CNN is on over the stationary bike at the gym. An FDA panel recommends lifting the ban on silicone breast implants.22 In the shower afterward, I note that my conditioner "contains essential nucleic acids for pH 5.5 balance."23 I brew in my travel mug some AllGoode brand DigestibiliTea, containing fennel, which "promotes relaxation of the smooth muscles of the digestive tract." At the bottom of the package, there's
a little disclaimer that reads: "The Food and Drug Administration has not evaluated these statements. This product is not intended to diagnose, treat, cure or prevent any disease."24
At the GNC store, I spot that disclaimer on almost every product. It's even on a yellow shelf placard, underneath a pronouncement that "amino acids
are the building blocks of proteins." Hmmm. Why the disclaimer? Amino acids are the building blocks of proteins, the same way letters are the building blocks of words. The FDA certainly knows this.
Curious about a radio ad that I hear on the drive home, I call up a company called CortiSlim, whose product, it claims, reduces levels of the stress hormone cortisol and thereby helps you lose weight.
Me: "So how does CortiSlim work to reduce cortisol?" Seller: "It decreases the level of cortisol in your body, just cancels it all out."25 Me: "OK, but how does it do that?" Seller: "CortiSlim evaporates
it and absorbs it and decreases it and cuts it down. So I want to tell
you about a ?buy two get one free' special we're running this week."
Eager to establish its scientific credentials, CortiSlim's Web site features MRI images of fat deposits along with a bold motto: "The new science in weight loss." In the site's nether regions, however, you'll find the FDA disclaimer. Let's be clear: Wherever you see this disclaimer, it signals that you have no reason to believe that there will be "practical significance" to using a product. The people wearing lab coats in the promo pics? They can be actors. Reported data from scientific studies? Could have been invented by someone who failed high school biology. Claims of health benefits? Well, you get the idea.
A 1994 federal law took the teeth out of the FDA's dietary supplement regulations, which cover products that are neither foods nor drugs, such as CortiSlim and AllGoode teas. The FDA
can yank a product off the shelves if it proves to be harmful (as it did to Ephedra) and it can prohibit companies from claiming to
cure specific diseases. AllGoode, therefore, can't be promoted as a cure to inflammatory bowel disease. But it can be sold to promote digestion, stimulate the digestive tract, maintain immune system balance?any medical-sounding thing that stimulates sales. Sellers of so-called "herbal Viagra alternatives" can imply the
same benefits provided by heavily researched and FDA-approved pharmaceuticals?indeed, can imply the extra natural goodness of herbal drug-alternatives?without
reference to scientific research. Companies with names like Medicures can hawk "100% All Natural
Doctor-Approved" pills, with names like Virility-Rx, which are neither medical nor, by their own disclaimered admission, cures.
The Fine Print
22. Breast implants: True. The FDA panel did
recommend lifting the ban, though the agency has since decided not to follow that recommendation.
23. Conditioner: Sounds scientific! Dermatologist Jerome Litt of Case Western Reserve University doesn't know what "essential nucleic acids for pH 5.5 balance" is supposed to mean in this phrase. "Any conditioner you like will work. They are all essentially the same."
24. Fennel: Unproven. Fennel is a folk cure for indigestion (some folk cures, of course, have been scientifically proven to work). AllGoode did not respond to repeated requests for the science behind this claim. We searched PubMed and found one study on the subject that showed that fennel stimulated contractions of smooth muscle in guinea pigs, and another that showed that fennel relieved smooth-muscle spasms in rats.
25. Cancels out all the cortisol: Bogus. Cortisol is a stress hormone?among other things, it regulates our fight-or-flight impulse?and has been weakly linked to one form of obesity. But "canceling out all cortisol would be disastrous," notes University of Virginia endocrinologist Mary Vance. Perusing the ingredients listed on the company's Web site, she says: "You might as well eat tree bark." The CortiSlim salesperson had apparently not read the Web site, which says the product helps "control cortisol levels within a healthy range." The site recommends the product for "millions of Americans. ...Anybody who leads a stressful lifestyle and wants to lose weight." Its home page features
a strong warning to consumers?against buying bogus CortiSlim.