FDA Compliance Status
For a long time we have been in the secondary packaging business. Recently we have moved to the primary packaging business and some of our customers are informing us they are considering our secondary packaging product as primary due to its application in the consumer market.
We aren't registered currently with the FDA. Is this something we should look into pursuing? Or is it required now that we have moved to the primary packaging business? Our 3rd party and customer audits so far have not yielded any answer to this, and nothing on the FDA website is pointing exactly to the answer to my question.
I don't want to do more than necessary, but I also don't want us to be non-compliant because I was uninformed about details concerning our new process. Thank you in advance for your help.
Do you sell packaging or do you package food products?
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Do you sell packaging or do you package food products?
We sell food packaging. No food products are in the facility.
FDA registration guidance: https://www.fda.gov/...n/UCM332460.pdf
C.1.12 [Added December 2016] Are facilities that manufacture food additives and color additives for food use required to register as a food facility? Food additives and color additives for food use are “food” as defined in section 201(f) of the FD&C Act (21 U.S.C. 321(f)). Therefore, many food additive and color additive facilities are required to register because these facilities manufacture/process, pack, or hold food for consumption in the United States. However, if a food additive is not intended to have a technical effect in or on the food and meets the definition of a food contact substance in section 409(h)(6) of the FD&C Act (21 U.S.C. 348(h)(6)), it is excluded from the definition of “food” for purposes of food facility registration (see 21 CFR 1.227). (See, for example, Questions C.2.5, C. 2.6, C.2.10, and C.2.12.). Consequently, facilities that manufacture food contact substances are not required to register.
If you only manufacture food packaging, you are exempt from registration. You must however, conform to the requirements for food contact substances and manufacture under an FDA approved process.