Why CBD Products Have a Hard Time Getting FDA Approval

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Although the popularity of CBD in the wellness industry continues to grow, the U.S. Food and Drug Administration (FDA) stands firm in its position that it needs more answers about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD. While some CBD wellness manufacturers are in favor of the FDA’s stance on CBD, others are concerned that it is misleading and could hurt small CBD wellness companies. 

Here’s what we know: the FDA has approved only one CBD product, a prescription drug called Epidiolex from GW Pharmaceuticals to treat two rare, severe forms of epilepsy; it is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement (although some forms of hemp, including hempseed are legal provided they comply with all other requirements); and the FDA needs more data on CBD safety. 

Some of the questions the FDA has regarding CBD safety is whether it has the potential to cause harm, such as liver damage. There are also concerns about side effects that might not be immediately noticed, such as changes in alertness and mood, and gastrointestinal distress. The FDA is concerned about the effects of CBD when taken daily for sustained periods of time; CBD on the developing brain, developing fetus, or breastfed newborn; and how CBD interacts with herbs and botanicals.

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“I am very much in favor of FDA regulations for the cannabinoid industry,” says Heather Kreider, co-owner of Hempfield Botanicals. “Currently, there are virtually no regulations to which CBD product manufacturers must adhere. The FDA has done some preliminary testing of these products but has not yet implemented any specific rules or oversight requirements, as it has not yet approved them for general medicinal use. Random testing has shown that many CBD products on the market right now do not contain the levels of CBD they purport to contain. This begs the question: what else are those manufacturers doing to mislead consumers?” 

While it is important for the FDA to create well-thought-out regulations and guidelines, Chris Diaz, CEO of Lacuna Botanicals, believes the messaging is somewhat misleading and the FDA’s current stance poses a potential risk to emerging CBD brands in today’s wellness market. “The one specific health risk that has been raised concerning CBD is potential liver damage,” says Diaz. “The most frequently cited research on this was conducted by the University of Arkansas. It conducted research of CBD dosing on mice based on the maximum maintenance dosage approved by the FDA for Epidiolex, which is 20 milligrams per kilogram of body weight per day.” According to him, this level of dosing is approximately 30 times higher than most retail CBD elixirs contain today. “If the FDA were to require FDA approval for companies to take CBD products to market, this would crush all small CBD companies,” says Diaz. 

However, Diaz does believe that the FDA can take certain steps to help the CBD wellness industry, such as establishing requirements on transparency in labeling. For example, according to him, 1,000 milligrams of full-spectrum extract does not equate to 1,000 milligrams of CBD (it’s somewhere closer to 600 to 700 milligrams of CBD) because full-spectrum hemp extract contains only around 60 percent of cannabinoids and approximately 40 percent of plant matter, which contains no CBD or other cannabinoids. Also, the FDA should require third-party testing. “Simple potency testing is typically less than $100,” says Diaz. “This is much less than the billions of dollars required for FDA approval and provides a tremendous amount of transparency for the consumer regarding the quality of the product they are purchasing.”
 

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