UPDATED DECEMBER 28th, 2018
Hemp and CBD are now legal in the U.S., but with serious restrictions. The newly-passed law, known as The Agriculture Improvement Act of 2018, brings about new changes to the production and marketing of both hemp and derivatives of cannabis with extremely low (less than 0.3 percent) of THC. Hemp is now removed from the Controlled Substance Act, which means that it is no longer an illegal substance under federal law. This does not mean CBD or Hemp can be grown and sold freely though.
First, it is important to note that Congress preserved the agency’s authority to continue to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act. This allows the FDA to continue to enforce the law to protect patients and the public while also allowing for products that contain cannabis and cannabis-derived compounds to be accessible to the public. But there are also limitations to how much THC can be present in CBD or hemp products or by-products. CBD products and hemp can’t contain more than 0.3 percent THC. If a cannabis plant contains more than .03 percent THC, then this would be considered a non-hemp cannabis plant, so it would be considered marijuana. Marijuana is still considered an illegal substance.
Secondly, there are strict regulations regarding the cultivation and production of hemp. Under section 10113 of the Farm Bill, state departments of agriculture are required to consult with the state’s governor and chief law enforcement office in order to devise a plan on the state’s license and regulations of hemp. A state plan to license and regulate hemp can only happen once the Secretary of USDA has approved that state’s plan. If a state does not seek to create a plan, the USDA will create a regulatory program which will allow help cultivators in those specific states to apply for licenses and comply with a federally-run program.
Thirdly, the law is pretty clear regarding violations of federal help law. If laws are broken, the law provides the details of possible punishments for such violations. The law also outlines pathways sellers can ensure they are compliant, and also what activities qualify as felonies.
Product Regulations with CBD and Hemp
With the increased interest in CBD and hemp also comes with the increased need for the FDA to clarify its regulatory authority over these products. The FDA states, “We treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products-meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp under the Agriculture Improvement Act.”
Essentially what this means is that it is unlawful to introduce any product (including food) that contains CBD or THC without FDA approval. To help the general public understand these regulations and how they apply to these products better, you can visit their website.
Therapeutic and Medical Claims
The FDA will also require any cannabis product that is marked with the claim of a therapeutic benefit, or with any other disease claim, to be approved by the FDA for it’s listed intended use before it may be sold to the general public. This is the same standard for any product marketed as a drug for human or animal use. Any cannabis and cannabis-derived products that claim they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases are considered new drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S.