Custom supplement manufacturing for US brands
British VitaTech is a custom supplement manufacturer for US brands: FDA registered, with US labels and documentation prepared during development.
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Dietary supplements made in England for US brands, labels included
British VitaTech is a custom supplement manufacturer for US brands. We develop and manufacture dietary supplements in Leicester, England, and prepare the US labels, claims and documents during development, not at the end: the Supplement Facts panel, each structure/function claim with its evidence, the finished product specification and the records your US importer needs. We are ISO 9001, HACCP and GMP certified by BSI, and FDA registered, and we work as a dietary supplement contract manufacturer from formula to finished, labeled product. Your formula is yours.
Demand is broad. In the Council for Responsible Nutrition's 2026 survey of 3,005 US adults (Morning Consult, September 2026), 75% said they use dietary supplements and 46% use them regularly. Nutrition Business Journal's 2026 Supplement Business Report (June 2026) finds specialty ingredients driving growth, with traditional tablets and capsules giving way to powders, liquids, chewables and gummies.
Formats and packs for US shelves
We make capsules, tablets, gummies, powders, stick packs and liquids in Leicester for US brands. Supplement Facts panels declare amounts in US units, with a percent Daily Value where one exists, so we set each dose with the US panel in mind. Packs are chosen from stability data: bottles with induction seals and a desiccant for moisture-sensitive capsules and tablets, and resealable pouches for powders and gummies. Every pack carries its lot code, and outer cases carry product, quantity and lot for your warehouse or fulfillment partner.
FDA registration, Part 111 and your importer's role
US rules at a glance
| Topic | US position as of October 2026 |
|---|---|
| Core law | The Dietary Supplement Health and Education Act (DSHEA): a dietary supplement is deemed a food |
| Approval before sale | None: FDA "does not have the authority to approve dietary supplements for safety and effectiveness or their labeling" (FDA, 2022) |
| New ingredients | Notification to FDA before launch for a new dietary ingredient, unless an exception applies |
| Manufacturing | FDA food facility registration and 21 CFR Part 111, overseas manufacturers included |
| Labels | Supplement Facts panel, "dietary supplement" in the statement of identity, a US address or phone number for serious adverse event reports |
| Claims | Structure/function claims with FDA's disclaimer, notified to FDA after first marketing |
| Imports | Prior notice and foreign supplier verification, both on the importer's side |
| States | Proposition 65 warnings in California; under-18 sales limits in New York, and in California from January 1, 2027 |
A registered manufacturer with Part 111 records
With limited exemptions, every facility that makes, packs or holds food for US consumption, dietary supplements included, must register with FDA before it starts, and a foreign facility names a US agent. We are an FDA registered food facility for dietary supplements, and our FDA registered facility page explains what registration covers. FDA's manufacturing rule, 21 CFR Part 111, covers supplements imported into the US as well as those made there. It expects specifications for identity, purity, strength and composition, limits on contamination, master manufacturing and batch production records, and reserve samples, and we prepare the specifications and records it expects for every US order. Our GMP certificate is BSI's HACCP and GMP certificate, built on Codex Alimentarius food hygiene principles and covering capsules, gummies, pouches and liquids. Amazon's US GMP verification needs a third-party 21 CFR Part 111 audit, which we plan around our US programs.
Your brand stays responsible too: FDA expects a brand that has its supplements made for it to know how they are made. We write your specification with you, so your brand holds the evidence, and no change to your formula or specification happens without your written sign-off.
A US importer
Your importer handles two FDA requirements. Prior notice must reach FDA before each shipment arrives, usually filed by the importer or its customs broker, and it asks for the manufacturer's FDA registration number. Under the Foreign Supplier Verification Programs (FSVP) rule, the importer verifies that our processes give the same public health protection as Part 111, by onsite audit, sampling and testing, records review or another appropriate activity. We supply our registration number and the specification, batch release records and certificates of analysis that verification draws on, and we host your importer's auditor when it chooses an onsite audit.
Ingredients that are lawful in supplements
A dietary ingredient not marketed in the US before October 15, 1994 is a new dietary ingredient. Unless it is already in the food supply in a form not chemically altered, the manufacturer or distributor must notify FDA at least 75 days before it goes on sale. NMN, for example, is a new dietary ingredient, so a notification comes first.
Some ingredients stay out. As of October 2026, FDA's position is that CBD is excluded from the dietary supplement definition, so CBD stays out of the US formulas we develop. From January 15, 2027, FD&C Red No. 3 can no longer be used in foods, dietary supplements included, so we color US gummies and coated tablets with other permitted colors.
