Senate FDA Appropriation Includes $2M For CBD Enforcement Discretion Policy

Instruction in Appropriations Committee report on FY 2020 spending bill garners support from some stakeholders while others say setting a safe level of CBD's use in non-drug products should come first. Senate appropriators endorses FDA policy that regulations allowing sales of CBD non-drug products "not discourage the development of new drugs."

US Senate appropriators direct the Food and Drug Administration to establish an enforcement discretion policy for products containing hemp-derived cannabidiol, but omit a step their House counterparts request of first setting a safe level for the ingredient's use in food and dietary supplements.

The instruction stated in the Senate Appropriations Committee's report on is fiscal year 2020 spending bill for agriculture, rural development, FDA and related federal agencies, which includes $2m for FDA's CBD-focused work, garners support from some stakeholders while others say setting a safe level of CBD's use in non-drug products should come first.

Natural Products Association president and CEO Daniel Fabricant said although the US market is flooded with food and supplement products containing CBD, the ingredient's safety profile is unclear and limits on the amount used in the products should be set before the FDA determines its enforcement policy.

NPA backs a provision in the House's FY 2020 appropriations that sets $100,000 for the FDA's CBD work and instructs the agency to determine safe levels for its use as a first step in establishing its regulatory framework around the ingredient's use in non-drug products. (Also see "FDA Appropriation Targets $100,000 To Find Safe CBD Level In Supplements" - HBW Insight, 24 Jun, 2019.)

"You can't have consumers getting hurt with a product like this. It damages the whole industry," Fabricant told HBW Insight.

The Council for Responsible Nutrition, on the other hand, supports the FDA provision in the Senate's spending bill report. If CBD-containing products are labeled and marketed as vitamins, mineral or supplements, the agency as soon as possible should make them subjectto the same regulations as other VMS products under its existing regulatory framework, CRN says.

"If people get hurt using CBD, the hemp farmers aren't going to be selling a lot of hemp." – NPA CEO Daniel Fabricant

"The instant FDA creates a legal CBD supplement market, there is a well-developed body of law and regulations governing dietary supplements that can and should be enforced. While CRN is always seeking additional resources for the FDA, it won’t take much for the FDA to have a big impact. Several high-profile enforcement actions would change the calculation of risk by companies who may be skirting the requirements of the law and can immediately change behavior," said president and CEO Steve Mister in CRN's 20 September statement.

Although the FDA's policy aligns with a "general presumption" that a VMS product may not contain an ingredient that was on the market or clinically investigated as a drug before its use as a dietary ingredient was known, consumer interest in CBD, burgeoning sales and "vast differences" in dosages used in drugs and supplements are compelling reasons for the FDA to make an exception for CBD, according to CRN.

"The FDA could literally take this action tomorrow and begin fully regulating the CBD supplement industry, and we implore them to do so. That’s the surest path to safety and innovation,” Mister said.

Fabricant expects, though, that a notice-and-comment rulemaking process will be needed to set the FDA's policy and would ill extend multiple years while CBD food and supplement products remain available under the agency's current policy of allowing sales and enforcing only against firms that use drug or other violative claims for their products.

"The only way this thing moves forward is if we set a safe level first," he said. "But they're saying we're going to keep being lax on enforcement until we can come up with a notice-and-comment rulemaking on CBD."

Senate majority leader Mitch McConnell's support for the provision, like his key role in de-scheduling hemp as a controlled substance through language in the 2018 farm bill, reflects his interest in helping hemp farmers in the Republican's home state of Kentucky and other states grow the market for the crop. (Also see "Hemp Product Market Future Backed By McConnell, Fate Depends On Farm Bill" - HBW Insight, 13 Sep, 2018.)

Potential findings of health problems from use of hemp-derived CBD in food and VMS products, however, could curb that market growth.

Senate appropriators urge policy on CBD but also direct FDA "to ensure that any future regulatory activity does not discourage the development of new drugs."

"If people get hurt using CBD, the hemp farmers aren't going to be selling a lot of hemp. Nobody would say everything's still safe and everything can stay on the market, " Fabricant said.

