We’ve written extensively on this blog about industrial hemp-derived CBD products, including CBD comestibles, CBD pet products, CBD in alcohol, and CBD topicals. Of all these categories of goods, the CBD industry seems to have reached a consensus that CBD topical products present the lowest level of risk for businesses, hence companies like CVS, Walgreens, and Sephora opting to offer the products for sale.

But a number of warning letters from the FDA, including one issued on October 10, 2019 to Rooted Apothecary LLC, make it very clear that sellers of CBD topical products do not have an unfettered pass from the FDA to sell these products.

As we’ve analyzed before, cosmetics are treated differently under federal law than food products. Cosmetics are “articles intended to be rubbed poured, sprinkled or sprayed on . . . or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering appearance,” except for soap which is classified separately. 21 USC 321(i). Cosmetics and ingredients in cosmetics are not subject to pre-market approval, unlike food and drugs. The FDA relies on consumer complaints to monitor the cosmetics industry. However, this does not mean that the FDA does not have regulatory authority over cosmetics and their ingredients. Some ingredients cannot be used in cosmetics (i.e. chloroform), and will lead a product to be deemed “adulterated.” The FDA has been clear that “certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients.

However, the FDA also makes clear that “[i]ngredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way.” And to add another layer of complexity to the analysis, it is possible for topical products to be deemed both a cosmetic and a “drug” by the FDA, and we know that CBD and CBD products cannot be marketed as drugs without having undergone the FDA’s drug approval process.

This takes us back to the October 10^th letter that the FDA issued to Rooted Apothecary. In that letter, the FDA laid out its determination that certain products sold by Rooted Apothecary, including a “Hemp Infused Body Butter,” are “unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).” The FDA also determined that these products were “misbranded drugs” under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1) and that introduction of these products into interstate commerce violates the FD&C Act.

The FDA reiterated its position that CBD products cannot be marketed for therapeutic or medical uses without having been reviewed for safety and effectiveness by the FDA – this requirement applies to all CBD products, including topical and cosmetic products. The FDA also seemed particularly concerned by the medical claims made by Rooted Apothecary because many of its products were being marketed for use in infants and children. Some of the problematic claims made by Rooted Apothecary for its “EARS – Essential Oil + CBD Infusion” topical roller product include the following:

• “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
• “Lavender . . . Analgesic, Antibacterial, Sedative . . .”
• “Melaleuca . . . Anti-parasitic, Antiviral . . . Decongestant . . ..”

Based on claims like the foregoing, the FDA determined that many of Rooted Apothecary’s products were drugs under section 210(g)(1) of the FD&C Act because they “are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.”

The letter also scrutinized Rooted Apothecary for selling “misbranded drugs” and making “unsubstantiated advertising claims,” and should serve as a cautionary tale to manufacturers and sellers of CBD topical products. CBD topical products may often be less problematic than edible products as far as the FDA is concerned, but making claims about your products that place them within the definition of a “drug” is certain to land you in the agency’s crosshairs. Thoroughly reviewing packaging, marketing copy, and websites for these types of claims will be crucial for every company offering topical CBD products for sale.

On Tuesday, the U.S. Department of Agriculture (“USDA”) released its interim final rule for the production of hemp under the 2018 Farm Bill. Although these rules are not final, they will go into effect once published in the Federal Register, at which point a 60-day public comment period will begin.

Upon the publication of the rules, our firm provided a broad overview of the provisions found in the rules. Today, we further discuss the THC testing requirements proposed in the rules and how they will impact the hemp industry.

TOTAL THC TESTING PROTOCOL

To the disappointment of many in the hemp industry, the USDA adopted a total THC testing requirement. As we previously explained, total THC is the molar sum of delta-9 THC (“THC”) and delta-9 tetrahydrocannabinolic acid (“THCA”). Using a total THC testing protocol will create additional hurdles for hemp farmers who are already engaged in a precarious industry. Not only does this testing method tend to increase the THC concentration in the hemp sample, and thus, pushes it over the 0.3 percent limit, it also limits the type of strains farmers can work with. This is because few hemp genetics currently on the market would comply with a total THC testing method. Consequently, this rule will force hemp farmers to carefully select the types of seeds they buy.

