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Exporting CBD Food Just Got Harder: The European Union Makes a Move

EU CBD food export

We’ve been writing a lot on this blog about the regulation and sale of cannabidiol (“CBD”) products at the state and federal levels. The United States is not the only international actor, however, that is concerned with regulating the sale of CBD products, including CBD-infused foods. The European Food Safety Authority (“EFSA”), the European equivalent of the U.S. Food and Drug Administration (“FDA”), recently changed guidance on cannabinoids, declaring that all new food products infused with the plant or its derivatives should receive a pre-market approval under the European Union “novel food” regulation.

Regulation 2015/2283, which is the latest food regulation adopted by the European Parliament and the European Union (“EU”), defines “novel food” as “food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of the Member States to the Union.”

The EU Novel Food Catalogue entry for CBD, which contains a non-exhaustive list of ingredients that inform member nations on whether a product will need an authorization under the Novel Food Regulation, now refers to a broader class of “cannabinoids” and provides that:

Without prejudice to the information provided in the novel food catalogue for the entry relating to Cannabis sativa L., extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically obtained cannabinoids are considered as novel.

This new EFSA guidance drastically expands the categories of cannabinoids that would require pre-market approval–note, however, that hemp seeds, flour and seed oil remain permitted–and it suggests that CBD-infused food could be off the European market for some time. Generally, it takes 3 years for an ingredient to gain novel food status.

A handful of European countries such as Spain, Italy, and Austria have already taken enforcement actions against CBD products on the basis of being “novel foods.” As such, it seems likely that these EU member nations will adopt the new EFSA guidance and continue their efforts in regulating CBD-infused foods as “new foods.”

The EU or its affiliates are expected to provide further guidance on this issue; however, due to administrative procedures and time required for adequate data collection, such publication won’t likely be released until 2020.

This new EFSA guidance will further complicate U.S. CBD companies’ ability to export their products overseas. In addition to potential international law violations, CBD companies run the risk of FDA and Customs and Border Protection (“Customs”) enforcement actions. The FDA has yet to release guidelines on shipping CBD products to other countries; however, the main FDA inquiry for the purpose of exporting CBD would likely be whether the CBD products were adulterated or mislabeled due to the fact that they were not manufactured or labeled in compliance with the target country’s law. Another risk in exporting CBD products is that Customs agents may not have a sophisticated understanding of the difference between hemp and marijuana, as demonstrated in recent state enforcement actions. If such confusion were to occur, Customs would likely seize the CBD shipment and potentially involve the Drug and Enforcement Administration.

In light of those regulatory changes, CBD companies should remain informed on domestic and international shipping laws and consult with experienced lawyers to assess the risks of exporting their products overseas.

For more on cannabis and international law, check out the following:

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Beyond the Crackdown: New York Classifies Hemp-CBD as a Dietary Supplement (Part Two)

new york cbd
Home of “dietary supplement” CBD.

This post is part two of two on how New York is regulating CBD.

On Monday, I wrote about the New York City Department of Health’s (“DOH”) recent crackdown on Hemp-CBD in food and how it was consistent with the New York State Department of Agriculture’s (“Department”) FAQs on hemp-derived CBD (“Hemp CBD”). In summary, the Department’s FAQs state that any Hemp-CBD product sold in New York state must be labeled and manufactured as a dietary supplement. Today’s post focuses on the Department’s Template CBD Processor Research Partner Agreement (“CBD Agreement”) which elaborates on the dietary supplement classification.

The CBD Agreement is a research contract between Hemp-CBD processors, referred to as “Research Partners” in the Agreement, and the Department. Its provisions would not bind other actors including Hemp-CBD sellers or Hemp-CBD processors legally operating in other states. However, the CBD Agreement does shed light on what the Department is going to require for Hemp-CBD.

Research Partners cannot process or sell Hemp-CBD as food. A Research Partner must also obtain written approval from the Department if it intends to sell or distribute Hemp-CBD dietary supplements in a form other than “pill, capsule, caplet, tablet, tinctures, droplets or elixir, chewable, or isolate form[.]”

The CBD Agreement expands on how Research Partners, or CBD processors in other states hoping to sell products in New York, can comply with FDA’s dietary supplement standards:

For the purposes of this Research Agreement, products and production methods used shall comply with FDA law, regulation and guidance concerning dietary supplements with respect to the standards for: personnel, facilities, production, process control systems, quality control measures, record retention, packaging, holding and distribution, supply chain management, recalls, returns, complaints and training associated with dietary supplements.

The dietary supplement standards are in addition to THC testing for CBD products. Hemp-CBD intended to be consumed or absorbed into the human body must also be tested under New York’s medical marijuana program for “cannabinoid profile, solvents, pesticides, heavy metals, bacteria and molds.”

The CBD requirements requires that Research Partners must also provide a serving size and applicable warning on the label. According to the CBD Agreement, CBD products shall also include the following information:

  • The list of all pharmacological active ingredients, including and not limited to THC, CBD, and other cannabinoid content over .05%;
  • The CBD product must set forth the servings per bottle/package, the amount of CBD in milligrams per serving and the total CBD content, in milligrams per package, and the maximum recommended daily amount;
  • The list of all solvents (pesticides) used in the cultivation/extraction process;
  • The manufacture date and source;
  • The batch number;
  • The product expiration date, and
  • The following warning, along with an appropriate warning to consult with a physician concerning the product use:

“This product is neither reviewed nor approved by the State of New York; and has not been analyzed by the FDA. There is limited information on the effects of using this product. Keep out of reach of children.”

