Suppliers, laboratories and manufacturers each hold part of an ingredient's evidence, and EUTECNIQ proposes to keep that evidence in one accountable record

1. Grower or wild collector. CITES permits for listed species; 31 CFR 560.201 prohibits importing goods of Iranian origin.
2. Primary processor. Dries, cleans, cuts and mills.
3. Extractor or ingredient maker. An operation that sells only to manufacturers who further process the ingredient is generally under Part 117; FDA states that such a firm is not subject to Part 111 if its only customers further process the ingredient.
4. Importer or distributor. Foreign Supplier Verification Program duties under 21 CFR Part 1, Subpart L, modified for supplements by 1.511.
5. Ingredient brand. A new dietary ingredient requires a notification to FDA at least 75 days before marketing (21 CFR 190.6).
6. Supplement brand or contract manufacturer. Part 111 applies to anyone who manufactures, packages, labels or holds a dietary supplement (111.1(a)).
7. Retailer. Part 111's holding requirements do not apply to holding at a retail establishment solely for direct sale to individual consumers (111.1(b)).

Alongside: testing laboratories (Part 111 requires scientifically valid methods, 21 CFR 111.75(h)(1)), contract research organizations (IRB review and informed consent under 21 CFR 50 and 56 for FDA-regulated investigations) and AI discovery firms.

• Importer and ingredient manufacturer sells material by the kilogram with a certificate of analysis (JiaHerb).
• Branded-ingredient developer sells a trademarked or patented ingredient and the studies behind it (Sabinsa, Nuritas).
• Contract testing laboratory sells a test result in a report (Eurofins, SGS, Alkemist Labs).
• Contract manufacturer sells manufactured batches and development services (NAI, Lonza Capsules & Health Ingredients).
• Contract research organization sells a study run to a protocol (Nutrasource, part of SGS).
• AI discovery firm sells candidate molecules or ingredients from data (Enveda, Brightseed, Nuritas).
• EUTECNIQ, proposed, would sell development programs and decision documents, with testing as a service; ingredients and manufacturing would follow later gates.

2000 founded in Xi'an, China; 2005 ISO 9001, ISO 14001 and HACCP; 2008 New Jersey location with NSF-GMP, ISO 22000 and ISO 17025 certifications; 2010 California location; 2012 USDA and EU organic certification; 2015 U.S. operations in New Jersey and California over 100,000 sq ft with over 2,500 tons stored; 2017 botanical identification chain-of-custody program; 2018 a 1.5 million sq ft manufacturing campus in China and FSSC 22000; 2019 sponsored and validated a USP monograph for feverfew extract (trade press); 2023 own organic-certified farm; 2024 a 140,000 sq ft laboratory and R&D center. Its site states an in-house ISO 17025 laboratory of 22,000 sq ft with HPLC, GC, HPTLC and ICP-MS, a HerbaLink chain-of-custody program using DNA, HPTLC and HPLC, and more than 500 ingredients.

"Our comprehensive strategic partnerships with our customers allow us to offer a wide range of innovative nutritional products and services to such customers including scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review, and international product registration assistance."

Sabinsa, Indena, Alkemist Labs, Eurofins, Lonza CHI, Enveda, Brightseed and Nuritas entries reuse the facts verified on Competitive landscape.

In an illustrative program, a collector, processor, importer, two laboratories, a formulator, a contract research organization and a brand each issue their own identifier, certificate or report; seven handoffs separate the harvest from the product. In the proposed model, the same partners would do the same work, but each result would be written to one lot record with its source document, method, raw data and reference material, and certificates would be printed from that record.

• One record from specification to identity evidence: every certificate line traceable to lot, method, raw data and reference material; a customer could ask for the record behind any line; it would not establish product safety or efficacy.
• Written decision gates: criteria written before data arrive, every stop or go dated and signed; checked by reading the gate document; it would not establish that the criteria suit every product.
• A recorded multi-objective decision: gates, limits, weights, the Pareto set and uncertainty stored with each ranking; checked by re-running the ranking; it would not establish that the weights match the customer's priorities unless the customer sets them.

In house, proposed: specification packages and method development; identity, strength and contaminant testing; development-scale extraction and formulation; stability programs; multi-objective decision records and models; notification dossiers with counsel's review. With partners: cultivation and wild collection; commercial-scale extraction; GLP toxicology; human studies under IRB oversight; finished-product manufacture in early phases; legal opinions; overflow and interlaboratory comparison. Not proposed: retail sale, commodity trading, operating farms or collection crews.

• Capital before revenue: phased build behind gates, services first.
• Utilization of fixed instruments: partners take overflow until volume justifies a purchase.
• Focus across many disciplines: narrow first programs, specialists as partners.
• Partner dependence: qualify each partner once and track every sample and result.
• Impartiality: a clause 4.1 risk register with separate review and sign-off.
• People: no one besides the founder has been hired; senior hires, partners or advisers for clinical, toxicology, regulatory and commercial roles.
• Data rights: ownership and use rules agreed before work starts.