To make things worse, the USDA rules also require that hemp be sampled and tested for total THC within 15 days of anticipated harvest. Given that the concentration of THC increases as harvest approaches, the rule will create additional challenges to get at or under the 0.3 percent limit. Although the USDA stated in its rules that it was “requesting comments and information regarding the 15-day sampling and harvest timeline,” the agency also explained that the rule “will yield the truest measurement of THC level at the point of harvest.” In light of these statements, it will be interesting to see whether stakeholders’ input on the matter will convince the USDA to revise this requirement.

DEA REGISTRATION

The USDA testing rules further require that the testing labs be registered with the Drug and Enforcement Administration (“DEA”). The rationale for this rule is that labs could potentially handle hemp that tests above the THC testing limit, and thus, would constitute “marijuana”, a Schedule I drug under the Controlled Substances Act. Because it is unlawful to possess marijuana without a DEA registration, all labs must be registered with the DEA in order to conduct hemp THC testing. However, the current DEA rules limit registration to labs located in jurisdictions in which the prescription, distribution, dispensing, research and handling of marijuana is legal. Accordingly, this USDA rule may reduce the number of labs that will be authorized to engage in this industry, which would be problematic given the fact that there are currently too few labs compared to the amount of hemp being produced.

Therefore, the proposed USDA rules present real challenges for the hemp industry as many crops will likely fail to meet the total THC limit and fewer labs will be allowed to test the crop.

If you would like to further discuss this issue, please contact our team of regulatory attorneys.

Today, the U.S. Department of Agriculture (“USDA”) released its interim hemp rules. This is a major step in the full implementation of the 2018 Farm Bill. These rules are not final but they will be effective as soon as they are published in the Federal Register. Stakeholders will have 60 days to submit comments on the interim hemp rules.

Expect to see additional analysis of these rules on this blog in the coming days. For now, we’ve highlighted some of the main points that stuck out to us.

State and Tribal Plans. The 2018 Farm Bill requires states and Indian Tribes to submit hemp cultivation plans to the USDA. The interim hemp rules require that these plans include a practice to collect, maintain and report information on hemp cultivators, the land where hemp is produced, and the status and number of licenses issued. Plans must include a procedure for testing hemp within 15 days of the anticipated harvest. Plans must also ensure that samples are representative of an entire hemp lot and the state or tribal agency charged with testing must have unrestricted access to all land, building, and structures used for the cultivation, handling, and storage of hemp. Hemp producers may not harvest before samples are taken. Hemp that tests above 0.3% THC is deemed a “non-compliant cannabis plant” and a state or Tribal plan must cover the destruction of such material. Non-compliant cannabis plants must also be reported to USDA, along with other information on hemp producers and production generally. States and Tribes must also establish lab standards for testing hemp.

The USDA will review state and Tribal plans within 60 days of receipt. States and Tribes can submit amended plans in the event that the USDA does not approve of the initial submission or if the state or Tribe alters a previously approved plan. The USDA will, from time-to-time, audit state and Tribal plans.

USDA Licensing. If a state or Tribal plan is not approved, would-be hemp producers can grow hemp in that state or Tribal area under a USDA hemp license, so long as “the production of hemp is not otherwise prohibited by the State or Indian Tribe.”

The USDA will issue hemp producer licenses. Applicants can apply 30 days after the rules are published in the Federal Register. After that, the USDA will accept applications between August 1 and October 31 each year. Applicants must submit their contact information and a criminal history report. Remember that a felony conviction, at either the state or federal level, results in a 10-year ban from participating in the legal hemp industry, unless a person was lawfully growing hemp under the 2014 Farm Bill before December 20, 2018.

