For brands selling into the United States
The Hive is the regulatory information and ordering platform from Supplement Factory, a UK supplement manufacturer. It brings published claim registers, market rules, regulatory alerts, and your quotes, orders and signed documents into one account. For business customers only.
The FDA does not approve a dietary supplement before it goes on sale. Under DSHEA the operator carries the whole of it, and enforcement is post-market, so the first official view of your product may arrive as an enforcement action rather than a query. Two questions decide most American outcomes. Is the ingredient lawful for supplement use, or does it need a notification seventy-five days before you market it? And does your claim describe a structure or a function, or does it describe a disease? The Hive holds the FDA’s own inventories, and California’s list on top of them.
The Hive brings PRAS+ alerts, your Vault, and your quotes and orders into one account. For business customers only.
What is actually in there
The two federal inventories that decide an ingredient’s standing, the Californian list that sits on top of federal compliance, and the registers of every other market an American brand exports to.
The Hive’s Market Registrations tool
The three pathways written out plainly: standard placement, the new dietary ingredient notification route, and the disease-claim risk that reclassifies a supplement as an unapproved new drug. With the labelling obligations, the DSHEA disclaimer and the GMP reference that go with them.
European Commission and GOV.UK
Held separately from one another, and available on the same account. American brands exporting east need the entry from the register that governs the sale, and since divergence that is two registers rather than one.
The US, Californian and Australian registers hold over 9,000 entries as at the date of publication. We do not publish counts for the GB and EU registers. Every source is attributed.
over 1,300
GRAS notices for the United States
US Food and Drug Administration · public domain
Where an ingredient’s safety standing is usually established first. Worth knowing what it does not do: a GRAS notice supports safety, it is not supplement approval.
over 1,300
new dietary ingredient notifications for the United States
US Food and Drug Administration · public domain
The route for anything not marketed in the United States before the 1994 cutoff, notified to the FDA at least seventy-five days before you sell. Also not an approval.
over 900
Proposition 65 listed chemicals for California
California OEHHA · publisher terms of use apply
California, in addition to everything federal. Frequently triggered by contaminants rather than by the ingredient itself, which is why a federally clean product can still owe a warning.
Mirrored
European health claim entries, permitted and not permitted
European Commission register, on EFSA opinions · CC BY 4.0
The first export register most American brands need, and the one that behaves least like the American system: a closed list of permitted wordings rather than a substantiation standard.
over 5,000
permissible ingredients for the Australian market
Therapeutic Goods Administration · publisher terms of use apply
Australia decides what may be used at all from a closed list, so it can reject a formula that has sold in the United States for years.
over 1,000
permitted indications for the Australian market
Therapeutic Goods Administration · publisher terms of use apply
And its claims are selected from a determination rather than written and substantiated.
Figures are stated as "over" because the registers are re-imported on a schedule and grow. The European claim register is shown as mirrored rather than counted: we do not publish a count for it. The Hive also holds the Great Britain claim register, novel food status and further national datasets that are not counted above.
The local part
The American system is permissive at the front and unforgiving at the back. Everything below is a consequence of that one design choice.
An NDI notification can be acknowledged or objected to by the FDA, and acknowledgement is not endorsement. A GRAS notice supports an ingredient’s safety; it does not make the ingredient approved for supplement use. Both are frequently described on a sell sheet as though they were a licence, and they are not.
Copy that implies treatment, prevention or mitigation of disease can cause the FDA to treat the product as an unapproved new drug, with enforcement to match. That risk lives in marketing language, not in the formulation, which means it can be created by somebody who has never seen the specification.
An ingredient not marketed in the United States before 15 October 1994, and not otherwise GRAS for supplement use, may need a notification before you can sell it. Novelty here is a legal question about history, not a judgement about how new the science feels.
The Californian warning obligation is driven by exposure, so it is often triggered by contaminants such as heavy metals or residual solvents rather than by anything you chose to put in. Safe-harbour levels exist for some chemicals, which makes this a testing question as much as a formulation one.
The FDA governs safety and misbranding. The Federal Trade Commission governs advertising. A claim can survive the label and still fail the campaign, and holding substantiation for what marketing says is part of the job rather than an optional extra.
