The recent report, issued by the Office of Inspector General of the Health and Human Services department, looked at the same 127 supplement products that were evaluated for another recent report on label claims.
The report found that of 79 companies interviewed that had one or more facilities that should have had registered, 28% had not registered their facilities with FDA as required by the 2002 Bioterrorism Act. In addition, officials at 32 of the 86 companies interviewed for the report were unaware of FDA registration requirements, leading the authors of the report to question whether companies were keeping the registry up to date. Implied in this statement is the idea that some of these company officials were hired after the initial registrations were done.
Some of these questions likely will be cleaned up after the companies start complying the new registrations that are required under a later law, the Food Safety and Modernization Act. Those registrations will be need to be completed before the end of the year, though FDA announced recently that it is not prepared to accept them as yet.
Among the report’s recommendations was a suggestion that FDA seek authority to impose monetary damages on companies that do not comply with the requirements, both for information on labels and in having updated facility registration information on file with FDA. The report’s authors said FDA concurred with the idea.
Ivan Wasserman, an attorney with Washington, D.C.-based law firm Manatt, Phelps & Phillips and an expert on FDA compliance issues, said it’s not surprising that some companies were ignorant of the law. It’s a big, variegated industry, he said, with large, sophisticated companies on the upper end and a contingent of recent entrants and smaller firms on the low end.
“Much like the claims report, I do think the vast majority of industry understands and is following the rules of who must register with FDA and when the registrations must be updated. The fact that some companies are unaware is not particularly surprising,” he told NutraIngredients-USA.
“I don’t think there is willful noncompliance. I don’t think it’s rampant.”
As far as the fines issue is concerned, Wasserman thought the money spent trying to impose and collect fines could be put to better use on outreach to try to educate more companies on the requirements.
“People won’t be scared of getting fined if they don’t know they were in violation in the first place,” he said.