Table of Contents
Phenylpropanolamine
Outline
What did we know about PPA when the HSP study was started?
PPA is an Effective OTC Ingredient.
PPA is Reasonably Safe for Continued Marketing
PPA is Reasonably Safe for Continued Marketing
PPA is Reasonably Safe for Continued Marketing
PPA is Reasonably Safe for Continued Marketing
PPA is Reasonably Safe for Continued Marketing
Summary
CHPA & the HSP Study
Outside Expert Reviewers
Independent Expert Panel
PPT Slide
Conclusions
FDA OTC Policy
HSP in context of FDA Policy
HSP in context of FDA Policy
Recommended Next Steps
PPT Slide
AER Profile: FDA SRS/AERSDiet Aid and Cough/Cold: Hemorrhagic Stroke-related, all ages
AER Profile:
PPA-related AERs: ‘81-’00
Obesity - the second leading cause of unnecessary deaths
Obesity/Overweight
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