Are cannabidiol products safe? The FDA will consider regulating them

The US Food and Drug Administration announced on Tuesday that it will hold a public hearing next month to discuss the development of a regulatory framework for the use of CBD in consumer products, including food and drink.

CBD, the abbreviation for cannabidiol, is one of the non-psychoactive ingredients in cannabis, and is believed to offer extensive health benefits, with few side effects and low risk of addiction or abuse. Tetrahydrocannabinol or THC is the most important psychoactive component of the cannabis plant.

FDA commissioner Dr. Scott Gottlieb said in a statement that the move was part of an attempt to build "lawful roads where appropriate products containing cannabis or cannabis-derived compounds can be marketed" and made "more predictable and effective. "

[In North Carolina, more regulations already are coming.]

Gottlieb, who announced last month that he had resigned from his post, also renewed his pledge to knock down companies promoting "unfounded, self-asserting claims about the ability of their products to restrict, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid disorders and other serious diseases. "

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Last month, he said the FDA sent notification letters to PotNetwork Holdings in Florida, Nutra Pure in Washington State and Advanced Spine and Pain in New Jersey to make unfounded claims linked to more than a dozen different products and spans multiple product websites, online stores and social media websites. "

It is illegal under the Food Drug Commerce Act to introduce CBD or THC into the food supply or market it as a dietary supplement, regardless of whether the substances are hemp-derived.

The FDA is not interested in disposing of that restriction immediately. because both "CBD and THC are active ingredients in FDA-approved drugs and were subject to significant clinical trials before they were marketed as food or nutritional supplements," Gottlieb says in a statement in December.

On Tuesday, Gottlieb declared "open questions remains about the safety "of widesp Read the use of CBD products, including CBD concentration and possible effects of long-term exposure.

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"It is critical that we address these unanswered questions about CBD and other cannabis and cannabis products derived to inform the FDA's oversight responsibility for these products," he said. "Especially as the agency considers whether it may be appropriate to exercise its authority to allow the use of CBD in supplements and other foods."

However, Gottlieb has previously clearly stated that foods coming from parts of the hemp plant which do not contain CBD or THC can be marketed with FDA approval. In December, he announced that hull frog seeds, hemp seed protein and hemp seed oil could be marketed as long as they did not claim disease treatment.

Legalization of hemp

In December, President Donald Trump signed Farm Bill law; Among other things, it legitimized the production of hemp, which contains high levels of CBD.

Later last year, the FDA approved the first cannabis-based prescription drug, called Epidiolex, to treat epileptic seizures, but Gottlieb recently told the Brookings Institute that legalizes CBD for use in food and diet products may take several years.

The legal limbo for products sold with CBD created a strain on the industry. In February, a bipartisan group of lawmakers sent a letter to Gottlieb about the breakdown of selling CBD food and beverages by officials in New York City, Ohio and Maine, saying that the actions "made a tremendous amount of confusion among product manufacturers, hemp farmers, and consumers of These products. We urge the FDA to quickly provide guidance on legitimate food pathways with the CBD. "

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The public hearing is scheduled for May 31, well after Gottieb leaves the office.

In response to Gottlieb's announcement on Tuesday, Rep. Chellie Pingree in a statement: "It is clear that Commissioner Gottlieb prioritizes this problem and takes it seriously. I hope his [successor] on the FDA will work with the same sense of urgency. After the FDA gathers stakeholder input through public comment and by May 31, the public meeting, I will consider any regulatory means that may be necessary to address this issue. "

Industry Response

Reaction from the industry was positive. "We are looking forward to the FDA being more open to assessing the medical benefits of cannabinoids and examining the research on the subject," said Morgan Fox, director of media relations for the National Cannabis Industry Association.

Erica McBride Stark, CEO of the National Hemp Association, said: "We encourage the FDA to move as quickly as possible to protect the interests of everyone and welcome the opportunity to bring this important industry out of the shadows. the legislation will protect both consumers and the industry. "

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