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Advancements on Capitol Hill: The Congress Directs FDA to Regulate CBD oil

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Members of Congress have called for the U.S. Food and Drug Administration (FDA) to establish a regulatory framework for CBD and other “cannabis-derived substances.”

In the fiscal year 2022 omnibus appropriations package, the U.S. Senate Committee on Appropriations has requested for the FDA to acquire the proper funds and resources needed to establish regulations for all cannabis derivatives, including CBD. The Senate committee also requested that the FDA consider moving forward with ongoing medical cannabis research regarding CBD.

Congress’ appropriations package, which was introduced to the U.S. House of Representatives on March 9, is meant to keep the federal government funded for the remainder of the current fiscal year. The Senate and House both voted to pass the bill prior to the government funding deadline of March 11. It now awaits approval by President Joe Biden, as reported by Roll Call.

The “Cannabis and Cannabis Derivatives” section of the appropriations package also states that “within 90 days of enactment of this Act, the 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 the FDA establishes a process for stakeholders to notify the FDA of use of CBD in products that include safety studies for intended use per product and makes a determination about such product.”

The committee also encourages the FDA to partner with an academic institution to expand sampling studies of CBD products currently on the market.

According to the U.S. Hemp Roundtable (USHR), the language under the cannabis section is nonbinding, but it shows Congress’ recognition of its role in directing the FDA to establish a regulatory framework for hemp-derived CBD products.

The USHR notes that the Senate report also addresses several other hemp-related topics, including:

The allowable level of THC in hemp, which the committee worries may burden hemp producers. The committee directed the USDA to work with the Department of Health and Human Services (DHHS) and the Drug Enforcement Administration (DEA) to determine a scientific basis for the current 0.3% THC limit and suggest alternate levels— “an effort to establish a dual designation for hemp as a specialty crop to ensure certain producers are not prevents from accessing USDA programs,” USHR reported.

Noting it will provide the USDA’s Agricultural Research Services (ARS) $2.5 million in funding to develop hemp cultivars, germplasm, and production systems and encourages the ARS to develop these systems through research partnerships.

Rejecting proposals to implement new user fees to cover government costs to provide services to specific beneficiaries, including domestic hemp production. Additionally, the committee would provide “$1.5 million in funding to the USDA Marketing and Regulatory Program for support,” USHR reported.

The importance of increasing ways for hemp and CBD-related businesses to raise capital. The report directed the Financial Conduct Authority (FCA) “to work with the institutions under its jurisdiction to provide access to guaranteed loans for hemp producers and businesses.”

Source: https://www.hempgrower.com/article/congress-directs-us-food-and-drug-administration-to-regulate-cannabis-derivatives-cbd-fy-2022-omnibus-appropriations-bill/

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