NPA, like other VMS industry stakeholders, urge the FDA to follow the model it established in 1999 in setting a level of red yeast rice allowed for use in supplements after it sought to remove from the market supplements containing the ingredient at same concentration as the compound was used in a high-cholesterol drug. Supplement firms contended red yeast rice extract had been used in food for health benefits for hundreds of years. (Also see "Red Yeast Rice History Offers Blueprint For Clearing CBD As Dietary Ingredient" - HBW Insight, 24 May, 2019.)

90 Days For Progress Report, 120 For Policy

In their report on the spending bill, S.2522, Senate appropriators say $2m in the bill is for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy and appropriate regulatory activities for CBD-containing products subject to FDA oversight, which would include personal care topicals and cleansers as well as food and supplements.

The report instructs the FDA, within 90 days of enactment of the agency's FY 2020 appropriation, to provide the committee with a report regarding its progress on obtaining and analyzing data to help determine its enforcement discretion policy and on its the process for evaluating the use of CBD, defined in the farm bill as hemp-derived and containing less than 0.3% of tetrahydrocannabinol, the psychoactive compound in marijuana.

Within 120 days, the committee members ask the FDA to issue an enforcement discretion policy for hemp-derived CBD that would be effective until the agency establishes a process for submitting notifications on CBD's use, with safety studies for intended use per product, and for making determinations on those notifications.

No new dietary ingredients for using CBD in supplements are under evaluation at the FDA because the agency's current, official policy is that the ingredient, as well as other hemp- or cannabis-derived substances, are not eligible for use in food or VMS product.

While CRN refers to the FDA's view that research on hemp- and cannabis-derived substances for use in drugs, and the 2018 approval of a drug with pure CBD as its active ingredient, preclude CBD's use in food and supplements as a "general presumption," the agency has been adamant about the distinction. At a public hearing in May on using substances made from hemp and cannabis in non-drug products, senior FDA officials emphasized that the determination will prioritize weighing the potential impact of slowing or interrupting the development of drugs using cannabis-derived substances. (Also see "FDA Road To Decision On Expanding CBD Uses Starts With Weighing Impact On Existing And Future Use As Drug" - HBW Insight, 2 Jun, 2019.)

Senate appropriators endorsed the FDA's approach. "The FDA is encouraged to consider existing and ongoing medical research related to CBD that is being undertaken pursuant to an [investigational new drug application'] in the development of a regulatory pathway for CBD in products under the jurisdiction of the FDA and to ensure that any future regulatory activity does not discourage the development of new drugs," they say in the report.

Both House, Senate Boost Total FDA Funding

The FDA's FY 2019 total budget was $5.6bn, including $3.1bn in direct appropriation from the US Treasury and $2.5bn from user fee programs.

The Senate's FY 2020 bill includes a total FDA budget of $5.76bn, with $3.15bn coming in a direct appropriation and $2.6bn un users. It sets user fee levels including $1.07bn from prescription drugs; $513m in human generic drugs; and $42m from biosimilar biological products.

Senate appropriators targeted $1.08bn for the FDA's Center for Food Safety and Applied Nutrition and related field activities by the Office of Regulatory Affairs and $1.97bn for the Center for Drug Evaluation and Research and related ORA activities.

The House in June passed its FY 2020 spending bill for the Department Agriculture, FDA and related agencies, HR 3164, as part of a $383.3bn "minibus" package, HR 3055, that also included appropriations language for the departments of Commerce, Justice, Interior and Veterans Affairs and related agencies. (Also see "Health And Wellness On Capitol Hill: Monograph Reform, Wyden On CBD Rule, OTC Daily Contraceptive Access" - HBW Insight, 26 Jun, 2019.)

For the FDA, the House set a budget of $5.8bn, with $3.25bn from direct appropriation and $2.6bn in user fees. It set CFSAN's budget at $1.1bn and CDER's at $1.98bn.

User fee programs in the House bill are set at $1.06bn from prescription drugs; $511.7m from generic  drugs; and $39.6m from biosimilar s.

Both the House and Senate bills note FDA user fee programs for food and supplement facility and import re-inspections, neither sets levels for the program as the agency has yet to start collecting the fees established in 2011 in the Food Safety Modernization Act.

Both bills also state that "contingent upon the enactment of the Over-the-Counter Monograph User Fee Act of 2019," OTC monograph drug user fees will be added to the agency's budget. (Also see "House Appropriators Propose OTC Monograph User Fee In FDA Budget" - HBW Insight, 27 May, 2019.)