Melissa McKee @melmckee3 - Twitter Profile

2 months ago

For four years, the 7-OH industry has told regulators, retailers, and consumers: “It isn’t an opioid.” “It doesn’t cause respiratory depression.” “Naloxone does not reverse it.” “It isn’t addictive.” “It’s just a dietary supplement.” Now read what Shaman Botanicals submitted in its own FDA New Dietary Ingredient Notification. Its proposed labeling admits that 7-hydroxymitragynine: * Is psychoactive * Interacts with the human opioid system * Is active at the mu, kappa, and delta opioid receptors * May be habit-forming * Can cause physical and psychological dependence * Can cause addiction and withdrawal * Should not be used with opioid medications * Can impair driving and machinery operation That is not language describing vitamins or ordinary botanical nutrition. It is the language of a pharmacologically active opioid product. FDA-2025-S-0023-0154_attachment_1.pdf The filing also discusses cases involving cardiopulmonary arrest or severe toxicity where individuals were revived with naloxone—Narcan. Instead of denying naloxone worked, the submission acknowledges the reversals and argues that fentanyl or another opioid may have been responsible. That is an extraordinary contradiction. For years, the industry dismissed naloxone reversibility. But when speaking to FDA, the argument becomes: Yes, naloxone reversed the opioid-type emergency—but perhaps another opioid caused it. You cannot claim 7-OH does not act like an opioid while stating that it is a partial mu-opioid receptor agonist, interacts with every major opioid receptor, can produce dependence and withdrawal, and has been involved in naloxone-responsive cardiopulmonary emergencies. The filing also acknowledges that researchers have identified respiratory depression following 7-OH administration. Their defense is not that respiratory depression is impossible. Their defense is that the cited research used intravenous administration and may not directly translate to oral use. The honest statement is not: “7-OH cannot cause respiratory depression.” The honest statement is: “Respiratory depression has been observed experimentally, but the company disputes how directly those findings apply to oral consumer use.” Those are not remotely the same claim. FDA-2025-S-0023-0154_attachment_1.pdf The submission compares 7-OH with buprenorphine, morphine, oxycodone and fentanyl while discussing opioid potency, overdose physiology, naloxone reversal, addiction, dependence and withdrawal. This is presented as a dietary-supplement notification while reading like the defense of an opioid drug candidate. To be precise, the filing does not prove that every reported cardiopulmonary arrest was caused solely by 7-OH. The authors dispute causation. But it destroys the categorical talking points that 7-OH has no respiratory-depressant potential, naloxone is irrelevant, addiction concerns are fabricated, or that 7-OH resembles an ordinary supplement. You do not get to market an opioid-receptor agonist, warn that it is psychoactive and habit-forming, acknowledge dependence and withdrawal, discuss Narcan reversals, and then hide behind the word “supplement.” This filing does not vindicate the 7-OH industry. It documents the hypocrisy. #7OH #SevenHydroxy #Kratom #FDA #PublicHealth #ConsumerSafety #OpioidCrisis #Naloxone #Addiction #RegulatoryCompliance https://t.co/UCTvMBShVG

13

16

3

2K

Melissa McKee

@melmckee3

Who to follow

Last Seen Users on Sotwe

Trends for you

Most Popular Users