What Is Dietary Supplement?
A product intended to supplement the diet that contains one or more dietary ingredients (vitamins, minerals, herbs, amino acids, or other substances) and is intended for ingestion as a tablet, capsule, powder, softgel, liquid, or other form.
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
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