Mitch McConnell Urges FDA To Ease CBD Regulations 'Within 120 Days'

Sens. Ron Wyden (D-OR) and Jeff Merkley (D-OR) sent a letter to the head of the U.S. Department of Agriculture (USDA) on Wednesday, requesting a series of changes to draft rules for hemp that the department released last month . The senators said they appreciate that USDA issued the proposed regulations, which is a “necessary step to establish a domestic federal hemp production program.” However, they wanted to highlight “several concerns about the unintended and potentially harmful effects this interim final rule would have on hemp production in Oregon and across the country.” In the letter to Agriculture Sec. Sonny Perdue, they listed five issues with the regulations and suggested potential fixes. Many of the concerns echoed those that stakeholders have submitted to USDA as part of a public comment period the department launched on October 31. Here’s what the senators highlighted: —As written, the draft rules call for hemp to be tested within 15 days before harvest. Farmers have argued that’s far too little time, and the senators said it presents an “impossible obstacle for growers to overcome.” Oregon regulations require testing within 28 days, so they said USDA should adopt a similar timeline. —USDA said that testing must be completed at a laboratory registered with the Drug Enforcement Administration. The senators said that will produce a bottleneck and delays for hemp producers, and that independent laboratories such as those operating in Oregon should be allowed to conduct the tests. —The senators said that USDA should allow for forms of THC concentration testing that do not involve post-decarboxylation and also argued that the congressional intent of hemp legalization was not to require testing of all THC compounds but rather just delta-9 THC in particular. —USDA requires that testing samples come from the top one-third of the flower portion of the plant. Instead, the senators said, samples should follow established protocol in states like Oregon, which stipulates that samples should be taken from the flowering tops when they’re present and be eight inches long. —While the Farm Bill defines hemp as cannabis containing no more than 0.3 percent THC on a dry weight basis, USDA gave slight margin of error and considers any plants with more than 0.5 percent THC to be in violation of the regulations. Farmers have called that limitation arbitrary and the senators said it would be more reasonable to set the negligence threshold at 1 percent, if there must be a THC restriction at all. “Farmers in Oregon and across the country are on the precipice of an agricultural boom that, with the right regulatory framework, stands to boost rural economies in every corner of the country,” they wrote . Wyden and Merkley have been some of the most vocal proponents of developing USDA regulations that bolster the hemp industry since the passage of the Farm Bill, through which they worked to legalize the crop in the first place. As early as February, Wyden and Senate Majority Leader Mitch McConnell (R-KY) were knocking at USDA’s door, urging the department to expedite the rulemaking process . Read the full senators’ letter to USDA on hemp regulations on our blog. Written By: Kyle Jaeger Original Article: https://www.marijuanamoment.net/senators-push-usda-to-adopt-five-changes-to-proposed-hemp-regulations/

Federal health regulators say the lack of scientific data about cannabidiol explains their delay issuing new guidance on over-the-counter CBD. The  U.S. Food and Drug Administration continues to accept comments on hemp- and cannabis-derived ingredients, months after the comment period closed, according to Sharon Lindan Mayl, senior policy adviser in the FDA’s Office of Food Policy and Response. Mayl said this week that the FDA needs more data about CBD, despite the more than 4,500 comments it has received since it began its review of regulations for hemp-derived CBD. A  landmark public meeting  about cannabis at FDA headquarters in May and the many online submissions didn’t yield enough scientific evidence in support of CBD, reported Informa Pharma Intelligence, a health care industry news source. At that hearing, an exchange between FDA analysts and a Colorado doctor underscored the problem. FDA officials asked Dr. Kevin Chapman, who was testifying on behalf of the American Epilepsy Society, how parents of epileptic children know how much CBD to give them. “They’re making it up as they go along,” Chapman said. The request for public comments about CBD research wasn’t much better, according to Mayl. “It’s safe to say that in 4,500 comments, we did not receive a lot of hard data around the issues that we specifically requested comments on,” Mayl told a group of attorneys and regulators at a conference on Monday. Law Blocked Research Mayl said the FDA recognizes that safety studies on CBD and other cannabis extracts were rare prior to hemp being descheduled as a controlled substance last December. The agency is open to being convinced through scientific data about the safety of CBD as an ingredient, Mayl said. Particularly, Mayl said, the agency needs to see total exposure data, as the use of CBD in the consumed products raises concerns about the potential risk to consumers. (Safety data related to the FDA-approved drug Epidiolex is not being considered in the agency’s evaluation of CBD safety for use in nondrug products.) Mayl reiterated comments made a week ago by Lowell Schiller, the FDA’s principal associate commissioner for policy, who told a gathering of nutritionists that there is no bias for or against CBD. “We do not hold CBD to a higher standard of safety – but we won’t hold it to a lower standard, either,” she said. The FDA also has to weigh whether or not the lawful use of CBD and other cannabis derivatives in food, beverages and dietary supplements will hinder further drug development, Mayl said. Read more about Mayl’s comments here . Original Article: https://hempindustrydaily.com/fda-says-more-scientific-data-needed-to-move-forward-with-cbd-regulation/

