cannabidiol and Epilepsy Meta-Analysis

How often have we heard, “More research is needed,” from those who would prefer to see no change in policies that should be informed by science? From climate denial to cannabis prohibition, the demand for absolute scientific certainty is a call for inaction.

It begs the question: When is there “enough” research?

How about not enough to eliminate all uncertainties, but enough to recommend medical treatment or change policy?

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Labeling CBD-Infused Foods in Oregon

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.

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Paul Ryan Supports Legalizing CBD and Industrial Hemp

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!

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Stiffed Drinks: CBD-Infused Alcoholic Beverages Banned in California

CBD alcohol california
Mint is still fine; CBD, not so much.

A few months ago, I spoke to a reporter from Quartz about cannabidiol (CBD). She told me that a local cafe was offering a CBD-infused latte and that it piqued her interest for a story. Her local baristas were not alone as numerous bars, restaurants, and cafes across the country have been experimenting with CBD-infused beverages. However, as with all things CBD, the regulatory framework is rapidly changing. If you’re a business owner looking to add a CBD beverage to the menu, it’s important to carefully consider state and local law.

That brings us to California. California is an excellent case study when it comes to CBD. The Golden State has a long history with cannabis, as it was the first state to create an affirmative defense for the medical use of marijuana in 1996. In 2016, California voters approved of recreational marijuana. California has also approved of an industrial hemp pilot program under the 2014 Farm Bill, but the program has been mostly dormant because the state’s laws and regulations make it nearly impossible to legally obtain hemp seeds. In addition, and perhaps most importantly when it comes to CBD, California has a propensity to regulate just about everything under the Sun.

Cue the California Department of Public Health’s (CDPH) infamous FAQs. As we wrote back in July, these FAQs stated that CDPH was banning the inclusion of hemp-derived CBD as a food, food ingredient, food additive, or dietary supplement. California’s Health and Safety Code defines food to include beverages meaning that CBD is not allowed in beverages of any kind. California’s Alcoholic Beverage Control (“ABC”) issued its own FAQs which stated that licensees could not serve alcoholic beverages mixed with cannabis, even if the licensee was using CBD. ABC cited to CDPH’s FAQs to prohibit the use of hemp-derived CBD.

The FAQs are examples of CDPH and ABC using policy statements to enact what feels like a new law or regulation. At the state level, laws are passed by both branches of a state legislature and signed into effect by the Governor. Laws establish requirements or prohibitions. In turn, regulations are issued by agencies to clarify their interpretation of a law and how a law will be implemented. Like laws, regulations also impose requirements or prohibitions. When an agency issues a new regulation, there are procedural requirements such as a public comment period where stakeholders can voice concerns over proposed regulations. Similarly, when the legislature passes a new law, lawmakers hold public hearings. These procedural requirements provide for transparency.

Agencies also can issue guidance or other policy statements to clarify how an agency understands and implements existing laws and regulations. Generally speaking, guidance and other policy statements are not mandates but rather are an expression by the agency of a suggested or recommended action. Agencies are not generally required to provide the public with a notice and comment period before issuing a policy statement because those statements shouldn’t establish requirements or prohibitions.

When it comes to CBD-infused products, the outright prohibition in California is stated in the CDPH’s policy statement. There is no law or regulation that specifically prohibits using industrial hemp derived CBD as a food additive but CDPH interprets its governing rules and regulations to prohibit CBD in food or drinks.

Alternatively, ABC’s guidance prohibiting the use of CBD in alcoholic beverages has been enacted into California law. Recently, Governor Jerry Brown signed Assembly Bill 2914 (the “Bill”) prohibiting alcoholic beverage licensees, like bars and liquor stores, from providing hemp-derived CBD cocktails. The Bill’s purpose is summed up as follows:

This bill would prohibit an alcoholic beverage licensee from, at its licensed premises, selling, offering, or providing cannabis or cannabis products, including an alcoholic beverage that contains cannabis or cannabis products, and would provide that no alcoholic beverage shall be manufactured, sold, or offered for sale if it contains tetrahydrocannabinol or cannabinoids, regardless of source.”

That last phrase, “regardless of source,” encompasses cannabinoids like CBD even if it was derived from industrial hemp.

California has codified the prohibition of CBD-infused alcoholic beverages. The similar prohibition on CBD in non-alcoholic beverages and other consumable products is not codified in a law or regulation. In that sense, the latter prohibition would be easier to reverse. That said, CDPH’s guidance is powerful as agencies are given broad deference when interpreting their own regulations, so if CDPH changes that guidance, it will likely be because it wants to or because the legislature writes a law to expressly allow CBD in non-alcoholic beverages and other consumables. It will not be the result of a private party lawsuit.

The idea of offering a CBD-infused cocktail in California is a non-starter. If you are hoping to enjoy a CBD cocktail, you’ll have to forgo California and book a flight east. CNBC reports a New York bar is experimenting with CBD cocktails. Perhaps New York regulators will take a different approach from their California counterparts. Time will tell.

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Hemp Testing

Altitude Consulting is not only a hemp testing laboratory, but an organization trusted to consult within the industry. Home growers and commercial farms around the world recognize that EPA based methodologies assure the most accurate and consistent data. Give us a call or bring us a hemp potency, residual solvent or terpene profile sample and see the difference.

Altitude Consulting
Denver’s most effective cannabis testing company.