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Husch Blackwell Expert Provides Clarity on Current CBD Landscape, Highlights Inconsistency

Aug 24, 2021 - IHS Markit

The development of cannabis-derived products can be a murky area when it comes to rules and regulations. IHS Markit Animal Health analyst Sian Lazell listened to Husch Blackwell legal expert Emily Lyons as she gave an overview of the issues veterinary CBD product developers in the US are currently facing.

While cannabis-derived animal health products are gaining popularity and present a potentially valuable new area of innovation, there remains a grey area over the rules and regulations for such products.

Husch Blackwell is a law firm with headquarters in the Kansas City Animal Health Corridor. Speaking at the KC 2021 Digital Animal Health Summit, senior associate attorney Emily Lyons said: “I don’t think there has been a hotter topic when I talk to clients about innovations in the animal health space. Everybody seems to be very interested in what kind of products they can incorporate CBD in and what kind of claims they can make on their products.”

Cannabidiol (CBD) is just one cannabis-derived compound and one of the most prominent under the spotlight of current innovation. Ms Lyons pointed out nomenclature is very important when it comes to CBD derived from industrial hemp. She explained all cannabis falls under the plant species Cannabis sativa. Cannabis involves two main categories – marijuana (regulated by the federal government as a schedule 1 controlled substance and including products that contain over 0.3% tetrahydrocannabinol or ‘THC’) and industrial hemp (used to produce products containing below 0.3% THC).

Hemp has historically been grown for use in food, dietary supplements, fabrics and textiles but in recent years there has been increase interest in the ability to grow industrial hemp for the extraction of CBD. CBD is one of many different cannabinoids found in C sativa, that is not psychoactive and has been found to have a number of potential applications in human and animal health.

Ms Lyons said: “An area where I get a lot of questions is what the 2018 Farm Bill [in the US] allowed and did not allow when industrial hemp was approved for growth in the US. Industrial hemp, those products with less than 0.3% THC, and all of its derivatives were removed from the federal definition of marijuana. Therefore, the USDA was allowed to be established as the primary regulator for hemp production, and issue licenses or allow states to provide licensing authority so growers could produce industrial hemp.”

However, she claimed there are a number of things people have misconceptions about regarding what the 2018 Farm Bill did not approve. It did not legalize marijuana or marijuana-derived CBD because those products have the potential to contain over 0.3% THC. The bill also did not change the FDA’s regulatory authority over cannabis or any cannabis-derived compounds like CBD, so businesses that want to use these compounds in their products need to continue to follow FDA regulatory programs. Additionally, the bill did not pre-empt any US state laws’ ability to regulate hemp through licensing programs or requiring specific labelling for hemp derivatives.

According to the Food, Drug and Cosmetic Act (FDCA), any article that is a new drug or authorized for investigation for which “substantial clinical investigations have been instituted and for which the existence of such investigations has been made public” is prohibited from being used in food, animal feed or dietary supplements. This is unless the article was first marketed as a supplement, food or animal feed, or the FDA authorizes its use through regulation. The restriction does not preclude the use of CBD in in a cosmetic or topical product, but other FDA and DEA restrictions may apply.

Ms Lyons noted: “Where things get complicated on sticking CBD in any product, is the FDA statutory prohibition. [For example], Epidiolex is a CBD anti-seizure drug that has been approved for use [in humans]. This makes things tricky because there is the statutory prohibition that doesn’t allow a new drug, that’s been either authorized for investigational use or approved by the FDA, to have that article – the [CBD] active ingredient – to be used in dietary supplements, food or animal feed, unless FDA allows that use through regulation.

“It gets a little complicated on what the actual article is there because Epidiolex happens to be CBD that is actually derived from marijuana instead of hemp. However, at this point, the FDA has said CBD has not been approved for use in a number of products because of this statutory prohibition. So, even if the FDA did decide to issue regulations on CBD, there would be a number of things you would need to comply with in addition to the allowed use of this product.

“For example, if you want to include CBD in an animal feed product, this ingredient would need to be ‘generally recognized as safe’, which the FDA has said it is not. It would need to be subject to an FDA food additive petition, which at this time it is not, or it needs to be listed in the official publication of the Association of American Feed Control Officials (AAFCO).

“Alternatively, if you want to use CBD in an animal drug, the product must go through the New Animal Drug Application (NADA) process with the FDA, which is a pre-market approval process for the use of animal drugs. Additionally, if this ingredient is ever approved for use in any kind of [veterinary] product, you would then need to follow GMPs, the Food Safety Modernization Act and any labelling requirements established by the FDA. Especially if this goes in any animal feed or pet treat product, it gets a little complicated with labelling, since you also have state animal feed regulation schemes that you need to follow.”

