Question: What is the FDA's current stand on cannabis and cannabis-derived compounds? Part I

Answer:
The following was released on December 20, 2018 from the FDA. Provided below are excerpts; you are encouraged to read the complete statement that can be found at the website at the end of the statement.

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency's regulation of products containing cannabis and cannabis-derived compounds.

"The Agriculture Improvement Act of 2018 (AIA) changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.

Just as important for the FDA is what the law didn't change: Congress explicitly preserved the agency's current authority to regulate products containing cannabis or cannabis-derived compounds. In doing so, Congress recognized the agency's important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds.

This increasing public interest in these products makes it even more important for the FDA to clarify its regulatory authority over these products. In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they're subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance.

In view of the proliferation of products containing cannabis or cannabis-derived substances, the FDA will advance new steps to better define our public health obligations in this area.

In particular, we continue to be concerned at the number of drug claims being made about products not approved by the FDA that claim to contain CBD or other cannabis-derived compounds. Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they're intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. (Emphasis added)

We'll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA's authorities. The FDA has sent warning letters in the past to companies illegally selling CBD products that claim to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food."

Editor's Note: The excerpts in answer to this question will be continued next week.

https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

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Telemedicine is frequently touted as a technology tool that can help improve healthcare access for rural populations, especially in areas with physician shortages. But telemedicine might not be the silver bullet to improve rural healthcare when those same areas have significant infrastructure challenges, according to researchers. Rural counties where access to primary care physicians and psychiatrists is inadequate also have substantially lower broadband penetration rates, according to a recent research report published in Annals of Internal Medicine.
https://www.fiercehealthcare.com/tech/poor-broadband-access-rural-areas-limits-telemedicine-use-study

Charcoal Toothpaste May Do Harm and Not Much Good
Charcoal toothpaste may be having a moment as a go-to brightening and whitening tool, but some dentists say these products might actually damage tooth enamel. At a minimum, any claims charcoal toothpaste marketers make have no scientific evidence behind them, the authors of a paper in the British Dental Journal warned. "The evidence highlighting any potential benefits of charcoal toothpaste over regular toothpaste is severely lacking," said Dr. Joseph Greenwall-Cohen of the University of Manchester Dental School in the UK, one of the coauthors.
https://www.reuters.com/article/us-health-toothpaste-charcoal/charcoal-toothpaste-may-do-harm-and-not-much-good-idUSKCN1SM2M3

Did You Know ...

...that Abraham Lincoln made the following statement?

"The brave men, living and dead, who struggled here, have consecrated it far above our poor power to add or detract. The world will little note, nor long remember, what we say here, but it can never forget what they did here."

We should keep this quote in mind as we approach Memorial Day.

Tip of the Week

"Memorial Day is a good time to remember our wonderful heritage, and some of the blessings we so take for granted. We often treat with indifference the sound foundations of our nation's life that were laid by consecrated and industrious hands. We should be grateful for our Constitution, which has safeguarded our liberty and protected its destruction by malicious minds or by blinded political prejudice. Every day is not too often to remember those men and women of vision and valor who bought our liberty, and particularly should they be remembered on Memorial Day." —Sir Oracle

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Looking Back

I know he's a wolf,
Said Riding Hood,
But Grandma dear,
He smells so good!
     Burma-Shave