+86 133 1888 8296jackliu@zoomsheal.com
GMP · NSF · ISO 22000 · HACCP certified
OEM / ODM from 3,000 pcs
Welcome to ZOOMSHEAL

Gluten-Free Supplement Manufacturer & Allergen Control OEM

ZOOMSHEAL produces gluten-free, allergen-controlled supplements for allergy-conscious brands in the US, EU and Australia. We run dedicated gluten-free lines or validated deep-clean changeover for capsules, tablets, gummies, protein powder and drops, test every batch below 20 ppm and document the results.

4-6 Weeks
Lead Time
5,000 Bottles
Starting MOQ
<20 ppm
Gluten Verified

Gluten-Free Supplement Manufacturing With Real Allergen Control

A gluten-free claim is only as strong as the plant behind it. A shared blender, a dusty conveyor or an unverified raw material can push a finished supplement over the 20 ppm gluten limit and put the whole claim at risk. ZOOMSHEAL runs gluten-free, allergen-controlled production in our GMP-certified Guangzhou facility, with dedicated lines or validated deep-clean changeover for every run.

We make gluten-free capsules, tablets, gummies, protein powders, oral liquids and kids formulas that also exclude the other major allergens: milk, egg, soy, peanut, tree nut, fish, shellfish and sesame. Brands in the US, EU, UK and Australia use our OEM/ODM and private label programmes to launch products for allergy-sensitive and gluten-sensitive consumers.

What Sets Our Gluten-Free Production Apart

Eight Major Allergen Exclusion
We build formulas that exclude gluten and wheat, milk, egg, soy, peanut, tree nut, fish, shellfish and sesame. Every raw material is supplier-verified against an allergen statement, and we keep a full allergen matrix for each SKU we run.
Gluten Tested Below 20 ppm
Every batch is tested for gluten with validated ELISA methods at a third-party laboratory, and the result is written onto the certificate of analysis. We target well under 20 ppm, the FDA and EU threshold for a gluten-free label claim.
Dedicated Lines, Validated Cleaning
Gluten and allergen products never share a line without validated changeover. We schedule dedicated gluten-free runs or carry out cleaning verification swabs that confirm no protein carryover before a batch is released.
Label Compliance and Non-GMO
We prepare gluten-free, allergen and non-GMO documentation for FDA, EU and Australia New Zealand (FSANZ) label rules, so your claim survives review. Artwork is checked for allergen statements, may-contain wording and local requirements.

Gluten-Free and Allergen-Free Specifications

FormSpecificationMOQLead Time
Capsules & TabletsGluten-free, 8-allergen-free, vegan HPMC or gelatin shell, 30-180 count5,000 bottles4-6 weeks
Protein Powder8-allergen-free protein, no dairy, soy or gluten, 1-5 lb jars or sachets3,000 jars4-6 weeks
GummiesPectin or gelatin, gluten-free and allergen-free, sugar-free option20,000 pcs4-6 weeks
Oral Liquids & DropsGluten-free liquid and alcohol-free drops, 30-120 ml bottles5,000 bottles4-6 weeks
Kids FormulasGluten-free kids chewables, gummies and powders, allergen-free5,000 bottles4-6 weeks

Our Gluten-Free Contract Manufacturing Process

01
Consultation & Allergen Brief
We review your market, the allergens you must avoid and your intended claim, then map a gluten-free, allergen-free specification that fits your volume and price target.
02
Formula & Pilot Sample
Our team selects supplier-verified raw materials, builds the formula and produces a pilot batch so you can check taste, colour, texture and label compliance before approval.
03
Quotation & Approval
When the pilot clears approval, we freeze the gluten-free specification, confirm MOQ, packaging and delivery dates, and send the final quotation and proforma invoice.
04
Production on Controlled Lines
Gluten-free batches run on dedicated lines or after validated deep-clean changeover, with in-process weight, potency and allergen-control checks recorded throughout.
05
Third-Party Testing & Release
Each batch goes to an independent laboratory for gluten ELISA testing at under 20 ppm, plus allergen screening, potency and microbiology. It is released only after the certificate of analysis is approved.
06
Packaging & Export Shipping
Finished goods are bottled, sealed, labelled and packed to your artwork with the correct gluten-free and allergen statements, then documented for air, sea or express export.

Quality Control for Gluten-Free Products

Gluten and allergen control is a plant-wide discipline, not a single test. We separate raw material intake, verify allergen statements from every supplier and store gluten-free actives in dedicated areas. Cleaning between runs is validated with swab and rinse sampling, and no batch starts until the previous residue check passes.

Production runs in a GMP-certified facility in Guangzhou following FDA, NSF and cGMP standards, with HACCP-based controls covering intake, blending, filling and packing. Every finished batch is screened for the eight major allergens and tested for gluten by ELISA, potency and microbiology, with third-party laboratories confirming the results we release.

GMPFDA standardsNSF standardscGMPHACCPISO 22000

Gluten-Free Supplement Manufacturing FAQ

What is the minimum order quantity for gluten-free supplements?+
Capsules and tablets start at 5,000 bottles, protein powder at 3,000 jars, gummies at 20,000 pieces, oral liquids at 5,000 bottles and kids formulas at 5,000 bottles. Bulk allergen-free powders start at 25 kg. Starter batches can be discussed for a new SKU.
Can you guarantee a gluten-free claim below 20 ppm?+
Yes. We test every batch with validated ELISA at a third-party laboratory and report the result on the certificate of analysis. Our routines target well under 20 ppm, matching the FDA and EU threshold for a gluten-free label claim.
Do you exclude all eight major allergens?+
We can exclude gluten and wheat, milk, egg, soy, peanut, tree nut, fish, shellfish and sesame. Each raw material is supplier-verified against an allergen statement, and we hold a full allergen matrix for your SKU.
How do you prevent cross-contamination?+
Gluten-free and allergen-free batches run on dedicated lines or after validated deep-clean changeover. We use cleaning verification swabs and rinse samples, and no batch starts until the previous allergen residue check has passed.
Do you follow FDA, EU and Australian gluten-free label rules?+
Yes. We prepare documentation for FDA, EU and Australia New Zealand (FSANZ) gluten-free and allergen labelling, including allergen statements and may-contain wording, and we check your artwork before printing.
Are your gluten-free supplements also non-GMO?+
We can source non-GMO and organic-certified raw materials and provide supporting documents. Vegan HPMC capsules, pectin gummies and allergen-free proteins are available for clean-label and non-GMO programmes.
Can you help with shipping and customs documents?+
Yes. We prepare the commercial invoice, packing list, certificate of analysis, gluten-free and allergen statements, certificate of origin and health certificates where needed, and ship by air, sea or express.
What payment terms do you offer?+
New gluten-free projects typically run on a 30% deposit with the balance before shipment, paid by T/T or another agreed method. Repeat customers can discuss more flexible terms, and pricing is quoted in USD unless you request otherwise.

Ready to Launch a Gluten-Free Supplement Brand?

Send us your dosage form, target market and the allergens you need to exclude, and our team will reply with a formulation plan, MOQ and quote within two business days. ZOOMSHEAL has handled gluten-free and allergen-controlled manufacturing since 2003.

Related Manufacturing Services

Request A Manufacturing Price Quote

Fill out our “request a quote” form so we can give you a custom price quote to get started with manufacturing your nutraceutical supplements.

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Our Certifications

FDA certifiedGMP certifiedISO certifiedHALAL certifiedNSF certified

*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.