Upcoming Changes to FDA's OTC and Sunscreen Monograph

TEANECK, N.J., Nov. 21, 2019 /PRNewswire/ -- With the upcoming changes to FDA's OTC and Sunscreen Monograph, it is more important than ever to ensure that your entire manufacturing process is fully compliant and up to date. With the FDA doubling down on the stance that testing is considered part of the manufacturing process, it's imperative that brands go through extended due diligence to ensure that their products are both fully compliant with Title 21 CFR regulations and that their laboratory partners are as well.  As an FDA Registered facility, Validated Claim Support is well versed in FDA practices.

As with the 2011 Monograph, it is very likely that all US-bound SPF products will require retesting in an FDA Registered facility over the next 12-24 months (the timeline has historically been gross sales dependent on a brand to brand level).  How can you determine if your CRO is registered?  It's not enough to take anyone's word for it. . . Visit US FDA's own registration site and search for the name of the CRO in question.  https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm  If there is no record of registration, then the lab in question is out of compliance, and accordingly, any products tested there are also not up to FDA regulatory requirements.  Make 100% sure all of your partners are fully registered.

Ensure that your testing labs are utilizing current equipment, that their calibrations are up to date, and that they have the relevant and functional equipment requirements to meet the needs of your product requirements.  Ask about how many Water Resistant tubs they have, if they are using multiport vs single port simulators, and then get out to the lab to perform a site audit at the sites where the work is being conducted.  Many CROs have multiple sites – it's imperative that you visit the sites that physically conduct the FDA mandated work that you are involved with specifically.  With everything currently going on in the testing world, it is simply too risky to take everyone's word at face value.

Double-check the calibrations of relevant test standards during your visit, and brush up on what it means to compare against a calibrated standard.  It's very likely that site audits are going to become mandatory for brands, and that FDA is going to put the burden of audit responsibility directly onto the manufacturers themselves.  This means that it's time to brush up on what exactly a static SPF test is and how the mean value is calculated in the first place!

For more information on how the upcoming regulatory changes can impact your brand and your label claims, please reach out to Validated Claim Support at [email protected].  We're happy to walk you through the intricacies of the individual test methods, and with 8 single individual water-resistant controlled immersion tubs, we have the capacity to help ensure that your product is both safe and effective. We'd also welcome you to visit us at the Glenpointe Center in Teaneck to learn more about the upcoming monograph changes and get to meet the team helping the industry to validate its claims ethically and transparently.

Media Contact:
Jared Sanborn
845.64.98772
[email protected] 

SOURCE Validated Claim Support

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