FDAの要件を満たすSupplement Factsパネル

プロプライエタリーブレンド

合計量(mg)を伴う「Proprietary Blend」行を追加できます。構成原材料は § 101.36(c)(4) に従い個別量なしで列挙されます。「†」記号と「Daily Value not established」の脚注が自動的に表示されます。

「Other Ingredients:」セクション

賦形剤(ゼラチンカプセル、セルロース、ステアリン酸マグネシウム、シリカ、香料)は § 101.36(d) に従いパネルの下に列挙されます。順序は含有量の多い順で、ドラッグ1回で並べ替えられます。

鉄分の警告 + 植物由来成分のフラグ

1回分あたり鉄分30mg以上の製品には、必要な過剰摂取警告のボックスが自動生成されます。エフェドラ、マオウ、メチオニンについても、それぞれの必須警告がフラグ表示されます。

DSHEA準拠のクレーム指針

サプリメントの栄養素含有量クレームは、食品と同様に § 101.13 に従います。構造・機能クレームには § 403(r)(6) の免責文言が必要です。当社のクレームバリデーターが、警告書につながりかねない表現をフラグ表示します。

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.