The CBD agreement also covers reporting, approved extraction methods, and sourcing hemp. According to the CBD Agreement, the Department may eventually require registration from entities selling Hemp-CBD.

Recently, I wrote about the FDA’s stated position is that Hemp-CBD is not a dietary supplement. As such, the Department’s position is contrary to the FDA’s. The following language in the CBD Agreement requires Research Partners to acknowledge the FDA’s position:

The Research Partner represents that it has sought whatever legal or other advice it believes to be appropriate and is not relying upon the Department’s approval of its research proposal or any other statement or conduct by the Department in connection with the Research Partner’s evaluation of any legal or other risk to which the Research Partner may be exposed in undertaking the project, including, without limitation, the FDA’s position with respect to CBD and dietary supplements.

For CBD Processors in New York, the CBD Agreement must be carefully observed. For CBD Processors operating in other states who wish to sell products in New York, the Department’s position makes things a little more complicated. For example, the FDA has different standards for cosmetic products. CBD Processors may want to argue that they are selling a CBD cosmetic not a dietary supplement. However, if that CBD cosmetic is sold in New York, it must be labeled as a dietary supplement. This may mean that the CBD cosmetic distributor may need to avoid New York or adopt labeling and manufacturing requirements as if the product was a dietary supplement.

Though it may be hard to comply with the Department’s regulations, the FAQs and CBD Agreement at least provide guidance. If you want to sell Hemp-CBD in New York, it must be sold as a dietary supplement, at least for now.

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Beyond the Crackdown: New York Classifies Hemp-CBD as a Dietary Supplement (Part One)

new york cbd
Home of “dietary supplement” CBD.

This post is part one of two on how the State of New York is regulating CBD.

Last week, New York City’s Department of Health (“DOH”) quarantined a number of edible products that contained hemp-derived CBD (“Hemp-CBD”) and announced that Hemp-CBD would not be allowed in food products in the City. Eater first broke the story, but the crackdown made national news with the Wall Street Journal, the New York Times, NBC, and Fox all publishing stories on the event. It is unsurprising that the DOH action drew such coverage. CBD is massively popular, New York City is the largest city in the United States, and the story is compelling because the DOH actually sent out agents to quarantine products, rather than simply issuing a statement. It seems to be this last point that garnered national attention based on the relative lack of coverage a very similar story garnered back in December 2018.

On December 18, 2018, shortly before the signing of the 2018 Farm Bill, the New York State Department of Agriculture and Markets (the “Department”) issued a series of frequently asked questions (“FAQs“) and a CBD Processor Template Agreement (“CBD Agreement“) that were both focused on Hemp-CBD. Unlike the DOH, the Department did not take any enforcement action. Coverage of the FAQs and the CBD Agreement was sparse. Now that New York City is taking action, it’s time to dig into the state’s position on Hemp-CBD.

The Department oversees New York’s industrial hemp program, which was promulgated under the 2014 Farm Bill. Rather than issuing licenses or permits, the Department enters into research agreements with individuals and companies who wish to process hemp into commercial products. The Department uses a number of template agreements available online. The CBD Agreement applies to processors who wish to create Hemp-CBD products intended for human consumption.

The FAQs and the CBD Agreement make it clear that the Department is intending to treat Hemp-CBD as a dietary supplement. The FAQs state that an individual cannot “sell any item for human consumption that has CBD as an ingredient unless” the two following standards are met:

  1. The item is produced under the rigorous dietary-supplement standards described in the CBD Agreement; and
  2. The item is properly labeled and packaged for sale pursuant to FDA regulations for dietary supplements.

The FAQs elaborate on its dietary supplement standard:

What is the difference between a dietary supplement and a food product?

No product for human consumption that has CBD added to it can be labeled and marketed as a food. All extracted CBD and CBD products must be manufactured pursuant to FDA dietary supplement standards and must be labeled and marketed as a dietary supplement[.]

What are “dietary-supplement standards” or “dietary supplement GMP”?

The FDA sets three levels of Good Manufacturing Practices (GMPs): one GMP standard for foods, a more rigorous GMP standard for dietary supplements, and an extremely rigorous GMP for pharmaceuticals. Products listing CBD as an ingredient must be manufactured pursuant to the dietary-supplement standards. The dietary supplement GMPs are federal, and are described here: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=111

This section is titled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.” Any product for human consumption that lists CBD as an ingredient must be manufactured pursuant to these dietary-supplement standards.

This dietary supplement classification applies to any “product that is a combination of ready-to-eat food with additional CBD infusions or CBD extracts, such as CBD chocolate syrup or CBD soda or CBD-infused frosting drizzled cookies.” The FAQs also make clear that they apply to products from other states: “products made from industrial hemp that are sold in NYS must meet NYS standards, regardless of where the product is processed or manufactured.”

It should be noted that the Department acknowledges that its jurisdiction over Hemp-CBD is limited. For example, the Department does not require businesses to apply to the Department to add pre-manufactured Hemp-CBD to another product such as a topical or to develop products using CBD is sourced from another state. There is also no requirement to obtain any authorization from the Department to sell Hemp-CBD products. However, if the product is sold anywhere in New York State, it must comply with dietary supplement standards.