Hemp farmers and industry advocates are alarmed that federal agriculture officials have brought drug enforcement back into the fold to ensure that cannabis produced for hemp in the United States does not exceed the acceptable limit of 0.3% THC. The U.S. Department of Agriculture’s  interim federal rules for hemp production , released Oct. 31, require that only laboratories registered with the U.S. Drug Enforcement Agency (DEA) will be qualified to conduct THC testing of hemp crops. Industry members worry the limitation could delay THC testing and create bottlenecks, especially in remote areas far from a DEA-registered lab. “It appears that many of the existing (DEA) labs don’t have the equipment and capacity to service the hemp industry,” cannabis attorney Shawn Hauser of Denver-based firm Vicente Sederberg said last week  during a webcast with Hemp Industry Daily . The rules propose that the U.S. Department of Agriculture (USDA) may establish an approval process for labs that want to offer THC testing services. Those labs would need certification by the International Organization for Standardization (ISO), which could be a suitable alternative, according to Hauser. If the USDA chooses to approve testing labs, it could accredit laboratories that perform to a certain quality, in addition to requiring a particular ISO accreditation. This is a departure for the DEA, which does not require labs to be accredited to handle narcotics. However, the USDA-approved labs would still have to be registered with the DEA. The alternate testing protocol “would give USDA the proper oversight of the laboratories doing the testing, providing quality assurance and control procedures that ensure a validated and qualified analysis, and defensible data,” the interim rules state. The USDA is requesting comments on the requirements for laboratories and will likely need to make changes regarding this issue, Hauser said. Lab Availability a Mystery The rules state that DEA-registered labs – and, potentially, USDA-approved labs –  will ultimately be listed on the Agriculture Department’s Domestic Hemp Production website. However, DEA spokeswoman Katherine Pfaff told Hemp Industry Daily  that agency policy conflicts with that statement. “DEA is still working through many of these details with USDA,” Pfaff wrote in an email to Hemp Industry Daily,  which asked about the testing plans. “We do not release information about specific DEA registrants, so we do not provide a list of labs registered with the DEA.” Meanwhile, laboratories looking for information on becoming DEA-registered to perform chemical analysis should visit the DEA Diversion Control Division website to apply for an analytical lab registration. Form DEA-225 should be used, according to Pfaff. DEA Anxiety For some, the idea that the DEA is involved at all is upsetting. Denver attorney Frank Robison said he counted the number of times DEA was mentioned in the rule. By his calculation, the agency had 42 mentions, compared with two references about banking. “It just shows that the priorities within the rule are skewed against the farmer in a way that would prohibit and restrict commerce as opposed to promoting commerce,” Robison told Hemp Industry Daily . “And, in my view, the intent of Congress is to promote a commercial environment and commercial industry for hemp. “We’re worried about 1,000 parts-per-million THC, when we should be worried about getting this industry off the ground and helping American farmers, providing them access to capital and making sure that their crops are insured.” Hemp industry consultant Ryan Pettigrew said it makes sense the DEA would be involved, considering that crops testing hot would technically be marijuana, which remains a Schedule 1 drug on the controlled substances list. “That one was obvious – there was really no argument to it,” Pettigrew told Hemp Industry Daily . “Granted, in a perfect world, they would just deregulate everything,” he continued. “But that’s just not going to happen.” The USDA predicted that about 20% of hemp samples collected in 2020 would exceed the 0.3% THC limit and need to be destroyed. The USDA rule lays out no plan to appeal testing results. Criminals, Not Farmers Robison contends that for the micro levels of THC involved with hemp production, the USDA shouldn’t have to involve drug law enforcement. “The USDA should have the capacity to manage 1,000 parts-per-million THC,” Robison said. The DEA should be focusing on drug criminals, not farmers, he said. “The folks that know how to work with crops are the people that should be managing the data and working with these farmers, not a law enforcement agency charged with pursuing crystal meth and fentanyl criminals,” Robison said. “They should not be even in the same ballpark.” Further, he continued, the U.S. Congress did not mean to scare farmers and put them on a watch list, but that’s the message the USDA rules send. Legitimate American farmers may have been sold “bogus seeds” or seeds that tested below 0.2% THC in Europe but went hot when grown in a warmer U.S. climate, he said. “Now, all of the sudden, because they wanted to be part of this congressionally opened-up market, why now are they in a DEA database?” Robison said. “Congress passed a law to promote the hemp industry in the United States of America,” he said. “The regs that just came down, the No. 1 thing that they accomplished, if I was a farmer, was to scare me and to provide me with a doubt of whether I should be entering this market until there is additional clarity about whether or not I’m committing a criminal activity.” Written By: Laura Drotleff Original Article: https://hempindustrydaily.com/the-dea-is-mentioned-42-times-hemp-industry-disturbed-by-agencys-involvement-in-thc-testing-rules/