Evidence for marketplaces
We make products for Amazon US and TikTok Shop US and prepare the documents each asks for. As of October 2026, Amazon's US store requires dietary supplements to be verified through a third-party testing, inspection and certification (TIC) organization, and a product becomes eligible for sale only once a passing result is received; TikTok Shop's US rules ask for a recent test report from an approved laboratory. Our guide to supplements for Amazon and TikTok Shop explains each marketplace's rules.
Supplement Facts, structure/function claims and state rules
A US label follows FDA's dietary supplement rules, which differ from UK and EU rules in layout, units and wording. We review your US label against them on every order (as of October 2026):
- Statement of identity: "dietary supplement", or a descriptive form such as "calcium supplement".
- Supplement Facts panel: the serving size and the amount of each dietary ingredient per serving.
- Name and place of business: your name with a phrase such as "Manufactured for" or "Distributed by".
- A US address or phone number: a domestic address or domestic phone number for reports of serious adverse events.
- Allergens: the nine major food allergens, sesame included.
- Warnings: for example, the accidental overdose warning for iron supplements in solid forms such as tablets and capsules.
Structure/function claims
US supplements can carry structure/function claims, such as "supports muscle function". Each claim needs competent and reliable scientific evidence (FTC, 2022) and FDA's standard disclaimer, next to the claim or linked to it by a symbol, and the manufacturer, packer or distributor must notify FDA no later than 30 days after first marketing the supplement with the claim. Claims that cross into drug territory make the product an unapproved drug, so ours stay within the structure/function rules. Our guide to claims, evidence and regulation by market compares US claims with UK and EU rules.
State rules
As of October 2026, California's Proposition 65 requires a clear and reasonable warning before a business exposes consumers to a listed chemical such as lead above its safe harbor level, which for lead is 0.5 micrograms a day, and its warning rules count dietary supplements as food. New York restricts sales to under-18s of supplements labeled, marketed or otherwise represented for weight loss or muscle building, and California adds a similar restriction from January 1, 2027.
Registrations
As of October 2026, US supplements need no product registration or listing. The manufacturer registers its facility, and a US warehouse that holds your product registers in its own right. Skincare follows a separate law: the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires cosmetic manufacturers and processors to register their facilities and the responsible person to list each product with FDA. Our FDA registration covers dietary supplements only, so we register our Leicester facility under MoCRA as US skincare programs start.
US growth by category, and what each means for a formula
US growth is running through specialty ingredients and easy formats. These are the signals we build on, and what each means for a US formula.
| Category | US signal | What it means for your formula |
|---|---|---|
| Healthy aging supplements | The fastest-growing condition in 2025, with sales up 14.3% (Nutrition Business Journal data reported by Ingredients Network, June 2026) | NMN, an NAD precursor, can be used subject to new dietary ingredient notification |
| GLP-1 support supplements | About 16 million active US users of GLP-1 medicines in 2026, with 30 to 35 million expected by 2030 (BCG, August 2026) | Protein, fiber, micronutrients and hydration in small servings, with no appetite or weight claims |
| Gut health supplements | Prebiotics and digestive enzymes named among the fastest-growing specialty ingredients (Nutrition Business Journal, June 2026) | An isolated or synthetic fiber counts as dietary fiber on the label only once FDA has recognized its beneficial physiological effect (FDA, 2024) |
| Gummies | Named among the consumer-preferred formats taking over from traditional tablets and capsules (Nutrition Business Journal, June 2026) | Dose per piece, sugar and color choices, and the overages that hold the label claim to the end of shelf life |
Two checks apply across categories: products marketed for weight loss or muscle building need a check against the New York and California age limits, and botanical, mineral and protein ingredients need a heavy-metal review for Proposition 65.
How we ready a US launch as your custom supplement manufacturer
We build the US requirements into development, so your product, label and documents are ready together.
- Brief and US screen. We check every ingredient's US status before formulation: new dietary ingredient status, any GRAS basis, colors and the state rules that touch your category.
- Formulation and specification. Our R&D team matches each ingredient's form and dose to the human evidence, sets the flavor and writes the specification Part 111 expects. R&D is a paid stage, included with an order of the right size.
- US label and claims. We draft the Supplement Facts panel and statement of identity, check allergens and warnings, and list each structure/function claim with its evidence and disclaimer, ready for the FDA notification. You approve the artwork.
- Testing plan. Every batch is tested by accredited partner laboratories (ISO/IEC 17025) as part of every order. We set the tests for your product and markets, including the identity test Part 111 requires on each dietary ingredient before use and the evidence your marketplaces ask for.
- Stability and shelf life. Stability runs in the final pack, and overages are set from measured loss rates, so every amount on the Supplement Facts panel holds to the end of shelf life.
