FDA doubles down on kratom in dietary supplement products

The nation’s top government official responsible for regulating dietary supplement products said she is bothered by a years-long trend of “completely ignoring what FDA is saying” about kratom.

Speaking June 25 in New York during an industry event, the official said the Food and Drug Administration has been seizing kratom products for several years yet continues to find them in the U.S. marketplace.

Kratom, or Mitragyna speciosa, is a tropical tree from Southeast Asia, and products containing it are used by millions of American consumers.

“We have invested a lot of resources into” attempting to make plain “FDA’s position on kratom in dietary supplements,” said Cara Welch, Ph.D., director of FDA’s Office of Dietary Supplement Programs (ODSP). “And unfortunately, we’re still seeing it out there.”

Welch spoke during the 12th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements, a two-day event hosted by the American Conference Institute and Council for Responsible Nutrition.

FDA’s position is that kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food. Based on scientific data and other information, the agency has concluded “kratom is a new dietary ingredient (NDI) for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury,” an FDA spokesperson told SupplySide Supplement Journal in a 2023 statement. “Therefore, dietary supplements that are or contain kratom are adulterated and subject to FDA enforcement.”

Related:Kratom groups, researchers sound alarm over 7-hydroxymitragynine products

FDA confirmed Thursday its position hasn't changed.

During the ACI-CRN conference, Welch cited a hypothetical scenario in which FDA clears the marketplace of kratom products, then added, “And I think six months later, we would be right back where we started.”

She said it’s “frustrating” when FDA is “explicitly clear on our position on an ingredient, and we still regularly find it.”

During a conversation with Welch at the conference, CRN President and CEO Steve Mister asked whether FDA is engaged with state legislators who are passing their own kratom consumer protection laws. In the most recent development, Rhode Island legislators passed a version of the Kratom Consumer Protection Act.

“States are passing their own laws that seem to be legitimizing kratom because they’re recognizing it can be sold in certain ways. Is FDA at the table when these states are passing these bills? Because I think if they knew how strongly FDA feels about kratom, they might not enact laws that seem to legitimize the sale of kratom,” Mister surmised. “Is FDA at the table when these bills are passed?”

Related:DOJ faces ‘capacity’ litigating dietary supplement cases

Welch declined to answer the specific question, though she added, “FDA’s relationship with the states is very important and we will be very quick to provide technical assistance when requested. Absolutely.”

A representative of the American Kratom Association (AKA) did not immediately respond to a request for an interview, in response to Welch’s comments. But in a 2023 “kratom fact sheet” submitted to the Rhode Island Legislature, the AKA asserted over “15 million Americans safely use kratom.”

“The FDA has repeatedly attempted to force kratom into Schedule I of the Controlled Substances Act by misstating the science, ignoring kratom’s long history of safe use, and falsely claiming kratom has the same effects as classic opioids,” AKA stated. “The FDA’s distorted record on kratom is clearly a part of the FDA’s long-standing bias against dietary supplements that are safely used by millions of Americans rather than chemical drug formulations that are subject to new drug applications that have their own potential and frequently serious adverse health impacts.”

According to the AKA’s website, 11 states have passed similar versions of the Kratom Consumer Protection Act: Arizona, Colorado, Florida, Georgia, Nevada, Oklahoma, Oregon, Texas, Utah, Virginia and West Virginia.

CRN’s Mister said FDA has been clear in letters related to new dietary ingredient (NDI) notifications that firms have failed to meet “a reasonable expectation of safety.” This is the safety standard for NDIs in the nearly 30-year-old Dietary Supplement Health and Education Act of 1994 (DSHEA).

Welch suggested that kratom products in the U.S. may be labeled as “dietary supplements” yet fail to follow the applicable federal regulations.

“Again, the entire supplement structure, it’s a good structure,” she observed. “When it works, it’s great. The problem is we’re finding so many situations for active constituents where they’re trying to shoehorn into the supplement framework and they’re not appropriate for it. They’re not making the right claims. They do not have the right safety standard.

“Whether it’s an approved drug or active pharmaceutical ingredient, or an active botanical, it’s really important to not allow them to … shoehorn their way in and besmirch the industry.”