How the FDA is Evaluating Hemp

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How the FDA is evaluating Hemp

In recent years there has been a growing interest in the use of hemp derived products, especially CBD, for cosmetic therapy, dietary supplements, treatment of medical conditions, and other purposes. There is an intense rise in the demand for this product since it has been reported by many users to be beneficial in numerous ways, and many people have been already applying it to their lives and giving constructive feedback.  As interest and research grows, it’s helpful to understand how the FDA is evaluating hemp products.

Like many commodities that are used for medical reasons, there must be FDA regulations that guide the market.  They also determine the guidelines for administering medication and the amount that can be sold and consumed. FDA evaluation of hemp is in the early stages, as research regarding the plant is ramping up around the world. 

What is Hemp?

Hemp is just another name for the Cannabis sativa plant. Depending on the variety of plant, it can be developed as marijuana or hemp. However, hemp products found on shelves, also known as industrial hemp, have a lot less of the chemicals found in the marijuana people use to feel high. The variation of the plant used to make such products is significantly lower on THC, the compound responsible for the psychoactive effects of smoking weed, so it is not possible to use hemp for recreational purposes.

The 2018 Farm Bill

In December of 2018, when Congress passed the Agriculture Improvement Act of 2018 (the 2018 Farm Bill), hemp became a big deal: Among other things, this law established officially the new category of cannabis classified as “hemp” – defined as cannabis and cannabis derivatives with extremely low (no more than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). The 2018 Farm Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law.

These plants are cultivated for their fiber or their edible seeds, the ones that produce the hemp oil that is used to make cosmetic and medical products. There is a high concentration of the CBD compound on hemp, responsible for the relaxing effects of these products and for the alleviation of symptoms on conditions such as Parkinson, hyperactivity, and many others.

The fiber extracted from the plant is renewable and also used in the production of fabrics that are stronger, better insulating, and water absorbent. Any product that consumes petroleum can be essentially made out of hemp, and many countries and markets are starting to take advantage of it to boost their economy. However, in the US, regulations are still very strict when it comes to legalized growth and the use of hemp.

The FDA’s role with Hemp

The FDA, Food and Drug Administration, is a US federal agency responsible for overseeing the safety of drugs, cosmetics, food, and other health-related products. Although hemp is no longer a controlled substance, Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.  This means that Congress recognized the agency’s important public health role in regulating products for human consumption. Therefore, the FDA will continue enforcing the law to protect patients and the public while also providing potential regulatory guidelines for products containing cannabis and cannabis-derived compounds.

Since they can’t test every single product out there in the market, the FDA does its best to administer goods by mixing regulations, under more than 100 separate laws passed by the Congress, guidelines issuing guidance on how to best use a product, inspections, and approval processes. The FDA has recently begun investigating and formulating potential regulations for the use of hemp oil as a cosmetic and medical good. The demand for the product and interstate commerce of hemp in the US increased significantly following the 2018 renewal of the Farm Bill.

FDA Questions regarding Hemp

While the FDA acknowledges such increased demand for hemp-derived products, they say that they will take a science-based approach to determine the safety and efficacy of the plant. On their website, the FDA claims that they are working on answering these questions with feedback from a recent FDA hearing and data and information gathered from a public docket that was open until July 16th.  The most immediate questions that the FDA wants to answer on hemp are:

  • Long-term effects of CBD, in particular, related to effects on the liver. 
  • The difference in the long-term effects of CBD depending on the people ingest it (eg: CBD infused food, drinks, creams) and how using multiple products at the same time affects the consumer. 
  • The effects of CBD on special populations (e.g., the elderly, children, adolescents, pregnant and lactating women).
  • The safety of CBD use in animals (e.g., species, breed, or class) including pets.

Statement from the FDA Commissioner

Even though hemp was removed from the definition of marijuana in the Controlled Substances Act by the recent Farm Bill renewal, CBD still falls under the same laws and requirements as other substances carrying FDA-regulated products. In his statement, given on April 2019, the FDA Commissioner Scott Gottlieb spoke about the agency’s concerns over the possible detrimental effects cannabis-containing and cannabis-derived products can have on the body.

“While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use. For example, during its review of the marketing application for Epidiolex – a purified form of CBD that the FDA approved in 2018 for use in the treatment of certain seizure disorders – the FDA identified certain safety risks, including the potential for liver injury. These are serious risks that can be managed when the product is taken under medical supervision in accordance with the FDA-approved labeling for the product, but it is less clear how this risk might be managed in a setting where this drug substance is used far more widely, without medical supervision and not in accordance with FDA-approved labeling.”

This means that like any food or drug, the FDA’s role is to exercise extreme caution in exploring all the risks and potential side-effects of a product. When a product is as widely available as CBD (and as popular) the FDA is going to be that much more careful to explore any and all risks, even if they exist for just a small fraction of users. 

With the recent changes on the Farm Bill and the growing interest in the use of CBD to treat symptoms of medical conditions, the FDA is invested in analyzing the long term effects hemp can have on people, both beneficial and otherwise, and how they can better make it available to the public. The hearings promoted by the agency and the willingness to hear public opinion on the matter are a way of making sure all desires are satisfied on the safest way possible.  As we wait for their findings, be sure to use only reputable CBD products with readily available third-party lab results, such as the products available through Rooted Hemp Co. 

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