Quick answer: Gummy supplements exported to the United States require factory FDA registration, cGMP (current Good Manufacturing Practice) compliance under 21 CFR Part 111, product labeling that meets DSHEA (Dietary Supplement Health and Education Act) requirements, and batch-level testing for potency, heavy metals, and microbiological safety. It is also strongly recommended that the manufacturing facility hold ISO 22000 and HACCP certification. Understanding the full compliance landscape is essential for any brand owner or importer planning to sell gummy supplements in the US market.
Critical Clarification: The FDA Does Not “Certify” Dietary Supplements
One of the most common misconceptions in the supplement industry is that the FDA “certifies” or “approves” dietary supplement products before they go to market. This is not how it works.
Under DSHEA (1994), the FDA does not approve dietary supplements before they are sold. Instead, the regulatory framework places responsibility on manufacturers and distributors to ensure their products are safe and properly labeled. The FDA’s role is post-market enforcement — it can take action against products that are adulterated, misbranded, or that make unauthorized health claims.
What the FDA does require is facility registration, not product certification. Every facility that manufactures, processes, packs, or holds food or dietary supplements for distribution in the US must register with the FDA. This registration must be renewed every two years (in even-numbered years, between October 1 and December 31).
Factory-Level Requirements
These are the certifications and registrations your manufacturing partner must hold. (For the questions to ask before you sign, see our guide on how to vet a gummy manufacturer.)
| Requirement | Details | Who Issues |
|---|---|---|
| FDA Facility Registration | Mandatory for all facilities that manufacture, process, pack, or hold food/supplements for US distribution. Free to register via the FDA FURLS system. Must be renewed in even-numbered years (Oct 1 – Dec 31). | FDA (US Food and Drug Administration) |
| cGMP Compliance (21 CFR Part 111) | Current Good Manufacturing Practice regulations specific to dietary supplements. Covers personnel qualifications, facility design, equipment calibration, production processes, quality control, complaint handling, and record keeping. | FDA (enforced through inspections) |
| ISO 22000 | International food safety management standard. Demonstrates a systematic approach to managing food safety hazards. Widely recognized by global buyers and importers. | Third-party certification bodies (e.g., SGS, BSI, TÜV) |
| HACCP | Hazard Analysis and Critical Control Points — a systematic, preventive approach to food safety. Identifies biological, chemical, and physical hazards and establishes critical limits at key control points. | Third-party certification bodies |
| Third-Party Audit Reports | Not legally required, but audit reports from recognized firms (SGS, Eurofins, Intertek) significantly strengthen buyer confidence and may be required by major retail chains. | Third-party audit firms |
Product-Level Requirements
Beyond factory certifications, each product must meet specific requirements before entering the US market.
1. Ingredient Compliance
Every ingredient in the formulation must be legally permitted in dietary supplements in the US. This means each ingredient must either be generally recognized as safe (GRAS), be an existing dietary ingredient (marketed before October 15, 1994), or have an approved New Dietary Ingredient (NDI) notification on file with the FDA. For gummy supplements, pay special attention to colorants, flavoring agents, and any botanical extracts — each must have a documented regulatory status.
2. Label Compliance (DSHEA / 21 CFR Part 101)
Labels must include: a product identity statement, a Supplement Facts panel (with serving size, each dietary ingredient, and %DV where applicable), a complete ingredient list, the name and address of the manufacturer/packer/distributor, the net quantity of contents, and any required allergen declarations. Structure/function claims (e.g., “supports immune health”) are permitted but must be truthful and not misleading, and must be accompanied by the mandatory disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
3. Certificate of Analysis (COA)
Every batch should be accompanied by a COA from the manufacturer or an independent laboratory. The COA documents the test results for identity, potency, and purity of the finished product. Major retailers and Amazon sellers increasingly require COAs before listing products.
4. Prop 65 Compliance (California)
If your product will be sold in California (which includes most e-commerce sales), it must comply with California Proposition 65 (the Safe Drinking Water and Toxic Enforcement Act). This requires warning labels if the product contains any chemical known to the state to cause cancer or reproductive toxicity, above specified safe-harbor levels. Lead, cadmium, and bisphenol A are common Prop 65 triggers in supplements.
Required Testing for Gummy Supplements
The following tests should be performed on each production batch.
| Test Category | Specific Tests | Purpose |
|---|---|---|
| Potency / Assay | Active ingredient quantification (e.g., melatonin, vitamin C, zinc) | Verify the labeled claim; typically ±10% of label declaration per USP |
| Heavy Metals | Lead (Pb), Arsenic (As), Cadmium (Cd), Mercury (Hg) | Ensure levels are below FDA guidance and Prop 65 limits |
| Microbiological | Total aerobic count, yeast & mold, E. coli, Salmonella, S. aureus, B. cereus | Confirm the product is free from pathogenic contamination |
| Physical Attributes | Weight uniformity, dimensions, color, texture, disintegration | Quality consistency and consumer acceptance |
| Moisture Content | Loss on drying or Karl Fischer | Shelf stability and texture control (gummies typically 12–18%) |
| Pesticide Residues | Multi-residue panel (if botanical ingredients are used) | Compliance with EPA tolerances and buyer requirements |
| Stability Testing | Accelerated (40°C/75% RH, 6 months) and real-time (25°C/60% RH, 24 months) | Establish and verify shelf life claims |
If you are bringing an existing product to your own label, our R&D team can also reverse-engineer your sample to reconstruct the formula before the first production batch is tested.
