Dietary Supplement Science,
Analytical QC & Global Compliance
Empowering international nutraceutical and dietary supplement brands with unyielding regulatory integrity. From FDA 21 CFR 101.36 Supplement Facts typography to ICP-MS heavy metal batch testing, we guarantee your formulations stay strictly compliant, legally unassailable, and rapid-entry ready for global markets.
Strict Dietary Supplement Guardrail (Non-Pharmaceutical)
Konnor operates exclusively in the manufacture of Dietary Supplements & Functional Nutraceuticals under US DSHEA & ISO/GMP guidelines. We do not manufacture synthetic pharmaceutical drugs, nor do we permit medicinal disease claims ("cure, prevent, mitigate"). Every formula is developed to support natural human health functions.
Anatomy of a Compliant Supplement Facts Panel
Under US FDA regulation 21 CFR 101.36, dietary supplements require distinct typography, explicit daily reference values (%DV), and meticulous allergen disclosures. Explore our interactive graphic breakdown below.
Supplement Facts
** Daily Value (DV) not established.
Strict Heavy Line & Font Typography Formatting
21 CFR 101.36 mandates specific hair-line and bold structural enclosures (typically 3-point to 8-point heavy bars separating general calories from botanical ingredients) ensuring instant readability for international consumers.
Group I vs. Group II Dietary Ingredient Stratification
Vitamins and minerals with established Daily Values (Group I) must appear first with exact %DV declarations. Specialty botanicals, enzymes, or herbal extracts (Group II) must be listed below with quantitative milligram declarations followed by the standard "** Daily Value not established" marker.
Mandatory FDA DSHEA Disclaimer Enclosure
Whenever Structure/Function claims are printed anywhere on the packaging, the FDA box disclaimer must be boxed and displayed with identical typographical clarity: "*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
FASTER Act Major 9 Allergen Declaration
Fully compliant with the 2023 US FASTER Act, designating sesame as the 9th major food allergen. We audit all excipients, colors, and natural flavor carriers to ensure zero cross-contamination in dedicated cleanroom facilities.
Structure/Function Claims vs. Prohibited Drug Claims
Cross-border e-commerce brands often face account suspension or FDA warning letters due to accidental disease claims. Below is Konnor's regulatory guidance matrix detailing compliant terminology versus prohibited language.
| Nutraceutical Category | Compliant Structure/Function Claim | Prohibited Disease / Drug Claim |
|---|---|---|
| Immune & Seasonal Health | "Supports normal immune cell activity & cellular defense*" | "Prevents influenza, treats common colds or cures respiratory infections" |
| Joint & Connective Tissue | "Promotes joint flexibility, cartilage lubrication & comfortable mobility*" | "Relieves arthritis inflammation, reverses osteoporosis or heals joint injuries" |
| Sleep & Night Relaxation | "Helps promote restful sleep cycles and calm nighttime relaxation*" | "Cures insomnia, treats chronic anxiety disorders or replaces sedative drugs" |
| Cognitive & Mental Alertness | "Supports daily memory retention, focus and cognitive reaction time*" | "Mitigates Alzheimer’s symptoms, reverses dementia or prevents brain degeneration" |
| Cardiovascular & Lipid Support | "Helps maintain healthy blood lipid levels already within normal range*" | "Lowers high cholesterol, prevents heart attacks or unblocks arterial plaque" |
Rigorous Laboratory Testing & Potency Verification
Every dietary supplement batch undergoes three-tier analytical verification: raw material quarantine, in-process blend uniformity, and finished goods release testing. Select a laboratory protocol below to view testing parameters.
Active Potency & Identity (HPLC / UV-Vis)
48 - 72 Hours Batch Release
Heavy Metals Trace Screening (ICP-MS)
24 Hours Rapid Screening
Microbial Pathogen & Spoilage Panel
3 - 5 Days Culturing (PCR for release confirmation)
Disintegration & Physical Uniformity
Immediate In-Process Batch Testing
Active Potency & Identity (HPLC / UV-Vis)
Quantifies target botanical actives, vitamins, and amino acids against validated reference standards. Guarantees 100% label claim over stated shelf life.
Key Tested Analytes & Specification Limits
Turnkey Export Clearance Dossier Package
Exporting dietary supplements requires exact cross-border harmonization. Every international order ships with a comprehensive regulatory dossier endorsed by official agencies to guarantee friction-free customs clearance.
FDA Food Facility Registration
Biennial US FDA FEI Number Renewal
Registered with the US FDA as a foreign dietary supplement manufacturing establishment. Qualified for Direct US Port entry and Amazon US gated category approval.
Batch Certificate of Analysis (COA)
Complete 3-Tier Quality Lot Release
Includes active assay chromatography, heavy metals mass spectrometry, microbial count, and sensory physical parameters signed by Lead QC Chemist.
Certificate of Free Sale (CFS)
Governmental Export Chamber Endorsement
Official governmental chamber of commerce legalization certifying that the nutraceutical formulations are freely manufactured and sold without legal impediment.
BSE / TSE & Animal Origin Free
Plant-Based & Vegetarian Compliance
Certifies zero bovine, ovine or porcine derivatives for vegan pectin gummies, plant cellulose capsules, and vegetarian dietary supplements.
Major 9 Allergen Declaration
FALCPA & FASTER Act Compliant
Formal declaration testing and confirming absence of undeclared Milk, Eggs, Fish, Crustacean Shellfish, Tree Nuts, Peanuts, Wheat, Soybeans, and Sesame.
Bilingual Technical Dossier & Spec Sheets
Ready-to-Submit Regulatory Master File
Turnkey product specification sheets, manufacturing process flow charts, stability study protocols, and safety data sheets (SDS) for rapid local country registration.
Frequently Asked Compliance Questions
Clear answers regarding US FDA regulations, Amazon ungating, and international dietary supplement import procedures.
Need Your Supplement Formula & Labels Audited for US Compliance?
Connect directly with our Chief Regulatory Chemist and International Trade Documentation Desk. We provide free pre-formulation feasibility checks, 21 CFR 101.36 label proofs, and full cGMP release batch samples.