The Prescription Drug User Fee Act (PDUFA) is up for renewal, and many kratom advocates are deeply concerned about its potential implications. If the proposed changes to the act are authorized, it could give the Food and Drug Administration (FDA) unprecedented power to restrict and even ban the sale of kratom at a national level. Advocacy organizations like the American Kratom Association (AKA) are working tirelessly in the hopes of preventing the worst possible outcome, and there are also steps that we can all take to help protect kratom in light of this new dietary supplement regulation.
What Is the Prescription Drug User Fee Act?
The Prescription Drug User Fee Act authorizes the FDA to collect fees from manufacturers that produce certain drugs and herbal preparations. The fees are used to fund the FDA’s research, testing, and other operations. According to the FDA’s own website, the fees have been instrumental in helping to expedite the drug approval process.
Although the PDUFA has been in effect since 1992, it has to be reauthorized every five years. It was last updated in 2017 and is up for renewal again in September of 2022. But rather than simply reauthorizing the act under the same terms, Congress reserves the right to introduce changes and amendments. As a result, each version of the PDUFA looks different from the last—sometimes with significant changes or additions.
How Will the Prescription Drug User Fee Act Affect Kratom?
The new proposed version of the act, PDUFA VII, is receiving a lot of attention for its potential implications for kratom and other botanicals. It contains language that requires mandatory product listings (MPLs) for all dietary supplements (including kratom) that are marketed in the U.S. In other words, kratom manufacturers would be required to develop standardized information labels outlining ingredients, alkaloid concentrations, and other pertinent information.
The concern here is that such a change to the Prescription Drug User Fee Act would give the FDA a license to implement backdoor kratom bans. If manufacturers must submit labels for approval, the FDA could potentially review the labels and deny approval before the products even hit the market, even though there’s no formal kratom ban in effect.
This concern isn’t unfounded. The government has long had its sights on kratom. In the past decade, the Drug Enforcement Agency (DEA) considered listing kratom as a controlled substance—and while this hasn’t yet come to pass, the DEA still lists kratom as a “drug of concern.”
In addition, the FDA has warned consumers against consuming products with mitragynine and 7-hydroxymitragynine—the most abundant alkaloids in kratom. If the FDA is granted the right to grant or deny approval to all supplements based on label information, there’s more than a reasonable likelihood that they could give the thumbs-down to products that contain these ingredients—this despite the fact that all-natural kratom has been shown to be generally safe and extremely well-tolerated. In addition, the benefits of kratom are well-documented.
Advocates have noted that MPLs are entirely unnecessary for kratom manufacturers because kratom labels are already widely available. Verified kratom vendors are happy to disclose their ingredients and lab test results, and more effective laws like the Kratom Consumer Protection Act would help to ensure that all kratom providers are subject to this type of transparency. MPLs don’t promote greater transparency; they just make it easier for the FDA to restrict products without formal authorization.
How Will This Dietary Supplement Regulation Affect Consumers?
To be clear, the proposed changes to the Prescription Drug User Fee Act do not affect the legal status of kratom. On the consumer side, you would still be permitted to purchase kratom from law-abiding manufacturers and retailers as you always have—so long as kratom is legal in your state (refer to our guide to Kratom Laws by State).
However, it’s possible that the new dietary supplement regulation could ultimately reduce the availability of kratom products on the market by imposing new red tape on manufacturers. If the FDA refuses to grant approval to products on the basis of their alkaloid content, it may become more difficult to find high-quality kratom for sale online and in stores. That’s why now is the time to speak up if you want to protect kratom at the federal level.
What Is Being Done to Protect Kratom?
There is some controversy regarding how the proposed changes to the Prescription Drug User Fee Act have made their way through Congress. The reauthorization was approved by the House of Representatives, but the version that House representatives voted on did not contain the language pertaining to dietary supplements. As a result, groups like the American Kratom Association are lobbying to have the added sections removed on the basis that they haven’t been subjected to proper congressional hearings.
To be clear, The Senate Health, Education, Labor and Pensions (HELP) Committee has voted 13-9 to approve the changes to the Prescription Drug User Fee Act. If no further action is taken, it will become law. However, that doesn’t mean that all hope is lost. The AKA is encouraging kratom advocates to write to their Senate representatives and encourage them to oppose mandatory product listings. View this AKA press release to learn more and find out what you can do.
While it might seem like a small step, even writing an email to your elected officials can make a big difference. For instance, kratom advocates recently succeeded in preventing a Nevada kratom ban from becoming law simply by appealing in large numbers to state legislators. If enough people raise their voices, it could turn the tide.
We will continue to monitor any new developments relating to the proposed dietary supplement regulation, and we’ll let you know as new information comes available. In the meantime, we hope you’ll join us in speaking up and supporting the efforts of the American Kratom Association.
Want to learn more about kratom quality and value? Start here:
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