December 10, 1999
Tip-Offs to Rip-Offs
Product No. 2: Over-the-counter
transdermal weight-loss patch
|FDA issued a warning letter to the marketer of
the weight-loss product described here because it did not have an approved new drug
application. Because of the newness of the dosage form--skin-delivery systems--FDA
requires evidence of effectiveness, in the form of a new drug application, before the
product can be marketed legally.
simple and natural-way to help you lose and control your weight."
Don't be fooled by the term "natural."
It's often used in health fraud as an attention-grabber; it suggests a product is safer
than conventional treatments. But the term doesn't necessarily equate to safety because
some plants--for example, poisonous mushrooms--can kill when ingested. And among
legitimate drug products, says Shelly Maifarth, a compliance officer and health fraud
coordinator for FDA's Denver district office, 60 percent of over-the-counter drugs and 25
percent of prescription drugs are based on natural ingredients.
And, any product--synthetic or natural--potent
enough to work like a drug is going to be potent enough to cause side effects.
Time-Tested or New-Found Treatment
revolutionary innovation is formulated by using proven principles of natural health based
upon 200 years of medical science."
Usually it's one or the other, but this claim
manages to suggest it's both a breakthrough and a decades-old remedy.
Claims of an "innovation," "miracle
cure," "exclusive product," or "new discovery" or
"magical" are highly suspect. If a product was a cure for a serious disease, it
would be widely reported in the media and regularly prescribed by health
professionals--not hidden in an obscure magazine or newspaper ad, late-night television
show, or Website promotion, where the marketers are of unknown, questionable or
The same applies to products purported to be
"ancient remedies" or based on "folklore" or "tradition."
These claims suggest that these products' longevity proves they are safe and effective.
But some herbs reportedly used in ancient times for medicinal purposes carry risks
identified only recently.
Guarantee: If after 30 days ... you have not lost at least 4 pounds each week, ... your
uncashed check will be returned to you ... ."
Here's another red flag: money-back guarantees, no
Good luck getting your money back. Marketers of
fraudulent products rarely stay in the same place for long. Because customers won't be
able to find them, the marketers can afford to be generous with their guarantees.
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