Importer Responsibilities Under FSMA
If you are importing gummy supplements into the US, the Foreign Supplier Verification Program (FSVP) under the Food Safety Modernization Act (FSMA) places specific obligations on the US importer:
- The importer must perform a hazard analysis for each imported product.
- The importer must evaluate the foreign supplier’s performance and verify that hazards are controlled.
- Verification activities may include on-site audits, sampling and testing, review of supplier food safety records, or other appropriate activities.
- The importer must maintain FSVP records for at least 2 years.
- Foreign suppliers must have a US Agent for FDA communications.
Subeau’s Certification & Compliance Package
Subeau is the international brand of Guangdong Xingjiayuan Health Technology Co., Ltd. Our products are manufactured by Chaozhou Chaoan District Xingjiayuan Food Co., Ltd., the facility that holds our FDA registration, ISO 22000, and HACCP certifications. Together, we maintain a comprehensive compliance portfolio to support clients exporting gummy supplements to the US and other international markets:
- FDA facility registration — current and renewed (FDA-registered facility, not “FDA approved”)
- ISO 22000 certification — internationally recognized food safety management system
- HACCP certification — systematic hazard analysis and control point management
- GB 14881 compliance — Chinese national food production hygiene standards
- Per-batch COA — full testing for potency, heavy metals, microbiology, and physical specifications
- Stability testing capability — accelerated and real-time studies to support shelf life claims
- Ingredient documentation support — GRAS letters, TDS, and specification sheets for all raw materials
- Private label labeling review — our regulatory team can review your label artwork for US compliance before production
Our gummy candy manufacturing capabilities span vitamin, probiotic, collagen, sleep, and kids’ formats, all produced under the same quality systems described above. When you manufacture with Subeau, compliance is built into the process — not added as an afterthought.
Frequently Asked Questions
Does the FDA approve or certify individual dietary supplement products?
No. The FDA does not approve dietary supplements before they reach the market. Instead, manufacturers are responsible for ensuring their products are safe and properly labeled. The FDA registers manufacturing facilities and conducts post-market enforcement. Claims of “FDA approved” on supplement labels are misleading and may result in regulatory action.
What is the difference between FDA registration and FDA approval?
FDA facility registration simply means the FDA knows your facility exists and where it is located — it is a notification requirement, not a quality endorsement. FDA approval applies to drugs, not dietary supplements. A registered facility is not “FDA approved” — it is “FDA registered.” This distinction matters for both marketing claims and regulatory compliance.
Do I need ISO 22000 and HACCP to sell gummies in the US?
ISO 22000 and HACCP are not legally required by the FDA for dietary supplements — cGMP compliance (21 CFR Part 111) is the legal requirement. However, ISO 22000 and HACCP are widely expected by buyers, retailers, and importers as evidence of food safety management. Many major retailers (such as Costco, Walmart, and Whole Foods) require or strongly prefer suppliers with third-party food safety certifications.
What heavy metal limits apply to gummy supplements in the US?
The FDA has published draft guidance levels for lead in dietary supplements (for adults, typically 0.5 mcg/day). California Proposition 65 sets its own, more stringent safe-harbor limits (e.g., 0.5 mcg/day for lead). For a comprehensive compliance strategy, test for lead, arsenic, cadmium, and mercury — and compare results against both FDA guidance and Prop 65 safe-harbor levels if you sell in California.
How often should gummy supplement batches be tested?
Every production batch should be tested before release. At minimum, test for active ingredient potency, heavy metals (Pb, As, Cd, Hg), microbiological safety (total plate count, yeast/mold, specified pathogens), and physical attributes (weight, moisture). Stability testing should be conducted for new formulations and periodically thereafter to verify shelf life.
Can Subeau help with US regulatory compliance for our gummy products?
Yes. Our manufacturing facility holds current FDA registration, ISO 22000, and HACCP certification. We provide per-batch COAs with full testing, support ingredient documentation (GRAS, TDS), and can review your label artwork for US compliance. Our team has experience supporting clients exporting to the US, the EU, Southeast Asia, and other international markets.
Ready to Start Your Gummy Project?
Contact Subeau today for a free consultation and quote, or contact our team here.
Website: subeaugummy.com
15+ Years Experience | 40M+ Gummies/Day | 500-Bottle Low MOQ | FDA Registered | ISO 22000 & HACCP Certified