Thursday, April 10, 2008

Trusting Dietary Supplements

The following are just 2 among a number of recent incidents involving dietary supplements.

The Incident

"Total Body Formula - A Complete Full-Spectrum Dietary Supplement For The Entire Family", was making people sick. Two weeks ago the FDA advised consumers to stop taking it. (The FDA has no recall authority). The manufacturer, Total Body Essential Nutrition, has since voluntarily recalled it.

The Problem

Total Body Formula is advertised to contain 200 micrograms of selenium.

The tolerable upper intake level (UL) for selenium is 400 micrograms/day, or 5 micrograms per kilogram body weight, whichever comes first. (That's 272 mcg/day for a 120 pound person.) Above this level one may experience significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, deformed fingernails (or they just fall out), and blistering skin.

How much selenium was in Total Body Formula?

"Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium--up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products."
- FDA Press Release, April 9, 2008, FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and "Total Body Mega Formula"

The Incident

Last week, US Marshals seized more than $1,301,712 of dietary supplements from LG Sciences.

The Problem
"The seized products previously were tested and found to contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to provide reasonable assurance that the ingredients do not present a significant or unreasonable risk of illness or injury."
- FDA Press Release, April 4, 2008, Products Alleged To Be Adulterated Under The Federal Food, Drug, And Cosmetic Act
The products seized were marketed under the names "Methyl 1-D," "Methyl 1-D XL," and "Formadrol Extreme XL." They're labeled as "anabolics." (It looks like Methyl 1-D is a prohormone or precursor to testosterone.)

The FDA has not advised consumers to stop taking these products, and has admitted they do not know whether or not they represent a hazard. There has not been a voluntary recall by the company, as far as I can tell. (Which makes me wonder how US Marshals justified the seizure.) And it looks like you can still purchase them online.

I suppose it's up to the consumer to decide whether to trust the safety of this product.

How tightly should dietary supplements be regulated? Unlike prescription drugs, manufacturers of dietary supplements are not currently required to submit safety or efficacy information before marketing their products.

Is it regulation that prevents a consumer from finding 200 times the active ingredient in, say, Viagra? Is it regulation that prevents a consumer from having to decide whether or not to continue taking their prescription meds while watching US Marshals seizing them from warehouses because they may not be safe? (Actually, the answer to this last question is "Yes." Although the answer to the question of whether or not it's safe to continue taking prescription meds when the manufacturer and the regulating agency both say they're safe is still, in my mind, murky.)

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