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面向补充剂品牌

经得起 FDA 审核的 Supplement Facts 面板

膳食补充剂有自己的规则手册(21 CFR § 101.36)。NFL 可构建成人、儿童、婴儿、孕期与哺乳期面板--包括专有配方与警示语。

构建补充剂标签查看功能页
Supplement Facts, drawn to §101.36.

全部 5 种人群变体

成人 DV 与食品面板一致。1–3 岁儿童使用 § 101.9(c)(8)(v) 儿童 DV 表。12 个月以下婴儿另有专表。孕期与哺乳期表格反映了铁、碘、叶酸和胆碱的更高需求。切换人群后所有 %DV 自动重算。

专有配方

添加“Proprietary Blend”行并填写总量(毫克)。按 § 101.36(c)(4),成分列出但不标单项用量。“†”符号与“Daily Value not established”脚注自动出现。

“Other Ingredients:”部分

辅料(明胶胶囊、纤维素、硬脂酸镁、二氧化硅、天然香料)按 § 101.36(d) 列在面板下方。顺序为含量降序--一次拖拽即可排序。

铁警示与植物成分标记

每份铁含量 ≥ 30 mg 的产品自动生成法定过量警示框。麻黄(ephedra、ma huang)与蛋氨酸会触发各自的强制警示。

符合 DSHEA 的声称指引

补充剂上的营养素含量声称与食品一样遵循 § 101.13。结构/功能声称需要 § 403(r)(6) 免责声明。我们的声称校验器会标记可能招致警告信的措辞。

The line between a structure/function claim and a drug claim

This is where supplement brands get warning letters, and the distinction is narrower than it looks from the marketing side.

A structure/function claim describes how an ingredient affects normal structure or function of the body. "Supports immune health." "Helps maintain healthy joints." "Promotes restful sleep." These are permitted under DSHEA, and they carry two obligations: the product must bear the disclaimer - "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." - and you must notify the FDA within 30 days of first marketing the claim.

A disease claim says or implies the product treats, prevents, cures, or mitigates a disease. "Relieves arthritis pain." "Lowers cholesterol." "Prevents colds." These are drug claims. Putting one on a supplement makes it, in the FDA's view, an unapproved new drug - and that is a different category of enforcement than a labeling correction.

The edge is genuinely subtle. "Supports healthy blood sugar already in the normal range" sits inside structure/function. "Helps control blood sugar" reads as a diabetes claim. Same ingredient, same dose, one of them is a problem.

New Dietary Ingredients

If your formula contains a dietary ingredient that was not marketed in the United States before 15 October 1994, it is a New Dietary Ingredient, and NDI status carries a premarket notification obligation: you file with the FDA at least 75 days before marketing, with the evidence supporting a reasonable expectation of safety.

Novel botanicals, newly isolated compounds, and ingredients produced by a manufacturing process that materially changes them are the usual candidates. It is worth checking before you formulate rather than after your first production run, because the answer can change what you are able to sell.

Serving size, and the manufacturing rules behind the panel

Supplement serving sizes are expressed in the unit the consumer actually takes - one capsule, two tablets, one scoop, one softgel - rather than in grams. If your directions say two capsules, the panel is per two capsules, and every %DV on it follows from that.

Behind the label, dietary supplements are manufactured under their own current Good Manufacturing Practice regulations at 21 CFR Part 111, which govern identity testing, batch records, and specifications. A correct Supplement Facts panel on product made outside Part 111 is still a compliance problem - the panel is the visible layer over a manufacturing obligation that a contract manufacturer will expect you to understand.

Supplement label requirements: common questions

Can I say "clinically proven"?
Only with substantiation that supports it, and the FTC governs advertising claims independently of the FDA's labeling rules. Two agencies, two standards, both applying to the same sentence.
Do I need the disclaimer on every claim?
On structure/function claims, yes. Nutrient content claims like "high in vitamin C" do not carry it.
What if my product is a food, not a supplement?
Then it takes a Nutrition Facts panel under § 101.9, not Supplement Facts under § 101.36. Functional foods and gummies sit near this boundary and the intended-use framing usually decides which side you are on.
Does the "†" footnote appear automatically?
Yes - proprietary blends and ingredients with no established Daily Value get the symbol and the "Daily Value not established" footnote generated with the panel.

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