Paneles Supplement Facts que la FDA aprobará

Mezclas propietarias

Añada una línea "Proprietary Blend" con un total en mg. Los ingredientes constituyentes se listan sin cantidades individuales según § 101.36(c)(4). El símbolo "†" y la nota "Daily Value not established" aparecen automáticamente.

Sección "Other Ingredients:"

Los excipientes (cápsulas de gelatina, celulosa, estearato de magnesio, sílice, sabores naturales) se listan bajo el panel según § 101.36(d). El orden es de predominancia descendente - ordenable con un arrastre.

Advertencias de hierro + señales botánicas

Los productos con ≥ 30 mg de hierro por porción autogeneran el recuadro de advertencia por sobredosis obligatorio. Efedra, ma huang y metionina activan sus respectivas advertencias obligatorias.

Guía de declaraciones conforme a DSHEA

Las declaraciones de contenido de nutrientes en suplementos siguen § 101.13 como los alimentos. Las declaraciones de estructura/función necesitan el descargo de § 403(r)(6). Nuestro validador de declaraciones señala la redacción que provocará una carta de advertencia.

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.