Kratom group says CBD regulatory experience offers some lessons
Mac Haddow, senior fellow on public policy for the American Kratom Association (AKA), said the state-by-state strategy followed by the proponents of medical marijuana and CBD is one that could work for his organization, too.
“FDA is stretching its regulatory authority in its effort to demonize kratom,” Haddow told NutraIngredients-USA.
Maintaining access through the states
Haddow said FDA’s campaign against the botanical, based on what AKA characterizes as ‘incomplete’ information, has had some success. But when AKA brings the full suite of scientific information on the botanical to the table, the results are unequivocal.
“Six states banned the substance, but those were all based on inaccurate or incomplete information at best,” he said.
“Just under 20 states have since had ban proposals on the table and we have won in every one of those just by going to the state legislators and presenting the science to the legislators,” Haddow said.
Kratom (Mitragyna speciosa) is a botanical native to Southeast Asia. It has been used to treat chronic pain, PTSD and is alleged to have helped some individuals wean themselves from addiction to opioid pain killers.
FDA first issued an import alert on kratom in 2014 when Dan Fabricant, PhD, was head of the Division (now Office) of Dietary Supplement Programs at FDA. The import alert was reissued this year to update some details, including the companies on the so-called ‘Red List.’
Despite import alert, trade is thriving
Haddow said import alert or no, there are tons of kratom coming into the country on a regular basis. What a marketer intends to do with the material should be a determining factor, he said.
“We think it’s a consumer product that should be available to consumers like a food or a dietary ingredient. Consumers have the right to make informed decisions about using products to maintain their health and well being,” he said.
Haddow said AKA does not support kratom vendors who make unsupported health claims on the product, and has even instituted a program to allow consumers to report such claims to the group.
Fighting off DEA listing
In 2016, AKA was among a group of stakeholders that successfully argued against a plan to add kratom to the list of controlled substances maintained by the Drug Enforcement Administration. A number of prominent politicians objected to the proposed emergency declaration, seeing it as both unnecessary and an overstep of DEA’s bounds. More recently, a group of researchers from Harvard Medical School, Johns Hopkins, Columbia and other prominent institutions argued that a schedule 1 controlled substances listing would do nothing except retard the urgently needed additional research into the botanical.
Hahn’s ‘fool’s game’ remark seen as significant
As AKA fights the proposed bans at the state level, Haddow said the experience with CBD provides some potential pathways forward. Many people in the industry took notice, he said, when a little more than a year ago former FDA Commissioner Dr Stephen MD, off script in a public address to say that CBD products had become so ubiquitous that trying to get them off the market at this point was “a fool’s game.”
Haddow maintained that FDA’s concerns about kratom have been throughly debunked. Specific safety concerns revolve around the dosages used by some in the West, which seem to be above what was traditionally used in Southeast Asia, as well as the possible existence on the market of products labeled as kratom that contain undeclared pharmaceutical ingredients. But he said in AKA’s view there is no issue with the underlying botanical itself.
“FDA is doing the same thing against kratom as they did with dietary supplements and vitamins in the 1990s. They were claiming that dietary supplements were killing people. They were right about adulterated products but were wrong about the dietary supplements themselves,” he said.