The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the first major change to FDA’s cosmetics authorities since the passage of the Food, Drug, and Cosmetic Act in 1938. Among other changes in requirements, MoCRA establishes the first ever requirement for cosmetic companies to monitor and document all consumer allegations of adverse health effects and report to the FDA …
SafetyCall’s Formal Affiliation with the University of Minnesota College of Veterinary Medicine
SafetyCall/ Pet Poison Helpline is excited to share that we have entered into a formal affiliation agreement with the University of Minnesota College of Veterinary Medicine (UMN CVM). Our collaborative relationship with the UMN CVM spans over several decades during which we have remained focused on our mutual commitment to graduate day-one-ready veterinarians.
SafetyCall/Pet Poison Helpline helps to prepare the …
FDA Food Safety Compliance Initiatives
Presently, although there is no requirement for submitting individual adverse event human case reports involving food products to the FDA the Agency does have the expectation that manufacturers have a strong quality management system in place to document and investigate adverse events. This will allow the manufacturer to identify unexpected new risks or hazards with their distributed food products and …
EPA and FDA CVM Hold Joint Public Meeting to Hear Comments on Modernization Plan
Last Wednesday, March 22nd, several members of SafetyCall’s regulatory team sat in on EPA and FDA’s Center for Veterinary Medicine (CVM) first joint public meeting in which they presented a general and high level rationale and framework for their proposed modernization plan and heard the public’s questions and comments. EPA and FDA gave no specific updates during the …
SafetyCall Attended The First Personal Care Product’s Council’s MoCRA Working Group Meeting
Last Thursday, March 23rd, SafetyCall attended the first of the Personal Care Product’s Council’s (PCPC) Modernization of Cosmetics Reform Act (MoCRA) Working Group meetings in New York. Over 100 cosmetics industry leaders and representatives attended the in-depth discussion co-hosted by
PCPC and their legal team at Covington & Burling LLC. The session focused on clarification of the law …
Proposed Change of Agency for Oversight of Animal Health Products
This past Wednesday, March 1st, EPA and FDA’s Center for Veterinary Medicine hosted a joint information session for industry stakeholders regarding a proposed change of agency for oversight of animal health products, such as flea/tick spot-ons and collars. An estimated 600 products would be impacted by this proposal, expected to take approximately 5 years to implement. This is …
SafetyCall International and Pet Poison Helpline: One team, Two Similar Missions
At SafetyCall, our mission is to make the world a safe place! We do this by reassuring and providing quality care for our clients, their customers, animals and pets by delivering immediate, 24/7 access to clear and trusted health, safety and medical information, and by enhancing and promoting product safety.
To further support animals and the veterinary community, SafetyCall developed …
Breaking news for cosmetic manufacturers! New mandatory adverse event reporting requirements!
During the 11th hour of 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MOCRA) as part of the Consolidated Appropriations Act. SafetyCall has been closely monitoring the proposed cosmetic legislation for several years and, as anticipated, the MOCRA of 2022 establishes new regulations related to monitoring adverse events and mandatory reporting of all …
SafetyCall at Supply Side!
SafetyCall recently attended the packed Supply Side West show in Las Vegas.
It was great to see the show back in full swing with so many new and familiar faces! Dr. Rick Kingston, SafetyCall’s President of Regulatory and Scientific Affairs, participated during the show in a panel discussion on the toxicity potential of white mulberry, hosted by Informa Markets’ Assistant …
Calendar of Activities for Monograph Over The Counter Products
FDA CDER’s Office of Nonprescription Drugs recently released its calendar of activities for monograph OTC products on September 30th. Planned activities largely surround GRASE status of active ingredients including codeine, oral benzocaine and/or phenol preparations, and ipecac. Additionally, the office will be reviewing PLLR labeling for NSAIDs; risks and benefits of cough/cold preparations for children under 6yrs; abuse/misuse risks of …