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ADVERSE EFFECTS/SAFETY DATA

ADVERSE EFFECTS/SAFETY DATA

There is limited published safety data specific to POM Wonderful PJ. The 6 published human clinical studies summarized in the Clinical Review section on page 11 included a total of 201 subjects who were exposed to POM Wonderful PJ for time periods ranging from 2 weeks to 54 months.9-14 Adverse event reporting included both clinical events and laboratory events. No clinical or laboratory adverse events were reported in any of these studies.

PJ is regulated as a food and has GRAS (generally recognized as safe) status with the FDA in the United States. Since it is not a drug or even a dietary supplement, adverse event reporting is not required. POM Wonderful has not formally implemented any Adverse Event Reporting system and therefore post-marketing surveillance data is not available on this product.

Although there are no reports on adverse effects with POM Wonderful PJ, there have been a total of 5 published case reports of allergic reactions to the ingestion or handling of pomegranate fruit/seeds.121,122,123 In summary, it appears that ingestion and/or handling of pomegranate seeds is capable of eliciting a type I hypersensitivity reaction. Due to a proprietary juice processing, POM Wonderful PJ does not contain pomegranate seeds and this reaction has not been noted in subjects consuming POM Wonderful PJ in clinical studies. It is possible that other commercial PJ may contain seed extracts and it may be prudent to advise patients with documented fruit and/or nut allergies to watch for potential signs and symptoms of allergic reaction when consuming these juices.