FDA Issues Warning Letters to CBD Hemp Oil Makers

The Food and Drug Administration has issued warning letters to “high CBD” hemp oil vendors, stating that their products are unapproved drugs that often don’t contain any active ingredient.

A list of firms that were issued warning letters for marketing “unapproved drugs for the diagnosis, cure, mitigation, treatment, or prevention of diseases” was posted on the FDA’s website to warn consumers about these mostly hemp-derived products. Capsules, dog treats, e-liquids and oils all claiming to have CBD tested either negative or very low for cannabinoids.

Many of these companies claim on their websites that their products are completely legal because they are made from hemp and don’t have any psychoactive properties. The truth is they exist in a legal vacuum as long as they don’t market their products as drugs, which is why the FDA has stepped in.

The Industrial Hemp Farming Act of 2013 amended the Controlled Substances Act (CSA) to exclude industrial hemp from the definition of “marijuana,” loosening the restrictions on strains of Cannabis sativa that are very low in THC. This has facilitated cultivation of hemp in the U.S., but a great deal of hemp still gets imported (1,138 metric tons in 2011) everyday from China, Canada and the EU. Before 2013, essentially all the hemp used for its fiber and seed was imported and regulated by the DEA. Since the Marijuana Tax of 1937, it has been legal to cultivate hemp with a DEA license, but the tight restrictions meant almost no one did it.

Cannabis sativa that is low in THC may still contain CBD, so whole-plant extracts of hemp grown for industrial purposes could make a product semi-rich in CBD, if done correctly. A cheap extraction process like steam distillation done on a sample of plant material that is mostly stalks and leaves might extract some CBD, but it can also extract unsafe pesticides and toxins absorbed from the soil.

Cannabis thrives in toxic soils and accumulates heavy metals, so the soils it grows in needs to be carefully selected and tested for pollutants. If grown in another country, especially one with lax environmental regulations, hemp products might be highly contaminated.

Anyone interested in getting cannabis flowers, extracts or infused products high in CBD should seek actual high-CBD cannabis (with CBD sometimes at more than 20 percent dry weight), not products made from industrial hemp. Cannabis bred for CBD and grown in healthy soils or in a clean hydroponic matrix is optimal for making safe medicinal products.

High Times has created a CBD Flowers, CBD Concentrates and a CBD Edibles category for the Cannabis Cups, giving anyone the opportunity to check the top contestants to find out who makes the best CBD products.