What can we learn from the American experience in bringing natural CBD food products and various supplements to the market?

In the United States, at the moment, there is a situation in which , while preparing the regulatory framework for the implementation of the pharmacological drug “Epidiolex” in the country, government officials not only have a certain paradigm of thinking that needs to be changed in the future in connection with the entry of natural cannabidiol into the market, not in as a pharmaceutical raw material, but as a component of food products or various additives. The main problem is that, while forming the regulatory framework “for themselves”, pharmacologists introduce novelties into the legislation, which further prevent the use of drug-free cannabinoids in other extremely high-margin markets.

In order to understand the logic of the actions of state structures that are the initiators of amending the current legislation, the editors of the specialized electronic publication of national hemp growers are closely monitoring the development of the situation around the regulation of the legality of the use of natural cannabidiol as part of food or as a food additive in the most highly developed country in the world . Understanding the difficulties that US manufacturers face when they demand from the state structures responsible for this issue actions aimed at regulating this type of activity, as well as the arguments of officials why the issue is not being resolved, it will be possible to initiate changes to the legal framework of Ukraine over time in order to so that natural cannabidiol is legally sold in our country as part of food products or as various additives (food, dietary, feed, etc.).

According to US Food and Drug Administration (FDA) First Deputy Commissioner Janet Woodcock, the above-mentioned government agency concluded that “a separate regulatory framework for plant-based cannabidiol (CBD) is needed that balances the desire of people to access CBD products with the regulatory oversight needed to manage the risks.” This means that the FDA does not consider the current regulatory framework for food and supplements to be appropriate for plant-derived cannabidiol.

Among other things, based on the above findings, the FDA denied three citizen petitions (the Consumer Health Products Association, the Council for Responsible Nutrition, and the Natural Foods Association) that asked the FDA to develop departmental documents that would allow cannabidiol to be sold as a dietary supplement.

The FDA cites concerns about the safety of long-term use of cannabidiol when it comes to liver function and the male reproductive system, as well as the need for additional safeguards, such as CBD content limits and a minimum age for purchase, to reduce the risk of ingestion by children. "FDA food and supplement authorities have been given only limited tools to manage the many risks associated with CBD products," Ms Woodcock said in a statement. “According to the current regulatory framework, any substance, including CBD, must meet certain safety standards in order to be legally sold as a food or dietary supplement.”

In addition, the FDA rejects CBD as a dietary ingredient because it is prohibited under current law because it is used as a drug. This means that since drug companies are researching this non-narcotic cannabinoid as a drug, it cannot be used as a dietary ingredient.

On the one hand, in the event that the regulatory framework was adjusted accordingly, or the FDA changed its agency documents in order to exempt CBD from the ban initiated by the pharmaceutical companies, nothing should prevent plant-derived cannabidiol from entering the market. according to the same rules as other “new ingredients”. On the other hand, as a result of the FDA's findings, the recently initiated Cannabis Access and Consumer Safety Act to exclude CBD and other hemp-derived cannabinoids from the no-drug clause may become impossible.

In turn, the US hemp industry is strongly expressing its disappointment with the FDA's opinion on this issue, disagreeing with its statements about the lack of safety and reliability of the current regulatory framework for plant cannabidiol.

“We were extremely disappointed by the FDA's announcement that a separate regulatory framework is needed to regulate the use of CBD as a food or dietary supplement. When it comes to CBD safety, the FDA is wrong. Contrary to the FDA's constant claims that natural cannabidiol is unsafe, there is clear, established evidence for the safety of its use over the years. CBD products have been retailing for nearly a decade without any major safety concerns. Interested cannabis businesses have met with the FDA and shared a wide range of safety studies demonstrating that standard CBD dosage sizes are safe, while the FDA continues to rely on pharmaceutical studies that show risk at significantly higher doses that are not commonly found in Retail CBD products," says Jonathan Miller, General Counsel for the USA Cannabis Roundtable Project.

A number of brands have conducted toxicology studies for independent GRAS (generally recognized as safe) opinions, including CV Sciences, Hemp Fusion and Charlotte's Web, and Validcare has shared positive results from its own safety studies with the FDA.

"It appears that no level of safety evidence will be sufficient for the FDA," Steve Meester, president and chief executive officer of CRN, said in a statement. “Over the past four years, the FDA has repeatedly ignored the safety evidence that is relevant to CBD at levels commonly used in supplements, and continues to rely heavily on the fictional safety concerns associated with high doses of Epidiolex in order to explain your inaction. The FDA has had enough time to review the scientific evidence and develop regulations for CBD within the existing regulatory framework. Since Congress passed the Farm Act of 2018, the inaction and indecision of the FDA has undermined consumer interest in having safe and wholesome CBD products available to them, allowing a gray market for CBD to emerge without sufficient government oversight. ".

NPA President and CEO Daniel Fabrikant emphasizes that “This is an astonishing dereliction of duty. After more than a decade of promises, hearings, data sharing, and staffing, the FDA Office of Dietary Supplements says it cannot do what Congress has authorized, which is to regulate dietary supplements according to law."

Commentary of the specialists of the Association “Ukrainian Industrial Hemp”

The skirmish between the FDA and lobbyists for the use of natural cannabidiol in food or as various additives leads to the following conclusions:

- US government officials, instead of regulating the legality of working with plant cannabidiol in the United States, within their powers, are only ready to state at the moment that this issue needs to be considered;

- it is extremely difficult for government officials to change their views, previously imposed on them by representatives of the pharmacological business, that plant cannabidiol is not only a raw material for the production of pharmacological preparations, but can be the basis for the production of food or various kinds of additives with powerful therapeutic potential;

- The FDA is rejecting plant-based CBD as a dietary ingredient because it is banned under current law because it is already used as a drug.

The main conclusion that can be drawn from what is currently happening in the United States regarding the regulation of the sale of natural cannabidiol as an ingredient in food products or various kinds of supplements is “whoever gets up first gets the slippers”. Those. Once again, the classic rule of the market is confirmed, according to which “the main prize goes to the one who enters the market first”. In other words, in the United States at the moment there is a situation in which , while preparing the regulatory framework for the implementation of the pharmacological drug “Epidiolex” in the country, government officials not only have a certain paradigm of thinking that needs to be further changed in connection with the entry into the market of natural cannabidiol not as a pharmaceutical raw material, but as a component of food or various kinds of supplements. The main problem is that, while forming the regulatory framework “for themselves”, pharmacologists introduce novelties into the legislation, which further prevent the use of drug-free cannabinoids in other extremely high-margin markets.

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