Classification
Product TypeIngredient
Product FormExtract (powder, beadlet, or oleoresin)
Industry PositionDietary Supplement / Functional Food Ingredient
Market
Lycopene in the United States is primarily a downstream consumption and formulation market tied to dietary supplements and related nutraceutical products. Market access is strongly shaped by FDA’s dietary supplement regulatory framework (DSHEA) and the dietary supplement cGMP requirements in 21 CFR Part 111, which drive expectations for identity control, quality systems, and recordkeeping. Imported bulk dietary ingredients and supplements can face entry disruption through FDA detention actions (including detention without physical examination) when products appear to violate U.S. requirements such as new dietary ingredient compliance or unsafe additive concerns. As a carotenoid pigment commonly obtained from tomatoes, lycopene is also used in certain food applications as a color additive under the broader U.S. color additive regulatory system.
Market RoleImport-dependent consumer and downstream supplement-manufacturing market
Domestic RoleHigh-consumption nutraceutical ingredient used by U.S. supplement brands and contract manufacturers
Risks
Regulatory Compliance HighU.S. FDA import enforcement can block or severely delay entry of bulk dietary ingredients and dietary supplements through detention without physical examination when products appear to violate U.S. requirements, including cases involving new dietary ingredient (NDI) issues or unsafe additive concerns.Perform a documented U.S. regulatory status review for the specific lycopene material and intended use (including NDI considerations where applicable), maintain complete quality and safety documentation, and align manufacturing/quality controls to 21 CFR Part 111 with importer FSVP readiness.
Labeling And Claims MediumNoncompliant “Supplement Facts” formatting or misbranding issues can trigger regulatory action, delays, or commercial rejection in the U.S. supplement market.Validate finished-product labeling against 21 CFR 101.36 and FDA’s Dietary Supplement Labeling Guide; run a claims review to avoid prohibited or misleading claims.
Food Safety MediumContaminant or identity failures in bulk dietary ingredients (e.g., incorrect identity or unacceptable impurities) can result in adulteration concerns and import disruption.Implement strong component qualification and identity verification consistent with dietary supplement cGMP (21 CFR Part 111), including supplier approval, testing strategy, and batch record controls.
Labor And Ethics LowWhere lycopene is tomato-derived, downstream customers may flag agricultural labor-rights exposure and request supply-chain assurance aligned with U.S. tomato sector human-rights monitoring programs.Map tomato-derived raw-material sourcing, provide supplier transparency, and document social compliance alignment where relevant (e.g., participation in monitored programs or equivalent due diligence).
Labor & Social- If lycopene is sourced from tomato-derived supply chains, some buyers may request human-rights due diligence aligned to programs that emerged from U.S. tomato labor rights concerns (e.g., Fair Food Program oversight), depending on supplier sourcing transparency.
FAQ
What U.S. rules govern manufacturing quality for lycopene used in dietary supplements?In the U.S., firms that manufacture, package, label, or hold dietary supplements must follow FDA’s dietary supplement current good manufacturing practice (cGMP) requirements in 21 CFR Part 111, which drive expectations for component controls, quality systems, and recordkeeping.
What nutrition label format is required for dietary supplements sold in the United States?Dietary supplements use a “Supplement Facts” panel with formatting and content rules set out in 21 CFR 101.36, and FDA also publishes a Dietary Supplement Labeling Guide to help firms apply those requirements.
Can imported bulk dietary ingredients be stopped at the U.S. border?Yes. FDA can detain imported dietary supplements and bulk dietary ingredients without physical examination under import alerts when products appear to violate U.S. requirements, including import alerts that address new dietary ingredient issues and unsafe additive concerns.