What Does the FDA’s CBD Announcement Mean?

What Does the FDA’s CBD Announcement Mean?

January 7, 2019

Hemp made history and headlines at the end of 2018 when the 2018 Farm Bill was passed and signed into law. Find out what the FDA’s stance on CBD means in the wake of hemp legalization with myCBD.org.

Are CBD Products FDA Approved?

Wondering what the FDA’s stance on CBD means legally? While the hemp industry’s historic legal win through the Farm Bill is poised to revolutionize and take the industry to new heights, less than 12 hours after the Farm Bill was signed into law, the FDA’s Commissioner Scott Gottlieb re-affirmed his agency’s stance that cannabidiol is a drug ingredient and that as such, it is illegal to sell CBD dietary supplements and infused foods without FDA approval.

According to the statement issued by Gottlieb and the FDA on December 20, 2018:  

“Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective.

The statement went on to reaffirm that under the FD&C Act, (Food Drug and Cosmetics Act), it is illegal to intro CBD or THC to market or sell them across state lines. Penalties for violation of the FD&C Act include: warning letters called ‘stop’ letters, fines, and even imprisonment.

What does the FDA’s 2018 Stance on CBD mean?

While some outlets reported the FDA’s stance cast a shadow on the huge win for legal hemp and CBD markets, it is important to note that there are still pathways and protections for companies and consumers seeking access to the CBD industry.

For companies, these pathways include seeking approval from the FDA itself. In June 0f 2018, an epilepsy drug containing cannabis-derived CBD, Epidolex, was approved by the FDA. Per the FDA’s announcement, approval was awarded to the drug based on the results of “adequate and well-controlled studies,” which give prescribing doctors confidence as to the drug’s safety, efficacy, and consistency.

What authority does the FDA have?

The Federal Drug Administration is a agency of U.S. Department of Health and Human Services, tasked with protecting the public health through ensuring the security, effectiveness, and safety of vaccines and drugs for both humans and animals, biological products intended for human use, and medical devices. The agency also is regulates the safety and security standards for America’s food supply, which extends to include: cosmetics, dietary supplements, tobacco goods, and products that emit radiation.

What does the FDA’s stance mean for CBD products?

In its announcement, the FDA noted that hulled hemp seeds, hemp seed proteins, and hemp seed oil was still considered safe and that products containing these ingredients would not require additional approval.

Prior to the legalization of hemp through the Farm Act, legal hemp and CBD markets existed in separates states. Now, with protections provided by legalization, hemp farmers and businesses will be able to apply for crop insurance, gain access to loans and grants, and write off their business expenses.

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