You can agree or disagree with the New York City DOH’s decision to start quarantining CBD in food, however, it does seem to be inline with the Department’s guidance. The Department is a state agency and the DOH is a city agency so DOH’s decision may be it showing deference to the Department.

Later this week, I’ll analyze the CBD Agreement and how it provides additional insight into the state’s position on Hemp-CBD.

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State Crackdowns Against CBD Products Have Begun

Earlier this year, the Food and Drug Administration (“FDA”) began seizing various cannabidiol (“CBD”) products from store shelves. These enforcement actions reflected the implementation of the agency’s position that CBD, regardless of the source from which it is derived, cannot be lawfully sold for human consumption.

A few states, including states that have adopted industrial hemp pilot research programs under the 2014 Farm Bill, now seem to have embraced this FDA position by banning certain CBD-infused products from local stores.

Last Friday, several New York restaurants, bakeries, and bars were forced to stop selling CBD-infused foods and drinks. Officials with the state Department of Health confiscated those products, marking them as “embargoed.” The embargo process consists of identifying, itemizing and removing products. The Department has yet to issue a public statement or to provide further information on these actions, but it appears that state health inspectors explained to the affected business owners that CBD could not be used as a “food additive”.

This argument was similar to that used by the Maine Department of Health and Human Services (“DHHS”). Earlier last week, Maine health authorities began notifying businesses that they were required to remove all CBD-infused foods, tinctures, and capsules from their shelves. Relying on an internal report by the state Attorney General’s Office, which concluded that CBD could not be used in mass-market food until Maine’s hemp pilot program receives federal approval pursuant to the 2018 Farm Bill, the Maine DHHS determined that CBD was an unapproved food additive that the FDA does not recognize as safe.

Section 201(s) of the Food, Drug, and Cosmetic Act (“FD&C Act”) defines “food additive” to encompass any substance that may reasonably be expected to directly or indirectly affect or become part of a food. Until a food additive is tested and reveals to be safe for its intended use, it is deemed unsafe. A food additive is considered safe if there is a reasonable certainty in the minds of competent scientists that a substance is not harmful under its intended use and condition. If a food additive is added to a food prior to FDA approval, its presence renders the food adulterated and subject to enforcement action.

Because the FDA has yet to approve CBD as a food additive, is it accurate that Hemp-CBD products, particularly edibles and infused drinks, would be deemed unsafe under the FD&C Act.

Although the state health authorities embargoed CBD edibles and other CBD products used for human consumption, they told affected business owners that they could continue selling CBD products that “could be smoked, vaped, worn as a patch or applied as lotion.” This is because cosmetics and smokable products are subject to less onerous FDA regulations than foods and dietary supplements. Nevertheless, this is all likely to change because the FDA will undoubtedly release a plan to regulate Hemp-CBD products soon.

These recent enforcement actions in places like New York and Maine threaten to spook this fast-growing industry and should remind industry players that business and legal considerations surrounding the sale of Hemp-CBD products are in a constant state of flux.

We will continue to monitor this issue and update you on other states CBD enforcement actions. Until then, don’t hesitate to contact our offices for additional information on the legal status of state and federal Hemp-CBD law and policy.

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Washington Cannabis: The Proposed Hemp Overhaul is Here

washington hemp

In light of the recent federal legalization of industrial hemp, Washington lawmakers are taking a hard look at the state’s hemp program. Senators Bob Hasegawa (D) of Beacon Hill, Steve Conway (D) of Tacoma, and Karen Keiser (D) of Kent recently introducing Senate Bill 5719. The stated purpose of SB 5719 is as follows:

Authorize the growing of hemp as a legal, agricultural activity in this state. Hemp is an agricultural product that may be legally grown, produced, processed, possessed, transferred, commercially sold, and traded. Hemp and hemp products produced in accordance with this chapter may be transferred and sold within the state, outside of this state, and internationally. Nothing in this chapter is intended to prevent or restrain commerce in this state involving hemp or hemp products produced lawfully under the laws of another state or country.”

The bill requires Washington comply with the 2018 Farm Bill, which removed industrial hemp from the federal Controlled Substances Act, and which provides for state- and tribe-level programs for the cultivation of industrial hemp. As such, the Washington State Department of Agriculture (“WSDA”) would need to submit a plan to US Department of Agriculture (“USDA”) pursuant to the 2018 Farm Bill. The plan would need to cover licensing, THC testing, enforcement, and a host of other topics required under federal law.

It’s too early to tell whether SB 5719 will ultimately become law, but it’s worth keeping an eye on at this point (and will be covered in our upcoming free CBD Webinar on February 21 at 12:00 PST).

Food and Hemp

SB 5719 would repeal Washington’s Industrial Hemp Research Program (RCW 15.120 et seq.) completely. This program was created under the 2014 Farm Bill, which was fairly light on details and limited to hemp cultivation for “research” purposes. Washington’s hemp program is fairly limited and has never really taken off like it has in Colorado, Kentucky, and Oregon. Washington’s hemp law is also extremely confusing thanks to RCW 15.120.020 which prohibits the “production of any part of industrial hemp, except seed, as food, extract, oil, cake, concentrate, resin, or other preparation for topical use, oral consumption, or inhalation by humans[.]” This provision only refers to the production of hemp, not the sale of hemp products, including widely popular hemp-derived CBD (“Hemp-CBD”) products. However, it has also stunted the retail sale of hemp products intended for human consumption under the idea that if it’s illegal to produce hemp for human consumption it is also legal to sell hemp products for human consumption. This would no longer be an issue if SB 5719 passes. However, SB 5719 does come with some ambiguity.

