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The Natural Products Association has launched a new database of more than 400 dietary supplement warning letters from FDA, as well as other regulatory enforcement actions taken since 2008.
The Natural Products Association (NPA; Washington, DC) has launched a new online database that includes dietary supplement warning letters from FDA, as well as other enforcement actions taken by FDA, FTC, and the Department of Justice (DOJ) since 2008.
The new online tool, which is available free to NPA members, allows users to view violations against dietary supplement GMPs, information about dietary supplement labeling regulation, and instances of companies making unauthorized health claims on product labels. While listing FDA warning letters is a big part of the database, it goes well beyond that, explained Dan Fabricant, CEO and executive director of NPA.
“It differentiates itself by capturing enforcement actions from various agencies,” Fabricant said. “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/claims categories and allow for customized reports by member end users.”
In addition to browsing the database by disease claims, users can search entries by company name, product name, regulation, issue date, and FDA action taken. The system contains more than 440 warning letters publicly released by FDA, in addition to the other included enforcement actions by FTC, FDA, and DOJ, such as seizures, forfeitures, injunctions, and criminal actions.
In designing the database, one of NPA’s hopes was that the dietary supplement industry can “learn, grow, and mature as a collective whole by correcting any mistakes or oversights now that someone else may be doing,” Fabricant said.
“FDA does not provide GMP compliance education, nor does it track these parameters for the industry,” Fabricant said. “Industry stakeholders need these types of tools to see how the industry is adapting to change and improving their compliance.”
Interested users can track the top GMP violations from year to year and see how enforcement trends have changed, Fabricant explained.
“It also begins to tell a story we could not tell previously without this data,” Fabricant said. “Are the violations changing as a result of a second, deeper layer cut FDA may be 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. This is one of several online tools we are offering members over the course of the next twelve months.”
NPA intends to update the database on a weekly basis.
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