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Adverse Event Reporting Now Required for Cosmetic Products

18 Jan 2024 6:51 PM | Anonymous member (Administrator)

MINNEAPOLIS, Jan. 15, 2024 -- It is a little-known business story that sounds too good to be true. A small start-up company from Minneapolis transforms consumer product safety across an entire industry – and then goes on to lead seismic shifts in two additional industries and counting. And it all began with a tainted bottle of Tylenol.

"I don't think there is any one organization that has had a greater impact on the safety of products than we have," said Dr. Richard Kingston, co-founder of SafetyCall International and Pet Poison Helpline. "Our expertise and assistance with adverse event reporting not only helps the businesses that are required to report, but benefits consumers with significantly improved product safety."

On December 29, 2023, the Food and Drug Administration (FDA) began requiring cosmetic companies to document any health-related adverse events associated with their products, along with other new reporting requirements. This major piece of legislation, called the Modernization of Cosmetics Regulation Act, or MoCRA, is the latest example of the life-changing impact SafetyCall International, and its subsidiary Pet Poison Helpline (PPH), has had on consumer and pet product safety in this country. The SafetyCall team works with companies to not only meet government reporting requirements, but to manage adverse events. They then analyze adverse event data and work directly with product development and company leadership to improve and confirm product safety.

In addition to working with the FDA and various trade associations on the MoCRA legislation, SafetyCall/PPH was instrumental in developing and implementing the reporting requirements for dietary supplements and before that working with EPA on adverse event reporting for pesticides in the 1990s.

The company is officially celebrating its 20th anniversary in 2024, but its co-founders have been advocating for human and animal safety since the early 1980s when they were colleagues at the University of Minnesota. These two visionaries, Drs. Leo Sioris and Richard Kingston, created Minnesota's first public poison control center while with the University of Minnesota and eventually created SafetyCall/PPH, along with their partners and colleagues Drs. Dean Filandrinos, John Gualtieri and Lynn Hovda. They continue to lead the company today. 

"SafetyCall is the only triple-licensed medical practice in the country -- perhaps in the world – meaning that we can consult on any medical incidents involving humans or animals," explained Dr. Sioris. "Not only do we provide poison control response to consumers, human health and veterinary professionals, but we consult with product manufacturers on how to improve product safety, labeling, testing and reporting. In fact, our work led to the first medical emergency phone number on an EPA-approved label." 

Two hours after they started taking calls at their first poison control center located in a university affiliated hospital in the Twin Cities, the 1982 Tylenol cyanide poisoning story broke. The center received more than 2000 calls in the first 24 hours, launching the team's success. 

"We believe that MoCRA will have an enormous, positive impact on the safety of cosmetics, significantly changing how cosmetic providers deal with product safety, labeling and reporting," Dr. Sioris added. "We're proud to be an integral, if not well-known part of that process."

Beauty Industry West (BIW) is a nonprofit trade organization focused on bringing together today's innovators, entrepreneurs, experts and future industry leaders.




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