Forest fires in the western United States pose problems for the cannabis harvest

The Food and Drug Administration (FDA) is releasing new draft guidelines aimed at streamlining approvals for generic oral CBD drugs. In a notice posted on the Federal Register on Wednesday, the agency said it is asking the public for feedback on its guidelines for researchers interested in submitting Abbreviated New Drug Applications (ANDAs) for CBD solutions are. To expedite the approval process, the FDA said applicants can apply for an exemption for an in vivo bioequivalence study if they meet certain requirements. This guide comes out two years after the agency approves GW Pharmaceuticals' Epidiolex, a CBD-based drug for epilepsy. If a drug manufacturer wants to produce generic versions of this 100 mg / mL cannabidiol solution in the future, they could follow certain rules to skip the step of the in vivo bioequivalence study when the draft guideline is finalized. The drug would have to be derived from Cannabis sativa L, contain no more than 0.1 percent THC and "have no inactive ingredients or other changes in the formulation compared to the \[reference list\] that could significantly impair systemic availability". Researchers must use "appropriate analytical methods" such as macroscopic or microscopic analysis or DNA barcode methods to determine that the solution was made from Cannabis sativa. "Because of the many varieties within this species, the identification and authentication of the plant species should be carried out at the variety (s) level if the potential variety (s) are to be used as the natural source of the \[botanical raw material\] "said the FDA. The agency also said that when collecting this raw hemp, applicants must "follow established Good Agricultural and Collection Practices (GACP) practices to minimize fluctuations in the BRM and ultimately ensure consistency of drug substance from batch to batch". The deadline for public comments on the draft FDA guidance is November 23rd. The FDA also recently closed a deadline for submitting a separate draft guideline for the development of cannabis-derived drugs. However, three other federal agencies are currently receiving submissions on a variety of other proposed cannabis and drug-related regulations. While this latest document isn't the separate comprehensive CBD guide that advocates and industry stakeholders have been waiting for, it is yet another example of how the scientific landscape surrounding cannabis is changing, with a federal agency helps facilitate the manufacture of cannabidiol-based drugs. Separately, the FDA announced on Tuesday that it would hold a public meeting in November to discuss the gender differences in the effects of CBD and other cannabinoids. The agency also recently held a meeting to educate cannabis researchers and breeders about ways to protect their proprietary information and to encourage studies on the plant. She also recently submitted draft guidance to the White House's Bureau of Management and Households on how to enforce the CBD - a long-awaited move coming after hemp legalization. The agency was tasked with coming up with an update to its regulatory approach to the CBD as part of budget legislation passed late last year, and it did so in March. The update said that "the FDA is currently evaluating the issuance of a risk-based enforcement policy that would provide greater transparency and clarity about the factors the FDA intends to consider in prioritizing enforcement decisions." The FDA has used the leeway for CBD in the years since hemp became legal. In certain cases - e.g. in cases where companies claimed the CBD could treat or cure the coronavirus - continued to issue warnings to cannabis stores and to issue public notices of product recalls. In July, the FDA also submitted a report to Congress on the state of the CBD marketplace, and the document outlines studies the agency has conducted on the content and quality of cannabis products that it has tested over the past six years. Also earlier this month, a Congressional spending bill for the FDA was released that contains a provision to "fund the development of a framework for regulating CBD products." The agency is also actively seeking a contract in support of research into the CBD, while the agency develops regulations for products containing the non-toxic cannabinoid. Healthy plants fight toxins At Aster Farms in Upper Lake, California, CEO Julia Jacobson said that while the nearest fire was 40 to 60 miles away, the smoky sky extinguished the sun. Jacobson was concerned about possible stagnation in her company's facilities, but the sky opened in late September. The other concern is that the change in sunlight could signal to the plant that it is later in the year than it actually is, and that the plant is finishing its cycle early, meaning that the flower will begin to harden rather than continue to grow . Jacobson is also concerned about what the smoke contains, including heavy metals or other toxins. "Fortunately, the smoke was superficial and we didn't have any ash on our plants," she said. Jill Ellsworth, founder and CEO of Denver-based Willow Industries, which provides decontamination technology for cannabis and hemp with a processing center in Oakland, Calif., Agreed with Jacobson. She hears of the plants blooming prematurely due to the California forest fires. "The plants are not getting the sunlight they expect and are used to this time of year," said Ellsworth. When cannabis is stressed by environmental conditions, it can be more susceptible to microbes. If the plants aren't getting the right nutrients to stay healthy and fight off the toxins in the air, that will affect yields as well. She also pointed out that climate change is causing extreme weather conditions and is causing more growers to use ruderalis cannabis strains. "We hear autoflower is the way to go," said Ellsworth. "If you can have some consistency, then definitely."