Natural kratom leaf consumers are being urged by 7-OH manufacturers and vendors to flood the federal government with comments opposing the scheduling of chemically manipulated 7-OH opioid products.
Do not participate in this deceptive campaign.
The Department of Health and Human Services’ Request for Information is not a public referendum on whether consumers like 7-OH opioid products. It is not a request for personal testimonials, political talking points, form letters or generalized claims that someone believes 7-OH helped them.
The request is narrowly limited to scientific evidence addressing whether the threshold established for 7-OH should be adjusted and whether a different method of measuring that threshold would better protect public safety. HHS specifically requested:
1. Additional scientific data supporting the proposed threshold or an alternative threshold, including evidence identifying the concentration or quantity of 7-OH that constitutes an imminent hazard to public safety; and
2. Scientific data supporting alternative ways to express or measure that threshold. (HHS.gov)
That means the government is asking for toxicology, pharmacology, analytical chemistry, product-testing data and other legitimate scientific research. It is not asking consumers to submit personal experiences in an effort to overwhelm the docket or create the false appearance of scientific disagreement.
Natural Kratom Leaf Is Not the Target
DEA, HHS and FDA have expressly distinguished natural kratom leaf from chemically manipulated 7-OH products.
The federal action targets 7-OH above a specified threshold and separately addresses mitragynine pseudoindoxyl, MGM-15 and MGM-16. HHS stated that the action is not intended to regulate natural kratom leaf that does not contain enhanced levels of 7-OH. DEA likewise stated that botanical kratom products containing naturally occurring 7-OH below the specified threshold are not covered by the temporary scheduling action. (DEA)
Claims that scheduling concentrated 7-OH will automatically result in natural kratom leaf being scheduled are false and are designed to frighten natural leaf consumers into defending an entirely different class of products.
Do Not Allow Your Voice to Be Hijacked
The manufacturers responsible for producing and selling chemically manipulated 7-OH products now want natural kratom consumers to recreate the grassroots opposition that successfully defended natural kratom leaf in 2016.
The circumstances are fundamentally different.
In 2016, consumers defended a botanical product with a long history of use and presented legitimate scientific objections to the proposed scheduling of mitragynine and 7-hydroxymitragynine as naturally occurring constituents of the kratom plant.
Today, the federal government is targeting commercial products containing highly elevated or synthesized 7-OH and related opioid compounds. FDA has stated that its action is specifically focused on concentrated 7-OH products—not natural kratom leaf. (HHS.gov)
The 7-OH industry should not be permitted to hide behind natural kratom consumers after deliberately marketing chemically manipulated opioids as though they were ordinary kratom products.
Personal Experience Is Not the Scientific Evidence HHS Requested
A consumer may sincerely believe that a 7-OH product helped with pain, withdrawal or another personal concern. That experience may be important to that individual, but it does not establish:
● A scientifically defensible safety threshold;
● The concentration at which 7-OH presents an imminent public-health hazard;
● The pharmacokinetic or toxicological effects of particular doses;
● The accuracy of product labels;
● The presence of pseudoindoxyl or other derivatives;
● The safety of repeated or escalating use; or
● A scientifically valid alternative method for measuring 7-OH.
Submitting personal stories as though they answer these technical questions risks contaminating a scientific record with irrelevant material. It also assists manufacturers seeking to portray an opioid-protection campaign as a natural kratom consumer movement.
Protect Natural Kratom by Defending the Distinction
Natural kratom consumers have a direct interest in ensuring that regulators maintain a clear line between:
● Natural kratom leaf and properly manufactured traditional extracts; and
● Chemically manipulated 7-OH opioids and related compounds such as mitragynine pseudoindoxyl, MGM-15 and MGM-16.
Blurring that distinction does not protect natural kratom. It places natural kratom at greater risk by allowing manufacturers of high-potency opioid products to continue calling their products “kratom.”
The responsible position is clear:
● Do not submit manufacturer-drafted form letters disguised as scientific comments.
● Do not repeat the false claim that scheduling elevated 7-OH automatically schedules natural leaf.
● Do not contact Congress merely because a 7-OH vendor tells you that natural kratom is under attack.
● Do not allow your support for natural kratom to be exploited to preserve the profits of companies selling chemically manipulated opioid products.
Researchers, toxicologists, analytical chemists and other qualified experts who possess responsive scientific evidence should submit it. Consumers should not be manipulated into pretending that personal testimonials constitute the scientific data HHS requested.
The Bottom Line
The HHS Request for Information is a request for science—not a political pressure campaign.
Natural kratom leaf consumers should reject every attempt by the 7-OH industry to misuse this proceeding, manufacture fear or falsely claim that defending concentrated 7-OH opioids is necessary to protect natural kratom.
It is not.
Protect natural kratom leaf. Reject chemically manipulated 7-OH opioids. Let legitimate science—not industry-organized misinformation—guide the federal government’s decision.
