Senate Majority Leader Mitch McConnell (R-KY) is moving to insert language into a congressional spending report that calls on the Food and Drug Administration (FDA) to clear a path for the lawful marketing of hemp-derived CBD products.
FDA has said that allowing CBD to be sold as food items or dietary supplements would require it to develop alternative regulations that could take years to complete without congressional action. But McConnell, who was the chief proponent of a hemp legalization provision of the 2018 Farm Bill, isn’t interested in waiting around.
In draft language shared by the U.S. Hemp Roundtable on Tuesday, the senator is asking FDA to “issue a policy of enforcement discretion with regard to certain products containing CBD” within 120 days—a move that industry stakeholders say will clarify rules so that banks are more willing to service CBD companies.
The provision of the spending report will be marked up in the Senate Appropriations Subcommittee on Agriculture on Tuesday. It will then go before the full Appropriations Committee on Thursday.
Prior to issuing its enforcement discretion policy under McConnell’s report amendment, FDA would have to submit a report to the committee within 90 days detailing its “progress toward obtaining and analyzing data to help determine a policy of enforcement discretion, and the process in which CBD meeting the definition of hemp will be evaluated for use in products.”
Once those provisional enforcement guidelines are established, they would remain in place until FDA finalizes the regulatory process.
“FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigation New Drug (IND) application in the development of a regulatory pathway for CBD in products under the jurisdiction of FDA and to ensure that any future regulatory activity does not discourage the development of new drugs,” the report states.
Outside of McConnell’s proposal, the bill funding FDA and the U.S. Department of Agriculture (USDA) already sets aside $2,000,000 to support research and regulatory activities surrounding hemp-derived CBD products.
The legalization of hemp and its derivatives has been met with intense interest from manufacturers and lawmakers alike, but limitations on the marketability of CBD has been an ongoing source of frustration.
Last week, a bipartisan pair of lawmakers asked fellow House members to join them in signing a letter to the head of FDA that similarly asks for enforcement discretion guidelines allowing companies to sell CBD products.
The House, which approved its version of appropriations legislation for the upcoming fiscal year prior to the summer recess, included a separate amendment that would require FDA to establish rules providing for the lawful marketing of CBD in food and dietary supplements.
Meanwhile, USDA is expected to soon release its broader hemp regulations soon.
Read McConnell’s full proposed CBD report language below:
“As previously mentioned, the Committee provides $2,000,000 for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy, and appropriate regulatory activities with respect to products under the jurisdiction of the Food and Drug Administration which contain cannabidiol (CBD) and meet the definition of hemp, as set forth in section 297A of the Agricultural Marketing Act of 1946 (7 U.S.C. 1639o). Within 90 days, FDA shall provide the Committee with a report regarding the Agency’s progress toward obtaining and analyzing data to help determine a policy of enforcement discretion, and the process in which CBD meeting the definition of hemp will be evaluated for use in products. Within 120 days, FDA shall issue a policy of enforcement discretion with regard to certain products containing CBD meeting the definition of hemp as defined by section 297A of the Agricultural Marketing Act of 1964 (7 U.S.C. 1639). Such enforcement discretion shall be in effect until FDA establishes a process for stakeholders to notify FDA for use of CBD in products that include safety studies for intended use per product, and makes a determination about such product. FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an Investigation New Drug (IND) application in the development of a regulatory pathway for CBD in products under the jurisdiction of FDA and to ensure that any future regulatory activity does not discourage the development of new drugs.”
Bipartisan Lawmakers Circulate Letter Urging FDA To Back Off CBD Companies Published 1 day ago on September 16, 2019 By Kyle Jaeger
A bipartisan pair of lawmakers are circulating a sign-on letter asking colleagues to join them in urging the Food and Drug Administration (FDA) to back off companies that are selling CBD products in a responsible manner.
The “Dear Colleague” letter, which is being led by Reps. Chellie Pingree (D-ME) and James Comer (R-KY), emphasizes that hemp and CBD were federally legalized under the 2018 Farm Bill and argues that the lack of regulations for such products is creating industry uncertainty that’s inhibiting economic opportunities.
The letter was first reported by the U.S. Hemp Roundtable, which is asking its supporters to encourage their representatives to sign on.
FDA has said it is in the process of developing rules for the non-intoxicating compound, including a potential alternative regulatory pathway allowing for CBD to be added to the food supply and as dietary supplements. That could take years, however, as former FDA Commissioner Scott Gottlieb has noted.
In the meantime, the agency is being selective about enforcement action against companies that make unsanctioned claims about their products while also maintaining that all businesses selling CBD food items are violating the law.
The lawmakers aren’t satisfied. They described FDA’s regulatory timeframe as “untenable,” particularly because the U.S. Department of Agriculture is expected to release its rules for hemp “any day now,” and an official revealed this month that its draft regulations are currently undergoing final White House and Department of Justice review.
The members of Congress added that FDA’s current approach to CBD has “created significant regulatory and legal uncertainty for participants in this quickly evolving industry.”
“Given the widespread availability of CBD products, growing consumer demand, and the expected surge in the hemp farming in the near future, it’s critical that FDA act quickly to provide legal and regulatory clarity to support this new economic opportunity,” they wrote.
“Please join us in signing this bipartisan letter to Acting FDA Commissioner Ned Sharpless urging the agency to adopt a risk-based policy of enforcement discretion that targets bad actors while eliminating uncertainty for responsible industry stakeholders and consumers. Additionally, we are requesting that FDA to issue an interim final rule to regulate CBD as a dietary supplement and food additive.”
In the letter to Sharpless that Pingree and Comer are asking fellow lawmakers to sign, they laid out two requests for FDA.
First, the agency should “promptly issue guidance announcing a policy of enforcement discretion that maintains FDA’s current risk-based enforcement approach towards hemp-derived CBD products.” And second, it should “consider issuing an interim final rule, pending issuance of a permanent final rule, to establish a clear regulatory framework for CBD as a dietary supplement and food additive.”
The lawmakers added that they appreciate that FDA has pursued “enforcement actions against the worst offenders,” but that “it can do so while eliminating regulatory uncertainty for farmers, retailers, and consumers.”
“Without a formal enforcement discretion policy, anyone participating in the growing marketplace for legal hemp-derived products will continue to face significant legal and regulatory uncertainty,” they wrote.
Though issuing guidance on a “policy of enforcement discretion” wouldn’t be a codified law allowing companies to market CBD in the food supply, it would demonstrate to the industry that some protections are in place while FDA continues to navigate the rulemaking process.
Lawmakers have until Tuesday to sign the letter to FDA.
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