Harris Bricken takes an in-depth look at hemp based CBD in California
A few months ago, I wrote a blog post about the precarious state of industrial-hemp derived CBD in California. Since then, as everyone knows, President Trump signed the Agricultural Improvement Act of 2018 (or “Farm Bill”). A lot of people think that in the wake of the Farm Bill, hemp-derived CBD (“Hemp CBD”) is now completely legal. This is in many cases a wildly inaccurate misconception—especially in California. Now, the legal status of Hemp CBD is arguably even more confounding than it was then. And it was pretty bad.
What did the 2018 Farm Bill Actually Do?
Before getting into California Hemp CBD laws, it’s important to discuss what the new Farm Bill even changes. If you follow us here at the Canna Law Blog, you know we’ve written pretty comprehensively on this topic. For a brief overview, the 2018 Farm Bill modified the Controlled Substances Act (the “CSA”) to exempt hemp from the definition of marijuana. Not only is hemp now clearly excluded from this definition and thus not a scheduled drug, but states and tribes also cannot prohibit the distribution of hemp. However, as I explain below, that doesn’t necessarily mean hemp or Hemp CBD can be sold without state restrictions.
The current Farm Bill also gives the U.S. Department of Food and Agriculture (the “USDA”) authority to oversee state hemp regulatory programs. For example, states and tribes must submit plans to the USDA for implementing regulatory schemes, and these plans must be approved by the USDA. In the event that they aren’t, the USDA can implement its own plan.
One other interesting component of the Farm Bill is that crop insurance coverage could be extended to hemp, meaning hemp crops could actually gain federal insurance. In a state like California that is prone to natural disasters, this is critical.
These aren’t all the changes that the new Farm Bill brought along, but they are some of the key ones. Now, on to California.
Hemp CBD in Food/Beverages in California
[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 Department of Public Health
Under California law, “food” is defined as “[a]ny article used or intended for use for food, drink, confection, condiment, or chewing gum by man or other animal” and“[a]ny article used or intended for use as a component of any article designated” in the foregoing definition. What this means is that the CDPH views anything that counts as food or drink that’s intended for human or animal consumption as unlawful.
On an important side note, the Medicinal and Adult-Use Cannabis Regulation and Safety Act (or “MAUCRSA”) defines “cannabis” to exclude industrial hemp (and therefore doesn’t regulate industrial hemp), and instead incorporates provisions of the California Health and Safety Code which leave the regulation of hemp cultivation to the California Department of Food and Agriculture (“CDFA”). The CDPH expressly cited this issue in MAUCRSA back in response to the 45-day comment period for its proposed regulations to note that the CDPH doesn’t have jurisdiction over regulating industrial hemp. This doesn’t mean that the CDPH can ban hemp in other things (like manufactured cannabis, see below), but it just means that under MAUCRSA, the CDPH can’t start issuing hemp regulations.
Back to the main story, it was pretty clear after the FAQs were issued that the CDPH wouldn’t continue to tolerate sales of foods or beverages with Hemp CBD for long. But we weren’t aware of any sort of enforcement efforts or actual regulations by the CDPH regarding Hemp CBD in foods or beverages. However, after the Farm Bill wound its way through Congress but before Trump signed it, there was some question on whether the Farm Bill would negate the CDPH FAQs.
A few days before the Farm Bill was signed, I wrote a post predicting that the 2018 Farm Bill would not do away with the FAQs. This was because the FAQs are based on the CSA’s prohibitions on hemp as well as the federal Food and Drug Administration’s (“FDA”) stance that Hemp CBD foods are not permissible. The Farm Bill changed the CSA, but not the position of the FDA.
In fact, while the ink from Trump’s signature on the Farm Bill was still drying, the FDA issued a statement (see here) telling companies to pump the brakes and that it still regulates hemp and CBD in at least medicines and foods. In an accompanying Q&A document, the FDA takes the fairly unequivocal position (see response to Q.13) that it is illegal to introduce into interstate commerce food that has CBD in it.
So what is going to happen now? As noted above, we aren’t yet aware of any enforcement actions in California. We’re also unlikely to see any sort of new guidance from the feds during the shutdown or in the immediate future thereafter. But localities may be taking a very different approach.
For example, the L.A. County Department of Public Health’s Environmental Health Division (“LADPH”) published an undated PDF concerning industrial hemp in food and saying that the LADPH will begin actually enforcing them: “Effective July 1, 2019, prohibited use of industrial hemp derived products in food will be considered adulterated and cited by [LADPH] as a violation resulting in a deduction of two (2) points on the official inspection report.”
This is one of the first instances we’ve seen of a county taking an official enforcement position on CBD food products, and interestingly comes on the heels of the L.A. Department of Cannabis Regulation (“DCR”) creating an attestation (which I wrote about here) for businesses who sell hemp products to advise that those products don’t fit within the legal definition of cannabis.
Now it seems like we have our first glimpse of what is going to happen when companies sell CBD foods or beverages. While this is only in L.A., we can assume that other counties will follow suit and may be even more aggressive in their pursuit of these hemp CBD food companies.