Under, SB 5719 “CBD and CBD products derived from hemp are considered a food product that must be tested and treated in accordance with other agricultural crop derived food products for human and animal consumption.” This could lead to confusion. For example, a Hemp-CBD topical cream would still have to be “tested and treated” as food. That is inconsistent with FDA regulation which treats food and cosmetics differently. Additionally, what does it mean to “treat” something as food? I read it to refer to things like manufacturing, labeling, and storing Hemp-CBD, but I could be wrong.

Licensing and Seeds

The WSDA would issue hemp producer licenses. Current hemp licensees could transfer into Washington’s new program once it’s up and running. Hemp producers will only be allowed to use seeds listed in SB 5719 or approved by the WSDA. The bill also contains a clever provision that distinguishes seed varieties based on THC percentage. Certain seed “cultivar” (i.e., “a variation of the plant Cannabis sativa L. that has been developed through cultivation by selective breeding”) will be exempt from THC testing. WSDA will have the authority to approve seed cultivar and determine whether THC testing is required. Cultivar that were brought into Washington state before January 1, 2022 so long as “the state has planting, growth, and stability records covering at least three years.”

Even though seeds will be regulated fairly robustly, SB 5719 does not indicate the need for seed-to-sale traceability as the WSDA will not be responsible for determining whether a hemp product was derived from an approved hemp cultivar.

Regulatory Authority

Though SB 5719 is a major overhaul, WSDA would still have authority over hemp in the Evergreen State. Both marijuana and hemp are ways to describe cannabis so it’s natural to wonder what is the LCB’s role in regulating hemp under SB 5719? SB 5719 specifically states that “all rules relating to hemp, including any testing of hemp, are outside the control of the [LCB].” However, the WSDA is mandated to consult with the LCB to establish rules and policies to prevent cross pollination between marijuana and hemp crops. In the event that a documented cross-pollination erupts between two farms growing hemp or marijuana, the farm operating first will be the victor. This first-in-time law would give marijuana farmers a massive upper-hand, at least initially, as Washington’s marijuana program is older and much larger than the hemp program. The WSDA and state lawmakers will undertake a task force for determining the need for crop insurance.

Bottom line

SB 5719, if passed in its current form, would drastically change Washington’s hemp laws. Like the 2018 Farm Bill, it’s a much more commercial friendly scheme. If you agree or disagree with the current version of SB 5719, you can submit comments here.

If SB 5719 becomes law, it will take effect immediately. Given that there are several time-sensitive provisions in the bill, it makes sense to start planning now. We’ll keep an eye on this and other hemp-bills in Washington and other states.

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Oregon’s New Industrial Hemp Rules and the 2018 Farm Bill

oregon industrial hemp cbd OLCC
Oregon hemp will see a little bit of each in 2019.

Last year was a big one for the Oregon industrial hemp program. If you recall, the state legislature enacted House Bill 4089, which provided a much needed regulatory framework for the crop and authorized its processing and sale into the Oregon Liquor Control Commission (“OLCC”) recreational market. To administer a portion of these statutory changes, OLCC drafted rule changes in September, which will soon be adopted.

However, a lot has happened since September. Indeed, the Agriculture Improvement Act of 2018, more famously known as the “2018 Farm Bill,” became law last month. Specifically, the 2018 Farm Bill legalized industrial hemp by removing the crop from the Controlled Substance Act—this means no more risk of enforcement action by the U.S. Drug and Enforcement Agency because industrial hemp, including concentrates and extracts, is no longer treated as a Schedule I substance—and delegated authority to states to regulate and limit its production.

The federal legalization of industrial hemp has triggered numerous inquiries from our Oregon clients regarding the impact, if any, of the new federal bill on the most recent set of OLCC rules. This post aims to answer this question.

Although industrial hemp is no longer illegal under federal law, states are not yet authorized to hold primary regulatory authority over the production of the crop. Before they can exercise this option, states will need to submit a regulatory plan (the “Plan”) to the U.S. Department of Agriculture (the “USDA”) for approval. However, approval won’t be given until the USDA promulgates rules and regulations regarding those Plans, a process that will most certainly take months, possibly more given the current government shutdown.

Section 7605(b) of the 2018 Farm Bill further provides that:

Effective on the date that is 1 year after the date on which the [USDA] Secretary establishes a plan under section 297C of the Agricultural Marketing Act of 1946, section 7606 of the Agricultural Act of 2014 (7 U.S.C. 5940) [the 2014 Farm Bill] is repealed.”

In other words, the 2018 Farm Bill won’t become effective until one year following the adoption of rules and regulations for the Plans by the USDA. Until then, the 2014 Farm Bill remains the legal framework under which state industrial hemp pilot programs operate.

Accordingly, states that have adopted an industrial hemp pilot program will continue to operate the way they have since before the passage of the 2018 Farm Bill into law. This means that the legal framework for interstate sales of Oregon hemp should not be affected. As far as sales into the OLCC market, growers, processors, and distributors will need to familiarize themselves with the new OLCC rules.

