As if the marijuana industry isn’t reeling enough with $75 ounces in multiple states, NASDAQ listed Akerna going under, and MSO Curaleaf pulling out of competitive markets like California and Colorado, more bad news hits the industry, this time, on the government side. It is devastating news for those who love CBD products. The Food and Drug Administration has declared that these items, made from cannabis or hemp, may not comply with federal safety regulations. These safety regulations will affect a wide range of products, from soap to seltzer, and require more stringent oversight.
The news was a significant setback for the rapidly growing CBD industry, as the hope for FDA approval was dashed. Instead, the agency has appealed to Congress to implement new regulations to govern the use of CBD.
An FDA representative stated that there are concerns over the safety of incorporating CBD into food and supplements. By law, the safety standards for such items are incredibly rigorous, and it remains to be seen how CBD could meet these stringent requirements.
The FDA has raised the alarm over the use of CBD due to various safety concerns that may arise from extended use. In their statement, they referenced studies that suggest potential harm to the liver and male reproductive system and dangerous interactions with certain medications. Additionally, the agency warned that CBD exposure might pose risks to vulnerable groups such as children and expectant mothers.
The 2018 Farm Bill legalized hemp, but the legality of hemp-derived CBD was still up in the air. This is because CBD can come from both hemp and cannabis, but if a hemp plant has more than 0.3% THC (the compound responsible for the “high” in marijuana), it is considered a marijuana plant under the Farm Bill. The classification was muddled, and experts predicted that creating and implementing regulations would take years.
In essence, the federal government has yet to determine whether CBD is safe for humans or animals to use in food or drinks. The Federal Food, Drug, and Cosmetic Act banned the addition of approved drugs to human or animal food traded across state lines. As a result, the use of CBD in food and drink remains illegal.
Despite the absence of official approval, CBD products have taken the market by storm, from energy drinks and sparkling water to topical creams and tinctures – even pet food. Industry forecasts predict the global CBD market will reach $1.25 billion by 2024, with thousands of CBD-infused products readily available online. However, the FDA’s current stance could mean a pause in the proliferation of CBD products.
As expected, the FDA’s decision faced criticism from advocacy groups and food industry experts. The General Counsel of the U.S. Hemp Roundtable, Jonathan Miller, declared in a statement that the FDA had missed the mark on the safety of CBD. He viewed the agency’s intention to enforce stricter regulations as “unprecedented and unjustified.” Still, he supported a legislative solution permitting CBD marketing in dietary supplements and food products.
Alex Buscher, a lawyer based in Colorado who provides legal counsel to hemp companies, also made some interesting comments. He stated that CBD does not appear to be more hazardous than other dietary supplements that have the potential to cause side effects if taken more than the recommended dose. “The FDA is deferring the decision to a fragmented Congress, which will take time to establish a new regulatory system,” he said. “We require concrete regulation from the FDA.”
Food safety specialists have argued that the FDA has found itself in an untenable situation as more states have decriminalized marijuana (which remains illegal under federal law), and related products have gained widespread appeal. According to the National Conference of State Legislatures, 37 states and territories have legalized medical marijuana use since February, and 21 states and territories have decriminalized recreational use since November 9th. This state legalization is a clear indication of a shift in public opinion.
“I believe that the FDA understood that no matter which direction they took, they would be facing an uphill battle trying to put the genie back in the bottle, and that would inevitably lead to political chaos,” said the Director of Food Policy for Consumer Reports, Brian Ronholm. “It’s not surprising that they sought refuge by turning to Congress.” The Executive Director of the Center for Science in the Public Interest, Peter Lurie, referred to the FDA’s appeal to Congress as “passing the buck.” However, he also pointed out that because there is a legal CBD-based drug, Epidiolex, which is used to treat a severe form of epilepsy, the FDA’s hands are tied in terms of expanding access to the substance. Federal law prohibits active compounds in prescription drugs from being used as food additives.
As support for cannabis regulation reaches a boiling point, the CEO of the National Cannabis Industry Association, Aaron Smith, emphasizes the necessity for Congress to step up and provide clear guidance on all cannabis-derived products. He states that the recent announcement from the FDA only highlights the urgency for Congress to take action and address the legal status of products from the cannabis plant, which has already been legalized in several states.” Our legislative leaders must catch up with public sentiment and provide a clear direction for the cannabis industry.
The FDA’s announcement on regulating CBD-infused products has created a storm of criticism and disagreement, with many advocating for clear and concise regulations to be established. Despite its growing popularity, the long-term safety concerns surrounding CBD and its ability to meet federal safety standards are yet to be resolved. The hemp industry, hoping for the agency to greenlight CBD’s use, has now been forced to take a step back. The appeal to Congress to draft new regulations has sparked discussions on the future of the burgeoning CBD market and the legal status of hemp-derived products. As public sentiment shifts towards decriminalizing marijuana and its related products, it remains to be seen what direction Congress will take in regulating this rapidly expanding industry. (Full Story)