If you sell dietary supplements into the US on Amazon, Shopify, or anywhere else, the single biggest avoidable reason your shipment gets held at the border is the words you printed on the bottle.如果你在美国卖膳食补充剂,无论是亚马逊、Shopify 还是其他渠道,最容易让你的货件在边境被扣的、且最可避免的原因是你印在瓶子上的那几个词。
The FDA distinguishes between "structure/function" claims (allowed for supplements) and "disease" claims (not allowed). The line between them is finer than most brand teams realize. Below are the seven phrases we see fail labels most often, and the safe rewrites we use.FDA 区分"结构 / 功能声明"(补充剂可用)和"疾病声明"(不可用)。两者的界限比品牌团队想象的要细。下面是我们最常见的 7 个会让标签被拒的措辞,以及我们用过的安全改写方式。
1. Why words on a supplement label matter so much1. 为什么补充剂标签上的措辞这么关键
A drug, in FDA's definition, is anything "intended to diagnose, cure, mitigate, treat, or prevent disease." If your label says your supplement does any of those things, you've just claimed your product is a drug — and an unapproved one. Customs holds the goods; FDA refuses entry.按 FDA 定义,"药品"是用于"诊断、治愈、缓解、治疗或预防疾病"的产品。如果你的标签说你的补充剂"治疗"了什么,那你就声明它是药品 —— 而且是未经批准的药品。海关扣货,FDA 拒绝入境。
A supplement can "support healthy joints." It cannot "treat joint pain." Same product, same dose, different word — the second one ends in detention.一款补充剂可以"支持关节健康"。它不能"治疗关节疼痛"。同样的产品、同样的剂量、不同的词 —— 第二个会让货被扣。
2. The seven phrases2. 七个高危措辞
| # | Risky phrase高风险措辞 | Why it fails为什么会失败 | Safe rewrite安全改写 |
|---|---|---|---|
| 01 | treats anxiety | Disease claim — anxiety is a disorder疾病声明 —— 焦虑是病症 | supports calm focus |
| 02 | cures inflammation | "Cure" + disease state"治愈"加病症 | helps maintain healthy inflammatory response |
| 03 | prevents osteoporosis | "Prevents" + disease"预防"加疾病 | supports bone density |
| 04 | lowers cholesterol | Implies treatment of hypercholesterolemia暗示治疗高胆固醇 | supports healthy cholesterol levels already in the normal range |
| 05 | fights diabetes | "Fights" + disease"对抗"加疾病 | supports healthy blood sugar metabolism |
| 06 | reduces arthritis pain | Treats symptom of named disease治疗已命名疾病的症状 | supports joint comfort and mobility |
| 07 | relieves depression | "Relieves" + diagnosed condition"缓解"加确诊状态 | supports a balanced mood |
A customer's quote saying "this cured my arthritis" on your product page or label is treated the same as if you said it. You are responsible for content you publish — including customer reviews you display.客户在你的产品页或标签上引用"它治好了我的关节炎",FDA 视同你自己说的。你对你发布的所有内容负责 —— 包括你展示的用户评价。
3. The safe pattern: "supports + healthy + body part / system"3. 安全模板:"support + healthy + 身体部位 / 系统"
If you remember one formula, remember this:如果你只能记住一个公式,记这个:
supports + healthy + [organ / system / function]支持 (supports) + 健康 (healthy) + [器官 / 系统 / 功能]
"Supports healthy joint function." "Supports healthy immune response." "Supports healthy energy production." These are structure/function claims and are allowed (with the standard FDA disclaimer printed on the bottle)."支持健康的关节功能。""支持健康的免疫反应。""支持健康的能量代谢。"这些是结构 / 功能声明,是允许的(瓶身需印 FDA 标准免责声明)。
What is NOT allowed: anything that names a disease, anything that uses verbs like "cure", "treat", "prevent", "diagnose", "fight", "relieve", "reduce" attached to a symptom of a named condition.不允许:任何命名疾病的措辞;任何把"治愈 / 治疗 / 预防 / 诊断 / 对抗 / 缓解 / 减少"与已命名疾病症状连接的措辞。
4. The mandatory disclaimer (and how it must look)4. 必须印的免责声明(以及它必须怎么排版)
Every supplement label that makes a structure/function claim must carry this exact disclaimer:凡是做结构 / 功能声明的补充剂标签,都必须印这一句:
"These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.""These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."(必须是英文原文)
Type-size rule: the disclaimer must be in a font no smaller than 1/16 inch. We see brands shrink it to 4pt to fit; that's a guaranteed flag.字号要求:不得小于 1/16 英寸(约 4.5pt 以上,实际推荐 6pt+)。我们见过品牌缩到 4pt 想塞下去 —— 这一定会被标记。
5. What our team actually does in label review5. 我们在标签审核时具体做什么
- Scan every word on the label against our 1,800-term disease-claim database.用我们 1,800 词的疾病声明数据库扫描标签每一个词。
- Flag every claim, classify it as compliant / borderline / fail, and propose a rewrite for each borderline+ item.标记每一条声明,分类为合规 / 临界 / 不合规,临界及以上的提出改写建议。
- Verify ingredient order, allergen statement, country-of-origin, net quantity, supplement facts panel formatting, disclaimer type size.核对成分顺序、致敏原声明、原产国、净含量、补充剂事实表排版、免责声明字号。
- Cross-check the brand's website and Amazon listing against the label — what you say online has to match what's on the bottle.交叉核对品牌官网与亚马逊页面 vs. 标签 —— 线上线下声明必须一致。
- Deliver annotated PDF + a pre-print proof you can hand to your printer.交付批注 PDF + 印前样张(可直接给印刷厂)。
Average turnaround for 10 SKUs: 3–5 business days. For ongoing engagements (registration + ongoing): all SKUs reviewed continuously as part of the retainer.10 个 SKU 平均周转:3–5 个工作日。"注册 + 持续"客户:所有 SKU 在月度框架内持续审核。