Dietary Supplements: Is the Fox Guarding the Hen House?

Most of the lay public, heck, most physicians aren't aware of the difference between over-the-counter medications and dietary supplements.  The former are under the strict regulation of the Food & Drug Administration (FDA) which can initiate action prior to injury.  Witness all the recent drug recalls of varied products, including acetaminophen just last week.  However, that is not the case with the latter which is under the protection of the Dietary Supplement Health & Education Act (DSHEA) of 1994, signed into power by President Bill Clinton.

DSHEA allows the manufacturer to market supplements without any proof of safety or efficacy as these supplements are considered foodstuffs, not medicines.  Said another way, DSHEA makes the manufacturer responsible for ensuring safety prior to marketing (akin to the fox guarding the hen house).  However, for the FDA to remove a supplement from the market, it must prove the product is unsafe, contains a controlled substance, or is missing an ingredient listed on the product label after it's reached the retail shelf (think "shoot first, ask questions later").

On the other hand, the supplement industry feels that the DSHEA allows the manufacturers to make structure & function claims as long as they don't also make claims to treat, prevent or cure any condition(s).  That's why you see that disclaimer on all dietary supplement labels but not on over-the-counter medication labels. But if you're not a savvy consumer, how do you differentiate the structure & function claims from those to treat, prevent & cure?  For instance, what's the difference between "calcium builds strong bones & teeth" which is allowed and "calcium is a treatment for osteoporosis" which isn't.

Of course, those in the industry are bristling under the weight of these imposed restrictions.  The manufacturers' Council for Responsible Nutrition claims that newly proposed regulatory powers by the FDA are too onerous, such that their industry's current mandate for New Dietary Ingredient's "reasonable expectation" of safety will soon look like that of current new food additive petitions which are required to demonstrate "reasonable certainty" of safety.  I would daresay that laymen & medical professionals alike would not find much difference in the nuance between "reasonable expectation" versus "reasonable certainty" but I can almost guarantee that any 1st year law student can drive a bulldozer through that loophole.

This arguing back & forth reminds me of the debate over the 1st Amendment's freedom of speech.  At what point do you draw the line between individual rights & public safety?  It's now established that we are not allowed to falsely yell "Fire!" in a crowded theater just because we want to do so, without reasonable suspicion and/or proof of said fire.  How many more injuries and how many deaths must occur before we gain control over an industry that seeks to separate us from our monies in the name of health.

Let's be clear.  I'm not an advocate for Big Brother, more government, more regulation, etc.  I'm just interested in a balance between capitalism and our health & well being.  And right now, that seesaw appears to be weighted in favor of the former.  Read the editorial just published in JAMA for more information.  I, for one, don't trust the fox to guard my hen house.

Dietary Supplements: Part 2
Dietary Supplements: Part 3