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A Shift in Nomenclature for Hemp-CBD Products

HEMP CBD FULL SPECTRUM HEMP FDA
… FULL SPECTRUM HEMP?

In a recent post regarding the labeling requirements surrounding dietary supplements containing industrial hemp-derived CBD (“Hemp-CBD”), we alluded to a recent movement in the industry to rename Hemp-CBD products “full spectrum hemp.” We now take a closer look at the reasons behind this shift in nomenclature.

Part of the impetus behind this movement might be linked to a 2001 court decision pertaining to the status of lovastatin, a compound found in red yeast rice.

Although red yeast rice had been used for healing purposes for thousands of years, the isolated compound was approved by the FDA as a drug in the treatment of cholesterol. Despite the FDA approval, companies continued to sell and market lovastatin as a dietary supplement. One of these companies was Pharmanex. The FDA challenged the sale and marketing of Pharmanex's product, Cholestin, and ultimately prevailed when Pharmanex challenged the FDA's position in federal court.

The court held that the lovastatin found in Cholestin was not in its natural form (i.e., as naturally occurring in red yeast rice) because its manufacturer deliberately selected and used a method to produce specific levels of lovastatin that were greater than those naturally present in red yeast rice. In addition, the court determined that Cholestin was a drug because it was specifically marketed as the isolated lovastatin compound.

There may be some parallels between the case of red yeast rice and Hemp-CBD. Indeed, like red yeast rice, hemp and hemp extracts have been consumed for hundreds of years as food and for their medicinal value. Similar to red yeast rice, hemp contains hundreds of compounds, including CBD. And like lovastatin, CBD was recently approved by the FDA via a drug known as Epidiolex—although it is important to note that the CBD approved by the FDA as a drug is derived from the cannabis plant, not industrial hemp grown under an eligible state program, pursuant to the 2014 or 2018 Farm Bill.

Accordingly, if a Hemp-CBD product were to meet the standard laid forth by the court for red yeast rice (i.e., unadulterated full-spectrum hemp marketed as full spectrum hemp, not CBD), its manufacturer may be able to use the nomenclature “full spectrum hemp,” which might mitigate the risk of FDA enforcement action against Hemp-CBD products.

However, given the varieties of hemp strains, and the fact that each contain various levels of naturally occurring compounds, it might be challenging to specifically assess what constitutes “naturally occurring” levels of CBD. Nonetheless, “full spectrum” is generally understood to mean that all the natural constituents of the hemp plant are in product at the same percentages as they would be found in nature. Because advertising cannot be false or misleading, the nature of each product would be dispositive—i.e., whether or not the natural constituents are there in natural percentages—in determining whether those products might fall outside the scope of FDA scrutiny.

Accordingly, before manufacturers of Hemp-CBD products consider renaming their product “full spectrum hemp” they should consult with experienced attorneys to review their manufacturing process and determine whether switching from “CBD” to “full spectrum hemp” in labeling and marketing would be allowed and beneficial.

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A Shift in Nomenclature for Hemp-CBD Products

HEMP CBD FULL SPECTRUM HEMP FDA
… FULL SPECTRUM HEMP?

In a recent post regarding the labeling requirements surrounding dietary supplements containing industrial hemp-derived CBD (“Hemp-CBD”), we alluded to a recent movement in the industry to rename Hemp-CBD products “full spectrum hemp.” We now take a closer look at the reasons behind this shift in nomenclature.

Part of the impetus behind this movement might be linked to a 2001 court decision pertaining to the status of lovastatin, a compound found in red yeast rice.

Although red yeast rice had been used for healing purposes for thousands of years, the isolated compound was approved by the FDA as a drug in the treatment of cholesterol. Despite the FDA approval, companies continued to sell and market lovastatin as a dietary supplement. One of these companies was Pharmanex. The FDA challenged the sale and marketing of Pharmanex’s product, Cholestin, and ultimately prevailed when Pharmanex challenged the FDA’s position in federal court.

The court held that the lovastatin found in Cholestin was not in its natural form (i.e., as naturally occurring in red yeast rice) because its manufacturer deliberately selected and used a method to produce specific levels of lovastatin that were greater than those naturally present in red yeast rice. In addition, the court determined that Cholestin was a drug because it was specifically marketed as the isolated lovastatin compound.

There may be some parallels between the case of red yeast rice and Hemp-CBD. Indeed, like red yeast rice, hemp and hemp extracts have been consumed for hundreds of years as food and for their medicinal value. Similar to red yeast rice, hemp contains hundreds of compounds, including CBD. And like lovastatin, CBD was recently approved by the FDA via a drug known as Epidiolex—although it is important to note that the CBD approved by the FDA as a drug is derived from the cannabis plant, not industrial hemp grown under an eligible state program, pursuant to the 2014 or 2018 Farm Bill.

