FDA's recent alert on alleged health risks associated with the herbal product kratom is being challenged by the American Kratom Association, which is petitioning the agency under the Information Quality Act to set up a special advisory committee of independent experts to review the accuracy and integrity of the data underlying FDA's advisory, and to hold a public meeting on the product.
This is not the first time an agency's attempt to restrict access to kratom, an herbal product popular in Southeast Asia to self-treat anxiety, depression and pain, has been met with backlash. Activism by the Center for Regulatory Effectiveness successfully pushed the Drug Enforcement Administration to reconsider a 2016 plan to make kratom a Schedule I controlled substance. Despite fierce advocacy by kratom supporters, one of the leading dietary supplement groups supports a ban on kratom due to alleged risks of addiction.
“Over the past several years, a botanical substance known as kratom has raised significant concerns given its increasing prevalence and potential safety risks. Today, the agency issued a public health advisory related to the FDA’s mounting concerns regarding risks associated with the use of kratom,” FDA Commissioner Scott Gottlieb writes in a Tuesday (Nov. 14) press release.
Gottlieb says evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases death. “Thus, it’s not surprising that often kratom is taken recreationally by users for its euphoric effects. At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning,” he adds.
In addition to its alleged narcotic-like effects, FDA is aware of 36 deaths associated with kratom, as well as liver damage, seizures and withdrawal, according to Gottlieb.
The FDA chief says FDA has taken a number of enforcement actions to stop the flow of kratom, including: treating the substance as an unapproved drug, issuing import alerts and detaining hundreds of shipments of kratom entering the United States via international mail facilities.
FDA is also working with DEA “to further evaluate kratom and determine how it should be scheduled,” the commissioner tweeted Tuesday.
Gottlieb says those advocating for kratom should go through FDA's review process for botanical drugs, noting no sponsors have sought approval for drugs containing kratom. “I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. The FDA has a well-developed process for evaluating botanical drug products where parties seek to make therapeutic claims and is committed to facilitating development of botanical products than can help improve people’s health,” he says.
Using the drug review process, Gottlieb says, would provide for a “much-needed discussion” among all stakeholders. “Until then, I want to be clear on one fact: there are currently no FDA-approved therapeutic uses of kratom. Moreover, the FDA has evidence to show that there are significant safety issues associated with its use,” Gottlieb adds.
“The public health advisory issued by the FDA and parroted in the Commissioner’s Statement contains numerous unsubstantiated and inaccurate statements that do not meet the standards of quality required by P.L. 106-554 and Office of Management and Budget (OMB) government-wide requirements for ensuring the quality of information they disseminate to the public, and therefore must be rescinded immediately,”
But the kratom lobby says the alleged risks are unsubstantiated “The public health advisory issued by the FDA and parroted in the Commissioner’s Statement contains numerous unsubstantiated and inaccurate statements that do not meet the standards of quality required by P.L. 106-554 and Office of Management and Budget (OMB) government-wide requirements for ensuring the quality of information they disseminate to the public, and therefore must be rescinded immediately,” the group writes.
AKA says that FDA has ignored scientific data included in dietary supplement applications for the substance. “The FDA Office of Dietary Supplements has also received one or more New Dietary Ingredient applications including scientific study data documenting the safety and the very low addiction profile of kratom and affirming the relative safety of kratom’s continued use. This data should help inform the FDA about the safety of kratom, but the Agency is clearly unwilling to factor in this safety data in their assessments of the safety of kratom for consumer use,” the group writes.
AKA also argues that FDA's advisory will lead state and local governments to ban the product, which is already banned in a number of states and countries, and in turn increase use of opioids. The group, citing an informal survey of its members, says kratom users may turn to illicit drugs should they not have access to kratom.
“It is inconceivable that the FDA would favor a policy that would foreseeably force a patient who [has] been weaned off of opioid addition back to dangerously addictive and potentially deadly opioid prescription medications,” the group writes.
But the supplement lobby, the Natural Products Association, has said kratom could exacerbate the opioid crisis, and has supported DEA's earlier attempts to designate the substance as Schedule I. “Adding an untested and unregulated substance such as kratom to our food supply without the application of longstanding federal rules and guidelines would not only be illegal, it could likely be dangerous, leading to serious unintended consequences as our nation struggles with the crisis of opioid addiction. ... As former Food and Drug Administration (FDA) officials and regulators of the dietary supplement industry, we can tell you that finished kratom products and raw kratom botanical ingredients have not met the strict standards products and new ingredients must adhere to in order to be marketed to the public and deemed safe for regular use in either our food or our drug supply,” the group wrote in 2016 comments to DEA. -- Nicholas Florko (firstname.lastname@example.org)
Article Source: Inside Health Policy
written by Nicholas Florko