USDA license will be valid until December 31st three years after the year the licensed was issued. Licenses cannot be sold, assigned, transferred, pledged or otherwise disposed of. An application is required for each location where hemp is grown. USDA licensees must submit tests within 15 days of harvest to the USDA or to a state agency, federal agency, or a person approved by the USDA to accept tests. Non-compliant plant material must be destroyed. USDA licensees will be subject to inspections and must maintain records relating to hemp.

Total THC Testing. The interim hemp rules also cover THC testing, which was a point of concern in the lead up to theses rules being released. The interim hemp rules state that:

A State or Tribal plan must include a procedure for testing that is able to accurately identify whether the sample contains a delta-9 tetrahydrocannabinol content concentration level that exceeds the acceptable hemp THC level. The procedure must include a validated testing methodology that uses postdecarboxylation or other similarly reliable methods. The testing methodology must consider the potential conversion of delta-9 tetrahydrocannabinolic acid (THC-A) in hemp into THC and the test result measures total available THC derived from the sum of the THC and THC-A content. Testing methodologies meeting these requirements include, but are not limited to, gas or liquid chromatography with detection. The total THC concentration level shall be determined and reported on a dry weight basis.

This appears to require Total THC testing, which includes THC-A, and as has been implemented in Oregon. Laboratories who test hemp will also report their “measurement of uncertainty” or “MU.” The USDA provides additional context on this concept:

The definition of “acceptable hemp THC level” explains how to interpret test results with the measurement of uncertainty with an example. The application of the measurement of uncertainty to the reported delta-9 tetrahydrocannabinol content concentration level on a dry weight basis produces a distribution, or range. If 0.3% or less is within the distribution or range, then the sample will be considered to be hemp for the purpose of compliance with the requirements of State, Tribal, or USDA hemp plans. For example, if a laboratory reports a result as 0.35% with a measurement of uncertainty of +/- 0.06, the distribution or range is 0.29% to 0.41%. Because 0.3% is within that distribution or range, the sample, and the lot it represents, is considered hemp for the purpose of compliance with the requirements of State, Tribal, or USDA hemp plans. However, if the measurement of uncertainty for that sample was 0.02%, the distribution or range is 0.33% to 0.37%. Because 0.3% or less is not within that distribution or range, the sample is not considered hemp for the purpose of plan compliance, and the lot it represents will be subject to disposal. Thus the “acceptable hemp THC level” is the application of the measurement of uncertainty to the reported delta-9 tetrahydrocannabinol content concentration level on a dry weight basis producing a distribution or range that includes 0.3% or less. As such, the regulatory definition of “acceptable hemp THC level” describes how State, Tribal, and USDA plans must account for uncertainty in test results in their treatment of cannabis.

Labs that test cannabis for THC levels must be registered with the DEA. The USDA is considering a fee-for-service that would allow labs to seek approval with the USDA for THC-testing.

Interstate Transport. The interim rules prohibit states or Tribes from “prohibiting the transportation or shipment of hemp or hemp products produced under a State or Tribal plan,” a license issued by the USDA, or “under 7 U.S.C. 5940[.]” What is 7 U.S.C. 5940? It’s the codification of the 2014 Farm Bill’s industrial hemp provisions. That means that states (looking at you Idaho) can not seize hemp produced under the 2014 Farm Bill, so long as it’s done in compliance with state law or cultivated by an institution of higher education.

Bottom line. We’ve just begun to scratch the surface. These interim hemp rules also outline hemp violations, the appeal process for hemp licensing, and touch on the interplay with the Controlled Substances Act. More than anything else, the USDA’s release of these rules means that we are finally headed towards full implementation of the 2018 Farm Bill. We expect the USDA to be inundated with state and Tribal hemp plans and applications for USDA hemp production licenses over the next few weeks, and then again early next year after many state legislature reconvene. We’ll keep an eye out for developments and suggest you do the same.

The passage of the 2018 Farm Bill and the legalization of hemp and hemp-derived products has sparked strong business interest from foreign stakeholders. For the past few months, our firm has received numerous inquiries from existing and prospective clients about the legality of importing the agricultural crop and its derived products, particularly hemp-derived CBD (“Hemp-CBD”), to the United States.

