While regulations governing the sale of products containing hemp and cannabis-derived compounds vary greatly by market, the global demand for cannabidiol (CBD) products remains steadfast. No matter the industry, manufacturers must analyze each market for compliance with their current product formulation – even then – some markets may prohibit CBD products altogether.
To convey the wide-ranging regulatory disparity as it relates to how these products are sold (or not sold), we’ve dissected relevant legislation of various markets across the globe. The following is a breakdown of those markets:
In January 2019, the European Commission (EC) updated the Novel Food Catalogue (NFC) to include some extracts of hemp; cannabinoids originating from a plant containing no more than 0.2 percent tetrahydrocannabinol (THC) are now permitted in novel foods. Specific health or nutrition claims approved in the EU Register are permitted for novel food products, however, a CBD product housing medical claims must be authorized as a medical product via the European Medicines Agency. The NFC serves as a reference for EU member states, helping them understand which foods are subject to the Novel Food Regulation.
Implications: This update means market authorization is required before products can be marketed. The hemp industry may suffer as a result of this prolonged, expensive process, and many feel only large corporations can afford the cost of approval. However, CBD products that lawfully achieved market entry prior to Jan. 1, 2018 will remain on the market if an application for authorization was submitted before Jan. 2, 2020.
On Sept. 2, 2019 Thailand’s Ministry of Public Health (MOPH) declassified hemp-derived seeds and oils as a controlled substance. Hemp, by itself, is still considered a controlled substance by the Office of the Narcotics Control Board (ONCB). However, if an extract contains CBD with THC content that does not exceed 0.2 percent by weight, it can be used in herbal products and drugs (must be prescribed). Foreign producers of cannabis-derived CBD products cannot import their products, only domestic production is permitted until 2024 (CBD used for medical research can be imported by government entities).
Implications: The new rules support local producers of CBD products while authorizing foreign investment within the industry. With its cannabis market now predicted to reach $660 million by 2024, the declassification of CBD-based products is likely to be fruitful for the country’s economy. The Thai FDA also plans to the allow the use of hemp extracts in cosmetic and food products in the future.
While many regulatory agencies are redefining their laws with leniency, others continue to enforce no tolerance policies. Singapore lists cannabis, cannabis resin, cannabinol and cannabinol derivatives as controlled drugs under the Misuse of Drugs Act, meaning cannabis-derived products are strictly illegal. Although authorities have recognized the potential use for cannabinoids in pharmaceuticals to manage seizures and epilepsy, these products undergo stringent review by the Health Sciences Authority before they can be registered.
Implications: The government is researching the therapeutic potential of synthetic cannabinoids -but as it stands – Singapore’s strict laws are not friendly to CBD producers, unless approved as a pharmaceutical drug. The law is not likely to change for some time.
Congress redefined its classification of cannabis through the Agriculture Improvement Act of 2018, which removed the term “hemp” from the law’s definition of marijuana. The bill cedes regulation of CBD to the Food and Drug Administration, however, the FDA’s stance on CBD products has been wishy-washy, causing confusion for the industry. Fundamentally, products containing CBD are not permitted to house therapeutic claims, as they would then be considered a drug under the FD&C Act. All drugs must obtain pre-market approval by the FDA; selling products with unsubstantiated product claims is in violation of the law.
Implications: Many CBD products in the U.S. are sold as dietary supplements despite that CBD products being excluded from the FDA’s definition of a dietary supplement under the FD&C Act. Companies selling dietary supplements that contain the molecule should refrain from using therapeutic claims – as doing so may draw unwanted attention from the FDA. Cosmetics, however, may currently be the best landing spot for producers looking to enter the CBD product landscape. The FDA allows for cannabis-derived ingredients in cosmetics.
Of China’s 34 provinces, Yunnan and Heilongjiang have officially legalized the cultivation of hemp. These regions are free to produce industrial hemp containing a THC content of 0.3 percent or less. Despite the restrictions placed on where hemp can be grown, China remains the world’s leading hemp producer and much of what’s grown is exported. As it pertains to the legality of CBD extracted from hemp plants, the Chinese National Anti-Drug Committee recently said CBD is not considered a narcotic. However, China’s NMPA (formerly known as FDA) has listed CBD as an unapproved drug, meaning CBD is not approved for use in medicine or food just yet.
Implications: CBD’s legal applications are quite limited in China. Use of CBD in cosmetics appears to be its only practical application at this time, as its use in food and medicine is prohibited. For instance, cannabidiol oil can be found in personal care products for sale on China’s largest ecommerce platforms (JD.com and Taobao).
Brazil provides us with an example of a country on-the-fence about enabling CBD products on the retail level. In 2015, the Brazilian Health Surveillance Agency (ANVISA) voted to include derivates of cannabis sativa in Administrative Act No. 344/98, approving cannabidiol and tetrahydrocannabinol for use only in medicine. Products containing less than 0.2 percent THC can be prescribed without much friction, however anything above that concertation is limited to terminal patients.
Implications: As like China, applications of CBD are very limited in Brazil. Having only been approved for use in medicine, other types of CBD products are out of question (no CBD in foods, cosmetics, etc.). However, CBD is expected to eventually be legal within the retail market, ultimately expanding its functionality.
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