Learning from others’ mistakes: NPA launches warning letter database

The online database is free for NPA members and will give regulatory, compliance, and QA/QC personnel of dietary supplement manufacturing facilities, own label distributors companies and retailers the ability to monitor and track the top GMP violations by year and see how those trends are changing.

The database also provides data on warning letters related to ‘technical adulterations’, dietary supplement labeling regulation, and making unauthorized health claims on products labels and in labeling.

“NPA is proud to announce a database for the industry that is more than just warning letters,”​ said Dr Dan Fabricant, CEO and executive director of NPA. “It differentiates itself by capturing enforcement actions from various agencies. While it is searchable in many different ways you would think a warning letter database would be; it is also being designed to search disease claims/claim categories and allow for customized reports by member end users.”​

‘Learn, grow, and mature as a collective whole’​

The database, which will be updated weekly, also tracks enforcement actions taken by various agencies against companies and contains over 440 Warning Letters that have been publicly released by FDA, in addition to the enforcement actions taken by DOJ, FDA, and FTC since 2008, giving users a wide ranging picture of federal actions against the industry beyond a warning letter, including seizures, injunctions, forfeitures, and criminal actions.

“The benefit to industry is to learn, grow, and mature as a collective whole by correcting any mistakes or oversights now that someone else may be doing,” ​said Dr Fabricant. “FDA does not provide GMP compliance education, nor does it track these parameters for the industry. Industry stakeholders need these types of tools to see how the industry is adapting to change and improving their compliance.​

“Another desired function is that you can search on claims/claim categories and misbrandings. NPA took the time to develop this project from start to finish to make it a highly functioning tool.” ​The database is searchable by company name, product name, issue date, regulation, disease claims/claim category, and FDA action taken.

While the database is only for NPA members the association said it will publish reports from time-to-time which will have a benefit for NPA members as well as consumers. 

GMPs​

GMP violations have changed over time, and the database will allow users to track changes.

“Tracking trends is always valuable for our members. That is something important for regulatory officers to know. It also begins to tells a story we could not tell previously without this data — are the violations changing as a result of a second, deeper layer cut FDA maybe taking or are FDA’s priorities changing? One trend to note is that the top 10 list of GMP charges cited by FDA is changing.”​ said Dr Fabricant.

Indeed, earlier citations were heavy on failure(s) to have/set specs whereas in the past two years there has been a decrease with those but they have been replaced by more technical charges like failing to test specs.