A federal health agency has published a new advisory on what it warns are the “potential harms, side effects, and unknowns” of CBD as more Americans use the popular cannabinoid. At the same time, the government body is also implying that products purchased from state-legal marijuana dispensaries may be safer than those found at gas stations and other retailers.

CBD has appeared on store shelves across the country following Congress’s legalization of hemp in the 2018 Farm Bill, and the Substance Abuse and Mental Health Services Administration (SAMHSA) advisory notes that “the popularity of CBD products continues to grow.” It points to an array of form factors—including CBD-infused topicals, fabric, food and beverages—now on the market at an estimated 270,000 retailers nationwide.

“It is critical that the general public be made aware of the potential harms associated with CBD use,” the agency said in an announcement about the advisory on Thursday, “and parents, in particular, should be advised not to let their children use non-FDA-approved CBD products.”

As many as 1 in 3 Americans reported using CBD products in 2020, the report says, citing a survey conducted by the prescription discount plan SingleCare. Given the widespread use, the agency warns, “The public should be aware of the misconceptions surrounding CBD products as well as the potential harms and risks associated with their use.”

The brief advisory is not intended to be a comprehensive evaluation of CBD or its medical potential, with SAMHSA saying it “focuses on the risks and harms of CBD, especially those sold over the counter.”

Many of the dangers identified in the report—such as a lack of safety standards, poor accuracy in labeling and inconsistent quality control—result from the federally unregulated status of CBD products.

For instance, the SAMHSA advisory says that CBD concentrations “may be more or less than advertised and, because of a lack of quality control, the manufacturing process may introduce harmful biological and chemical contaminants, including the psychoactive [cannabinoid] THC.”

“The lack of safety standards, accuracy in labeling, and quality control,” the report continues, “may lead to additional concerns for unintended intoxication, particularly among children.”

Last month, FDA announced that it will not be creating rules to allow CBD to be marketed as a dietary supplement or food item despite repeated calls for administrative action from lawmakers, advocates and other stakeholders. Instead, the agency said that it wants to “work with Congress on a new way forward.” Officials also denied three citizen petitions requesting rulemaking for the marketing of CBD.

Other potential health and safety effects of CBD use, the SAMHSA report says, could include “adverse drug interactions, liver toxicity and reproductive and developmental effects.” It says more clinical research is needed to conclusively determine whether CBD products are safe and effective.

The advisory does not attempt to compare potential side effects of CBD to complications involved with prescription medications, for example opioids. A number of studies have indicated that easier access to regulated cannabis, which includes CBD products, can reduce patients’ reliance on opioids to treat conditions such as chronic pain.

So far the only FDA-approved CBD product is Epidiolex, a prescription medication that consists of purified CBD and is intended to treat a rare form of epilepsy in children.

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Non-FDA approved products are marketed as a potential treatment for a wide range of other health conditions, only some of which are supported by research.

Citing survey data from 2019, the agency said that 40 percent of CBD users purchased products from marijuana dispensaries. About a third (34 percent) bought CBD from a different retail store, 27 percent shopped online and 12 percent obtained it from another source.

Cannabis retailers, which are typically licensed and heavily regulated at the state level, may offer better and more consistent CBD products than are available at national retailers, SAMSA said—a notable admission from the agency while marijuana dispensaries remain federally illegal.

“Although regulations and enforcement vary from state to state,” the advisory said, “CBD products purchased from dispensaries may be subject to some form of oversight and standardization.”

It also noted, however, that “products sold at cannabis dispensaries are not FDA-approved and may contain more than 0.3 percent THC, depending on the state’s definition of allowable CBD products.”

Consumers, businesses and even members of Congress have expressed frustration at the general lack of regulatory guidance on CBD from federal agencies. Last September, U.S. Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf demanding answers over the continued lack of regulations. Earlier this year, a key Republican lawmaker, Rep. James Comer (R-KY), pledged to take FDA officials to task with his new House chairmanship for failing to enact CBD regulations.

At DEA, meanwhile, officials recently weighed on on two other cannabinoids that can be derived from legally grown hemp: delta-8 THC-O and delta-9 THC-O, which are not naturally found in the cannabis plant but can be produced from other natural cannabinoids. DEA said that because the two cannabinoids “do not occur naturally in the cannabis plant and can only be obtained synthetically,” they do not fall under the definition of hemp and are therefore considered illegal controlled substances.

FDA also recently touted its role helping a state agency crack down on a company selling delta-8 THC gummies that they said are linked to “serious adverse events.”

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Photo courtesy of Kimzy Nanney.

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