There are over a hundred cannabinoids found in the marijuana plant, so as a result, it is also referred to as cannabis. The primary cannabinoids of interest in cannabis are cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC). THC is the psychoactive compound which causes the “high” experienced by cannabis users. There are some limited medicinal uses of THC such as treating some of the symptoms of multiple sclerosis. However, there is much more medicinal interest in CBD which resulted in a growing legal acceptance of CBD not only in prescription medications but also in food, beverages, and treating minor, often sports-related, pain.
The 1996 election in the US elected the US president, 435 congressional representatives, and 34 US senators. Many states also had important ballot initiatives, giving US voters the opportunity to make direct decisions on legal and regulatory proposals. Among these ballot initiatives was the 1996 California Proposition 215 (Prop 215) which marked the first modern US law legalizing marijuana for medical purposes. This law set a precedent for other states and regions to review and debate the legitimate use of marijuana and its derivatives.
After California Prop 215, many other states considered and passed legislation on the legal medical and recreational use of cannabis despite the classification of marijuana as a Schedule I drug at the federal level. The US FDA considers cannabis a Schedule I drug, a substance having a high abuse potential and no accepted medical use.
Hemp is a variety of Cannabis sativa with low levels of THC: while marijuana typically contains >15% THC, hemp contains <0.3%. Hemp has industrial uses, and there was growing interest in the therapeutic study of CBD (present in both hemp and marijuana), so a bill was passed regulating its growth and use. The 2014 Farm Bill contained provisions to allow academic and government operations to grow hemp for research purposes. Since all cannabis was still considered a Schedule I controlled substance, this created considerable confusion. Another bill, the 2018 Farm Bill, sought to clarify this confusion and further expand the production and harvest of industry hemp. This bill removed hemp from the definition of marijuana in the Controlled Substances Act, so hemp was no longer a Schedule I substance if the THC concentration was <0.3%.
Despite the change in the legal status of hemp and its derivatives, the legal situation surrounding cannabis remains complicated. The FDA retains authority to regulate any therapeutic products derived from cannabis including THC and CBD. Any use for the treatment or diagnosis of diseases or their symptoms must go through new drug approval as would any other medicine. Furthermore, the FDA dictates that CBD- or THC-containing products cannot be marketed as dietary supplements. Instead, they require a drug submission, review, and approval.
In light of the restrictive federal status of cannabis and its derivatives, it may be surprising that marijuana is legal for medical use in 35 states, 4 US territories, and the District of Columbia, and for recreational use in 15 states, 2 territories, and the District of Columbia (Table 1). Furthermore, non-medical cannabis has been decriminalized in 16 states and the US Virgin Islands, meaning that possession or use of small amounts is illegal, but only subject to civil penalties—typically small fines similar to a minor traffic violation penalty—rather than criminal punishment such as incarceration.
Where medical use is allowed, the allowable amount of THC for individual possession/use and medical professional authorization can vary considerably between regions. In states and territories where recreational use of cannabis is allowed and the desired products have a high concentration of THC (15% or more), restrictions on growth, distribution, possession, route of administration, and where and how the products can be used are similarly varied. The fact that these products remain illegal at the national level introduces further complications.
The relationship between national policy and state restrictions must be viewed from the standpoint of the authority the federal government over states. The federal government can restrict interstate commerce, including transfer of funds. So, in states/territories where recreational cannabis is legal, for example, not only is it forbidden to transfer the products across state lines, but financial transactions are typically restricted to cash-only since credit cards, bank transfers, or related transactions involve transfer of funds between states/territories.
The trend in the US is clear, however. More and more states are legalizing the use and possession of cannabis for both medical and recreational purposes. It is expected that the federal government will need to review and revise its current legal management of cannabis for clarity, though each state will continue to manage local requirements as they see fit.