This blog posts briefly addresses the risks and feasibility of engaging in this business at the moment.

IMPORTING HEMP

Although the 2018 Farm Bill legalized the commercialization of hemp and its derivatives, the production of the crop has yet to be regulated by the U.S. Department of Agriculture (“USDA”), which is tasked with adopting rules that will serve as a road map for states and Indian tribes wishing to regulate hemp within their borders.

The USDA had anticipated issuing its rules by the end of summer; however, the agency only recently submitted (on September 13) its proposed rules to the White House Office of Budget and Management (“OBM”), which reviews all regulations adopted and implemented by a presidential administration. Until this process is complete, we are left with little guidance on the production of hemp, including its transportation — note that the OBM approved the proposed rules on Friday, October 25, which means they should be released any day now.

Back in April, the agency issued a statement in which it expressly legalized the importation of hemp seeds and set forth ways in which the seeds should be imported from Canada and other foreign countries. Then on October 16, the agency quietly updated its guidelines to allow the importation of both hemp seeds and plants in the United States. According to the USDA’s webpage, hemp plants for planting that originate from Canada and other foreign countries may be imported so long as certain requirements are satisfied. Hemp plants from Canada must be accompanied by “a phytosanitary certificate from Canada’s NPPO to verify the origin of the plant and to confirm no plant pests are detected.” Hemp plants from countries other than Canada must also be accompanied by a phytosanitary certificate as well as an application for a Permit to Import Plants or Plant Products, better known as a PPQ 587 permit

These new guidelines align with the position taken by some U.S. courts that foreign hemp may be freely shipped to the U.S. because hemp is now excluded from the Controlled Substances Act (“CSA”)’s definition of marijuana. Yet, in practicality, these court decisions did not eliminate the risk that foreign hemp be seized at the border. This is because hemp is hard to differentiate from marijuana. The crop looks and smells like its psychoactive cousin, which means additional guidelines were desperately needed from the USDA.

Although the agency’s guidelines confirm the importation of hemp plants is lawful, the rules do not mention the need to attach a copy of THC testing results, showing that the plant meets the 0.3% THC limit imposed under federal law. Therefore, it will be interesting to see whether hemp will now freely pass U.S. Customs and Border Protection or if additional regulations, such as testing protocols will be needed.

IMPORTING HEMP-CBD PRODUCTS

In addition to removing the hemp plant from the CSA, the 2018 Farm Bill legalized hemp concentrates and extracts, including Hemp-CBD. Nevertheless, the new law preserved the authority of the Food and Drug Administration (“FDA”) to regulate Hemp-CBD products, including but not limited to foods and dietary supplements. From the moment hemp and its derivatives were legalized, the FDA took the position that the use of Hemp-CBD in foods, dietary supplements and unapproved drugs is unlawful in the United States because CBD was already approved as an active ingredient in a drug used in the treatment of epilepsy (i.e., Epidiolex).

Given the popular demand of Hemp-CBD products, the federal agency has been pressured by lawmakers and stakeholders to reconsider its position on CBD and forge a pathway towards legalizing their sale and marketing in the United States.

Consequently, until the agency adopts new rules and regulations, the sale of these products will remain unlawful in the United States, even if manufactured and imported from overseas — although the FDA seems on board with the sale and marketing of Hemp-CBD topicals.

For more information on this issue, contact our team of regulatory attorneys.

The Agriculture Improvement Act of 2018 (“2018 Farm Bill”) legalized hemp by removing the crop and its derivatives from the definition of marijuana under the Controlled Substances Act (“CSA”) and by providing a detailed framework for the cultivation of hemp. The 2018 Farm Bill gives the US Department of Agriculture (“USDA”) regulatory authority over hemp cultivation at the federal level. In turn, states have the option to maintain primary regulatory authority over the crop cultivated within their borders by submitting a plan to the USDA.

This federal and state interplay has resulted in many legislative and regulatory changes at the state level. Indeed, most states have introduced (and adopted) bills that would authorize the commercial production of hemp within their borders. A smaller but growing number of states also regulate the sale of products derived from hemp.

