Contract Manufacturing Terms & Conditions
Standard Commercial Terms governing contract formulation, high-speed blending, encapsulation, packaging, and analytical lot release at Micelle Nutraceuticals Labs (Carrollton & Van Alstyne, TX).
1. Scope & Acceptance of Terms
These Manufacturing Terms and Conditions (“Agreement”) govern all manufacturing, processing, packaging, testing, and handling services provided by Micelle Nutraceuticals Labs (“Manufacturer” or “MNL”) to any commercial brand, purchaser, or client entity (“Customer”).
Submission of a Purchase Order (PO), payment of an engineering deposit, or written approval of a Master Manufacturing Record (MMR) constitutes full acceptance of these terms.
2. cGMP 21 CFR Part 111 Compliance Standards
MNL covenants that all manufacturing operations are conducted in strict compliance with FDA 21 CFR Part 111 Current Good Manufacturing Practices for Dietary Supplements. We maintain registered facilities in Carrollton and Van Alstyne, TX, execute electronic Master Manufacturing Records (MMRs) for every batch, and verify raw material identity via FTIR spectroscopy before blending.
3. Purchase Orders & Production Scheduling
Each production run requires a formal Purchase Order detailing target batch volume, bill of materials, packaging formats, and delivery destinations.
- Production Clock: Manufacturing lead times (standard 4–6 weeks for repeats, 6–8 weeks for custom R&D) commence upon completion of three conditions: (a) receipt of confirmed deposit, (b) signed MMR approval, and (c) dock arrival of all cleared raw materials and packaging.
- Batch Yield Variations: Commercial supplement manufacturing is subject to normal volumetric yield tolerances of ±5% to ±10%. Invoiced totals reflect actual finished units produced and released.
4. Toll Blending & Customer-Supplied Materials
For Toll Blending contracts where Customer supplies active ingredients or custom packaging:
- All customer-supplied raw ingredients must be accompanied by an accredited Manufacturer Certificate of Analysis (COA) specifying botanical identity, assay strength, and heavy metal screening.
- Customer materials remain subject to mandatory dock FTIR identity confirmation under 21 CFR §111.75. Any material failing identity or heavy metal screening will be rejected back to Customer at Customer's freight expense.
5. Intellectual Property & Formulation Confidentiality
Customer retains 100% exclusive intellectual property rights, ownership, and copyright to all custom formulation recipes, active ingredient ratios, and brand trademarks developed or transferred to MNL upon payment in full.
MNL operates under strict mutual NDA terms and will never manufacture competing house brands utilizing Customer formulation architectures.
6. QA Testing & Certificate of Analysis (COA) Release Protocol
No commercial finished product leaves MNL facilities without an authorized, lot-numbered Certificate of Analysis (COA) signed by our Director of Quality Assurance.
Each commercial COA includes: physical dimensions/weight uniformity, HPLC/UPLC active compound potency assay, ICP-MS heavy metals testing (Lead, Mercury, Arsenic, Cadmium), and comprehensive microbiological pathogen screening (USP <2021>/<2022>).
7. FDA Label Compliance & Allergen Declarations
While MNL provides complimentary pre-print regulatory reviews of Supplement Facts panels under FDA 21 CFR Part 101, Customer maintains final legal responsibility for all marketing claims, structure/function statements, and front-of-pack claims printed on finished packaging.
Customer must fully declare any intended allergens pursuant to the Food Allergen Labeling and Consumer Protection Act (FALCPA) and enforce California Proposition 65 requirements where applicable.
8. Shipping, Title & Freight Risk
All shipments are dispatched Ex Works (EXW) or Freight on Board (FOB) from our Carrollton or Van Alstyne, TX facilities. Risk of loss and title transfer to Customer upon loading onto the commercial carrier. MNL assists with LTL bill of lading (BOL) coordination, pallet stretch-wrapping, and Amazon FBA palletization.
9. Mandatory FDA Dietary Supplement Disclaimer
“These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.”
Products manufactured by MNL are dietary supplements regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). They are not pharmaceuticals and are not approved by the FDA to treat clinical disease.
10. Governing Law & Dispute Resolution
This Agreement shall be governed by and construed in accordance with the laws of the State of Texas, without giving effect to conflicts of law principles. Any dispute arising out of contract manufacturing services shall be resolved through binding arbitration in Dallas County, Texas under the commercial rules of the American Arbitration Association (AAA).