Accordingly, if a Hemp-CBD product were to meet the standard laid forth by the court for red yeast rice (i.e., unadulterated full-spectrum hemp marketed as full spectrum hemp, not CBD), its manufacturer may be able to use the nomenclature “full spectrum hemp,” which might mitigate the risk of FDA enforcement action against Hemp-CBD products.

However, given the varieties of hemp strains, and the fact that each contain various levels of naturally occurring compounds, it might be challenging to specifically assess what constitutes “naturally occurring” levels of CBD. Nonetheless, “full spectrum” is generally understood to mean that all the natural constituents of the hemp plant are in product at the same percentages as they would be found in nature. Because advertising cannot be false or misleading, the nature of each product would be dispositive—i.e., whether or not the natural constituents are there in natural percentages—in determining whether those products might fall outside the scope of FDA scrutiny.

Accordingly, before manufacturers of Hemp-CBD products consider renaming their product “full spectrum hemp” they should consult with experienced attorneys to review their manufacturing process and determine whether switching from “CBD” to “full spectrum hemp” in labeling and marketing would be allowed and beneficial.

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Industrial Hemp and the Banks: Slow Going

industrial hemp bank credit union

We have spilled a lot of ink on this blog related to the 2018 Farm Bill, which legalized hemp at the federal level. It’s huge news. And there are so many ramifications, from food law to trademarks to the environment for financial services. This blog post is going to cover financial institutions and hemp at about 10,000 feet. Since late December, we’ve had many clients come to us with frustrations about the ongoing lack of access post-Farm Bill, and questions about how things will play out in 2019.

To frame this issue, it’s important to summarize what the Farm Bill actually is and does. In a recent post, we explained that “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.” Seems easy, right?

If only. Going forward, hemp will be subject to stiff regulation at the state and federal levels. For example, although growing hemp no longer violates the CSA, the Farm Bill prohibits hemp production in states and tribal jurisdictions that lack an industrial hemp “plan.” Those plans will be nuanced, and what any state’s plan will look like next year is unknown. That fact alone may be the biggest reason that most financial institutions are still on the sidelines.

Financial institutions are also conservative by nature. We represent a handful of banks (and a larger handful of credit unions), and we give those outfits advice on banking hemp and marijuana. A few of these clients are relatively nimble and bold, but at the end of the day they are still banks. They have directors who worry about individual liability, lawyers and officers who worry about byzantine state and federal laws and policy, and shareholders and members who may see outsized risk and steep learning curves. When banks move into these areas, they tend to offer limited services, which are seldom more than basic merchant accounts.

Financial institutions also understand that when a new piece of federal regulation is enacted, it takes some time for rules to be written in support of the new law (both federally and by states), for programs to be staffed and built, for guidance to issue, etc. Finally, there is often a wave or two of litigation to interpret the administrative environment. All of that happens over the course of years and not months, and all of that will happen with hemp and the Farm Bill. Like the rest of us, financial institutions cannot see around corners and will be watching closely.

So what does all of this mean? Ultimately there will be banking, but banks and credit unions will not come in all at once. When they do come in, the early actors will probably provide services for hemp clients that looks similar to what is out there today in states like Washington and Oregon for hemp and marijuana businesses. This means limited access to institutional lending, ongoing compliance reporting and audits, and short leashes overall. Everything that happens will be fluid and consistent with best practices for high-risk industries.

Ending prohibition is a lot of fun, but then you get to wake up and go to work. We are optimistic that the hemp industry will have ample banking options. It will take some time, though. In the meantime, we will continue to monitor this issue and other hemp-related matters closely. Stay tuned.

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FDA Enforcement Against Hemp-CBD Products Has Begun

fda cbd food
Not OK per FDA.

On January 3rd, according to the owner of a smoke shop in Yuma, Arizona, officials from the Food and Drug Administration (FDA) seized a variety of CBD products from the store’s shelves. The officials took fewer than fifty items and told the owner to anticipate follow-up paperwork within seven to ten business days.

According to the owner’s account, FDA officials had stopped by the shop a few days earlier and asked what products were edible and intended for humans. When those officials returned, they informed the owner that CBD cannot be sold for human consumption.

This squares with what we have written about extensively, and also with what FDA Commissioner Scott Gotlieb has stated:

[I]t’s 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.”

Gottlieb also made clear that things like claiming CBD or cannabis products cure diseases prior to undergoing FDA approval are not lawful, and that the FDA will not hesitate to warn consumers and initiate enforcement actions against CBD companies. The enforcement against the Yuma store seems to indicate that those enforcement actions have begun in earnest.