Under the OLCC rules, hemp handlers and growers will need to be certified by the Commission in order to place their products in the recreational market. The OLCC will then monitor and track this new input into the market via the Cannabis Tracking System (“CTS”). But hemp growers and handler certificate holders won’t be the only actors obliged to comply with these rules. Recreational licensees, processor licensees, and wholesale licensees will also be subject to a new set of guidelines.

For more information on these rules and how they might affect your business operations, don’t hesitate to contact our Portland office.

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Senators Push for Updates to FDA Regulation of CBD Food Products and Dietary Supplements

fda cannabis dietary supplement food

With the passage of the 2018 Farm Bill and the proliferation of food products containing CBD, we’ve been writing extensively about how the United States Food and Drug Administration (FDA) and in particular, the United States Food, Drug, and Cosmetic Act (FDCA) apply to the interstate sale of CBD products. Unfortunately, however, we have little guidance from the FDA regarding how hemp-CBD products such as foods, beverages, dietary supplements and cosmetics should comply with basic FDA requirements, including labeling rules.

What we do know is that the FDA has consistently taken the position that 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. Therefore, the FDA maintains, as stated by Commissioner Scott Gottlieb, that:

[It is] unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”

On January 15, 2019, in light of the FDA’s current position on hemp-derived CBD and the recent passage of the 2018 Farm Bill, Senators Ron Wyden (D-OR) and Jeff Merkely (D-OR) sent a letter to FDA Commissioner Gottlieb urging the Commissioner to update federal regulations governing the use of certain hemp-derived ingredients in food, beverages, and dietary supplements. The Senators began their letter by stating,

As authors of the Hemp Farming Act, which removed the outdated restrictions on the production and marketing of industrial hemp, we urge the U.S. Food and Drug Administration (FDA) to immediately update federal regulations governing the use of certain hemp-derived ingredients in food, beverages or dietary supplements.”

The Senators go on to note that the Act removed from the federal list of controlled substances the hemp plant, and “derivatives of cannabis, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol (THC) concentration of less than 0.3 percent on a dry weight basis. Under this definition, Congress legalized the production and sale of industrial hemp and hemp derivatives, including hemp-derived cannabidiol (CBD).”

Because of the removal of hemp-derived CBD from the list of controlled substances, as well as growing interest from the public in CBD products, the Senators argue that the FDA’s regulations are outdated, and urge the agency to “immediately begin updating regulations for hemp-derived CBD and other hemp-derived cannabinoids, and [to] give U.S. producers more flexibility in the production, consumption, and sale of hemp products.” The Senators also requested a response from the FDA to the following questions within thirty days:

  1. What steps are the agency advancing to clarify to the public the authority the agency has in the production and marketing of hemp, specifically Cannabis sativa L. and its derivatives?
  2. What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverages or dietary supplement, including into interstate commerce?
  3. Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverages or dietary supplement by the agency?
  4. Will the agency consider issuing a regulation, or pursuing a process, that would allow Cannabis sativa L. and its derivatives in food, beverages or dietary supplements that cross state lines?

Given the ongoing government shutdown that has left the FDA short on staff, we will be waiting to see if they are able to respond to the Senators’ questions within the requested thirty days. There is no doubt that thorough responses to these questions would provide the hemp-CBD industry with some much needed clarity regarding the FDA’s position on the sale of these products.

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FREE Webinar February 21: West Coast Hemp CBD

hemp cbd farm act

In December 2018, Congress passed the Agricultural Improvement Act of 2018 (better known as the “Farm Bill”). Among other things, the passage of the bill removed industrial hemp from the federal Controlled Substances Act, allowing legal production of the crop. Despite this landmark legislation, pitfalls still lay on the path ahead. The legality of many industrial-hemp derived cannabidiol (“CBD”) products is in question now more than ever, with different states and federal agencies taking vastly different approaches on every facet of the hemp CBD industry.

Interest in hemp is at an all-time high, and with an industry that has a potential to be worth $20 billion by 2022, it is easy to see why. If you are a hemp CBD business, have interest in the industry or are interested in the state and future of hemp CBD legality, please join us on February 21, 2019 at noon (PST) for the latest installment in our lunchtime webinar series entitled “West Coast Hemp CBD After the Farm Bill.”

In this hour-long session, Harris Bricken lawyers Daniel Shortt (Seattle, Washington), Nathalie Bougenies (Portland, Oregon), and Griffen Thorne (Los Angeles, California) will provide an in-depth look at changes in federal law and policy post Farm bill, as well as its impact on each of the three west coast states (Washington, Oregon, and California). Throughout the presentation our team will also discuss the status of laws and regulations in each state. Some of the topics we will cover include:

  • the future of hemp permitting;
  • Farm Bill implications for Internal Revenue Code section 280E;
  • banking for hemp CBD businesses;
  • intellectual property for hemp CBD businesses;
  • CBD in food, beverages, vape cartridges, oils, topicals, and other products; and
  • the Food and Drug Administration’s role in hemp CBD.

With moderator Hilary Bricken, our panel of attorneys will address audience questions throughout the presentation. Please register for the event here! Should you have any further questions, please feel free to reach us at firm@harrisbricken.com.

