DMHA / Octodrine (1,5-Dimethylhexylamine)Banned Substance

• FDA's reasoning runs on three legs. DMHA is not a dietary ingredient under the FD&C Act, not an approved food additive, and not generally recognized as safe for this use [1].
  
  That makes it an unsafe food additive, and every supplement containing it adulterated [1]. ^[1]

• On April 10, 2019 the FDA sent 9 warning letters to companies selling DMHA-labelled supplements [2].
  
  They were part of a batch of 12 that day, the other 3 covering phenibut [2]. ^[2]

• Legal analysts writing in NutraIngredients called those letters unusual [13].
  
  They rested entirely on whether DMHA counts as a legal dietary ingredient, with no manufacturing-practice failures or illegal disease claims cited alongside [13]. ^[13]

• Nothing indicates DMHA was on the US supplement market before DSHEA's grandfather date of October 15, 1994 [13].
  
  No New Dietary Ingredient notification and no GRAS safety dossier has ever been filed for it [13]. ^[13]

• The US Department of Defense carries DMHA on its Prohibited Dietary Supplement Ingredients list, per Operation Supplement Safety [3]. ^[3]

• The "it's natural" defence does not hold, and the sources disagree about how much is even there. Products market DMHA as an extract of aconite, English walnut (Juglans regia), or Kigelia africana [17].
  
  BSCG's answer: those plant parts were not part of the pre-1994 food supply, and walnut seed is not reported to contain the compound at all [17].
  
  Analytical chemists found a reductive-amination synthesis byproduct in seized supplement samples, which points to lab-made material [4]. ^[17]

• Start with what is missing. No placebo-controlled human trial has tested DMHA's safety, and its metabolic pathway in people has never been published [11].
  
  USADA flags that gap directly: an unstudied sympathomimetic taken during hard exercise is a risk nobody has quantified [11]. ^[11]

• The cardiovascular picture comes from roughly a dozen animal studies run between the 1940s and the 1970s [4].
  
  In those experiments octodrine raised blood pressure and cardiac output [4]. Animal work also recorded higher heart rate, stronger myocardial contraction, and a raised pain threshold [11]. ^[4]

• Adverse effects reported in humans: hypertension, dyspnea (shortness of breath), and hyperthermia [5].
  
  Catalani and colleagues drew those from case reports and doping-test detections, not from any controlled trial [5]. ^[5]

• Self-reported use on online forums describes tolerance, dependence, and withdrawal, sitting alongside the stimulant effect people were after [11]. ^[11]

• Consumer drug references rate oral DMHA possibly unsafe by analogy to DMAA, a related stimulant linked to heart attack and death [6].
  
  WebMD and RxList both advise against it in pregnancy or breastfeeding, and with high blood pressure, glaucoma, arrhythmia, or surgery coming up [7]. ^[6]

• RIVM, the Dutch national institute for public health, notes that sympathomimetic amines in this chemical class can produce pharmacological effects at oral doses as low as 4 mg/day [10]. ^[10]

• The honest caveat, which the sources themselves insist on. Nearly every cardiovascular finding above comes from mid-century animal work, one adulterated-product recall, and doping-test detections [10].
  
  RIVM, Catalani and colleagues (2018), and USADA all state that the magnitude of human risk is not firmly established [10]. ^[10]

• It began as a medicine. Octodrine sold in Germany through the 2000s as Ambredin, Ordinal Retard, and Ordinal Forte for low blood pressure, at 8.2 mg, 16.5 mg, and 33 mg per tablet [10]. ^[10]

• Around 2015 it resurfaced in pre-workouts and fat burners [5].
  
  Online marketing called it "the next big thing" and "the god of stimulants" [5]. ^[5]

• Australia moved first. DMHA went onto the Schedule 10 poisons list — sale, supply, and use prohibited — effective October 1, 2017, citing its structural similarity to DMAA and high misuse potential [10]. ^[10]

• April 10, 2019: FDA issued 9 warning letters to makers of DMHA-containing supplements [1].
  
  Two more followed the same year — Alternative Laboratories in September, Revital U International in October [1]. ^[1]

• WADA's 2020 Prohibited List added octodrine by name, as a specified stimulant in category S6b [8].
  
  Until then its banned status had only been inferred from structural similarity to methylhexenamine (DMAA) [8]. ^[8]

• In May 2020 FDA warned contract manufacturer NutraCap Labs LLC over DMHA-containing products, alongside separate manufacturing-practice deficiencies [14]. ^[14]

• FDA last updated its DMHA guidance page in March 2023, restating that the ingredient is an unsafe food additive and supplements containing it are adulterated [1]. ^[1]

• April 27, 2023: TruVision Health recalled its Truvy, TruVision, and reFORM lines [9].
  
  The reason was undeclared octodrine and hordenine found in the products [9]. ^[9]

• Warning letters did not clear the shelves. A study published in JAMA in July 2022 followed 31 products FDA had cited for BMPEA, methylsynephrine, or octodrine [15].
  
  Only 1 of 31 had been recalled by its manufacturer, and 29% were still purchasable online an average of six years later [15]. ^[15]

No human-validated dangerous dose or lethal dose for DMHA has been published anywhere in the sources reviewed [10].

RIVM concluded the toxicology data cannot support a health-based guidance value. Long-term, reproductive-toxicity, and carcinogenicity studies are all absent, as are oral-route animal studies [10].

What has actually been measured is what sits in the products. Supplements have been found carrying up to 72 mg of DMHA per serving [10].

One analysed pre-workout held about 30 mg of octodrine per gram of powder. Its recommended one-scoop (6 g) serving worked out to roughly 180 mg [8].

An older human pharmacology study gave single oral doses from 1 to 4 mg per kg of body weight [10].

Only the highest, 4 mg/kg, produced a measurable rise in blood pressure [10].

Where regulators estimate risk at all, they read across from DMAA rather than from DMHA data of its own [10]. None of these figures is a safe-intake threshold, and no source offers one. ^[10]

No DMHA-specific poison-control case series turned up in this research pass [9].

The nearest thing is the 2023 TruVision recall. Consumers of those products reported chest pain, chills, diarrhea, dizziness, fatigue, headache, high blood pressure, high heart rate, jitters, nausea, nervousness, rash, stomach pain, sweating, and vomiting [9].

FDA's recall notice told consumers to stop using the affected products immediately [9].

For a suspected poisoning emergency — collapse, loss of consciousness, seizure, trouble breathing — US guidance is to call 911 [18].

Otherwise the poison helpline on 1-800-222-1222, or webpoisoncontrol.org, gives free and confidential advice [18].

Read this section as two partial things stitched together: general poison-control protocol that is not DMHA-specific, plus self-reported adverse events from one adulterated product [19].

A DMHA-specific clinical toxicology study does not appear to exist in the public literature [19]. ^[9]