Prohormones, the Clear, 4-etioallocholen-3,6, 17-trione and Patrick Arnold

Prohormones.  Those substances made famous by Mark McGwire during his record setting HR year when Andro was discovered in his locker.

Seems that the first prohormone was DHEA, which is a precursor in the steroid synthesis biopathway.  DHEA appears to be a weak androgen.  Some research has been done;  there are some papers on DHEA in the aging population.  Basically, a substitute for declining levels of testosterone.

How did the other prohormones pop up.

Patrick Arnold is called the 'father of prohormones'.  The same Patrick Arnold who is named in the BALCO scandal?  The one identified in 'Game of Shadows' as the chemist who synthesized the clear (an undetectable androgen)?  His bio is here.

Seems one in the same.  Arnold has a BS in Chemistry.  He is also the founder of several businesses like Ergopharm , and Proviant Techologies.

Ergopharm puts out many products such as prohomones, and a new one called 6-OXO, a natural aromatase inhibitor - blocks estrogen.  Yet is supposedly targets the hypothalmus to increase testosterone production.

From Ergopharm:

6-OXO (allegedly) acts to inhibit the aromatase enzyme and block the conversion of testosterone to estradiol. A consequence of this is a signal from the brain to increase production of testosterone to compensate for the blocked estradiol production. As testosterone levels increase, so do estradiol levels since more substrate has now become available for the aromatase enzyme. Basically, what has occurred is the establishment of a new baseline level of testosterone to maintain the body's normal levels of estradiol.

Further:

A complete metabolic analysis was done examining changes in blood cells and lipids, liver function, kidney function, and immune function. No adverse changes were observed in any of these areas over the course of the three weeks. In fact, indications are that liver function actually improved slightly, and average cholesterol level dropped by about 26 points. That is an 11.6% reduction in cholesterol in 3 weeks! The explanation for this dramatic improvement is not known at this time.

Wow.  How does a company synthesize new hormones, or 'drugs', do clinical studies including lab work, market the 'drug' and entirely SIDESTEP all the requirements for FDA approval (and I tell you it is VERY expensive and time consuming to get FDA approval)?

I am not a great fan of the FDA.  However the rest of us have to play by the rules (I have been part of many clinical pharm trials).  How does this drug sneak by?

Arnold has been in the news lately:

Liability suit re: side effects

The government raided Proviant as part of BALCO .  They (Arnold) are accused of synthesizing 'the clear'.

This article from the Champaign (ILL) newspaper documents the raid and charges.  Charges from US Attorney Ryan includes:
– Conspiracy to distribute anabolic steroids.
– Conspiracy to defraud consumers and the government by introducing misbranded drugs into interstate commerce.
– Introducing and delivering "the Clear  (tetrahydrogestrinone, or THG.)" into interstate commerce with the intent to defraud.
And here from Chemical and Engineering News
And from the San Diego Union-Tribune this story.   With this quote from Arnold:

There may be some that know certain aspects of pharmacology (the cell biology stuff) more than I do, but when you add up OVERALL knowledge of chemistry and pharmacology, I will go up against the best of them. Especially on the chemistry part, I know by heart how to make most every steroid.

The raid was documented in the San Francisco Chronicle.  Even the UK's Observer was on record here.

In trouble for an amphetamine-like substance (Geranamine, methylhexaneamine ) used in Ergopharm's AMP.   Story here.   Washington Post article found here.

A report  of the FDA's early warning to Arnold here.

Another lawsuit here.

And, of course, the announcement of the guilty plea related to BALCO.
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Questions:
1.  How does a company or an individual completely bypass the FDA in marketing a drug (a reiteration)? 
2.  How does a company get by with all the 'claims' and no actual accepted evidence for these drugs?
3.  And how does that company mislabel the drugs; or use psychoactive, and metabolically active ingredients without proper labeling?