What is much less clear though is what this means for simply manufacturing or distributing food products that contain hemp CBD. The CDFA’s website Q&As still say that “California law does not currently provide any requirements for the manufacturing, processing, or selling of non-food industrial hemp or hemp products.” It seems like we will need to wait and see what the final answer is.
Licensed Cannabis Products
Cannabis products will generally contain at least some level of CBD naturally. But what about adding CBD from an industrial hemp source to a manufactured product under the Medicinal and Adult-Use Cannabis Regulation and Safety Act? Well, the CDPH (which governs the manufacture of all cannabis products in California) says no. In the proposed final regulations (no. 40175(c)), the CDPH states pretty clearly that, “A manufacturer licensee shall only use cannabinoid concentrates and extracts that are manufactured or processed from cannabis obtained from a licensed cannabis cultivator.” With this regulation, the CDPH has effectively cut Hemp CBD out of the manufacturing process altogether.
In 2018, the California legislature passed a piece of legislation that prohibits cannabis or alcohol licensees from introducing Hemp CBD (or THC) to alcoholic beverages. You can read more about that here.
Dietary Supplements and Medicinal Products
The FDA’s statement makes clear that it will retain jurisdiction over CBD products making medicinal claims, and the accompanying Q&A (see response to Q.12) says that the FDA views dietary supplements containing CBD as unlawful. That said, the FDA notes that there is at least a path towards FDA approval. For what it’s worth, the FDA’s not all talk—see the case of Epidiolex (and see
Vaporizers and Other Products
We recently wrote a comprehensive post about Hemp CBD in vape cartridges. What we said then still holds—it’s a grey and undefined area. This is probably another area that the FDA may eventually regulate given its similar work with nicotine-based vape products. But given the shutdown and just the general speed of regulators, we’re unlikely to know anytime soon.
For what it’s worth, the FAQs are only tailored to food, but it’s possible that regulators could view all products containing Hemp CBD intended for human consumption as unlawful. This seems a bit less likely to happen right away because the CDPH and other agencies have had ample chance to do this but haven’t. But it’s certainly possible, and we’ll make sure to keep you informed of any developments.
We know that at least for cultivation, California’s recent bill SB-1409 (which we’ve written about here and here) was intended to create an application and registration scheme for cultivators. Now that the Farm Bill will require states to submit plans to the USDA for hemp production, it’ll be interesting to see what happens with SB-1409.
Packaging and Labeling
Anyone in the California cannabis game knows that the packaging and labeling regulations are tough, ever-changing, and hard to comply with. The point of these laws seems straightforward—regulators want people to know what they are consuming, and to ensure that cannabis products are properly labeled so that people don’t unwittingly ingest cannabis. They also want to avoid false and misleading claims in labeling.
Because CBD products in California are either in grey or quasi-illegal areas, things aren’t so clear. There aren’t specific packaging and labeling laws for it here, so people who still are selling these products are operating in a labeling wild west. This is different from states like Oregon or Indiana, which have actually begun to figure out how some CBD products should be labeled. We published a post recently on the complexities of and in many cases lack of instruction for hemp labeling laws at the FDA level—and the fact that there may not be guidance for another year or two.
The FDA’s Q&As (see response to Q.15) note that in deciding whether to institute enforcement actions, the FDA will now consider factors, such as “agency resources and the threat to public health.” This may be the FDA’s way of saying that in light of its limited resources, it’s going to spend its enforcement power on those companies selling dangerous products or making false or misleading health claims. One thing we do already know is that the FDA has already sent warning letters to companies that have marketed CBD as new drugs, in the FDA’s view. So in post-shutdown mode, we may see the FDA step in more aggressively on enforcement, especially for products and claims that it views as unlawful.
With the passage of the Farm Bill comes the possibility of a completely new playing field for industrial hemp producers. It appears that the question of whether IRS Code 280E (which prohibits deductions for any amount paid or incurred in carrying on any trade or business that consists of trafficking in a Schedule I or II controlled substance under the CSA) will apply to hemp producers is now settled.
But what about issues like banking or federal intellectual property protections? While it seems like these may be a reality soon, the answer is not as clear cut. If the FDA starts using its enforcement powers against companies that make Hemp CBD foods, for example, it’s certainly possible that banks will still stay away from those companies or that the USPTO won’t register their trademarks. It’s all too soon to say how this will play out, so stay tuned to the Canna Law Blog.
It may seem difficult to understand why cannabis, which is still prohibited federally, is at the state level treated more liberally than Hemp CBD. But the reason is clear—there are strict regulatory testing and quality assurance requirements for cannabis, there will be a track-and-trace system in place to ensure that only white market sources are used, and there are tight packaging and labeling rules that create uniformity in how cannabis products are identified to consumers.
That level of regulatory security doesn’t really exist yet for Hemp CBD and so regulators and lawmakers are naturally more concerned about products that they cannot trace, that may not be labeled at all, and that have undergone zero testing. When Hemp CBD is regulated more like cannabis, regulators may very well relax some of their positions.
Stay tuned to the Canna Law Blog as we will be sure to follow and interpret each and every development in this complex and fast-moving space.
Source: Canna Law Blog