First, yes.
If your activities qualify for importing certain foods from certain small foreign suppliers, you are still required to have a DUNS number and to comply with the identification requirements at entry, but you are subject to significantly relaxed requirements in other areas. For example, you are not required to complete hazard analyses on the foods that you import; nor are you required to have supplier evaluation nor perform supplier verification activities. In addition to the identification requirements, you are subject to the following:
- You must obtain written assurance from your foreign supplier that they meet the definition of a small foreign supplier before approving the supplier for the applicable calendar year and thereafter on an annual basis by December 31 of each calendar year, for the following calendar year.
- Your remaining requirements depend on the classification of the small importer, but generally, you must obtain written assurance from your supplier prior to importing the food and at least every 2 years thereafter that they are producing the food in compliance with the applicable FDA regulations (or FDA-recognized equivalent laws of a foreign country).
- If you are not a Very Small Importer, you must also initially, and at least every three years, document your evaluation of the supplier’s compliance with relevant FDA regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action.
Sources:
- Federal Register Volume 80, Number 228, Page 74315 Sec 3 M. Very Small Importers
- 21 CFR 1.512