Small Minnesota Company Leads Implementation of New FDA Legislation

24 January 2024

SafetyCall International and Pet Poison Helpline revolutionize consumer product safety

In a remarkable turn of events, a small start-up company from Minneapolis has become a driving force behind the implementation of new FDA legislation. SafetyCall International and its subsidiary, Pet Poison Helpline, have not only transformed consumer product safety but have also led significant shifts in multiple industries. This extraordinary journey began with a tainted bottle of Tylenol and has since propelled SafetyCall International to the forefront of product safety and adverse event reporting.

A Catalyst for Change in the Cosmetics Industry

On December 29, 2023, the FDA introduced the Modernization of Cosmetics Regulation Act (MoCRA), which mandates cosmetic companies to document any health-related adverse events associated with their products. SafetyCall International played a pivotal role in developing and implementing the reporting requirements for MoCRA. By working closely with the FDA and various trade associations, SafetyCall ensures that companies not only comply with government regulations but also effectively manage adverse events. The company’s expertise in analyzing adverse event data enables them to collaborate with product development teams and company leaders, leading to improved product safety and enhanced consumer protection.

A Legacy of Advocacy for Safety

SafetyCall International’s journey began long before the implementation of MoCRA. The company’s co-founders, Drs. Leo Sioris and Richard Kingston, have been champions of human and animal safety since the early 1980s when they established Minnesota’s first public poison control center at the University of Minnesota. Building on their experience, they created SafetyCall International and Pet Poison Helpline, along with their partners and colleagues. The company’s triple-licensed medical practice sets them apart, allowing them to consult on medical incidents involving both humans and animals. Their comprehensive approach includes providing poison control response, consulting with product manufacturers to improve safety measures, and contributing to regulatory advancements.

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From Tylenol Crisis to Industry Leaders

The pivotal moment for SafetyCall International came in 1982 when the Tylenol cyanide poisoning incident shook the nation. Just two hours after opening their first poison control center, the team received over 2000 calls, establishing their expertise in adverse event management. Since then, SafetyCall International has been at the forefront of product safety, continuously working to enhance labeling, testing, and reporting practices. Their efforts even led to the inclusion of the first medical emergency phone number on an EPA-approved label.

Expanding Impact in Multiple Industries

SafetyCall International’s influence extends beyond the cosmetics industry. They have also played a significant role in shaping adverse event reporting requirements for dietary supplements and pesticides. Their collaboration with the EPA in the 1990s paved the way for improved safety measures in the pesticide industry. By leveraging their expertise and experience, SafetyCall International continues to advocate for enhanced product safety across various sectors, safeguarding both consumers and the environment.

Celebrating 20 Years of Making a Difference

As SafetyCall International marks its 20th anniversary in 2024, the company’s co-founders, Drs. Sioris and Kingston, remain at the helm, leading the charge for product safety. With over four million managed product incident cases, SafetyCall International has positively impacted the safety of products worldwide. Their dedication to innovation and high-value services has made them a trusted partner for industry and government alike.

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SafetyCall International and Pet Poison Helpline have emerged as unlikely heroes in the realm of consumer product safety. Through their expertise in adverse event management and regulatory compliance, they have not only influenced the implementation of new FDA legislation but have also led the way in multiple industries. Their commitment to enhancing product safety, labeling, testing, and reporting has made a lasting impact on the well-being of consumers and their pets. As SafetyCall International continues to advocate for improved safety measures, their legacy as pioneers in the field of adverse event reporting is set to endure.

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