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Hemp-Derived CBD Not Allowed in Food (or Pretty Much Anything Else) in California

CBD lawyers

Last week, the California Department of Public Health’s Food and Drug Branch (CDPH-FDB) issued a revised FAQ on cannabidiol (CBD) in food products that will likely block the sale of hemp-derived CBD products in California — which if you’ve been in the state lately, are pretty much already everywhere.

CDPH-FDB has determined that CBD sourced from industrial hemp cannot be added to food (including drinks) for either humans or pets:

[A]lthough California currently allows the manufacturing and sales of cannabis products (including edibles), the use of industrial hemp as the source of CBD to be added to food products is prohibited. Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.

California’s Health and Safety Code defines “food” as “a raw, cooked, or processed edible substance, ice, beverage, an ingredient used or intended for use or for sale in whole or in part for human consumption, and chewing gum.” Further, CDPH-FDB’s FAQ elaborates on what will not be allowed in food in California as follows:

  • Any CBD products derived from cannabis
  • Any CBD products, including CBD oil derived from industrial hemp
  • Hemp oil not derived from industrial hemp seeds
  • Industrial hemp seed oil enhanced with CBD or other cannabinoids
Seeds derived from industrial hemp and oil made from industrial hemp seeds are allowed in food if the distributor of those items makes no medical claims about the seeds and/or oil.
CDPH-FDB also made the following distinction between “hemp seed oil” and CBD oil:
Industrial hemp seed oil and hemp-derived CBD oil are two different products. Industrial hemp seed oil is derived from the seeds limited to types of the Cannabis sativa L. plant and may contain trace amounts of CBD (naturally occurring) and other cannabinoids. Food grade Industrial hemp seed oil is available from a variety of approved sources.
However, CBD or CBID oil derived from industrial hemp is NOT approved for human and animal consumption by the FDA as food and therefore cannot be used as a food ingredient, food additive, or dietary supplement.
CDPH-FDB confirmed in is FAQ that “there is no regulatory agency that provides oversight for the production of CBD oil from industrial hemp,” but CDPH does have authority over food and dietary use products generally and, therefore, food products containing CBD oil are within its authority to regulate. The FAQ also adds that “CBD is an unapproved food additive and NOT allowed for use in human and animal foods in California regardless of where the CBD products originate.” So, no out-of-state hemp-CBD loophole.
CDPH-FDB distinguished cannabis edibles sold under MAUCRSA and regulated by CDPH’s Manufactured Cannabis Safety Branch from non-cannabis food products sold outside of that regulatory framework. Yet in another blow to hemp-CBD, the Bureau of Cannabis Control will not allow MAUCRSA-licensed retailers to sell stand alone hemp-CBD products even though BCC rules explicitly allow for selling non-cannabis products at licensed retail storefronts.

The FAQ also addresses the Food and Drug Administration (FDA), which has a complicated relationship with CBD. The FDA states in its own THC/CBD FAQs that it is prohibited to “introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added.” The FDA has also sent out cease and desist letters (see here, here, and here) to CBD producers and sellers across the country that were making medical claims about their CBD products in violation of the Federal Food, Drug & Cosmetic Act . The FDA takes the position that CBD is neither a conventional food nor a supplement exempt from drug testing. Recently though the FDA approved Epidiolex, the cannabis-based drug used to treat severe forms of epilepsy. This approval does not mean the FDA now allows for all CBD products or that it will now allow businesses to make medical claims about CBD for products that have not been approved as drugs under the Federal Food Drug & Cosmetic Act –in other words, anything containing CBD that is not Epidiolex.

Essentially, California is letting the FDA dictate what it will do with hemp CBD. Though many other states allow hemp CBD for human consumption pursuant to Federal Farm Bill programs, California is following nearly lock-step with big brother on this one. How exactly CDPH-FDB plans to enforce its FAQ is not clear given that hemp CBD products are already rampant in California.

Our CBD lawyers will continue monitoring this evolving situation as hemp CBD makers and sellers struggle to navigate and comply.

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Labeling CBD Products: The Unique Case of Indiana

indiana cbd hemp
Home of legal CBD sales!

Indiana has uniquely positioned itself with some of the most robust regulations of hemp-derived CBD products. On March 21, 2018, Senate Bill 52 became law, allowing the distribution and retail sale of “low-THC hemp extract,” defined as a product “(1) derived from Cannabis sativa L. that meets the definition of industrial hemp; (2) that contains not more than 0.3% delta-9-THC (including precursors); and (3) that contains no other controlled substances.”

Exciting news, right? Indiana is a red state that has been slow to implement any kind of meaningful cannabis regulations. Prior to SB 52, Indiana implemented a strict CBD-only medical marijuana program and an industrial hemp program that has not really launched.

That’s what makes SB 52 so interesting. It shows that Indiana is cognizant of the existence of CBD products and has made a decision to allow their sale. The catch is that those sales are restricted to a certain class of CBD products, and they are heavily regulated.

Specifically, under SB 52, “low-THC hemp extracts” are only permitted for sale in Indiana if they are extracted from hemp that was tested by an accredited, independent laboratory. The distributor of low THC hemp extracts must have lab results showing “(1) the low THC hemp extract is the product of a batch tested by the independent testing laboratory; and (2) the independent testing laboratory determined that the batch contained not more than three-tenths percent (0.3%) total [THC], including precursors, by weight, based on the testing of a random sample of the batch.”

