AndrostenedioneBanned Substance

• Congress did this, not a regulator. The Anabolic Steroid Control Act of 2004 added androstenedione to the Schedule III anabolic steroid list, signed October 22, 2004 and effective January 20, 2005 [2]. ^[2]

• The rationale in the House Judiciary Committee report was that steroid precursors are as dangerous to the body as the steroids already banned by the 1990 Act [3].
  
  It also pointed at spread beyond professional athletes, into college, high school, and even middle school use [3]. ^[3]

• Before the criminal ban, FDA tried a narrower route. On March 11, 2004 it sent warning letters to 23 companies, arguing their andro products were adulterated new dietary ingredients with no safety notification [7]. ^[7]

• HHS's 2002 Monitoring the Future survey found about 1 in 40 US high-school seniors had used andro in the past year [7].
  
  That figure is what FDA cited when it moved against the category. ^[7]

• FDA's own 2022 scientific memorandum lays out the hazard case: once swallowed, andro is metabolized into testosterone and estrogen [1].
  
  So it carries the endocrine, reproductive, cardiovascular, and carcinogenic risk profile of taking an anabolic steroid directly [1]. ^[1]

• That memorandum also says the Schedule III status is itself cause for serious safety concern, incompatible with any recognition as safe for food use [1]. ^[1]

• In men, long-term use is associated with testicular atrophy, impotence, and gynecomastia, meaning breast enlargement [1]. ^[1]

• In women, documented virilization includes voice deepening, male-pattern hair loss, extra facial and body hair, and clitoral enlargement [1].
  
  Abnormal menstrual cycles, abnormal bleeding, and blood clots are also on the list [1]. ^[1]

• In children and adolescents, the flagged risks are early-onset puberty and premature closure of the growth plates [1].
  
  That second one caps adult height permanently. ^[1]

• 200 mg/day for 12 weeks significantly lowered HDL cholesterol and raised estrone and estradiol in men aged 35-65 [1].
  
  That is the lipid pattern linked to atherosclerosis risk [1]. ^[1]

• IARC classifies anabolic-androgenic steroids as Group 2A, probably carcinogenic to humans, and estrogens as Group 1, carcinogenic to humans [1]. ^[1]

• The National Toxicology Program's 2-year gavage studies found clear evidence of carcinogenic activity in male and female mice [5].
  
  The tumours were hepatocellular adenoma, hepatocellular carcinoma, and hepatoblastoma; evidence in rats was more equivocal [5]. ^[5]

• Individual case reports include priapism in a 30-year-old man after just 7 days of daily use [1].
  
  Another describes impotence with severe oligospermia in a 29-year-old bodybuilder, from suppression of the hypothalamic-pituitary axis, resolving only after he stopped and had testosterone replacement therapy [1]. ^[1]

• There is no upside on the muscle side to weigh against any of that.
  
  Randomized trials by King in 1999, Broeder in 2000, and Beckham and Earnest in 2003 found no significant gain in strength, size, or lean mass at 100-300 mg/day over 2-3 months [13]. ^[13]

• 1990-1991: the original Anabolic Steroid Control Act put anabolic steroids under the Controlled Substances Act from February 27, 1991, but named only 27 specific steroids [2].
  
  Androstenedione was not one of them, which is exactly why it stayed sellable as a dietary supplement [2]. ^[2]

• 1998: a jar of andro turned up in Mark McGwire's locker on August 22, during his record home-run season [10]. ^[10]

• Per Wikipedia's doping-in-baseball article, andro was not actually on MLB's own banned-substance list at that point [11].
  
  The IOC, NFL, and NCAA had already banned it under their own rules [11]. ^[11]

• 2001: MLB started its first random drug-testing program, covering only minor-league players not on the 40-man roster [11]. ^[11]

• March 11, 2004: FDA's first formal move — warning letters to 23 manufacturers, on an adulteration theory rather than a criminal ban [7]. ^[7]

• October 22, 2004: President Bush signed the Anabolic Steroid Control Act of 2004, naming androstenedione among 59 listed Schedule III anabolic steroids [2]. ^[2]

• January 20, 2005: the statute's self-implementing changes took effect [2].
  
  From that date, making, distributing, dispensing, importing, exporting, possessing, or using androstenedione without DEA registration became a federal crime [15]. ^[2]

• December 16, 2005: DEA published its final rule conforming its own regulations, 21 CFR Parts 1300 and 1308, to the statute [2]. ^[2]

• Running underneath all of that, androstenedione sat on the World Anti-Doping Agency's Prohibited List as a banned anabolic agent for sport, separate from US domestic law [18]. ^[18]

No human lethal dose or acute-toxicity threshold appears in the sources reviewed, and that looks like a real data gap rather than an omission [5].

Andro's documented harms come from repeated supplement-style use, not from a single large exposure.

What is on record is the exposure range: historical over-the-counter labels recommended 100 to 1,200 mg/day, roughly 1.4-17.1 mg/kg/day for a 70 kg adult [5].

Clinical research clustered far lower, at 100-300 mg/day, and one supervised experiment gave hypogonadal men 1,500 mg/day for 12 weeks [1].

In the National Toxicology Program's 2-year mouse study, repeated oral doses of just 2-50 mg/kg body weight produced clear carcinogenic activity — below the human label doses on a per-kg basis [5]. ^[5]

No androstenedione-specific poison-control protocol or accidental-exposure case report was found in this research pass — flagged as a gap, not filled in with a guess.

America's Poison Centers' general guidance covers any suspected poisoning: call 911 if the person has trouble breathing, has collapsed, is seizing, or cannot be woken [23].

Otherwise the Poison Help line is 1-800-222-1222, free and staffed around the clock [23].

Why pediatric exposure gets escalated rather than watched: FDA's review cites clitoromegaly, acne, and pubic-hair growth in children under six after unintentional topical testosterone contact [1].

That is a related hormone-exposure pathway, not an androstenedione ingestion case, and it is hedged as such [1]. ^[23]