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Proposed California Legislation May Allow Hemp CBD in Foods

california hemp cbd food ab 228
Keep your fingers crossed for AB 228.

On January 17, 2019, California Assembly Member Cecilia M. Aguiar-Curry kept her promise and introduced a piece of hemp legislation, AB 228. This bill is aimed at paving the way for adding industrial hemp derived cannabidiol (“Hemp CBD”) to foods, beverages, and cosmetics. The text of AB 228 is relatively short and would add the following two provisions to the California Health and Safety Code which contain provisions of the Sherman Food, Drug, and Cosmetic Laws (the “Sherman Laws”):

110611. A food or beverage is not adulterated by the inclusion of industrial hemp products, including cannabidiol derived from industrial hemp. The sale of food or beverages that include industrial hemp products or cannabidiol derived from industrial hemp shall not be restricted or prohibited based solely on the inclusion of industrial hemp products or cannabidiol derived from industrial hemp.

111691. A cosmetic is not adulterated because of the fact that it includes industrial hemp products, including cannabidiol derived from industrial hemp. The sale of cosmetics that include industrial hemp products or cannabidiol derived from industrial hemp shall not be restricted or prohibited based solely on the inclusion of industrial hemp products or cannabidiol derived from industrial hemp.

AB 228 thus narrowly targets California regulators’ ability to penalize companies for selling Hemp CBD beverages or foods on the grounds that they are “adulterated” under California law. This is an interesting piece of legislation, as the biggest major legal roadblock to selling Hemp CBD foods in California is the California Department of Public Health’s (“CDPH”) Hemp CBD FAQs, which don’t in fact claim that Hemp CBD makes foods or beverages “adulterated” (and says nothing about cosmetics). The only citation in the FAQs to the Sherman Laws is for the definition of foods (see footnote 1). That said, the Los Angeles Department of Public Health will soon begin taking the position that Hemp CBD foods and beverages are “adulterated” and issuing penalties based on that position.

If AB 228 becomes law, it will take the legs out from under one of the major arguments that could be used against Hemp CBD food products. The law wouldn’t change the federal Food and Drug Administration’s position that Hemp CBD is unlawful in foods, and so it will be interesting to see how California cannabis regulators treat Hemp CBD in the wake of AB 228 passing (if it does).

Ultimately, AB 228 isn’t perfect, but it’s a step in the right direction. Stay tuned to the Canna Law Blog for more updates on this and everything else Hemp CBD.

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The FDA’s Stance on Hemp-Derived CBD as a Dietary Supplement (Part 2)

fda hemp cbd red yeast rice

This is the second installment in our series on the Food and Drug Administration (“FDA”) and hemp-derived CBD (“Hemp-CBD”). Our last post focused on the Drug Exclusion Rule, which essentially states that an article cannot be marketed as a dietary supplement if it was investigated or approved as a drug before the article was marketed as a dietary supplement (or food). Today, we’ll take a look at what that use of “before” really means.

Prior Market Clause

A key component of the Drug Exclusion Rule is that the article at issue was not previously marketed before the article was evaluated or approved by the FDA (the “Prior Market Clause”). So what does it mean to “market” a product? Helpfully, the FDA FAQs link to Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (“NDI Guidance”) to provide an explanation of the phrase “marketed as.”

The NDI Guidance, which like the FDA FAQs is nonbinding, elaborates on the idea of “marketing”:

FDA considers ‘marketing’ a dietary ingredient to mean selling or offering the dietary ingredient for sale (1) as or in a dietary supplement, (2) in bulk as a dietary ingredient for use in dietary supplements, or (3) as an ingredient in a blend or formulation of dietary ingredients for use in dietary supplements. A dietary ingredient may be “marketed” by offering the article for sale online or at a retail establishment, listing it for sale in a catalog or price list, or through advertising or other promotion, if the promotion makes clear that the article is available for purchase. ‘Coming soon’ advertisements would not qualify.”

The NDI Guidance goes on to state “[i]n considering whether a substance has been ‘marketed as a dietary supplement or as a food,’ FDA looks for evidence of one of the following:”

1. Evidence that the substance itself was sold or offered for sale in the U.S. as a dietary supplement, dietary ingredient for use in dietary supplements, or conventional food. For example, a catalog listing a product identified as a ‘Substance A supplement’ would establish the marketing of Substance A as a dietary supplement. Similarly, business records documenting that a substance was sold or offered for wholesale or retail sale for use as an ingredient in a conventional food would establish the marketing of the substance as a food.

2. Evidence that the substance was a component of a food or dietary supplement that was sold or offered for sale in the U.S., and that a manufacturer or distributor of the food or dietary supplement marketed it for the content of the substance by, for example, making claims about the substance or otherwise highlighting its presence in the product. For example, in Pharmanex v. Shalala, the firm marketed lovastatin, a component of its red yeast rice product Cholestin, by promoting the lovastatin content of Cholestin. Merely showing that the substance was present as a component in a marketed food would not be enough to show that the substance was ‘marketed,’ however.”

