House bill weighs in on CBD, keeps FDA funding intact
A preliminary House appropriations bill holds the line on FDA funding while setting a boundary on the CBD market.
Language in an FDA funding appropriation appears to set limits around what kind of CBD products will be on the market in the future. It also holds the line on funding for the agency.
But such language is not binding, so industry stakeholders are taking a wait-and-see attitude on both aspects of the bill.
The Fiscal Year 2024 Agriculture, Rural Development, Food and Drug Administration, And Related Agencies Appropriations Bill was passed recently by the House Appropriations Committee on 34-27 vote.
The bill concerns funding for a wide variety of programs, of which FDA is only one. The bill appropriates $6.58 billion for the agency, which is a $16 million increase over the previous year’s budget. Considering inflation, that amounts to a small cut.
In real dollars, though, that amounts to a slight increase, which will be supplied by the collection of additional user fees that are paid by pharmaceutical companies, according to the committee’s report on the measure. That’s a significant distinction because the measure calls for significant cuts in other agencies and programs.
In an early evaluation of the funding process, Steven Grossman of the Alliance for a Stronger FDA said that much is yet to be decided. FDA’s eventual budget could end up slightly less or slightly more than its current level, but Grossman said his group does not foresee a big swing in either direction.
No mention of MPL in bill
Kyle Turk, head of government affairs for the Natural Products Association, said NPA paid attention to one thing that’s missing in the bill.
“Broadly speaking, we’re certainly pleased the bill does not include any proposals on mandatory product listing,” Turk said in an interview.
Mandatory product listing (MPL) is an idea that FDA and some industry stakeholders have advocated for. The idea in its simplest form would be a requirement to inform FDA of a new supplement product and its ingredients before it goes to market. Agency personnel have said that not knowing what’s on the market at any one time complicates the job of regulating the industry.
Some prominent groups, like the American Herbal Products Association (AHPA) and NPA, have pushed back on that idea. MPL would constitute a regulatory complication for companies without solving any problems, in their view.
One portion of the bill’s text took aim at problematical products within the industry.
The House Appropriations Committee "supports increased inspections and enforcement for high-priority supplements with a history of being tainted and bearing illegal claims, including, but not limited to, products marketed as supplements for weight loss, muscle, arthritis or pain, or diabetes,” the committee’s report stated.
“At the end of the day, FDA just needs to get back to enforcing DSHEA,” Turk said, commenting on the Dietary Supplement Health and Education Act of 1994.
One compound to rule them all?
On the subject of CBD, the committee’s report mentioned as a concern the large number of CBD-containing products that are “marketed in violation of the FFDCA (Federal Food, Drug & Cosmetic Act).”
“The Committee recognizes that FDA intends to work with Congress on creating a regulatory framework that could permit one compound in cannabis, cannabidiol (CBD), in consumer products,” the committee report read.
That mention of “one compound” caught the eye of Steve Hoffmann, principal in the firm Compass Natural Marketing. Hoffmann has worked on CBD and cannabis-related legislation and marketing campaigns for years.
Hoffmann said that particular emphasis mirrors to some degree developments in the market, in which CBD products are now being adopted for use by some sports organizations.
“The brands that are working with the sports leagues, I think they are working toward assuring a zero THC level,” Hoffman said.
While emphasizing he’s not a formulation expert, Hoffman said it’s his impression that it is far easier to achieve zero THC in a product when starting with a CBD isolate.
“It just makes it harder for CBD broad spectrum and full spectrum products to be in the market,” Hoffman said.
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