Company leads industry with its own voluntary reporting system since 1988
GHENT, NY – In the wake of the Senate and House passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which was sponsored in the Senate by Sen. Orrin Hatch, R-Utah, and in the House by Rep. Chris Cannon, R-Utah, Bioforce USA has announced its full support.
In fact, the company has been following its own rigorous AER protocol since 1988. For the past 11 years, Eileen Sheets, managing director of Bioforce USA, has been responsible for the company’s adverse event reporting. “We take everything seriously; it is our responsibility,” she comments. “Even if a customer calls and says ‘I took your product and than I felt funny’ we treat it as an adverse event and report it to the Medical Dept. at Bioforce AG in Switzerland. It is evaluated and entered into the AER database. Interesting, we never had a major complaint that would require notifying the FDA from any of our dietary supplements. However, you never can rule out that someone may have an unusual sensitivity to any product.”
Bioforce USA president Pierce Sioussat, remarks, “To the best of our knowledge, Bioforce was the first supplement company in the US with a formal AER process. This process was implemented as part of a broader GMP initiative which had been in place for nearly 20 years”
Bioforce USA hails the bill as progressive and a benefit to the industry as a whole, as it will create and accelerate consumer confidence, which has been sadly undermined by all the negative media. Tracking AERs will give the industry the ability to prove that dietary supplements provide a safe addition to health care. “It also goes a long way in abolishing the erroneous belief that our industry is ‘unregulated,’ Sheets adds.
Sheets and Sioussat are available for interviews about AERs. Each may be reached at (800) 641-7555.