In light of these legislative changes, we are presenting a 50-state series analyzing how each jurisdiction treats hemp-derived cannabidiol (“Hemp CBD”). Each Sunday, we summarize a new state in alphabetical order. Today, we turn to Maryland.

Maryland’s Industrial Hemp Pilot Program opened a little more than a year ago. In line with the 2014 Farm Bill, the purpose of the program was and is to authorize and facilitate research of industrial hemp and any aspect of cultivating, manufacturing, transporting, marketing, or selling industrial hemp for agricultural, industrial, or commercial purposes. The Maryland Department of Agriculture (“MDA”) or an institution of higher education that submits an application to the MDA may cultivate, manufacture, transport, market, or sell industrial hemp if the hemp is cultivated to further agricultural or academic research—notably, an undefined term in Maryland’s law.

Last year, MDA issued hemp regulations to govern its program. Per MDA guidance, farmers can partner with institutions of higher education, but otherwise, general commercial cultivation is prohibited. MDA also notes that it does not have jurisdiction over hemp processing or sale.

Earlier this year, Maryland’s governor approved of HB-1123, which includes specific provisions for hemp production and requires the MDA to create a plan for monitoring and regulating hemp production in the state.

That said, Maryland isn’t as open to Hemp CBD. The Maryland Department of Health sort of follows the FDA’s approach and holds that foods and beverages containing Hemp CBD are adulterated and can’t be sold in Maryland (sorry, no Maryland Hemp CBD crab cakes). The state has not really addressed many other types of products, but it could change its position to include Hemp CBD products such as vapes, cosmetics, or topicals (apparently, the state will try ban flavored vapes in the future).

Stay tuned to the Canna Law Blog for developments on hemp and Hemp CBD in Maryland and other states across the country. For previous coverage in this series, check out the links below:

• Alabama
• Alaska
• Arizona
• Arkansas
• California
• Colorado
• Connecticut
• Delaware
• Florida
• Georgia
• Hawaii
• Idaho
• Illinois
• Indiana
• Iowa
• Kansas
• Kentucky
• Louisiana
• Maine

The Agriculture Improvement Act of 2018 (“2018 Farm Bill”) legalized hemp by removing the crop and its derivatives from the definition of marijuana under the Controlled Substances Act (“CSA”) and by providing a detailed framework for the cultivation of hemp. The 2018 Farm Bill gives the US Department of Agriculture (“USDA”) regulatory authority over hemp cultivation at the federal level. In turn, states have the option to maintain primary regulatory authority over the crop cultivated within their borders by submitting a plan to the USDA.

This federal and state interplay has resulted in many legislative and regulatory changes at the state level. Indeed, most states have introduced (and adopted) bills that would authorize the commercial production of hemp within their borders. A smaller but growing number of states also regulate the sale of products derived from hemp.

In light of these legislative changes, we are presenting a 50-state series analyzing how each jurisdiction treats hemp-derived cannabidiol (“Hemp CBD”). Each Sunday, we summarize a new state in alphabetical order. Today, we turn to Maine.

Maine began authorizing the commercial sale of industrial hemp and Hemp-CBD products in 2015. Following the enactment of the 2018 Farm Bill, the state passed H.P. 459 and S.P. 585 to align Maine with the 2018 Farm Bill and clarify the legality of Hemp-CBD foods.

Under S.P. 585, which generally went into effect on September 19, “hemp” means:

the plant Cannabis sativa L. and any part of that plant, including the seeds and all derivatives, extracts, cannabinoids, isomers, acids, salts and salts of isomers, whether growing or not, with a delta-9-tetrahydrocannabinol concentration that does not exceed of not more than 0.3% on a dry weight basis and that is grown or possessed by a licensed grower in compliance with this chapter” and “includes agricultural commodities and products derived from hemp and topical or ingestible consumer products, including food, food additives and food products derived from hemp.” (Emphasis added).