There seems to be a good amount of misunderstanding about how the passage of the Agriculture Improvement Act of 2018 (or the “2018 Farm Bill”) affects the legality of selling industrial hemp-derived CBD products. But to reiterate, nothing in the 2018 Farm Bill alters the FDA’s position on CBD pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA). Here are some additional highlights from that statement:

  • The FDA will continue to enforce the law, including the FDCA, in an effort to protect patients, the public, and to promote the agency’s goals of promoting public health;
  • Products containing cannabis or cannabis-derived compounds, including CBD, will be subject to the same regulations and requirements as other non-cannabis FDA-regulated products;
  • Hemp or hemp-derived CBD products that are “marketed with a claim of therapeutic benefit, or with any other disease claim” must be approved by the FDA before being introduced into interstate commerce;
  • Hemp or hemp-derived CBD products marketed “for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases” are considered drugs and must be approved by the FDA before they are marketed for sale in the United States; and
  • It is “unlawful under the FDCA 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.”

It remains to be seen whether the FDA will introduce new regulations pertaining to the sale of hemp-derived CBD products intended for human consumption. For now, the agency has indicated that its position on CBD products is clear. We’ll be watching closely to see if this enforcement action constitutes a ramp-up of enforcement against CBD companies nationwide.

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The Even More Perplexing State of Hemp CBD in California

california hemp CBD
We’ve got you covered on California, hemp, FDA and CBD.

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

Over the summer, the California Department of Public Health (“CDPH”) issued its now infamous FAQs (the text is here), which took the position that:

[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.”

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.

Alcohol Products

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 subsequent statement by California’s Attorney General, Xavier Becerra, on Epidiolex). Also, the same day that it issued the statement discussed above, the FDA issued a companion statement listing as generally recognized as safe (“GRAS”) hulled hemp seed, hemp seed protein powder, and hemp seed oil. The FDA is making clear that it’s willing to work with the CBD industry, but it will probably not be cheap.

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.

Cultivation

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.

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Hemp-CBD and FDA: Labeling Dietary Supplements

fda hemp cbd labeling
Get the inside AND the outside right.

There is no doubt that the enactment of the 2018 Farm Bill, which legalized industrial hemp by removing the crop from the Controlled Substance Act’s definition of “marijuana,” will lead to increased sales and growing opportunities for hemp-derived cannabidiol (“Hemp-CBD”) companies in the new year. In fact, we have already seen an uptick in new and current client inquiries, even in the past few weeks.

As we previously explained, however, there is little information provided by the Food and Drug Administration (“FDA”) about how Hemp-CBD products, including foods, dietary supplements, and cosmetics, should comply with the basic mandatory requirements imposed by the FDA. According to a report released by the Brightfield Group, we will need to wait another 18 to 24 months before the FDA makes a decision regarding the approval of Hemp-CBD products.

Until then, Hemp-CBD companies should handle these uncertainties and the lack of specificity regarding the legal status of Hemp-CBD by being extremely prudent when marketing their CBD products. To that end, we previously discussed the FDA labeling rules and regulations imposed on foods. We now turn to the marketing and labeling requirements imposed on dietary supplements.

For the last three years, the FDA has taken the position 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.

In response to the federal agency’s position on CBD not qualifying as a dietary supplement, an increasing number of Hemp-CBD companies have embraced a change in nomenclature and have begun manufacturing products that contain hemp extracts standardized for total cannabinoid content rather than isolated CBD. The challenge of course is to not highlight the CBD content in the dietary supplements. Yet, aside from general legal risk, it is important to understand that the terminology “hemp extract” will not shelter a Hemp-CBD company from FDA enforcement should the amount of CBD present in the dietary supplement be higher than other cannabinoids.

In addition to navigating the muddy waters surrounding the product’s nomenclature, Hemp-CBD companies that manufacture, package or distribute dietary supplements must also ensure that their labels contain the basic required components. Generally, a dietary supplement label must include:

  1. An Identity Statement: For example, “dietary supplement” or “botanical supplement”.
  2. A Net Quantity of Contents Statements: An accurate statement of the quantity of the content in weight, measure, or numerical count.
  3. An Ingredient Statement: A list of the product’s ingredients in descending order of predominance by weight in the product.
  4. A Responsibility Statement: The name and place of business of the manufacturer, packer, or distributor.
  5. A Nutrition Statement: Must appear by way of a prescribed format that provides detailed “Nutrition Facts” and “Supplement Facts” on the product.

Each component must appear in the correct format, or the product will be considered misbranded and subject to FDA enforcement action, unless an exemption applies.

Lastly, Hemp-CBD companies must refrain from making claims that their dietary supplement prevents, diagnoses, treats or cures serious diseases, such as cancer. The FDA deems any product containing a health claim as a drug for human use and must go through the FDA drug approval process before it is marketed in the U.S.

As this post highlights, the marketing and labeling rules surrounding CBD, or more accurately, hemp extract dietary supplements are incredibly complex and nuanced. Also, given the lack of precise FDA guidelines regarding Hemp-CBD products, companies in this space should consult with attorneys who specialize in federal regulations to discuss the potential liability of introducing their product into interstate commerce and ensure the legally defensible marketing of their products.

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