Saturday, 07 December, 2019


FDA Publishes Revised Consumer Update On CBD

A can of E-fast energy drink is poured at the CBD Hive stand at the Europe CBD Expo at the Excel in London U.K. on Friday Jul. 12 2019. U.K. investors eager for a piece of the cannabis market are being deterred by a broad catch-all law on proceeds FDA says CBD not recognized as safe for food use, issues 15 warning letters
Patty Aguilar | 30 November, 2019, 23:07

FDA also has to weigh if lawful CBD use and its application in food, beverages and dietary supplements will hinder drug development said Mayl.

An FDA Consumer Update on CBD products is available here.

"We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products", said Dr. Abernethy. The FDA also published a revised Consumer Update outlining more generally its safety concerns about CBD products. Yesterday, the company sent an e-mail to customers and associates from Stuart Tomc, the company's PlusCBD Oil division vice president, regulatory science and education, titled: "CBD: Is this Sh*t Even Safe?"

While the FDA has yet to pronounce on the status of CBD, at a federal level, the industry will resolutely hope that Scott Gottlieb's latest pronouncement is not indicative of his former employer's position.

The FDA said it "has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason". Mister said FDA has not established an appropriate framework to encourage more of the research it claims to seek: "T$3 he agency declines the opportunity to create incentives for that research or to give this data assurances of confidentiality that drug submissions are accorded".

CBD might not be as safe as the companies selling it say it is, the Food and Drug Administration is warning consumers. While CBD has been found effective and is legal in prescription form to treat two rare forms of epilepsy, the center says there is no evidence that cannabidiol will lower the risk of diabetes, shrink tumors, wean a person off opioids, ease schizophrenia or calm anxious pets - despite the claims of companies actively marketing CBD products.

Speaking to FoodNavigator-USA after the FDA warned 15 companies about "illegally selling products containing cannabidiol", and threated "legal action, including product seizure and/or injunction", William Garvin, shareholder at Buchanan Ingersoll & Rooney PC, said: "It increases the risk that FDA might take enforcement action against you". However, the warning letters indicate that the FDA will crack down on companies it believes are acting unlawfully and putting consumers at risk.

In the absence of an effective regulator, consumers can turn to organizations such as the Council for Responsible Nutrition to help them distinguish responsible supplement companies from those who may or may not be.

Some of the products are foods to which CBD has been added.

Over the past several weeks, there has been pressure building on the FDA to articulate its views on CBD products.

The agency stated that there is no FDA evaluation of whether these products are effective for their intended use, guidance on proper dosage, how they may interact with FDA-approved drugs, side effects or other safety concerns or manufacturing practices. Nonetheless, the FDA said it was exploring potential pathways for CBD products to be sold legally.

The FDA has requested responses from the companies within 15 working days stating how the companies will correct the violations.

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