Moreover, S.P. 585 provides that:

[n]otwithstanding any other provision of law to the contrary, food, food additives or food products that contain hemp, including cannabidiol derived from hemp, are not considered to be adulterated or misbranded under this subchapter based solely on the inclusion of hemp or cannabidiol derived from hemp.” (Emphasis added).

Accordingly, the manufacture and sale of Hemp-CBD food products seem to be authorized in the state so long as they comply with the THC testing and marketing requirements.

The state has adopted labeling requirements for packaged and unpackaged Hemp-CBD foods. Packaged food labels must:

1. Indicate that the food, food additive or food product contains hemp or Hemp-CBD;
2. Describe the CBD content by weight or volume;
3. Include the source of the hemp from which the CBD was derived;
4. In the case of extracts or tinctures, indicate the batch number; and
5. Include a disclosure statement that the food product has not been tested or evaluated for safety.

Unpackaged Hemp-CBD foods, which are foods sold in public eating places, such as retail stores, hotels and restaurants, must be accompanied by a conspicuous label or sign indicating that the product contains CBD either on the menu or in an open manner where the food order or food product is served. In addition, the public eating place must conspicuously display a directory for use by customers that contains information on the contents of all unpackaged Hemp-CBD products.

However there is one requirement that applies to both packaged and unpackaged Hemp-CBD foods: they cannot be marketed with any claims that the products can “diagnose, treat cure or prevent any disease, condition or injury” without approval from the FDA. If you follow our blog, you know it is wise not to make statements about the therapeutic value of Hemp-CBD products (see here and here). So by imposing this requirement on Hemp-CBD manufacturers and public eating places, the state is helping Hemp-CBD stakeholders mitigate their risk of FDA enforcement.

Turning to other categories of Hemp-CBD products, the sale of Hemp-CBD smokable products is neither restricted nor authorized under the law whereas the sale of cosmetics (i.e., topical) is expressly allowed under the definition of “hemp”.

Overall, it’s fair to say that Maine is a “Hemp-CBD friendly state.” In fact, no enforcement action has been taken against Hemp-CBD products since the enactment of H.P. 459 in March 27, 2019.

On October 12, 2019, Governor Newsom announced that he had signed SB-153, a bill aimed at making significant changes to California’s hemp cultivation law. As I’ve written before, the bill is a major change for California hemp laws for the following reasons:

• The bill adds a new definition of “industrial hemp”. If the bill becomes law, then there will be separate (and slightly different) definitions for hemp generally under the California Health and Safety Code, and now under the Food and Agriculture Code relative just to hemp cultivation.
• California will be required to submit a 2018 Farm Bill-compliant hemp production plan to the U.S. Department of Agriculture by May 2020. This is required under federal law, in order for states to comply with the 2018 Farm Bill. We still are awaiting USDA regulations to see how the submission process will work, but CA is now locked into submitting a plan.
• SB-153 will narrow the scope of who qualifies as an established agricultural research institution (“EARIs”) to be more consistent with federal law. Under current California hemp cultivation laws, the definition of EARIs is much broader than under federal law. SB-153 will, once the USDA approves of CA’s hemp production plan, narrow the scope of who qualifies as an EARI to be consistent with federal law.
• California will mandate registration for commercial and non-commercial growers who don’t qualify as EARIs. Currently, only commercial growers must register. These modifications, in combination with the narrowed definition of EARIs, will require that some current hemp cultivators who qualify as EARIs will then need to register as non-commercial cultivators.
• California will also mandate registration for EARIs and require them to submit “research plans” to their local county agricultural commissioner that detail what their cultivation operations will look like. This is a brand new concept that was not included in the original California Industrial Hemp Farming Act and is likely going to be a major change for cultivators across the state operating under research memoranda of understanding with EARIs.
• The bill will create enforcement provisions, penalties for false statements on applications, and a bar on persons from being a part of the industrial hemp program if they had a conviction relating to controlled substances in the prior 10-year period.
• SB-153 clarifies that hemp can’t be cultivated in a licensed cannabis premises, but that if it is, it will be considered cannabis.

