The Natural Products Association has launched its database of Food and Drug Administration warning letters — a free online tool for members to research violations of good manufacturing practices, labeling regulations and making unauthorized health claims.
Dietary supplement manufacturers, distributors and retailers can monitor and track the top good manufacturing practices violations by year and see how those trends are changing. The database will also allow end users to create their own reports.
“NPA is proud to announce a database for the industry that is more than just warning letters,” said NPA CEO Daniel Fabricant, Ph.D. “It differentiates itself by capturing enforcement actions from various agencies. While it is searchable in many different ways, … it is also being designed to search disease claims/claim categories and allow for customized reports by member end users.”
The database is searchable by company name, product name, issue date, regulation, disease claims/claim category and FDA action taken. With the database, companies can more easily avoid misbranding their products or making unauthorized claims. It also tracks agencies' enforcement actions — including seizures, injunctions, forfeitures and criminal actions — against companies found to be violating agency rules.
“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,” Fabricant said. “The 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 more than 440 publicly released FDA warning letters and enforcement actions taken by the U.S. Department of Justice, the FDA, and the Federal Trade Commission since 2008. Fabricant added, “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 comprehensive database is a valuable tool for manufacturers, retailers and consumers who want to see if the FDA has found any issues with a company’s good manufacturing practices before purchasing products. The NPA will update the database weekly as new warning letters and enforcement actions are announced through various media.
“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 [the FDA might be] taking or are [the] FDA’s priorities changing? One trend to note is that the top 10 list of GMP charges cited by FDA is changing,” Fabricant said. “This is one of several online tools we are offering members over the course of the next 12 months.”