In late July 2013, the US Food and Drug Administration (FDA) released two major import verification rules affecting food products, including dietary supplements, under the terms of the Food Safety Modernization Act (FSMA). Now it has announced a new meeting intended to demystify its new Foreign Supplier Verification Program (FSVP), the backbone of its new regulations.
The common statistic brandished by FDA is that it regulates approximately a quarter of all products sold in the US. While this includes a great many drugs, medical devices and biological products, the biggest piece of the pie of regulated products belong to food, which contributes around 8% of the US' gross domestic product.
And, as with its healthcare counterparts, FDA has been having an increasingly difficult time regulating food products in recent years as supply chains become increasingly globalized, making it nearly impossible for FDA to ensure the safety of every food product exported to the US.
And with domestic government spending caps in place under the terms of budget sequestration, simply increasing FDA's budget to allow it to hire more inspectors isn't going to happen.
As a result, FDA has announced its plans to adopt the FSVP program, which heavily leverages third-party inspection capabilities in the hopes of allowing more routine regulatory inspections to be conducted by contractors, leaving FDA's own inspectors free to target more serious threats to the regulation of food products.
These changes, in addition to affecting more traditional food products like vegetables and fruits, will also impact another food product: dietary supplements.
Under the terms of the regulation, supplement manufacturers would need to certify that their products were produced in conformity and compliance with current good manufacturing practices and that they are not misbranded under the Federal Food, Drug and Cosmetic Act (FD&C Act), the backbone of US federal healthcare product regulation.
In order to do so, importers would have to obtain written assurance from a "qualified" entity that would be charged with performing an analysis of the product. FDA would "qualify" entities and individuals, which would require them to go through a training process or show technical competencies.
Any qualified entity that found that products were not manufactured or produced in accordance with good manufacturing practices (i.e. the product is adulterated) would have to take steps to prevent the product from entering into US commerce.
The entire system is also buttressed by a third-party auditing system, which is meant to ensure the safety of manufacturing facilities, and not just the products (as the first rule pertains to).
"Having comprehensive oversight of a credible and reliable program for third-party audits and certifications of foreign food facilities will help FDA prevent potentially harmful food from reaching U.S. consumers and thereby improve the safety of the US food supply," FDA wrote in its regulation, Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications. "We believe that a trusted program for foreign food safety audits and food and facility certifications-with clear requirements, standards, and procedures and operated under government oversight-will be appealing to accreditation bodies, auditors/certification bodies, and foreign food facilities."
Under the proposed system, FDA would recognize auditing organizations, which would then audit foreign food (including dietary supplement) facilities and issue certifications. In "limited circumstances," FDA said it would also allow some organizations to become directly accredited, allowing them to accredit other auditors and certification bodies on its behalf.
For our complete analysis of the FSVP regulations, please see our 26 July 2013 story, Dietary Supplements to be Subject to New Import Verification, Auditing Procedures.
Clarifying the New Requirements
But with such massive changes coming down the pipeline, FDA evidently understands that industry and the public may have some questions about the implementation and execution process under the FSVP, and has announced that a public meeting will be held on 19-20 September 2013, approximately two months before comments on the rule are due to FDA.
"Under the proposed FSVP rule, those importing FDA-regulated food into the United States will be held accountable for verifying that their suppliers produce food in a manner consistent with U.S. standards. Under the proposed rule that would establish the Accreditation of Third-Party Auditors/Certification Bodies program, FDA would recognize accreditation bodies based on certain criteria such as competency and impartiality. The accreditation bodies, which could be foreign governments or their agencies or private companies, would in turn accredit third-party auditors to audit and issue certifications for foreign food facilities and food."
So if you have a question for FDA with respect to how this program will work, now's your first chance to ask the agency in person. At least two other meetings will be scheduled in the coming months, FDA added, with other "additional public meetings [to be held] in diverse geographical regions of the US."
All of those meetings will have an identical agenda, FDA added.
FSVP Meeting Notice