Given the intricacies of cannabis regulation, it is unsurprising that its impact on flavors is similarly complicated. Most edible applications of cannabis involve infusing food, typically gelatin-like gummies or and beverages, with oils or extracts. The FDA is clear both on its stance that THC is a controlled substance and that CBD cannot be added to food marketed as a dietary supplement. CBD products are becoming ubiquitous despite this because the FDA is focusing primarily on health claims. That is, the FDA does not support health claims associated with CBD unless they have been proven in accordance with FDA guidelines. If hemp oil-containing products are marketed without making any such claims, the FDA seems to be more tolerant. That is not to say this federal government recognizes the legal status of these products, but rather that they focus their efforts on health claims and controlling interstate commerce.
Even in states where recreational cannabis is legal, the impact on flavors is unclear. In these states, cannabis is considered neither a food nor a pharmaceutical, but rather as its own product category. In many cases, cannabis is sold as edibles, where the extract or oil is infused or injected into consumable items like gummies. Those products, like their food-only counterparts, are typically flavored with the intent to make them more palatable. The cannabis provider is therefore responsible for the safety and assessment of their final product, because once infused with cannabis, resulting edibles are no longer considered food, but rather a cannabis product. Flavors and fragrances are sometimes used more directly, for example in scented infused oils or tinctures, but the result is the same: the final product is considered a cannabis product and is regulated as such.
Some states allow for cannabis delivery through vaping but may have additional requirements for this use. For instance, Oregon requires that any non-cannabis additive in vaped solutions be documented to be intended for human inhalation. For the most part, flavors and fragrances are not evaluated for inhalation safety, so it is unlikely that there are authorized flavors for vaping applications. For all states, it is clear the cannabis firm must determine the safety of their product since there is no authorized use of flavor and fragrances in these systems. It should be noted that in states where cannabis is permitted, many have laws banning the marketing of cannabis products to minors including laws prohibiting candy- or fruit-like flavors as well as candy-like packaging.
Many countries have addressed the legal status of cannabis, legalizing limited medical use and decriminalizing possession of small amounts (Table 2). However, it was the South American country of Uruguay that first legalized the recreational use of cannabis in 2013. Canada legalized medical cannabis in 2001 and became the second country to legalize recreational use in 2018, though requirements for purchase and use vary by province or territory.
Guidance from Canada’s regulatory body, Health Canada, indicates that edible cannabis products are subject to the same requirements associated with food and food ingredients. Health warnings have been issued for vaping products in Canada indicating that flavor use for this application is untested and could have a negative health impact. Currently there is also a call for comments on a proposed rule that would limit the use of flavors in vaping cannabis products similarly to their limitation in tobacco vaping products, and it is expected that flavors will be further restricted and controlled.
Mexico decriminalized possession of small amounts of cannabis in 2009 and allowed limited medical use in 2017. In 2018, the Mexican supreme court determined that prohibition of recreational cannabis was unconstitutional, but legalization requires additional action by the Mexican Congress. Despite being delayed many times, as of March 2021 the lower house of the Mexican Congress passed a bill to legalize cannabis, so it is likely that recreational cannabis will soon be legal in Mexico.
In 2018, South Africa legalized recreational cannabis and the country of Georgia also ruled that consumption of cannabis is legal. In Australia, recreational cannabis is legal in the Australian Capital Territory and decriminalized in South Australia and the Northern Territory but is restricted to medical use in the remaining Australian states and territories.
Recreational cannabis has been available for purchase at so called “coffee shops” in the Netherlands since 1976. Though technically illegal, the sale of small quantities from licensed “coffee shops” is not punishable and therefore has a quasi-legal status. As with all regions, however, cannabis in the Netherlands is strictly controlled and very complicated. It is illegal to grow or import cannabis, though licensed shops may purchase and sell small quantities to persons 18 or older. Municipalities may also prohibit sales to non-citizens.
Cannabis laws and regulations are rapidly developing around the world. More and more regions are expanding the acceptable use cannabis including decriminalizing possession of small amounts, as well as authorizing medical and recreational use. As cannabis becomes more acceptable, the demand for products with flavors and fragrances will increase. This will undoubtedly complicate cannabis regulations and necessitate an evolution of the regulatory and legal landscape.