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CBD Takes A Hard Hit From The FDA

CBD products have really proliderafted this year, even as the US FDA failed to place a regulatory and enforcement framework in place, but now after months of silence the FDA has come down hard against CBD infused food and beverages. 

A recent study predicted the global cannabidiol market will increase from $311.7 million in 2019 to reach an impressive $1.25 billion by 2024; it is estimated that there are currently 1,000 CBD infused products available online. Hemp farming has more than quadrupled this year since this crop was legalized in 2018 by the Farm Bill which allows for a massive new growth of opportunities for the beleaguered American farmers.

The US FDA just this week issued 15 warning letters to companies which it deemed as illegally selling products that contain CBD, citing violations of the Federal Food, Drug, and Cosmetic Act; along with the warnings the FDA also published a revised Consumer Update which laid out the details of broad safety concerns about CBD products. Basically the FDA is saying that the bottom line of it all is that the federal government has not concluded that CBD is generally recognized as safe for use in human or animal food, thus CBD is still illegal in food and drink. 

While this may seem to have come out of nowhere due to the silence and lack of regulatory framework, it really should come as no surprise as CBD comically remains on Schedule 1 controlled substances under federal law alongside of substances such as cocaine and heroin, thus they are illegal with the exception of pharmaceutical grade CBD products which have been approved by the FDA. 

“It came out of the blue. We were just at a CBD show last week, and there were hundreds of similar products and websites,” said Brad Ridenour, chief executive of Koi CBD, one of the 15 companies to receive warning letters. The companies that were issued warnings have been given 15 working days to respond to the FDA on how they will be moving forward to correct their violations. 

Many companies have been working full speed on developing/marketing CBD infused food/drink as they waited for official direction from the FDA on how to label and market these products and grew increasingly frustrated with the lack of clear regulations. 

“They keep telling us they’re going to come out with guidance, and they don’t,” Ridenour said. "They just tell us what not to do. We’re ready to comply with anything they throw at us.”

Amy Abernethy, the FDA’s principal deputy commissioner said in May, “We are reviewing available databases and medical literature about CBD’s safety. Thus far, the data appear insufficient."

The FDA document What You Need To Know released in June highlighted the warning that the agency considered CBD products as being illegal stating, “We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is currently illegal to market CBD this way.”

The FDA has remained largely silent on the subject until this week:

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law,” Abernethy said in a statement. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ ”

According to The Center for Science in the Public Interest while CBD has been found to be effective and it is legal in prescription form to treat two rare forms of epilepsy there is no clear evidence that cannabidiol can lower the risk of diabetes, shrink tumors, curb opioid use, ease schizophrenia, or calm pets despite what companies selling the products claim. 

“The marketplace is full of products that are essentially unknown,” said Laura MacCleery, policy director for the Center for Science in the Public Interest. “What that means is they are experimenting on consumers, and I don’t think people are aware that they are guinea pigs.”

MacCleery said CBD products have been marketed for use in children and in pregnancy which hasn’t been adequately studied, and some products may be mislabeled or contain contaminants with no clear regulations on production and labeling. “It’s an industry that is untethered to relationships of oversight,” MacCleery states.

According to The Council for Responsible Nutrition, which is the trade association for the dietary supplement industry, this move by the FDA has unnecessarily alarmed consumers, and argue that the inaction for the past year has facilitated an unregulated marketplace which is bad for consumers and the burgeoning CBD industry. 

“It’s time for FDA to announce a legal pathway to market for these CBD-containing supplements and to commence meaningful enforcement against products that flout category-wide requirements for dietary supplements,” said Council president Steve Mister.

The FDA crackdown will likely have little effect on the industry’s growth suggests Melissa Bane who is the managing director of market research and consulting firm Grail Insights. Despite the claim of there being no evidence, there have actually been a number of published studies to demonstrate the positive effects of CBDs in the ongoing investigation of cannabinoids. 

This same week a major published report describing diminished life expectancy for Americans attributed to drug overdoses and suicides among young and middle aged adults suggests that people are looking for mechanisms to manage mood and stress such as CBDs.

“CBD is marketed as a more natural alternative to alcohol, sugar, tobacco and opioids. Sixty-two percent of younger users say they use it to manage stress. Do we see the demand changing? No, we don’t. But consumers want clarity on safety. This [the FDA’s statement this week] leaves the American consumer without answers," Bane said.

Organic hemp oil manufacturer Alon Shabo, founder of ShaiDee who received a warning letter thought that the company was in compliance, and the FDA may have targeted high visibility brands to send a message to the industry; the specific issue with their products the FDA took issue with is their claims for animal products and with consumer reviews on their website that made medical claims to which the company is taking down the consumer reviews and reprinting labeling for the one product. 

According to Shabo once there is clear regulatory framework in place there will be another rush of institutional funding and acquisitions, as people are still ready to dive into the CBD marketplace. “Everybody is bulldozing full speed ahead,” he said. “People are still quite bullish.”

You will have to pardon the skepticism from those who determine this move to be more than a little hypocritical due to the continued allowance of the sale of alcohol and cigarettes which are the two most suffering inducing products that one can legally purchase; and that is not even taking into account the multitude of e-cigarette/vaping products which are also legal and suggested to have managed to hit the market without legitimate and unbiased testing. CBD testing is underway, it appears to be safe, can the same be said for any of the other aforementioned legal products, inquiring minds would like to know. 

Originally Posted by WHN (here)

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