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Adverse Event Reporting (AERs)

AER System Aids Soy Flour Recall

When FDA issues a recall alert for soy flour, the National Animal Supplement Council (NASC) used its adverse event reporting system to locate and notify companies selling the products. ...More
October 21, 2011
Posted in News
FDA Releases ‘At-A-Glance’ Guide on AERs

FDA released an "At-A-Glance" adverse event report (AER) document designed to outline the reporting requirements for the natural product industry and other useful information as it pertains to serious AERs. The two-page document gives a quick overview AERs ...More
August 12, 2011
Posted in News
NOW Foods Recalls Softgels for Excessive Vitamin D

NOW Foods recalled its Calcium & Magnesium Softgels after it determined the supplements contained 50 to 66 times more vitamin D than declared on the label. NOW reported it discovered the excessive levels after lab tests confirmed two adverse event reports (AERs) related ...More
June 8, 2011
Posted in News
The Supreme Court's Matrixx Initiatives Decision

Publicly traded companies can learn from Matrixx’s mistake of not disclosing serious adverse events for its Zicam Cold Remedy, which lead to losing a court battle and declining stock prices. ...More
April 6, 2011 By Marc Ullman
Posted in Articles, Immune Health
Regulatory Enforcement is Here

For years, the dietary supplement industry complained that FDA was not enforcing the law, and rightly so. Those days are over, and aggressive FDA enforcement is upon us. ...More
January 11, 2011
Posted in Blog
FDA Issues Staunch Warning on Adulterated Products

Products containing drug compounds but marketed as dietary supplements are illegal and their makers subject to criminal penalties, says a new warning letter from FDA. ...More
December 15, 2010
Posted in News, Sports Nutrition
Safety Beyond AERs

Companies that adhere to adverse event reports (AERs) by the book follow the law, but may not be increasing the safety of the industry or the public as a whole, said Rick Kingston, PharmD, president of regulatory and scientific affairs, SafetyCall International PLLC ,at the ...More
November 24, 2010
Posted in News, Contract Manufacturing
Bitter Orange Not Cause of AERs

The Journal Of Functional Foods (JFF) found bitter orange – a natural ingredient commonly found in dietary supplements, fruits and juices – was not responsible for adverse events presented in the 22 reports received from April 2004 to October 2009. ...More
November 23, 2010
Posted in News
FDA Issues Warning on Sex Product

FDA issued a consumer warning regarding Vigor-25, a product marketed as a dietary supplement for male sexual performance that in fact contains the active ingredient found in Viagra. ...More
November 19, 2010
Posted in News
Deep in the Heart of Texas

CRN's annual conference was a big Texas event slathered with rich education, networking and BBQ sauce. ...More
October 7, 2010
Posted in Blog