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August 11, 2021

American Kratom Association Takes Legal Action Against FDA

For seventeen days, the United States Food and Drug Administration (FDA) sought public comment on kratom. But it’s unlikely that the agency wants to be convinced of kratom’s virtues.

Instead, the comment period was nothing more than a formality: an obligatory step on the FDA’s path towards encouraging the World Health Organization (WHO) to ban kratom internationally. And while pro-kratom comments weaken their position, on August 9th, 2021, the FDA’s comment period came to a close as legally required.

At the time, the American Kratom Association (AKA) reported that they had received about fifty-thousand comments on their own comment portal. But, seemingly discontent with that number, the pro-kratom organization has sought to extend the FDA’s comment period — and they’ve gone to the courts to make it happen.

Taking Legal Action

On Friday, August 6th, 2021, the AKA and its attorneys filed a complaint against the secretary of Health and Human Services (HHS), the acting administrator of the FDA, and the two organizations. “We argued that seventeen days did not provide a meaningful opportunity for people to exercise their rights under the Controlled Substances Act and under the Administrative Procedures Act,” said AKA attorney Richard Oparil during a webinar on Monday.

Had the FDA’s comment period been longer, the AKA believes they would’ve been able to collect more pro-kratom comments. Those comments “… would help [the World Health Organization] understand how significant kratom has been in the journey that many people have in dealing with pain and addiction issues,” said AKA representative Mac Haddow on Monday.

The judge denied the AKA’s motion for a temporary restraining order (TRO). However, Oparil said the court verdict might be in their favour: “There’s reason to believe that the FDA will reopen the comment period sometime this week until August 23rd or 24th.”

The AKA’s other attorney, Bob Durkin, described that the judge seemed sympathetic to their cause. “There were some things that the judge took special notice of today,” he said during Monday’s AKA webinar. “One was the duration of time that the FDA was aware of WHO’s request for information before they actually made a request for information of their own on the federal register … The FDA’s comments were due back to the WHO [on Tuesday, August 10th], so the judge was a little curious how they expected to do any meaningful review of comments considering that they have to turn them around in less than 24 hours.”

The AKA’s efforts proved to be successful. Soon after the AKA took legal action, the FDA requested to extend their comment submission deadline from August 10th to August 27th, 2021, according to AKA attorney Oparil.

Future Plans

The FDA may extend their kratom comment period — but the AKA’s work is far from finished. During Monday’s webinar, AKA representative Mac Haddow detailed their future efforts.

Over the coming months, the AKA will develop a presentation to show to the WHO Expert Committee in Geneva. According to Haddow, they’ll bolster the presentation with testimonials from stakeholders, scientists, advocacy organizations, and congress members.

Despite opposing a ban, Haddow seems to believe that sensible kratom regulation is necessary. “Rather than banning it, they should be working to cultivate a good research base and identify the pathway to good regulations that will allow for safe kratom products to be manufactured appropriately with good manufacturing practices to ensure that the contaminants of e.coli, salmonella, and heavy metals are eliminated from kratom products,” he said on Monday.

As for the international kratom ban timeline, Haddow noted that the WHO & United Nations could begin taking action as early as March of 2023. “Even then it might be several months beyond, even if everything went against us, which we’re not going to allow to happen,” Haddow during Monday’s webinar. “We’re going to have our voices heard.”

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