New software enables consumers to report adverse effects of cosmetics directly via QR codes | 23-09-2024 |

Registrar Corp, headquartered in the USA, which claims to be the world’s largest FDA compliance company - with over 32,000 clients in 190 countries - has launched adverse event management (AEM) software in response to FDA’s Modernization of Cosmetics Regulation Act (MoCRA) according to a recent report in Packaging Digest. 

FDA’s new regulation stipulates that contact information for reporting adverse events must be displayed on both primary and secondary packaging. The rule also calls for the collection of detailed personal and medical information from the consumer and has a tight reporting timeframe.

The AEM software solution provides cosmetic companies with an electronic contact in the form of a brand-specific URL or QR code that the consumer can use to report an adverse effect, according to Jaclyn Bellomo, Registrar’s senior director of cosmetic science and regulatory affairs. 

The company believes cosmetics companies are poorly prepared for the FDA’s new Adverse Events Requirements. The new regulations will not only impact compliance and regulatory departments but require tight coordination with marketing (product labelling), quality and manufacturing (investigation), legal (consumer liability), and R&D (formulation safety).

“As a brand, you want to be the first one to know there is an issue with your product,” says Bellomo. “This contact communicates to the consumer where to report the adverse event so they avoid using other platforms, such as reporting an event to the FDA versus the brand.”

Consumers who visit the URL or scan the QR code on the package are directed to a landing page where they can enter all the necessary data required under MoCRA for reporting adverse events. The form, which consists of 40-plus fields, is designed to ensure that brands collect as much information as possible during this first point of contact with the consumer.

After collecting the data, the AEM platform tracks all adverse events for all products globally, transmits information to internal stakeholders and formats serious adverse events to the FDA MedWatch format for submission to the FDA.

Although Registrar launched the software to meet an immediate need in the cosmetic industry, Bellomo believes that the company is developing the software management solution for use in other industries in the future. 

“Pharmaceuticals and nutraceuticals cannot have an electronic contact on the packaging for adverse event reporting, but the system can eventually be used to manage adverse events that come in via the mail or a phone call,” she says.

Once adverse events are entered into the system, the software would allow pharmaceutical and nutraceutical companies to manage communications between the consumer and the brand as well as internally among quality, safety, regulatory, and manufacturing departments.

“In the past six months, we have helped over a thousand cosmetics companies get MoCRA ready with product listings, registrations, and label reviews,” said Raj Shah, CEO of Registrar Corp. “As FDA enforcement now ramps up and retailers press on brands to get fully MoCRA compliant, we recognized the urgent need to solve their Adverse Events need with our AEM software.”

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