食品与膳食补充剂Food & Dietary Supplements

食品设施注册与续期Food Facility Registration & Renewal

在美国生产、加工、包装或仓储供人类/动物消费食品的企业，须向 FDA 注册食品设施。这是食品出口美国的第一道门槛，没有注册，货物到港就可能被扣。Facilities that manufacture, process, pack, or hold food for human or animal consumption in the US must register with FDA. It's the first gate for food exports — without registration, shipments can be held at the port.

• ✓谁要注册：Who must register: 境内外所有食品设施；纯境外企业必须指定一名美国代理人（US Agent）。All domestic and foreign food facilities; foreign facilities must designate a US Agent.
• ✓续期：Renewal: 每偶数年 10 月 1 日–12 月 31 日续期一次。2026 年就是续期年，窗口为 2026-10-01 至 2026-12-31。Every even-numbered year, October 1 – December 31. 2026 is a renewal year: the window is Oct 1 – Dec 31, 2026.
• ✓官费：Official fee: FDA 食品设施注册不收官费（$0）。FDA charges no fee for food facility registration ($0).
• ✓逾期风险：Risk of missing it: 未按时续期会被从注册库除名，FDA 与海关数据联动，货物可能被扣留。Late renewal means removal from the registry; FDA-Customs data sharing can get your shipments held.

膳食补充剂Dietary Supplements

膳食补充剂在美国上市前不需要 FDA 预先批准，但这不等于“零监管”：生产企业同样要做食品设施注册，并遵守 cGMP（21 CFR Part 111）。Dietary supplements don't need FDA premarket approval in the US — but that doesn't mean zero regulation: manufacturers must still register as food facilities and follow cGMP (21 CFR Part 111).

• Supplement Facts 标签须符合 21 CFR 101.36 的格式与内容要求。Supplement Facts labels must meet the format and content requirements of 21 CFR 101.36.
• 结构 / 功能声称（structure/function claims）须有科学 substantiation，并在上市后 30 天内通知 FDA。Structure/function claims need scientific substantiation and FDA notification within 30 days of marketing.
• 新膳食成分（NDI）上市前 75 天须向 FDA 提交通知。New dietary ingredients (NDI) require FDA notification 75 days before marketing.

标签合规Labeling Compliance

标签是 FDA 检查与进口抽查的高频问题点。我们提供中英文标签逐项审核，覆盖：Labels are a top trigger for FDA inspections and import exams. Our bilingual item-by-item label review covers:

• Nutrition Facts / Supplement Facts 营养成分表格式与计算。Nutrition Facts / Supplement Facts format and calculations.
• 过敏原声明：FALCPA 九大过敏原，含 2023 年起新增的芝麻（FASTER Act）。Allergen declarations: the FALCPA major allergens, including sesame added in 2023 (FASTER Act).
• 净含量、成分表、产地、警示语与各类声称（营养声称 / 健康声称）的合规边界。Net quantity, ingredient lists, country of origin, warning statements, and the compliance boundaries for nutrient / health claims.

罐头食品 FCE + SIDCanned Foods: FCE + SID

向美国出口低酸罐头食品（LACF）或酸化食品（AF），除食品设施注册外，还须完成两件事，缺一不可：Exporting low-acid canned foods (LACF) or acidified foods (AF) to the US requires two additional filings beyond facility registration — both are mandatory:

• FCE（食品罐头企业注册）：生产企业向 FDA 注册为罐头食品企业。FCE (Food Canning Establishment registration): the manufacturer registers with FDA as a canning establishment.
• SID（工艺备案）：每个产品的杀菌工艺 / 酸化工艺向 FDA 备案。SID (Scheduled Process filing): the scheduled thermal / acidification process for each product filed with FDA.

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