The food that we consume can have a range of effects on our body, from caffeine content to levels of unsaturated fat. Recently, products containing cannabidiol (CBD) have appeared on the market, which provides another level of potential effects consumers need to consider.
CBD is a chemical compound that occurs naturally in the cannabis plant. By itself, it does not cause the “high” that people associate with cannabis, however. According to the World Health Organization, CBD has “no effects indicative of any abuse or dependence potential” in humans.
Last December, the 2018 Farm Bill was signed into law. This bill removed industrial hemp and its derivatives, including CBD, from the list of Schedule I drugs under the Controlled Substances Act. This action has made it legal to conduct CBD transactions across state lines, provided that the THC content is no more than 0.3 percent.
However, this rule is only the tip of the iceberg when it comes to government regulation of CBD—or lack thereof.
The Legal Standing of CBD
Importantly, the 2018 Farm Bill did not legalize marijuana-derived, but rather only hemp-derived products. Marijuana-derived CBD remains a Schedule 1 controlled substance.
Perhaps more importantly, the Food and Drug Administration (FDA) has not approved CBD in foods and beverages. This means that the FDA still prohibits adding CBD to foods, drinks, and supplements and making any therapeutic claims about these products. The agency has expressed concern over the safety of ingesting CBD.
People who have seen CBD appearing on menus and in products in their city may wonder how this is possible without FDA approval. The FDA has not been actively enforcing its prohibition against ingestible CBD, except in cases where companies advertised particular health benefits in relation to the product.
However, in November, the FDA issued warning letters to 15 companies for illegally selling products containing CBD, saying they had violated the Federal Food, Drug and Cosmetic Act.
“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt,'” the FDA said in a statement.
The agency also stated that it was working to clarify its regulatory approach for products containing CBD and that it would “continue to monitor the marketplace and take action as needed against companies that violate the law.”
The warning letters issued by the FDA have all focused primarily on health claims rather than CBD’s inclusion in general.
Some, such as the Center for Science in the Public Interest, have praised the FDA’s move, saying that there is no evidence that CBD can fulfill the claims that many companies are making about their CBD products—for example, that CBD can reduce a person’s risk of diabetes, treat schizophrenia, or shrink tumors. None of these claims have been evaluated by the FDA or demonstrated scientifically.
On the other side of the argument, the Council for Responsible Nutrition, which represents the dietary supplement industry, said the FDA’s action unnecessarily alarms consumers, given the agency’s inaction and lack of guidance on CBD over the year prior. The Washington Post also reported that many companies with CBD products in development or currently for sale have been frustrated with the FDA’s lack of clear regulations. CBD is now a big business—major brands including Anheuser-Busch, Ben & Jerry’s, and Unilever have announced CBD products in development.
Meanwhile, the Federal Trade Commission (FTC) has taken a similar approach. In September, the FTC sent warning letters to three companies who were selling CBD-containing products under claims that they were treatments or cures for serious diseases and other health conditions.
The FTC is currently monitoring CBD advertising and has reminded companies that any claims they make about the health benefits of their products need to be supported not just by general research on CBD and its benefits, but also on the individual CBD-containing products they offer. Different products have varying levels and types of CBD ingredients, so blanket claims cannot openly apply to all products.
State Laws Governing the Legality of Producing and Selling CBD
Many states have already created laws about the production and transportation of hemp-derived CBD, but these laws are also changing constantly and can vary an incredible amount across state lines.
Furthermore, many states have regulatory frameworks that are either inconsistent or ambiguous, which makes it even more difficult to manage these products.
That being said, virtually all states have created a policy on ingestible hemp-derived CBD and have adopted prohibitions that align with the FDA policy. This is true even in progressive states like California, which permits recreational marijuana use for adults. The California bill AB 228, which would have permitted CBD in food and health supplements, died in September.
Regulatory Complications Involved in the Production of CBD
Even the process of transacting in hemp-derived CBD products is challenging. A number of states require processing organizations to be licensed or registered. This applies to cultivators, manufacturers, distributors, and even retailers. In addition, many states require companies to test their CBD independently and verify that the percentage of THC is within limits and that the product is safe for ingestion.
For example, in Texas, organizations need a license for possession and storage of hemp, and a separate one for the processing of hemp-derived CBD. Before selling any CBD in Texas, a company needs to prove that it has been tested for THC content. Other states have similarly complicated regulations.
A number of states have passed bills in 2019 to regulate industrial hemp programs under the 2018 Farm Bill. However, the US Department of Agriculture (USDA) has not yet developed regulations for the implementation of the 2018 Farm Bill. Once that happens, states will need to seek approval for primary regulatory authority. Until this occurs, states can only legally cultivate hemp through the pilot programs that were authorized through the 2014 Farm Bill. Many state legislatures are waiting until the USDA implementing rules are adopted before creating their own state rules.
One thing is certain right now: it’s a time of great confusion—and growing pains—in the CBD industry.