Supplement, food, or drug

A tub of powder can sit in any of three regulatory categories depending on how it is presented, and the choice determines the label, the rules and the obligations.

Three categories, three regimes

A dietary supplement, under DSHEA and 21 CFR 111, with a Supplement Facts panel.

A conventional food, with a Nutrition Facts panel and food manufacturing rules.

A drug, if it claims to treat, prevent or cure, which is a different universe entirely.

The same powder can be any of them. What decides it is how you present and label it.

What makes it a supplement

DSHEA created dietary supplements as a distinct category covering vitamins, minerals, herbs, botanicals, amino acids, concentrates, metabolites and extracts, intended to supplement the diet.

The product must be identified as a dietary supplement on the principal display panel and carry a Supplement Facts panel rather than Nutrition Facts.

That naming is not cosmetic: it is what places the product under 21 CFR 111 rather than food cGMP.

Where a powder drifts into food

This is a live question for meal replacements and protein powders, which look like both.

Presenting a product as a food, as a meal, as a beverage, with food-style serving suggestions and a Nutrition Facts panel, makes it conventional food. Presenting it as supplementing the diet, with a Supplement Facts panel, makes it a supplement.

Pick one deliberately. A product with a Supplement Facts panel and food positioning, or the reverse, is a labeling problem waiting to be noticed.

The drug line

Structure/function claims are permitted with substantiation and the DSHEA disclaimer: supports, maintains, helps.

Disease claims are not. Treats, prevents, cures, or names a condition, and the product becomes an unapproved drug regardless of what the panel says.

That line is crossed in marketing copy far more often than on labels, and a reposted customer testimonial describing a condition being treated is your claim now.

References