More than four years after the 2018 Farm Bill legalized industrial hemp, the Food and Drug Administration still hasn't regulated the cannabis compound CBD — and the agency said it has no plans to.
The FDA announced in late January that it plans to defer to Congress for rulemaking over concerns that existing regulations for food and supplements don't go far enough to manage the risks of CBD. That could mean more delays.
"The FDA's existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive," Dr. Janet Woodcock, the FDA principal deputy commissioner, said in a statement.
Michelle Bodian, partner at cannabis-focused law firm Vicente Sederberg, said that, while disappointing for the cannabis industry, the decision is unsurprising.
"The lack of traction that's gone over in the intervening years since the first farm bill, it's led us all to conclude that this isn't something they're trying to work towards finding a pathway to regulate," she said.
CBD or cannabidiol is a non-psychoactive compound found in hemp or cannabis plants. It is technically legal if it comes from hemp and contains 0.3 percent or less of the psychoactive compound THC, but it exists in a regulatory gray area that has led to a surge in CBD-based businesses selling everything from topicals to tinctures. CBD has shown some promise for its anti-inflammatory effects, and it forms the basis of an FDA-approved drug called Epidolex that combats rare forms of epilepsy in children. But it is not the panacea that some businesses have claimed, and research shows that it isn't completely harmless.
According to the FDA, studies have shown CBD can cause possible harm to the liver and male reproductive system, as well as have negative interactions with some medications. The FDA also cautioned against exposure for pregnant people and children.
"We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods," Woodcock said.
Aside from the possible side effects, Bodian said CBD's use in Epidiolex could be a factor in the FDA's inaction. The Food, Drug and Cosmetics Act prohibits active ingredients in prescription drugs from being used as food additives and dietary supplements. In the past, hopeful advocates predicted that FDA, Congress, or both could design regulations that permit CBD in both pharmaceutical medications and in lower potency over-the-counter formulations.
With Congress on the hook to act, odds of a speedy regulatory process look distant, especially with Republicans in charge of the House of Representatives. For now, in the absence of federal regulation, CBD businesses will be forced to continue navigating a patchwork of state-level regulations, just like in the cannabis industry.
The FDA has granted emergency use authorization to Pfizer's pill to treat covid-19. The treatment, called Paxlovid, is the first antiviral covid-19 pill that people can take at home.
Pfizer says the pill can reduce the risk of severe illness by 90 percent and is intended for people at high risk for severe disease, including those over 65, people with obesity, diabetes, or a weakened immune system. Professor Peter Pitts, Founder, Center for Medicine in the Public Interest & Former FDA Associate joined Wake Up with Cheddar to discuss.
Ahead of a four day week for the markets due to the upcoming Christmas holiday, investors hoping for a quiet end to the year, or even a Santa Claus rally, may not be in luck. Investors are still digesting the latest from the Fed regarding a quicker than expected taper, as well as ever increasing blow back as the Omicron variant spreads. Octavio Marenzi, CEO of Opimas LLC, explains why the markets have been so volatile ever since the emergence of the latest variant and what to expect going forward into 2022.
Carlo and Baker cover the heartening news on the Covid front ahead of the holiday, plus President Biden punting student loan repayments again, a new space telescope and Love, Hate, Ate: Christmas Eve Eve Edition!
Pfizer, one of the makers of a currently available COVID-19 vaccine, has taken another critical step forward in combatting the pandemic by getting regulatory approval for Paxlovid, a pill treatment rather than IV or injection as others have been. Dr. Purvi Parikh, an immunologist with the Allergy and Asthma Network, spoke to Cheddar about the ramifications of the authorization. "This is huge, especially because we know early treatment does keep people out of the hospital, especially with this antiviral," Parikh said. "The fact that people can start a regimen at home so they don't have to leave and further expose others is a big breakthrough." She also explained how the drug is a combination of two antiviral medications that are not without its risks but should be safe over the short term.
This year's worldwide semiconductor shortage limited the supply of everything from new cars to smartphones; and now, many in the chip industry expect the shortage to continue deep into 2022, and maybe even 2023. Semiconductor senior research analyst for Robert W. Baird & Co., Tristan Gerra, joins Cheddar News' Closing Bell to discuss.
Direct health care company Nomi Health recently raised $110 million in a Series A round. Nomi Health lets public and private organizations directly purchase healthcare at reduced costs, and pay providers in real-time. It also delivers healthcare directly to under-served communities via its fleet of mobile care units, which the company says is the largest in the country. Nomi Health says its mission is to improve the health care experience for all Americans. Nomi Health CEO Mark Newman joined Cheddar News' Closing Bell to discuss.
The airline industry says it is contending with staff shortages that threaten to hamper operations amid the COVID resurgence, andDelta Airlines CEO Ed Bastian called on the CDC to revise its guidance for vaccinated workers who test positive from a 10-day quarantine to just five. Chuck Liberman, chief investment officer and managing partner at Advisors Capital Management LLC, joined Cheddar to talk about the current guidance on isolation and why he believes the omicron variant calls for more relaxed guidance given its reportedly mild symptoms.
The boys discuss President Biden's plans to send out free rapid tests as the testing supply chain starts to buckle ahead of the holidays. Also, why aren't Americans having more babies, and The Matrix returns.
NASA is launching its new generation of space telescopes just before Christmas. The James Webb Space Telescope, set to launch on December 24th, will succeed the Hubble space telescope as the world's most powerful complex space observatory. The project has been 30 years in the making and is one of the most highly anticipated space science missions of the 21st century. Klaus Pontoppidan, astronomer and JWST Project Scientist at the Space Telescope Science Institute joined Cheddar's Opening Bell to discuss.
With Omicron becoming the dominant COVID-19 variant in the U.S., President Joe Biden announced that he will make 500 million rapid tests available to Americans in January 2022. Cheddar News speaks with Dr. Shereef Elnahal, President and CEO of University Hospital why testing is key to combatting the spread of the virus.
