64 Food & Drug L.J. 503 (2009)
Dietary Supplement Adverse Event Reports: Review and Analysis

handle is hein.journals/foodlj64 and id is 523 raw text is: 





          Dietary Supplement Adverse Event Reports:
                        Review and Analysis


                        ASHISH R. TALATI*
                      ABHisHEK K. GURNANI**

                             INTRODUCTION

  The Food and Drug Administration (FDA) works actively to ensure that all
the dietary supplements currently in the market are safe for the public. Existing
policies are often remodeled and new regulations are developed periodically. A
recent change t9 supplement regulations includes the implementatign of a system
that allows consumers to contact the FDA or product manufacturer directly to
report an adverse reaction as a result of dietary supplement consumption. FDA
has employed an adverse event reporting (AER) system that is aimed to police
postmarketing effects of dietary supplements.
  This article will shed light on the importance of tracking serious adverse events
with respect to dietary supplements that have already been marketed. Various data
from the FDA database will be quantified to identify the most common dietary
supplement products, companies and adverse events that were reported to FDA's
AER program between October of 2007 and February of 2009. Manufacturers and
distributors will gain valuable feedback that will allow them to enhance safety and
effectiveness measures. Using this data, dietary supplement companies will be able
to take the necessary steps to ensure that their products remain safe for the public
by removing problematic ingredients from their products and engaging in more
effective labeling and product disclaimer practices.
  In January of 2009, a Freedom of Information Act (FOIA) Request was submit-
ted to FDA to obtain the records of all dietary supplement adverse reports received
between October 2007 and February 2009. A total of 711 reports were dissected,
and information regarding manufacturers, products, ingredients and adverse events
experienced were reviewed and quantified for further analysis.

                I. APPLICABLE LAW AND FDA GUIDANCE

  In December of 2006, Chapter 7 of the Food, Drug and Cosmetic Act (FDCA)'
was amended to include the Dietary Supplement and Nonprescription Drug Con-
sumer Protection Act2 (Act). The Act required the reporting of serious adverse
events occurring as a result of consuming dietary supplements. The Act further
required labels of supplements marketed in the United States to include a domestic
address or domestic phone number through which the responsible person ... could
receive a report of a serious adverse event with such a dietary supplement.3 The


      Mr. Talati is a Partner and Chair of the Food and Drug Law practice group at Amin Talati,
LLC, Chicago, IL.
      Mr. Gurnani is a first year Associate at Amin Talati, LLC, Chicago, IL.
      FDCA, 21 U.S.C. 371 et seq.
    2 Dietary Supplement and Non Prescription Drug Consumer Act, Public Law No: 109-462.
    3 21 U.S.C. 343(y).


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