Berks County Medical Society Medical Record Fall 2018 - 25

Safety and Compliance
with FDA Regulations of
Intravaginal Products
by Adam G. Dykie and Mark G. Martens, MD, FACOG

METHODS:
Twenty-two common intravaginal products, including
moisturizing creams and personal lubricants, were tested for pH.
Samples were tested in triplicate to assess potential variability
between different batches, though some were only examined once
due to available supply. The measurements were considered in
context of the normal vaginal pH range.

RESULTS:

INTRODUCTION:
The Food and Drug Administration (FDA) is the main body
for regulating pharmaceuticals and medical devices. Policy dating
back to 1994 concerns the regulation of over-the-counter vaginal
products such as lubricants, moisturizers, and cosmetics. Many
topicals have recently been introduced, particularly for postmenopausal women. Due to minimal testing of these products, and
calls for information by the FDA, however, their safety for vaginal
application is a concern. The optimal pH of the vagina is between
3.5 and 4.5. A more acidic vaginal pH, typically below 3.0, is
associated with epithelial damage, while a pH above 5.0 leads to
changes in bacterial flora and conditions such as bacterial vaginosis.
A study was conducted using a set of recently introduced vaginal
products through which pH was measured to assess their safety with
vaginal application.

Among the products examined, only nine had an average pH
within the optimal range of 3.5-4.5. With thirteen products falling
outside the range, three were below 3.5 with the most acidic being
Replens® Silky Smooth at a pH of 2.75. Ten products were above
this range with the most alkaline being FemGlide® at 6.20. There was
some variability between batch measurements.

CONCLUSIONS:
Several of the products had a pH outside of the optimal range
of the healthy vagina, which raises concerns regarding their safety.
Given the increasing market for intravaginal drugs, greater FDA
oversight and potential revisions to regulatory policies are needed.

Adam G. Dykie is a first-year medical student at
the Drexel University College of Medicine.

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FALL 2018

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Berks County Medical Society Medical Record Fall 2018

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