Do you need a license to sell herbal products?

Herbal products may be regulated as conventional foods, dietary supplements, cosmetics, or drugs depending on their formulation, intended use, labeling, and advertising. A botanical capsule marketed for general wellness may qualify as a dietary supplement, while the same ingredient promoted as treating or preventing a disease could be regulated as a drug.

Potential requirements include:
• General business and seller permits
• State or local food-manufacturing licenses
• FDA food-facility registration for applicable facilities
• State dietary supplement or product registrations
• Importer and customs compliance
• Dietary supplement GMP controls
• New dietary ingredient notification where required
• Accurate Supplement Facts, ingredient, allergen, and warning labels
• Substantiation for marketing claims
• Serious adverse-event reporting and complaint records

The FDA does not routinely approve dietary supplements before marketing, but the responsible company must ensure that the product is safe, legally formulated, properly labeled, and not adulterated or misbranded. Some botanicals may also be restricted because of safety concerns, controlled-substance rules, wildlife protections, or import and agricultural requirements.

Online sales do not remove these obligations. Private-label businesses should obtain and review manufacturing agreements, certificates of analysis, ingredient specifications, label approvals, insurance, and recall procedures. Because herbal-product requirements vary substantially among jurisdictions, a regulatory review should be completed before manufacturing, importing, or launching the product.