Supplement AER Numbers Could Raise False Alarm About Product Safety
This article was originally published in The Rose Sheet
CFSAN publishes data on more than 55,000 AERs received from January 2004 through September 2016 for dietary supplements, food – including food additives and color additives –and cosmetics. Quarterly updates begin in February with information from reports submitted during the 2016 fourth quarter.
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FDA’s release of AER data removes some secrecy surrounding cosmetic product adverse events but could create a false alarm about the industry. The data dump comes as Congress is considering legislation that would mandate that cosmetics firms provide FDA with reports of serious adverse events they receive.
Reports of serious adverse events in the dietary supplement industry have increased exponentially since reporting was made mandatory in 2008, and FDA warning letters citing failures to report have been on the rise as companies labor to keep up with investigations and reporting duties. Similar challenges could lie ahead for the cosmetics industry under proposed bills in the US House and Senate.
FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.