Global regulatory trends in CBD use in food and food supplements

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This article examines the regulatory trends for using cannabidiol (CBD) as an ingredient in foods and food supplements and provides guidance for companies to interpret current regulation and predict its future direction. The author examines navigating current regulatory complexity to realize commercial opportunities and the challenges and opportunities for bringing food and food supplement products containing CBD to markets around the world.
 

Introduction

Cannabidiol is one of the naturally occurring cannabinoids found in cannabis plants.1 The hemp plant Cannabis sativa L. (C. sativa) contains a number of cannabinoids, with delta-9-tetrahydrocannabinol (THC) and CBD being among the most common.2
 
Hemp-derived CBD ingredients, including plant extracts or isolates, have become extremely popular for use in foods, beverages, and food supplements because of their very low levels of THC (the psychoactive compound of the plant) and the claimed health benefits related to stress relief, mood enhancement, and so on. CBD ingredients can be found in a range of products such as oils, confectionery, baked products, beverages, food supplements.
 
The hemp and CBD market is reported to be one of the fastest growing product categories in the world. Among the reasons for this rapid growth are that hemp has been categorized as a legal agricultural commodity; it has been promoted because of the environmental benefits of its cultivation; and recent changes in food policy now consider CBD a suitable ingredient for use in food.
 
However, the regulatory status of hemp and CBD as a food ingredient is a recent development in several markets around the world. In some cases, there are specific regulations and guidelines with clear conditions of use of CBD in food and food supplements. In other cases, safety assessments still need to be performed before products containing hemp-derived CBD ingredients can be legally marketed. In many other countries, however, CBD ingredients are still not permitted, or are highly restricted, for use in foods and beverages.
 
Concerns about CBD as an ingredient relate to food safety and public health, mainly due to the presence of THC. There are also concerns around the marketing of CBD products, whose claimed health benefits have to be scientifically substantiated before obtaining an authorized health claim.
 
In this sense, the result of the safety evaluations could contribute to the further commercialization of foods containing hemp-derived CBD ingredients and encourage other countries to follow suit in also regulating their use.
 
Given current regulatory status and trends regarding CBD as a food ingredient, companies need to be aware of the critical requirements and conditions to identify challenges and opportunities when planning marketing strategies. 
 

CBD classification in international law

The United Nations Single Convention on Narcotic Drugs, adopted in 1961 and amended in 1972, included cannabis – meaning any plant of the genus cannabis – and certain products derived from cannabis on its lists of controlled substances. These lists include Schedule I for “drugs subject to all measures of control applicable to drugs” and Schedule IV for “drugs subject to all measures of control applicable to drugs included in Schedule I and to additional special control measures.” Although the convention does not apply to the cultivation of the cannabis plant for industrial (e.g., fiber and seed) or horticultural purposes, countries that allow cannabis cultivation are required to adopt control measures deemed necessary to prevent its misuse.3
 
The World Health Organization (WHO) issued a report in June 2018 concluding that there is no evidence of any public health-related problems associated with the use of pure CBD.4 In addition, in January 2019 the WHO issued specific recommendations to the UN Commission on Narcotic Drugs (CND) regarding the review of cannabis and cannabis-related substances,5 including the following:

  • Cannabis and cannabis resin were to be deleted from Schedule IV of the 1961 Single Convention on Narcotic Drugs.
  • Extracts and tinctures of cannabis were to be deleted from Schedule I of the 1961 Single Convention on Narcotic Drugs.
  • A footnote should be added to the entry for cannabis and cannabis resin in Schedule I of the 1961 Convention to read as follows: “Preparations containing predominantly cannabidiol and not more than 0.2 percent of THC are not under international control.”

 
The 63rd session of the CND, while voting in favor of deleting cannabis and cannabis resin from Schedule IV, voted against the other two recommendations.6 Following this decision, extracts and tinctures of cannabis remain in the list of internationally controlled substances, with no exemptions for CBD preparations of not more than 0.2% of THC.
 
An underlying question in this regard was to what extent the decision would affect the interpretation of the conventions by regulatory authorities across the globe in considering the classification of CBD.
 

CBD in foodstuffs: Trends by region

There are diverse examples of how foods and food supplements containing hemp-derived CBD ingredients may be marketed in Asia, Europe, Latin America, North America, and Oceania.
 
Asia
The available rules for marketing CBD in food and food supplements are limited in Asia. In some cases, it is required to observe positive or negative lists of substances for use in foods or for nondrug use as follows: 

  • In Japan, the C. sativa’s treated seed is included in the “nondrug list.” CBD oil extracted from mature stem and seed is not regarded as cannabis. In this regard, imports of CBD products, such as CBD oil, free of THC, would be permitted according to the 1999 guidelines issued by the Ministry of Health, Labour, and Welfare. Imports of chemically synthesized CBD would also be permitted, provided the importer proves it is not cannabis.7

In China, the mature seed of C. sativa has a long history of use as traditional medicine (for digestive health) and as food. It was in the first batch of “list of botanical ingredients recognized as food and medicine use” issued by the Chinese authority in 2002.8 On the other hand, it remains to be seen whether the recent inclusion of four kinds of cannabis-related raw materials including CBD in the lists of banned ingredients and raw materials for cosmetics could have an impact on further bans as regards the use in other product categories.

  • In South Korea, the hemp seed is also allowed as a food ingredient, provided that the shells (bracts and outer epidermis) have been completely removed.9
  • In Hong Kong, CBD, free of THC, is not in the scope of Dangerous Drug Ordinance, and therefore permitted for use in food.10
  • In Southeast Asia, Thailand adopted a regulation earlier this year aiming to promote and develop hemp as an economic crop. Use of CBD oil, from hemp seeds only, is allowed in foods and food supplements. The regulation establishes clear conditions for the use of hemp or C. sativa seeds, hemp seed oil, hemp seed protein in different food categories, including food supplements, and maximum limits of THC and CBD.11

 
Europe
Recent decisions by international organizations and European courts of justice have contributed to changes of assessment in qualifying CBD as a food or even a novel food. In October 2020, the European Commission announced its preliminary view on CBD,12 which can be summarized as follows:

  • CBD extracted from the flowering and fruiting tops of the hemp plant is covered by Schedule I of the UN Convention (i.e., “extracts and tinctures of cannabis”) and is therefore considered a narcotic and excluded from the European Union (EU) definition of food.
  • Synthetic CBD does not fall in the scope of the UN convention because it is not extracted from the plant and can therefore qualify as “food.”
  • In cases in which CBD does not fall under the…

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