Different opinions

Ms Lyons highlighted the biggest factor in CBD innovation is that products can only bear lawful claims. She said at this point in time, the FDA has specifically stated there should be no animal feed or food that contains CBD or other hemp extracts, because these ingredients have not gone through any of the approval processes. At present, the FDA also believes CBD should not be used in animals as a new drug or be marketed as such.

AFFCO and the National Animal Supplement Council (NASC) have also weighed in on the matter. AAFCO strongly believes CBD needs to be regulated as a drug by the FDA and is not necessarily appropriate to go through the AAFCO official publication review process. However, the association recognizes other hemp-derived ingredients/parts of the plant may be appropriate for use in animal feed. At the organization’s last meeting, some cannabis-derived ingredients were put forward for its review process but none have yet been listed.

In contrast, the NASC – often looked to in order to help regulate animal supplements – has said CBD could be used in pet supplement products, which are regulated by the FDA as animal feed, unless they make drug claims and as a result would fall under the NADA process. However, the council has laid out a roadmap for its members, outlining what it believes is a legal and prudent way to market animal supplements that include CBD. This roadmap pinpoints very specific testing and labelling requirements, as well as restrictions on the types of claims that can be made.

Ms Lyons stated: “So where are the risks? Since we have the FDA saying you shouldn’t really put CBD in anything, but other agencies and other groups are saying it may be appropriate. We’re also seeing some US states that are allowing the use of CBD and other hemp derivatives in animal products.

“The FDA and FTC – the Federal Trade Commission, which has jurisdiction over marketing and advertising – have sent a number of warning letters to companies outlining specific claims they believe are in violation of the FDCA and do not have a scientific basis. These have targeted many pet products and animal feed products.”

She said the warning letters from the agencies have specifically focused on claims related to health impacts, such as joint pain, anxiety and hyperactivity. However, as the 2018 Farm Bill did not pre-empt state laws relating to CBD and these laws vary greatly, Ms Lyons noted it is currently “kind of a guess” where a company thinks it may land with its CBD veterinary product and how the business wants to market it.

“All of the states have a different approach to this,” she remarked. “Some have no regulations, some have very robust regulations that allow the use of CBD in animal products. Florida has a fairly robust program that allows CBD in pet foods and other animal foods, while South Carolina fully prohibits it and just recently, the state of Montana passed a law that allows the use of hemp and hemp derivatives inn animal feed.”

Ms Lyons stressed it is of utmost importance that businesses developing CBD products check the laws in each specific territory where they plan to market a CBD product, to determine what kind of regulatory and legal aspects apply.

Legal action

Ms Lyons noted there is also currently a significant amount of litigation in the consumer class action lawsuit space related to pet products and a lot of legal cases in the human space. Many of these lawsuits mirror the information issued in the FDA and FTC warning letters. Some cases have been temporarily stayed while the FDA figures out its ‘enforcement mechanism’ for the issue, but many are proceeding.

The cases vary, from accusations that products do not have as much CBD as they claim to contain, to allegations that products are illegal and have been illegally marketed.

Ms Lyons warned: “Another area companies should be aware of regarding potential enforcement is from competitors. Your competitors have the ability to review your claims and say: ‘We don’t believe this is correct and it is presenting a false presentation of these claims.’ However, the key to defending any kind of claim related to advertising and marketing of products is having substantiation that is created by your company prior to the claim being made. The big take-away from the legal status and enforcement is don’t market unapproved products with unsubstantiated or unapproved therapeutic claims.

“We’re seeing a lot of people continuing to want to use CBD or other cannabinoids in products for animals. It is a pretty big risk but at the same time, if you don’t include unsubstantiated or unapproved therapeutics claims, you’ll likely be less of a target for both the FDA as well as consumers or competitors.”

Horizon of CBD innovation

In recent years, the FDA has been working on an enforcement policy related to cannabis and cannabis-derived compounds.

Husch Blackwell expects the policy will look very similar to what has already been published in the warning letters issued to companies regarding CBD products. Nevertheless, the firm believes there is the potential the Department of Justice could consider taking action on its own to force the prohibitions in the FDCA.

Additionally, Ms Lyons said there could be the possibility that in a “very long-term sense” the FDA could issue rulemaking to allow the use of CBD in animal products. However, she pointed out the FDA is currently “very unsure on the safety of CBD, especially in animals, and those animals used for food purposes”.

She concluded: “Until that point, we’ll have a patchwork of state laws allowing or prohibiting CBD, or waiting for the FDA or AAFCO to determine the status of CBD and allow its use in either an animal drug or animal feed. Additionally, we’ll see more consumer class action lawsuits, especially if there is more enforcement from the federal government or even state governments. But in the long run we’re going to see the continued proliferation of products that contain CBD, that are meant to treat companion animals and potentially livestock.”

Reprinted with permission of IHS Markit




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