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October 20, 2000
Issue #17

2




 

 

Who Do You Trust?
The Case of the DSHEA Versus the FDA
by Nelson Montana

They say, "The road to hell is paved with good intentions."  This cynical axiom can easily be applied to the bodybuilder's worst bureaucratic nightmare--the Food and Drug Administration.

The intentions of the FDA, at least in its original conception, were noble.  Their role was designed to act as watchdogs for the consumer.  Before a drug can be approved for nationwide distribution,  it must first pass a series of tests in order to determine its safety.  Fair enough.  We should be grateful that such an organization exists, for without it, any wacko would be able sell whatever he wanted, regardless of the product’s potential harm. The FDA is a necessity, or what some people would consider a "necessary evil."  Its negative perception stems from the fact that many of its decisions have been tainted by lobbyists, public opinion, and ignorance.  Such influence is what's responsible for taking the bodybuilder's most powerful tool, anabolic steroids, and classifying them a scheduled drug on par with narcotics such as cocaine and heroin.  Steroids are an easy target because most citizens are ill-informed to their benefits.  Unlike narcotics, however, no rehabilitation programs exist for steroid users.  Why should they?  Steroids are not addictive or mind altering.  Their use poses no threat to society.  Nevertheless, if you're caught with them...you're going to jail.

It's fascinating that the criminalization of drugs is meant to be in the people's best health interest, yet if someone takes the drugs, they're prosecuted and persecuted.  That doesn't sound like the people's best interests are at heart.  Is something else going on here?

If drugs are sold illegally, doesn't that mean the pharmaceutical companies’ profits are cut into? Damn straight!  And like any business, drug companies don't like anyone working their side of the street.  This is what makes the FDA such a great ally to big business, namely the American Medical Association and the large pharmaceutical companies.

Is this to suggest that the FDA is corrupt?  No way!  That would be as cynical as thinking that politicians lie or lawyers defend people who they know to be guilty and, as we all know, that never happens. 

Maybe it's more a matter of ignorance than illicitness.  In the case of steroids, the FDA classifies all steroids as "androgens."  Therefore, it doesn't matter whether it's Anadrol or Anavar; to this herd, it's all the same.  Frustratingly, even novice bodybuilders with a minimal knowledge of steroids can tell you that the above two substances are as different as gunpowder and gummy bears.  Then again, bureaucrats aren't paid to think--they're paid to make and enforce laws.  Power corrupts.  Add stupidity into the mix and the results are swifter and more lethal.

A few years back, the FDA got its hands into the supplement arena.  Depending on whom you speak with, the intent was either to protect the public from products making false claims or it was an attempt from the AMA and pharmaceutical companies to halt the sale of products which may work as well as drugs.  The fine folks over at the FDA probably weren't aware of this, but by putting a possible ban on the sale of many supplements from protein powders to vitamins, they were tinkering with another staple of bodybuilding ammunition.  But it isn't only bodybuilders who use supplements.  Millions of Americans have discovered the benefits derived from over the counter products.  This caused an outcry against the FDA's actions.  Tens of thousands of people wrote to their congressmen demanding the continued non-prescription sale of food supplements. Suddenly, it wasn't just the "fringe society" of bodybuilders who were upset.  It was normal people! People who vote!   That got the attention of Congress.  And it encouraged the passage of the Dietary Supplements Health and Education Act of 1994, better known as the DSHEA.

The DSHEA was set up specifically to deal with supplements.  According to the statement release: the DSHEA acknowledges that millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits.  Congress' intent in enacting the DSHEA was to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products remain available to those who want to use them.  In the findings associated with the DSHEA, Congress stated that there might be a connection between dietary supplement use, reduced health care expenses, and disease prevention.

Maybe we're actually making progress with the red tape machine.

Through the DSHEA, Congress expanded the meaning of the term "dietary supplement" to include substances such as herbs and prohormones.  This is where things started getting interesting.

DSHEA now determines and defines what the FDA has to do in order to pull a supplement off the shelves, or not allow it in the first place (more red tape).  This has become a raging battle between the FDA and proponents of DSHEA.  It would seem that bodybuilders should be rooting for DSHEA because of its leniency.  When interpreting a substance's validity, DSHEA allows more potentially beneficial compounds to be marketed.  But that's a double-edged sword.

More and more supplement companies are making claims outside of what the FDA has allowed in the past.  If interpretation and restriction of claims gets too liberal, anyone can say anything about any product!  And, that's been the state of affairs in the last few years.  In other words, if I wanted to sell freeze dried goat feces and claim it "helped lower LDL levels," I'd have a pretty good shot of getting away with it.

There is currently a new form of prohormone on the block, which can technically be considered a prosteroid!  Although there are many intriguing possibilities surrounding this compound, it is still a virtually untested product.  You might think more testing would take place before its release.  Think again.  Whoever gets it out first will claim to be the "great innovators of new technology!" This will then force other supplement companies to follow suit.  If it turns out the product has an unforeseen problem, or even if it works a little too well, that's going to get the FDA pounding on the doors of every major company faster than some fitness models can drop to their knees in the judge's dressing room.  

This action will most probably instigate an investigation surrounding many of the current supplements we now take for granted such as Aminos, Tribulus, Acetyl-L-Carnitine,  Methoxyisoflavones, DMAE, Gingko, SAMe, Yohimbe, and Ephedra--to name just a few!  Zinc and magnesium formulations will still be available, however, so we'll just have to depend on that to get huge.  (I will now remove tongue from cheek.)

As it stands, DSHEA and the FDA are at each other's throats, each pushing the envelope of ethicality and legality in an effort to obtain control.  The FDA is still taking substances that clearly fit the description of a "dietary supplement" and, according to the DSHEA, not following protocols to remove them from the marketplace.  They don't have to prove that the product is dangerous.  All they have to do is say that it’s an “unapproved new drug.”

Case in point.  Last year, all of the GHB mimickers such as 1,4-Butanediol or GBL products like Enliven, RemForce, Blue Thunder and Renewtrient were pulled from the shelves even though they were clearly a nutritional supplement.  Of course, these products had intoxicating effects if misused and, as can be expected, they were.  But it left supplement suppliers and health food store outlets holding the bag.  Naturally, it's better than being sued by some moron who takes nine times the recommended dose, but none of this would have occurred had the DSHEA not allowed the product's release in the first place.  It also showed that the FDA is pretty much going to do what it wants to do.

Where does all this leave us?  It's hard to say.  Whenever people’s choices are mandated, a mess is sure to follow.  Wherever unscrupulous supplement distributors are allowed to do business, consumers will be suckered out of money.  In the meantime, the best approach is to remain educated on the details, stay abreast of the fluctuating regulations, and choose your supplement sources wisely.   Keep in mind, things can change at any time.  

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