Now that SB-153 is the law, hemp businesses across the state will need to adjust how they operate to ensure compliance with the law. It’s not clear from SB-153’s text when certain parts take effect, and we don’t yet have any official guidance by the California Department of Food and Agriculture (which regulates hemp cultivators) on compliance, so compliance may be a mess—as usual. Stay tuned to the Canna Law Blog for more California hemp cultivation updates.

According to recent reporting, pet industry spending is expected to reach $96 billion by 2020 with CBD as one of its fastest growing sections. Following the enactment of the Agricultural Improvement Act of 2018 (“2018 Farm Bill”), there has been a huge interest in the use of hemp-derived cannabidiol (“Hemp-CBD”) for our furry friends. Yet, public demand for Hemp-CBD pet products may be pushing the market ahead regardless of legal requirements.

While there are many Hemp-CBD pet products on the U.S. market, this blog post provides a brief overview of the regulatory framework surrounding Hemp-CBD pet foods.

FEDERAL POLICIES

Hours following the passage of the 2018 Farm Bill, Scott Gottlieb issued a statement in which the then-FDA Commission clarified that the federal legalization of the crop did not strip the agency of its regulatory authority over products containing hemp and its derived compounds, including Hemp-CBD pet foods.

Pursuant to Sections 301(ll) and 201(ff)(3)(B) of the Food, Drug and Cosmetic Act (“FD&CA”), food cannot contain an ingredient also found in an approved drug. Because the FDA approved CBD as an active ingredient in Epidiolex, a drug used in the treatment of epilepsy, for which substantial clinical investigations have been instituted, the FDA posits that it is unlawful to use CBD as an active ingredient in human and pet foods.

There is an exception to this rule if the substance was “marketed as” a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. Consequently, the sale and marketing of Hemp-CBD pet foods currently violates FDA policies.

The FDA has limited its enforcement actions against Hemp-CBD products for pets by issuing warning letters to companies that have been making unsubstantiated, egregious claims about the therapeutic value of their products. Therefore, if a company decides to enter the Hemp-CBD pet market regardless of FDA policy, it should, at a minimum, refrain from making any health claims.

STATE LAWS

Although the FDA prohibits the sale and marketing of Hemp-CBD pet foods in interstate commerce, several states have enacted legislation that expressly legalized the sale of these products. Oregon, for example, authorizes the manufacture, distribution and sale of Hemp-CBD pet foods, which are limited to “dog and cat” foods containing no more than 0.3 percent total THC. In addition, Hemp-CBD pet foods manufactured, sold and marketed in the Beaver State must meet other testing requirements imposed by the Oregon Health Authority, including but not limited to microbiological contaminants.

Other states have not taken a position on the sale of these products, rendering these products illegal at worse and unregulated at best.

So similarly to Hemp-CBD human foods, Hemp-CBD pet foods cannot lawfully be sold throughout the United States. As such, manufacturers, distributors and retailers of Hemp-CBD pet foods should consult with regulatory attorneys to understand and mitigate the risk of enforcement action by the FDA as well as state and local enforcement groups that prohibit the sale of these products.

For more information on this issue, please contact our hemp regulatory team.

The Agriculture Improvement Act of 2018 (“2018 Farm Bill”) legalized hemp by removing the crop and its derivatives from the definition of marijuana under the Controlled Substances Act (“CSA”) and by providing a detailed framework for the cultivation of hemp. The 2018 Farm Bill gives the US Department of Agriculture (“USDA”) regulatory authority over hemp cultivation at the federal level. In turn, states have the option to maintain primary regulatory authority over the crop cultivated within their borders by submitting a plan to the USDA.

This federal and state interplay has resulted in many legislative and regulatory changes at the state level. Indeed, most states have introduced (and adopted) bills that would authorize the commercial production of hemp within their borders. A smaller but growing number of states also regulate the sale of products derived from hemp.

In light of these legislative changes, we are presenting a 50-state series analyzing how each jurisdiction treats hemp-derived cannabidiol (“Hemp CBD”). Each Sunday, we summarize a new state in alphabetical order. Today, we head to the bayou: Louisiana.

