The 2018 Farm Bill that was passed by Congress and signed by the president removed hemp from the Controlled Substances Act, if the hemp in question contains 0.3 percent or less of tetrahydrocannabinol (THC) the active ingredient in marijuana that produces the “high” when people ingest it. In New York, Gov. Andrew Cuomo recently signed legislation that regulates the production and sale of hemp extracts such as cannabidiol (CBD) in New York State.
In February 2018, the World Health Organization recommended that marijuana, hemp plants and extracts be reclassified under international treaties, “Taken together, recommendations, if adopted, would represent a formal recognition that the world’s governing bodies have effectively been wrong about marijuana’s harms and therapeutic benefits for decades. WHO’s new position comes at a time when a growing number of countries are moving to reform their cannabis policies,” says an article in Marijuana Moment.
This is all part of a hemp explosion sweeping the United States and other countries, and that includes agricultural operations in New York and Pennsylvania. While proponents argue that hemp can be grown and manufactured to help create hundreds of products, the most visible and written about product is CBD, which has been promoted as being beneficial in dozens of ways.
One online article (www.tinyurl.com/yejnrc2c) claims that CBD can be an effective treatment for pain, reduce anxiety, alleviate cancer-related symptoms and might even reduce acne. The market, while estimated at widely different dollar amounts, is expected to grow to anywhere from $646 million to more than $20 billion by 2022.
The U.S. Food and Drug Administration (FDA), however, says this paints too rosy a picture for the industry, and that many of the claims being made now are not supported by research. On November 25, 2019, the FDA sent warning letters to 15 companies for marketing CBD products in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act).
The FDA has approved only one CBD drug, which is used to treat two rare pediatric epilepsy disorders. The rest of the CBD products on the market do not have FDA approval. “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,’” said principal deputy commissioner Amy Abernethy, M.D.
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public-health concerns. In line with our mission to protect the public, foster innovation and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” Abernathy said.
But this uncertainty about whether the FDA considers CDB products to be legal has lead to other issues for the CDB industry, including class-action lawsuits. Groups of consumers who have purchased and used CBD products have sued manufacturers for a variety of reasons from deceptive marketing to selling products labeled “THC-free” that contained trace amounts of the drug. Though manufacturers believe they can pause these lawsuits until the FDA reaches more regulatory decisions about CBD, the lawsuits leave the future cloudy with CBD providers wanting the FDA to move sooner rather than later.
Further complicating the issue is that another federal agency, the United States Department of Agriculture (USDA), is also pursuing regulation of the hemp and CBD industry. In October 2019, the USDA released interim final rules (IFR) as required by the 2018 Farm Bill. The IFR has a few elements that trouble hemp growers. One is that any hemp grown with more than 0.3 percent THC will be considered to have a negative impact on the industry. The USDA estimates that some 20 percent of hemp plants may result in levels above 0.3 percent. If plants, however, reach more than 0.5 percent of THC, they must be destroyed and may not be sold, even in states that have approved recreational marijuana.
This, along with another requirement establishing that all testing be done within 15 days of the planned harvest of the hemp, and that testing be done at a facility approved by the U.S. Drug Enforcement Agency, has sparked concern in the hemp-growing community. Many growers have complained that the testing requirements will make it impossible for them to produce plants that will comply with federal regulations and still deliver a quality product.
According to Jason Minard, an attorney for Hempire State Growers in the Mid-Hudson, New York can keep its current pilot program for another year and doesn’t have to adopt IFR immediately. Still, at this point, it seems like federal regulatory agencies are holding the industry back.