Suppose that somebody calls your dietary supplement company to report that he experienced shortness of breath and heart palpitations shortly after taking one of your products.  He is en route to the hospital, and he believes that your product is to blame.  Who at your business takes this call?  How does he or she respond?  How do you document this report?  How do you determine whether this was a non-serious adverse event or a Serious Adverse Event (“SAE”)?

Since 2007, manufacturers, packers, and distributers of dietary supplements have been required to report information about SAEs associated with the use of their supplements to the Food and Drug Administration (“FDA”).  An “adverse event” is “any health-related event associated with the use of a dietary supplement that is adverse.”  A SAE is an adverse event that results or could result in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or is considered an important medical event.  For SAEs, a supplement company must submit an Adverse Event Report (“AER”) to FDA using the MedWatch 3500A Form for each SAE report it receives.  Each company is also required to identify a Responsible Person, whose name is on the 3500A Form, and who serves as FDA’s contact person.

We work closely with Supplement Safety Solutions, a physician-based consulting company cofounded by Dr. Hector Lopez and Dr. Stephen Schmitz.  Supplement Safety Solutions recently launched Nutravigilance, a full-service safety and adverse event reporting program.  It can help companies improve their AER systems to exceed current regulatory standards.  Supplement Safety Solutions also offers a Nutravigilance verified seal.  Companies may license and display the trademarked seal, provided that they meet the program’s minimum requirements.  Nutravigilance-certified companies train their employees to recognize adverse events, maintain detailed standard operating procedures to process and report adverse events, perform signal detection activities to assess ongoing product safety, and stay abreast of relevant scientific and medical literature for safety-related reports.

According to Dr. Schmitz, “If you are not taking proactive steps to protect product safety, then you’re not doing enough.  That makes you vulnerable to regulatory liability and safety issues.”  We and Supplement Safety Solutions provide a safety net of product-safety monitoring, SAE reporting, and legal guidance.  Together, we strive to avoid FDA and other regulatory, criminal, and civil actions related to supplement safety.  And if your company comes under scrutiny, we can advise you on how to proceed.

If you or anyone you know has a question about Adverse Event Reporting or supplement safety, or if you would like to optimize your Adverse Event Reporting procedures, please contact us any time at 516-294-0300.

If you have a legal matter or question surrounding dietary supplement law/FDA Law, or are faced with an FDA Warning Letter, possible supplement recall or criminal charges surrounding dietary supplements, you need experienced counsel, straight answers and prompt attention. Call the dietary supplement lawyers of Collins, McDonald & Gann, P.C., at 516-294-0300 today to discuss how we can help in all aspects of dietary supplement law. We may be reached via facsimile at 516-294-0477 or by email at[email protected].