Louisiana lawmakers recently adopted House Bill 138 (HB 138) and House Bill 491 (HB 491) in light of the 2018 Farm Bill. HB 138 amends Louisiana’s definition of marijuana to exclude “industrial hemp that is in the possession, custody, or control of a person who holds a license issued by the Louisiana Department of Agriculture and Forestry, or is cultivated and processed in accordance with the U.S. Agriculture Improvement Act of 2018.” In turn, HB 138 defines industrial hemp as “the plant Cannabis sativa and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids and salts of isomers, whether growing or not, with a delta-9-tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis and cultivated and processed in accordance with the U.S. Agriculture Improvement Act of 2018, or the plan submitted by the Louisiana Department of Agriculture and Forestry that is in compliance with the U.S. Department of Agriculture rules.” In Louisiana, hemp is only legal if it meets the THC concentration outlined in the 2018 Farm Bill and also was cultivated and processed legally, either in Lousiana or elsewhere.

HB 491 lays out the details of Louisiana’s hemp cultivation plan. The Louisiana Department of Agriculture and Forestry (LDAF) oversees the program. LDAF issues the following licenses:

• Grower License – authorizes the licensee to cultivate, handle and transport industrial hemp;
• Processor License – authorizes the licensee to handle, process and transport industrial hemp;
• Seed Producer – authorizes the licensee to produce, transport and sell industrial hemp seed; and
• Contract Carrier – authorizes the licensee to transport industrial hemp (required when the transporter is not the licensed grower or processor of the plant material).

LDAF has not yet begun issuing these licenses as the USDA has yet to approve any state plan, including Louisiana’s. With regards to hemp cultivation, HB 491 tracks the farm bill closely. It is worth mentioning that any person transporting or delivering hemp in Louisiana must carry a dated invoice, bill of lading, or manifest which shall include the seller and purchaser’s name and address, the specific origin and destination, and the quantity of hemp. That’s important to note for anyone traveling through Louisiana with hemp.

HB 491 also covers Hemp-CBD products. No person may process or sell (1) any part of hemp for inhalation, (2) any alcoholic beverage containing CBD, or (3) any food product or beverage containing CBD unless the FDA approves CBD as a food additive. All Hemp-CBD products must be labeled and registered in accordance with Louisiana’s Food, Drug and Cosmetic Law (R.S. 40:601 et seq.). Hemp-CBD may not be marketed as a dietary supplement. In addition, Hemp-CBD labels must meet the following criteria and be approved by the Louisiana Department of Health:

• Contain the following language: “This product has not been evaluated by the Food and Drug Administration and is not intended to diagnose, treat, cure, or prevent any disease.”
• Contain no medical claim
• Have a scannable bar code, QR code, or web address linked to a Certificate of Analysis (COA)

COAs for Hemp-CBD products in Louisiana must contain the following:

• The batch identification number, date received, date of completion, and the method of analysis for each test conducted.
• Test results identifying the cannabinoid profile by percentage of dry weight, solvents, pesticides, microbials, and heavy metals.

Retailer sellers of Hemp-CBD must (1) register with the Office of Alcohol Tobacco Control (OATC) and (2) meet the above specific labeling and testing requirements. Hemp-CBD may only be sold by businesses holding a CBD Dealer Permit from OATC, which requires a location in Louisiana where products are stored and/or sold. CBD Dealer Permit applicants must also have been residents of the state of Louisiana for two years prior to applying. These provisions make the online sale of Hemp-CBD in Louisiana impractical in most cases.

Stay tuned to the Canna Law Blog for developments on hemp and Hemp CBD in Louisana and other states across the country. For previous coverage in this series, check out the links below:

• Alabama
• Alaska
• Arizona
• Arkansas
• California
• Colorado
• Connecticut
• Delaware
• Florida
• Georgia
• Hawaii
• Idaho
• Illinois
• Indiana
• Iowa
• Kansas
• Kentucky