FDA Explores Regulating CBD in Foods, Supplements

In the coming months, the agency studying cannabis-based ingredients plans to share its safety regulations with the public.

Key takeaways:
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    The FDA is researching the use of cannabis in food and health supplements to determine what regulations are necessary for the public.
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    The FDA says cannabis may pose health risks for children, women pregnant or breastfeeding, and when mixed with specific medications.
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    Epidiolex, which treats certain severe seizure disorders, is the only FDA-approved prescription CBD medicine out now.

The Food and Drug Administration (FDA) is conducting research to determine if it is safe to use cannabis in foods and health supplements.

Officials said in the coming months, the FDA intends to offer health recommendations for controlling the growing number of cannabis products.

“We want to be clear that the data on CBD point to real risks that need to be considered. Risks include liver injury, harm to the male reproductive system, and side effects, such as changes in alertness and other symptoms,” Kristi Muldoon-Jacobs, Deputy Office Director, Office of Food Additive Safety said to the FDA in a report.

FDA officials continue researching further cannabis and CBD concerns, including how it may affect pregnancy and fertility.

In 2018, Congress legalized hemp use. However, it left hemp regulations to the FDA. While some states have created their own rules around cannabis, other makers of products like CBD oil have released products without specific guidelines.

Hemp plants contain high levels of CBD. THC and CBD are similar, though CBD isn't usually considered to have intoxicating effects on the brain and body like THC.

The FDA notes that CBD can clash with other medications. Some medications, including some antidepressants, and pain relievers, can lose their effectiveness if taken with CBD.

The FDA has not yet allowed cannabis-derived products to be treated as food or supplements, rather than as drugs. Also, the agency has not approved companies to market cannabis products for the treatment of any disease or condition except to treat certain severe seizure disorders in patients two years old and older.

Epidiolex is the name of the drug, and after research, it was found that the benefits outweigh the risks for the people it was made for when used under close medical supervision.

Currently, if a company says that its cannabis product has therapeutic benefits, it must show those benefits through clinical trials.

However, the industry is still growing rapidly. A recent report by a cannabis data company said that by 2026, global cannabis sales could increase from $30 billion in 2021 to $57 billion.

According to the National Institutes of Health, cannabinoid research is still in the early stages. While some research says cannabis products may help ease pain, other studies suggest CBD may be harmful to some.

Once the FDA has reviewed more research, the agency plans to offer regulations for legal cannabis products. Some of the regulations may require new laws from Congress.

The FDA regulates medicines, medical devices, dietary supplements, and food, like baby formula. The agency recently began watching how tobacco products are made, sold, and marketed.

Officials say that new cannabinoid chemicals like Delta-8, which has been on the market for a few years, complicate the agency’s research. The new cannabinoid meets the legal definition of cannabis, but unlike CBD, it can be intoxicating.

“Data on CBD points to real risks, and the FDA is especially concerned about the risks to children, people who are pregnant or breastfeeding, and people taking other medications,” said Muldoon-Jacobs, “Consumers should be aware of the risks and should speak with a medical provider about the use of any CBD product. We want people to make informed choices about their health.”

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