Page 47 - Prevention - USA (April 2020)
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For FDA-registered
products, the com-
pany determines what
language is used on the
packaging and what
a device claims to do.
Since scientific studies
are very expensive and
aren’t required at this
point in the process,
they’re not performed,
since it’s not in a compa-
ny’s best interest to do so
(why spend millions on
a study that might prove
that a product doesn’t,
say, eliminate wrinkles?).
Thousands of
products pop up
online and bombard
desperate people with
sketchy promises. For
example, in 2019 the
FDA sent warning letters
to 17 companies illegally
FDA REGISTERED OR FDA LISTED: selling products that claimed to prevent
A Squishy Designation or cure Alzheimer’s disease. The FDA
This category is the most troublesome. stated, “These products may be ineffec-
Devices and drugs that make claims tive, unsafe and could prevent a person
related to wellness and fitness rather from seeking an appropriate diagnosis
than treatment of a specific medical and treatment.”
condition don’t need to go through If you’re confused about all these
premarket evaluation. For example, a categories, you’re not alone. It doesn’t
device that claims to tighten the pelvic help that a product’s packaging might
floor but markets itself as treating state that it’s FDA approved when it’s
actually FDA listed—so some healthy
incontinence (a medical condition)
GETTY IMAGES. would need to be FDA cleared. A skepticism is appropriate. When in
similar device that claims to “enhance
doubt, visit the FDA’s website (fda.gov)
for more information.
intimacy” needs only to be registered.
AP R I L 2020 • PREVENTION.COM 45
