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What are the requirements for having to register with the FDA?

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brianweber

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Posted 22 May 2015 - 04:19 PM

What are the requirements for having to register with the FDA? We do not package food and we do not ship over seas. However we do make food grade packages. Composite paperboard containers. I have gone over the FDA website and have not been able to locate much on packaging unless we actually package food. Any help would be greatly appreciated!


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scottsc

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Posted 22 May 2015 - 04:29 PM

Hello Brian,

 

It seems like the link below addresses your question.

 

Regulatory Report: FDA's Food Contact Substance Notification Program

 

http://www.fda.gov/F...S/ucm064161.htm

 

Regards,

 

Scott



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K Hallman

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Posted 22 May 2015 - 05:28 PM

http://www.fda.gov/F...ion/default.htm

 

16.10 Q: Are facilities that manufacture food packaging required to be registered as food facilities? 

A: No. The definition of "food" in 21 CFR 1.227(b)(4)(i)(A), for the purposes of food facility registration, excludes food contact substances as defined in section 409(h)(6) of the FD&C Act

(21 U.S.C. 348(h)(6)). Consequently, a facility that manufactures/processes, packs, or holds food contact substances, i.e., food packaging, is not required to be registered.



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xylough

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Posted 23 May 2015 - 04:01 PM

Brian,

 

This analysis of the FDA  FSMA rules by SGS indicate that packaging manufacturers are exempt from registration. The rules are not yet final and some tweaking of the proposed rules continues, including the rules on registration, but there is scant indication that the exemption for packaging manufacturers will change.

 

Regards

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