STAGE TWO DECISIONS

1. ADVERTISER: Ethical Remedies

COMPLAINANT: Biosyent

SUBJECT: c16-03 EBMFer (NPN80042242) APS

PRECLEARANCE: No

ALLEGATIONS: • The claim to superiority in the promotion piece is a hanging comparison, which is an implicit comparison to all other iron products used for iron-deficient anemia (IDA), including FeraMax® 150. The absence of an express reference to the brand is irrelevant and is not a legitimate defense.

• Second, ER admits, in its response, that absorption data is not relevant to the question of clinical efficacy. It notes, specifically, that: “It’s important to note that there has been no effort in the literature to link absorption with clinical efficacy in IDA …”. ER effectively admits that its absorption claims serve no legitimate purpose. They are used in the promotional piece to impliedly suggest that EMBFer™ has superior efficacy due to its allegedly superior absorption.

• Third, as was previously noted, ER does not have any studies or literature that supports the claimed 40% absorption figure in connection with the EMBFer™ formulation itself. ER response does not provide any authoritative data in support of such a cross-reference claim.