What Is Dietary Supplement?

Why It Matters for Supplement Brands

A product's classification as a dietary supplement (rather than a food, drug, or cosmetic) determines which regulatory framework applies. DSHEA and its associated rules only apply to products that meet the legal definition of a dietary supplement. Products that fall outside this definition face different — often stricter — regulatory requirements.

How It Works

Under DSHEA (21 USC §321(ff)), a 'dietary supplement' must meet ALL of these criteria:

1. **Intended to supplement the diet** 2. **Contains one or more dietary ingredients**: vitamins, minerals, herbs or other botanicals, amino acids, concentrates, metabolites, constituents, or extracts 3. **Intended for ingestion**: pills, capsules, tablets, powders, softgels, gelcaps, or liquids 4. **Not represented for use as a conventional food** or as a sole item of a meal 5. **Labelled as a dietary supplement**

Products that don't meet this definition may be regulated as drugs, foods, or cosmetics, each with its own set of requirements. For example, a topical cream containing vitamins is a cosmetic, not a supplement, even though it contains dietary ingredients.

Common Mistakes to Avoid

• ✗Assuming any product containing natural ingredients qualifies as a dietary supplement
• ✗Marketing injection or topical products as dietary supplements (must be intended for ingestion)
• ✗Not labelling the product as a 'dietary supplement' — this is a specific legal requirement

Related Terms

See It in Action

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