Assuming these products clear testing, the sellers of low THC hemp products must distribute them in packaging that includes the following:

(1) A scannable bar code or QR code linked to a document that contains information with respect to the manufacture of the low THC hemp extract, including the:

(A) batch identification number;

(B) product name;

(C) batch date;

(D) expiration date, which must be not more than two years from the date of manufacture;

(E) batch size;

(F) total quantity produced;

(G) ingredients used, including the:

(i) ingredient name;

(ii) name of the company that manufactured the ingredient;

(iii) company or product identification number or code, if applicable; and

(iv) ingredient lot number; and

(H) download link for a certificate of analysis for the low THC hemp extract.

(2) The batch number.

(3) The Internet address of a web site to obtain batch information.

(4) The expiration date.

(5) The number of milligrams of low THC hemp extract.

(6) The manufacturer.

(7) The fact that the product contains not more than three-tenths percent (0.3%) totaldelta-9-tetrahydrocannabinol (THC), including precursors, by weight.

That may read like a long list, but it’s roughly equivalent to what we see as far as packaging and labeling requirements for cannabis products in Washington, Oregon and California, the states in which our cannabis business attorneys are located.

This will also prove challenging for distributors who send products across the country as they now must consider Indiana’s labeling requirements. This will likely lead to some CBD distributors deciding not to sell products in Indiana. Other’s may choose to comply with Indiana’s labeling restrictions and place Indiana-complaint labels on products that are made available in other states.

Indiana is unique in the sense that it allows CBD and also regulates its sale so robustly. Let’s hope for more positive cannabis developments in the Hoosier State.

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CBD: My Miracle Medicine

I was born with a rare, degenerative hereditary motor and sensor neuropathy called Charcot-Marie-Tooth (CMT), a disorder of the peripheral nervous system characterized by a progressive loss of muscle tissue and touch sensation across various parts of the body. It wasn’t until I was 12 years old that I was diagnosed with Charcot-Marie-Tooth and for the following 22 years I have faced enormous challenges because of Charcot-Marie-Tooth and cannabis prohibition.

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Study on cannabis and chronic pain management

The University of Michigan is now conducting TWO studies on medical cannabis and we’d like you to participate!

The information you provide will help inform physicians, researchers, policy-makers, and patients about potential benefits and risks of cannabis as a therapeutic or recreational agent.

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The End of Industrial Hemp Prohibition: Almost There!

industrial hemp cannabis farm bill
We like this one.

For the past few months, the U.S. Senate has made significant strides toward legalizing industrial hemp. That is welcome news to many of our clients, who are working with the plant under federally approved Agricultural Pilot Programs, while also dealing with almost absurdly complex issues surrounding the legality of cannabidiol (“CBD”) sales.

The legislative developments began in earnest earlier this year, when Senate Majority Leader Mitch McConnell (R-KY) introduced the short and sweet Hemp Farming Act of 2018 (the “Hemp Farming Act”), which aims to lift an 80-year old ban on hemp as an agricultural commodity. We analyzed that development here.

Then, on June 5th, the Senate adopted its third annual non-binding resolution that recognized “the growing economic potential of industrial hemp” and its “historical relevance,” further suggesting Congress’s intention to legalize the non-psychoactive cannabis cousin of marijuana. Around the same time, Senate Leader McConnell incorporated the Hemp Farming Act into the wide-ranging agriculture and food policy bill known as the 2018 Farm Bill to ensure a greater chance of success, and it worked. Last week, the Senate overwhelmingly approved the 2018 Farm Bill, including the Hemp Farming Act, by an unambiguous 86-11 vote.

As with the Strengthening the Tenth Amendment Through Entrusting State Act (the “STATES Act”), which we covered here and here, the Hemp Farming Act provides for the removal of industrial hemp from Schedule I of the Controlled Substance Act (“CSA”). This removal would explicitly legalize the cultivation, processing and sale of all hemp-derived products, including CBD. This means that if cannabis legislation continues to move forward in Congress—which seems highly probable given the fact that the Hemp Farming Act has passed the Senate and that the STATES Act has reached the House—Congress will likely reconcile these pieces of legislation and industrial hemp prohibition will end.

In addition to removing industrial hemp as a Schedule I drug of the CSA, the passage of the Hemp Farming Act into law would:

  • Empower states and tribes to regulate the production of hemp without fear of federal intervention;
  • Permit farmers to grow, process and sell hemp-derived products as an agricultural commodity, which in turn would create economic opportunities and stimulate economic growth in rural communities;
  • Make hemp plants eligible for crop insurance;
  • Ensure access to public water rights for hemp farmers;
  • Enable hemp farmers to access the national banking system;
  • Recognize that some hemp-derived products, such as CBD oils, have valid medical use;
  • Make hemp-derived products eligible for federal trademark protection; and
  • Advance research opportunities by enabling hemp researchers to apply for grants with the U.S. Department of Agriculture.

Although the passage of the Hemp Farming Act in the Senate is a promising step toward the legalization of industrial hemp, more hurdles must be overcome before the federal legality of hemp becomes the law of the land. The Hemp Farming Act now must be merged with a competing version from the House, which does not provide for the legalization of industrial hemp, before it can reach President Trump’s desk for signature.

Whether the final version of the Hemp Farming Act will become law is purely speculative at this point; however, the fact that Senate Majority Leader McConnell (i.e., THE most powerful senator) is its most fervent supporter seems to suggest that the Hemp Farming Act is likely to survive and (hopefully) become law. We will definitely keep you posted.

In the meantime, for more on industrial hemp and CBD, check out the following:

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