The Natural Products Association (NPA), Washington, D.C. has launched its highly anticipated warning letter database. This database will be a free online tool for NPA members to view violations against the dietary supplement Good Manufacturing Practices (GMPs), which are deemed as ‘technical adulterations’ by FDA, dietary supplement labeling regulation, and making unauthorized health claims on products labels and in labeling. Regulatory, compliance, and QA/QC personnel of dietary supplement manufacturing facilities, own label distributors companies and retailers can use this information to monitor and track the top GMP violations by year and see how those trends are changing. The database will also allow end users to create their own reports. According to NPA CEO Dr. Daniel Fabricant, “NPA is proud to announce a database for the industry that is more than just warning letters. 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.”
 
The database is also beneficial for those responsible for labeling compliance to avoid the introduction of misbranded products into interstate commerce and those marketing with claims. The database also tracks enforcement actions taken by various agencies against companies. NPA wants their members to be able to view the entire scope of federal actions against the industry beyond a warning letter, including seizures, injunctions, forfeitures, and criminal actions. Added Dr. Fabricant, “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. 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.”
 
The database 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. Added Dr. Fabricant, “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.
 
The comprehensive database is a valuable tool not only for dietary supplement manufacturers, but also retailers or consumers who want to see if FDA has found any issues with a company’s GMPs before purchasing their products. NPA will update the database weekly as new warning letters and enforcement actions are added through various public and federal agency media outlets.
 
“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. “This is one of several online tools we are offering members over the course of the next twelve months.”