- Production and release. A pilot batch on production equipment proves the process before the first commercial run. Labels are verified on every batch as the critical control point, every batch is released by quality control against its specification, and we keep three retained samples per batch for shelf life plus one year.
- Shipping documents. Your importer receives our FDA registration number for prior notice, plus the specification, batch release records and certificates of analysis for its FSVP file.
What you receive with every US order
- A certificate of analysis for the batch from our accredited partner laboratories
- A batch release confirmation signed off by quality control
- The finished product specification and the US label review
- Our FDA registration number for your importer's prior notice
- The records your importer's FSVP file draws on
We prepare products and documents for the UK, the EU and the US, and our clients sell in Europe, the USA and Mexico. Launching in Europe too? Read about supplement manufacturing for EU brands, or see supplement manufacturing for every market. Our supplement regulation watch tracks each US change with its date and source. Start your project.
References: Dietary Supplement Health and Education Act of 1994, 21 U.S.C. 321(ff) and 350b (1994); 21 CFR 101.93, statements for dietary supplements (2026); 21 CFR Part 111, dietary supplement manufacturing practice (2026); 21 CFR Part 1, Subparts H, I and L, food facility registration, prior notice and foreign supplier verification (2026); US FDA, response to the citizen petition on NMN, docket FDA-2023-P-0872 (2025); US FDA, regulation of cannabis and cannabis-derived products, including CBD (2024); Council for Responsible Nutrition, 2026 Consumer Survey on Dietary Supplements (2026); Nutrition Business Journal, 2026 Supplement Business Report (2026).
Where this is going
To 2030
Mixed: a tougher path for new ingredients if FDA ends self-affirmed GRAS, and possible mandatory product listing
To 2036
Uncertain: depends on legislation surviving political change
What to watch
Political reversal; industry opposition
Questions brands ask
Can a UK manufacturer make dietary supplements for the US market?
Yes. As of October 2026, a foreign facility can make dietary supplements for the US once it is registered with FDA as a food facility, and FDA's manufacturing rule, 21 CFR Part 111, applies to it as it does to US makers. British VitaTech is FDA registered and prepares the specifications and records Part 111 expects. Your importer files prior notice for each shipment and runs foreign supplier verification, and we supply the documents for both.
Does FDA approve dietary supplements before they go on sale?
No. FDA "does not have the authority to approve dietary supplements for safety and effectiveness or their labeling" before they are sold (FDA, 2022). As of October 2026, the brand and its manufacturer answer for safety and labeling. A new dietary ingredient needs FDA notification at least 75 days before it enters interstate commerce, and structure/function claims are notified to FDA no later than 30 days after first marketing.
What do we need to do when we use a structure/function claim?
Hold the evidence, print FDA's disclaimer and notify FDA. As of October 2026, each claim needs competent and reliable scientific evidence (FTC, 2022), and the label carries FDA's disclaimer next to the claim or linked to it by a symbol. The manufacturer, packer or distributor notifies FDA no later than 30 days after first marketing the supplement with the claim. We prepare the claim list, the evidence file and the notification wording with you.
Who handles prior notice and FSVP when we import from the UK?
Your US importer does. As of October 2026, prior notice must reach FDA before each shipment arrives and asks for the manufacturer's FDA registration number. The FSVP importer, the US owner or consignee at entry, verifies that our processes give the same public health protection as Part 111, by onsite audit, sampling and testing or records review. We supply our registration number, specifications, batch records and certificates of analysis, and we host your importer's auditor if it chooses an onsite audit.
Which state laws affect supplements sold in the US?
Plan first for California's Proposition 65 and the under-18 sales limits in New York and California. As of October 2026, Proposition 65 requires a warning when exposure to a listed chemical such as lead exceeds its safe harbor level, 0.5 micrograms a day for lead. New York restricts sales to under-18s of supplements marketed for weight loss or muscle building, and California adds a similar limit from January 1, 2027. We review heavy metals and positioning before the label is final.
Which supplements can't be sold in the US?
Products that rely on ingredients that are not lawful in dietary supplements. As of October 2026, FDA's position is that CBD is excluded from the dietary supplement definition, so it stays out of the US formulas we develop. A new dietary ingredient used without the required notification can't be lawfully sold, and from January 15, 2027, FD&C Red No. 3 can't be used in foods, supplements included. We screen every ingredient at the brief, before formulation starts.
Can our supplements be sold on Amazon US?
Yes. We make products for Amazon US and prepare the documents it asks for. As of October 2026, Amazon's US store requires dietary supplements to be verified through a third-party testing, inspection and certification (TIC) organization, and products become eligible once a passing result is received. We supply the samples, specification and batch documents the TIC organization asks for. Amazon's US GMP verification needs a third-party 21 CFR Part 111 audit, which we plan around our US programs.
Start your project
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