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A formal documentation package proving that your food product is exempt from FCE-SID filing requirements under 21 CFR 108, 113, or 114. Useful when customs, retailers, or third parties ask whether you're required to file.
What's Included:
Written determination that your product is eligible for an exemption
Professionally formatted Exclusion Certificate (PDF) for sharing with buyers, customs, or auditors
One revision included if product details change within 30 days
Who It's For:
Manufacturers or importers of food products that fall outside FCE-SID jurisdiction — typically fresh products, naturally low-pH foods, or products in non-hermetic packaging — who need formal documentation of the exemption for compliance files or customer requests.
FAQs:
Q: How do I know if I'm exempt?
A: Generally, foods that are not low-acid canned, not acidified by adding acid or fermentation, or not in hermetically sealed containers may be exempt. We review your product details and confirm.
Q: Is this accepted by FDA?
A: FDA doesn't issue exclusion certificates — they're a private compliance document. But the analysis we provide cites the regulatory basis, which is what an FDA inspector or customs official would want to see.
Q: What if I'm uncertain about my exemption status?
A: Order the certificate. If our review determines you actually need to file, we apply the $389 fee toward the FCE-SID Filings service.
A formal documentation package proving that your food product is exempt from FCE-SID filing requirements under 21 CFR 108, 113, or 114. Useful when customs, retailers, or third parties ask whether you're required to file.
What's Included:
Written determination that your product is eligible for an exemption
Professionally formatted Exclusion Certificate (PDF) for sharing with buyers, customs, or auditors
One revision included if product details change within 30 days
Who It's For:
Manufacturers or importers of food products that fall outside FCE-SID jurisdiction — typically fresh products, naturally low-pH foods, or products in non-hermetic packaging — who need formal documentation of the exemption for compliance files or customer requests.
FAQs:
Q: How do I know if I'm exempt?
A: Generally, foods that are not low-acid canned, not acidified by adding acid or fermentation, or not in hermetically sealed containers may be exempt. We review your product details and confirm.
Q: Is this accepted by FDA?
A: FDA doesn't issue exclusion certificates — they're a private compliance document. But the analysis we provide cites the regulatory basis, which is what an FDA inspector or customs official would want to see.
Q: What if I'm uncertain about my exemption status?
A: Order the certificate. If our review determines you actually need to file, we apply the $389 fee toward the FCE-SID Filings service.