Inside the Hive
Eight tools, each built against a specific mistake. For an American brand, Claims Explorer and Test My Supplement do the most work: one keeps the wording on the right side of the disease line, the other turns Proposition 65 from a worry into a measurement.
Relates to Mistakes 01 and 02
Search the health claim register by ingredient, by claim or by body system. You see the permitted wording, the conditions of use including the dose the claim requires, and the entries that are recorded as not permitted. It helps you check a claim before a designer sets it in type.
Relates to Mistake 03
The requirements for each market you are considering, in one place: what has to be notified, what is restricted, what a label has to carry. It helps you ask whether a formulation can be sold in a market while the question is still cheap to ask.
Relates to Mistake 05
PRAS+ alerts you to changes in the sources it monitors, for the categories you select. It may not cover every change. Regulatory alerts and recall notices are included for Supplement Factory customers.
Relates to Mistakes 01, 02 and 04
Ask a regulatory question in plain English. Supplement Genius is designed to answer from the registers and show the entry, publisher and date. Check the source before relying on an answer. It tells you what the register says, not what to do about your product.
Relates to The mistake of not being able to prove it later
Signed orders, terms, specifications and certificates are filed under your account and available to you there, so you are not searching an old email thread when a retailer asks for documentation.
Relates to The mistake of claiming what you have not verified
Scan a label, see which tests match the ingredients, see the price on screen, send it in. Results and certificates are filed to your Vault. Access is included and tests are charged. Every membership level carries a discount on testing.
Relates to Mistake 02
Artwork approvals and uploads run inside the Hive and are part of the Hive. Design and compliance services are priced separately, per project.
Relates to The mistake of not asking
Message your concierge and book a client care call. Concierge Lite on Hive Plus covers messages and booked calls, and we aim to reply as quickly as we can. The full service on Hive Pro adds priority handling and arranges the travel and hospitality benefits for you.
Membership is the same everywhere: The Hive, Hive Plus and Hive Pro. For business customers only. See the full pricing.
Straight answers
These are answers about how the rules work and what the Hive shows you. They are not advice about your product, and nothing here replaces your own regulatory or legal counsel.
No. The FDA does not pre-approve dietary supplements, and its enforcement is post-market.
Responsibility for safety, lawful composition, conforming labelling and claim substantiation rests with the operator from the start. The practical consequence is that no one will tell you the product is wrong until somebody official has a reason to look, and by then it exists in quantity.
A new dietary ingredient notification is a submission to the FDA, made at least seventy-five days before marketing, for an ingredient that was not marketed in the United States before 15 October 1994 and is not otherwise GRAS for use in dietary supplements.
It is a notification, not an application. The FDA may acknowledge it or object to it, and acknowledgement does not constitute endorsement of the product. The Hive holds the NDI inventory and the GRAS notice inventory side by side so you can see what standing an ingredient already has before you commission the work.
A structure/function claim describes how a nutrient affects the normal structure or function of the body; a disease claim says or implies that a product treats, prevents, mitigates or cures a disease.
The second one can cause the FDA to classify your supplement as an unapproved new drug. Dietary supplement labels carry the DSHEA disclaimer for this reason, and the risk is not confined to the pack: a landing page, an email or an influencer script can create it just as effectively.
Yes, potentially. Proposition 65 applies in addition to federal compliance, and meeting federal requirements does not answer it.
The obligation is based on exposure to listed chemicals rather than on the legality of your ingredients, so it is often triggered by contaminants such as heavy metals or residual solvents. Safe-harbour levels exist for some chemicals, below which no warning is required, which makes analytical testing the practical route to an answer.
No. A GRAS notice supports an ingredient’s safety for a stated use; it is not approval of a dietary supplement.
It is a genuinely useful signal and it is regularly oversold as a permission. The Hive holds the FDA’s own GRAS notice inventory so you can look at what was actually notified rather than at how a supplier described it.
No, not as written. Great Britain and the European Union work from closed registers of authorised claims with conditions of use attached, rather than from a substantiation standard you meet yourself.
A structure/function claim that is perfectly lawful in the United States may have no authorised counterpart in either register, and rewording an authorised entry until it fits your marketing is itself a failure. The Hive holds both registers, so the question can be answered before a European launch has a print run behind it.
American law will let you go to market on your own judgement. It will also hold you to it, in public, afterwards. The inventories are open, and reading them first costs an afternoon.
