FDA wants to approve CBD-based products faster in the future
The US Food and Drug Administration intends to use this to accelerate the approval process.
Frank LehmannOctober 3, 2026
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 filing Abbreviated New Drug Applications (ANDAs) for CBD solutions. To help expedite the approval process, the FDA said applicants can request an in vivo bioequivalence study waiver if they meet certain requirements. This guide comes two years after the agency approved GW Pharmaceuticals' branded CBD-based epilepsy drug Epidiolex. 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, plant species identification and authentication should be performed 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 cannabis, applicants "must follow established Good Agricultural and Collection Practices (GACP) practices to minimize variations in the BRM and ultimately ensure consistency of drug substance from batch to batch". The deadline for public comments on the draft FDA guidance will be November 23. The FDA also recently closed a comment period on a separate draft guidance document on the development of cannabis-derived drugs.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 to 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 on ways to protect their proprietary information and to encourage studies on the plant. She also recently submitted a draft guide to the enforcement of the CBD to the White House's Bureau of Management and Households - a long-awaited move that comes after hemp legalization. The agency was mandated to come up with an update to its regulatory approach to the CBD under 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. The agency has continued to issue warnings to cannabis stores in certain cases - e.g. in cases where companies claimed the CBD could treat or cure the coronavirus - and issued 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 includes a provision providing "Funding to Develop a Framework for the Regulation of CBD Products." The agency is also actively seeking a contract to help study the CBD while the agency develops regulations for products containing the non-toxic cannabinoid.
