October 10, 2013
NPA Issues Letter to The Children's Hospital
Sarah Erush, PharmD, BCPS
The Children’s Hospital of Philadelphia
34th Street and Civic Center Boulevard
Philadelphia, PA 19104
Dear Dr. Erush,
As an organization staunchly dedicated to improving the health of young people
all across the world, we would expect The Children’s Hospital of Philadelphia
to strongly support any legitimate product shown to benefit the well-being
of your patients. Therefore, it’s unfortunate to hear that the hospital has made
the decision to remove most dietarysupplements from its Formulary.
According to your release
, CHOP’s decision to discontinue the use of most
dietary supplements is based mainly on the notion that these products are
not regulated. This inaccurate understanding of the supplement industry is
doing a disservice to both the hospital and its patients.
Dietary supplements are regulated as a unique category of food by the U.S.
Food and Drug Administration (FDA). Under the regulations governing dietary
supplements, manufacturers must:
•Adhere to strict current Good Manufacturing Practices (cGMP),
requiring identity, potency, and contaminant testing on all
ingredients, with additional testing requirements for finished
•Only use ingredients that are federally sanctioned.
•Not add pharmaceutical ingredients, including steroids, to
dietary supplements, as this effectively turns the product into
an unapproved new drug.
•Report to the FDA any information regarding serious adverse
events that might
be associated with the use of their product.
Manufacturers must keep records of all adverse events, including
non-serious events,for six years.
•Register with the government, and give advance notification of raw
The FDA has been regularly inspecting facilities regarding their GMP
compliance, and the rate of these inspections has almost doubled each
year for the past few years. Based on the regulations listed above and
the number of inspections performed, we would dispute the hospital’s
impression that dietary supplements are “essentially unregulated” and
aren’t “routinely reviewed” by the FDA.
The Natural Products Association agrees that consumers should always
discuss their supplement regimen with their healthcare providers. However,
we would strongly oppose the barriers you’ve set in place for patients to
continue their use of dietary supplements. The benefits of supplementation
have been confirmed by decades of solid research and in recommendations
from the World Health Organization and the American Heart Association,
We understand Dr. Paul Offit is on staff at the hospital and even on the
Therapeutic Standards Committee, so while we're disappointed, we are
not necessarily surprised at CHOP’s position regarding dietary
supplementation. We’ve been responding to Dr. Offit’s misguided
viewpoint of the dietary supplement industry for the past few months now.
NPA would like to serve as an industry resource to you, and we welcome
an opportunity to engage more on this issue to ensure you and your
patients are receiving the most reliable information about supplementation.
Executive Director & CEO
Natural Products Association
Cara Welch, Ph.D.
Sr. Vice President, Scientific & Regulatory Affairs
Natural Products Association