Fsvp Importer Agreement

We believe that, given the nature of the imported product, these specification and verification rules contained in the CGMP Dietary Supplement Regulations provide reasonable assurances that the supplier produces the food in accordance with Sections 402 and 403(w) of the FD&C Act. For this reason, we propose in section 1.511(a) that importers who, pursuant to subsections 111.70(b), (d) or (f) are required to establish specifications for a food they import and who meet the requirements of Part 111 that apply to determine whether those specifications are met, are not required to meet the provisions of paragraphs 1.503 to 1.508 (with the exception of subsections 1.506(a)). In addition, proposed Article 1.506(g)(5) states that the importer shall take appropriate corrective action in accordance with proposed Article 1.507(c) if the results of verification activities show that hazards that were reasonably likely to a food are not properly controlled. As stated in Section II.H.3 of this document, Article 1.507(c) would require an importer to immediately take appropriate corrective action when it finds that its foreign supplier is not producing a food in accordance with processes and procedures that provide at least the same level of public health protection as required by points 418 or 419 of the FD&C Act if falsified or poorly falsified food labeled in accordance with Section 403(w) of the FD&C Act are produced. Appropriate remedial action would depend on the circumstances, but could include stopping the use of the foreign supplier until the cause or causes are properly addressed. . . .