Red Yeast Rice

The NDI Guidance’s reference to Pharmanex v. Shalala is of note as that case may have a major bearing on Hemp-CBD. Back in April 1997, the FDA issued a warning letter to Pharmanex, stating that it was selling a drug as a dietary supplement. Pharmanex manufactured Cholestin, a dietary supplement derived from red yeast rice intended to promote healthy cholesterol levels. Cholestin contained the substance mevinolin. Mevinolin was chemically identical to lovastatin, the active ingredient in the prescription drug Mevacor. The FDA approved Mevacor back in 1987. The FDA advised Pharmanex that it considered Cholestin to be a drug which could not be marketed without FDA approval. Pharmanex argued that red yeast rice had been used a food ingredient for thousands of years. The FDA was not convinced, ultimately holding that Cholestin containing lovastatin did not meet the definition of a “dietary supplement” because lovastatin was an “article” that had already been approved as a drug. The FDA determined that Cholestin did not satisfy the Prior Marketing Clause because it did not contain red yeast rice as that product had traditionally been manufactured and marketed. The FDA ran tests on samples of red yeast rice and found small amounts of lovastatin. In the FDA’s view, Pharmanex had manipulated red yeast rice to increase the lovastatin content and therefore the Drug Exclusion Rule applied.

Pharmanex challenged the FDA’s ruling in district court. The district court set aside the FDA’s decision, agreeing with Pharmanex that the term “article” as used in the FDCA did not refer to a single ingredient in a drug. The Court of Appeals for the Tenth Circuit reversed, holding that “article” could include the active ingredients of approved new drugs, such as lovastatin, which would exclude them from the dietary supplement definition. On remand, the district court affirmed the FDA’s original conclusion that lovastatin was not marketed as a dietary supplement or food before the FDA approved Mevacor as a prescription drug.

Cholestin containing lovastatin is no longer on the market in the US. There are still red yeast rice supplements available but the FDA monitors whether those supplements contain more than the naturally occurring amount of lovastatin.

The Future of Hemp-CBD

The Pharmanex case could dictate how the FDA treats Hemp-CBD. Hemp contains many active compounds, including cannabinoids like CBD and terpenes. Hemp can be processed in a number of ways, some of which will isolate these active compounds. Chemical extraction methods can isolate these active compounds while removing water, fiber, and other unwanted material. Alternatively, hemp can be processed without the use of chemicals (e.g., dried flowers; chopped up plant material placed in pellets, etc.).

“Full spectrum” extracts are the extracts that contain a wide array of compounds found in the hemp plant, including cannabinoids and terpenes. Processors can also isolate specific compounds by repeatedly extracting and refining the compound. Epidiolex is an example of a CBD isolate. A CBD isolate generally contains almost no other compounds. In turn, full spectrum extracts contain trace amounts of CBD and their compounds.

Following the reasoning in Pharmanex, CBD isolate may be subject to the Drug Exclusion Rule, but processed hemp, including full spectrum extracts may not due to the Prior Marketing Clause. This is because like Red Yeast Rice, hemp has been consumed as food and medicine for thousands of years. Hemp is not the same as the CBD isolate. The Pharmanex case turned on the an interpretation of the term “article.” CBD isolate is the article that was approved as a drug. Full spectrum extracts and other processed hemp products that contain naturally occurring CBD also may be outside of the scope of the Drug Exclusion Rule by way of Epidiolex. In turn, CBD isolate or processed hemp that had isolated and increased CBD could only legally be sold as drugs.

Though the parallel between Hemp-CBD and red yeast rice are impossible to ignore, there is no gaurantee that the FDA will take the same exact approach. For one, perhaps it can be established that CBD, in its isolated form was marketed prior to the Epidiolex studies being made public. CBD was first discovered by Dr. Roger Adams at the University of Illinois in 1940. However, any marketing of CBD isolate prior to the first Epidiolex investigations in 2014, would have likely violated federal law because the 2014 Farm Bill was not yet in effect, making it illegal under federal law.

However the FDA’s statement following the 2018 Farm Bill included some very interesting language:

[P]athways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process.”

The FDA Secretary can override the Drug Exclusion Rule by issuing “a regulation, after notice and comment, finding that the article would be lawful under [the FDCA].” The statement also went onto ask for input on the future of Hemp-CBD:

Given the substantial public interest in this topic and the clear interest of Congress in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share their experiences and challenges with these products, including information and views related to the safety of such products.”

We will continue to monitor the FDA for additional updates on Hemp-CBD.

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The FDA’s Stance on Hemp-Derived CBD as a Dietary Supplement (Part 1)

fda dietary supplement cbd hemp

Since the 2014 Farm Bill passed, products containing cannabidiol (“CBD”) derived from hemp (“Hemp-CBD”) have become widely popular and available in a wide range of stores and online. The Food and Drug Administration (“FDA”) has, for the most part, sat on the sidelines. The FDA has occasionally sent out warning letters to Hemp-CBD distributors who made medical claims about their products, but that was it. The days of relative non-enforcement may be over, as the FDA has recently seized Hemp-CBD products.

This two-part series will take a look at how the FDA will regulate Hemp-CBD. Today’s post will focus on why the FDA does not currently view Hemp-CBD is a dietary supplement. Tomorrow, we’ll examine some issues with the FDA’s position and look at how the agency may regulate Hemp-CBD in the near future.

The 2018 Farm Bill makes it explicit that it does not limit the FDA’s authority to regulate consumer products, and the FDA has made clear that it is focused on Hemp-CBD, making an announcement on Hemp-CBD just moments after the 2018 Farm Bill was signed by Trump. FDA’s jurisdiction over products is triggered by the Food, Drug & Cosmetics Act (“FDCA”).

For the purposes of this post we’ll look at the following categories of products under the FDCA and FDA regulation:

  • “Drug” is any article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” or “intended to affect the structure or any function of the body of man or other animals. In addition, anything intended as a component of a drug is also drug. 21 USC § 321(g). The FDA’s jurisdiction is triggered by the intended use oof an item. The FDA determines intended use generally based on claims made by the distributers of a product, which are often uncovered on labeling, advertising, and other promotional activities related to a product. Drugs are tightly regulated by the FDA and subject to pre-approval before being introduced into interstate commerce.
  • “Food” is any “article for use as food or drink for man.” Unlike drugs, which are determined by intended use, the FDA exerts its jurisdiction over food based on actual use.
  • “Dietary supplement” is a product intended to supplement the diet that contains one or more of the following: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (a) through (e). 21 U.S.C. § 321(ff).

Hemp-CBD appears to makes the most sense as “dietary supplement.” After all, it is is a concentrate of a botanical: hemp. Hemp-CBD could also be a food (based on actual use) or drug (based on intended use). The FDA’s warning letters mostly have focused on Hemp-CBD as a drug, but those letters and other statements by the FDA make it clear that the FDA does not believe that Hemp-CBD qualifies as a dietary supplement or food. For today’s post, we’ll focus on the dietary supplement side of things.

Drug Exclusion Rule

There is an exclusion clause in the definition of “dietary supplement” that generally disallows the use of an FDA approved “drug” as a dietary supplement. We will call this the “Drug Exclusion Rule.” The FDCA’s definition of “dietary supplement” excludes any article that is approved as a new drug or has been subject to a publicized Investigational New Drug (“IND”) clinical investigation, unless the substance was marketed in food or as a dietary supplement before the FDA approved it as a new drug or began the IND investigation. The FDA addresses numerous cannabis related issues on its “FDA and Marijuana: Questions and Answers” page (“FDA FAQs”). According to the FDA FAQs, products containing CBD cannot be sold as dietary supplements because CBD has been investigated and approved as a new drug, namely Epidiolex.

Though the FDA FAQs is a nonbinding guidance document, it seems to indicate that the Drug Exclusion Rule applies to CBD, because of the approval of Epidiolex and IND investigations of CBD:

The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome ).”

However, to determine whether the Drug Exclusion Rule applies, the FDA also needs to prove that CBD was not marketed as a food or dietary supplement prior to those investigations, which started in 2014. Check back early next week, when I’ll take a close look at the FDA’s position on that issue, and take a look at how the agency may regulate Hemp-CBD in the near future.

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Quick Hits

Some recent highlights and curiosities from the amazing world of cannabis science and therapeutics:

  • CBD and autism. In his first article of the new year, Raphael Mechoulam and other Israeli scientists look at the “real life experiences of medical cannabis treatment in autism.” Published in Nature, the study found that just under a third of patients report significant improvements and over half report moderate improvements while using CBD-rich oil derived from cannabis (30% CBD, 1-2% THC). The improvements include decreased aggression and agitation, fewer seizures, and better sleep, appetite and ability to concentrate. Around 10-20% of patients stopped taking various medications (mostly antipsychotic and antiepileptic drugs) within 6 months of starting cannabis treatment. One quarter of people experienced some negative side effects like sedation or restlessness, but none were severe. And about one in 5 stopped treatment because it wasn’t effective. Even though there remains a lot to be discovered about how and why CBD can improve the lives of people with autism, it is clear that cannabis can be used safely by this population and should be studied further.
  • Cannabis and ADHD. A study in Molecular Psychiatry with tens of thousands of people found an association between ADHD and cannabis use. Their data suggests that ADHD causes later cannabis use, which may support the notion that THC is used to self medicate (although ADHD is associated with heavier use of many drugs). Previous research has found that THC may be effective for some cases that do not respond well to Ritalin.
  • Self medicating for endometriosis. Endometriosis is a poorly-understood condition causing severe chronic pain and alterations in a woman’s menstrual cycle. As an understudied disease, treatment is limited. Scientists surveyed over 400 Australian women to see what actions they took to treat their pelvic pain. Cannabis, heat, CBD oil, and dietary changes were rated most effective by women, in that order. Unfortunately, more women used alcohol than cannabis to manage symptoms; self-medicating with alcohol promotes chronic inflammation and led to worsening pain and fatigue in over half of such women. This underscores the importance of not treating cannabis like alcohol in the ongoing saga of legalization. (Note: endometriosis is diagnosed with an invasive surgical procedure, and so many women who likely have endometriosis go undiagnosed. The group that responded to this survey had a confirmed diagnosis.)
  • Concussions and alcoholism. Traumatic brain injury (TBI) leads to numerous problems, including alcoholism and suicide. New findings indicate that endocannabinoids aid TBI recovery: When researchers boosted 2-AG levels shortly after injury, rats displayed less anxiety and less interest in alcohol. This is significant since alcoholism is a serious comorbidity of brain injury. The researchers link the protective effect of 2-AG to changes in glutamate transmission in the central amygdala, the part of the brain that processes traumatic and fearful memories. Other preclinical research has demonstrated that endocannabinoids can play a protective role after traumatic brain injuries, like concussion, by ameliorating glutamatergic toxicity.

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