Country-Specific Regulatory Notice

EFFECTIVE & LAST UPDATED: 6 SEPTEMBER 2026
COUNTRY-SPECIFIC REGULATORY NOTICE

How Cutting Drops is classified and regulated in every country we ship to.

Cutting Drops is a liposomal botanical blend (ginger, fennel, peppermint, dandelion, burdock root and elderberry extracts, in a purified water, vegetable glycerin and natural flavour base) sold as a general-wellness dietary/food supplement, not as a medicine. Because the legal category a product like this falls into — and the wording it's allowed to carry — differs by country, this page sets out, market by market, which regulator applies, how our current claims are positioned within that framework, and where we've flagged a claim, ingredient or market for further regulatory or legal review before we treat it as settled. It's written to be read alongside our Ingredient Transparency and Health & Medical Disclaimer pages.

AU
THERAPEUTIC GOODS ADMINISTRATION (TGA) & FOOD STANDARDS

Australia

Whether an ingestible product like Cutting Drops is regulated as a food (under the Australia New Zealand Food Standards Code, administered by Food Standards Australia New Zealand) or as a therapeutic good (under the Therapeutic Goods Act 1989, administered by the TGA) depends on the combination of its ingredients, its physical form, and — most importantly — the claims made about it. A liquid drop product and a tablet containing the very same extract can sit on different sides of that line, and the same product can cross the line simply by changing its marketing wording.

The food/medicine test that applies to Cutting Drops

Current position: sold as a food-type wellness product, not a Listed Medicine

Cutting Drops is currently sold and marketed with traditional-use, general-wellness wording (for example, "traditionally used to support smooth digestion") rather than with therapeutic claims that a product will diagnose, treat, cure or prevent a disease or condition. On that basis, it is positioned in the food category and is not required to hold an AUST L (Listed Medicine) number on the Australian Register of Therapeutic Goods (ARTG).

Where the line gets genuinely close

Several of the ingredient descriptions on our own site — "support the body's natural detox pathways", "support liver function", "support natural detox pathways" alongside dandelion and burdock root — sit closer to the therapeutic side of the TGA's Food-Medicine Interface guidance than a plain digestive-comfort claim does. "Detox" and "liver function" language is a recognised trigger point the TGA has taken enforcement action over in other products, even where the seller considered the claim to be general wellness language. We have not independently confirmed with a TGA regulatory consultant that this specific wording, on this specific liquid formulation, stays on the food side of the line — that confirmation is still outstanding.

Action flagged for regulatory review

Before continuing to advertise Cutting Drops with digestion, detox or liver-support wording in Australia, we recommend a TGA regulatory consultant confirm in writing whether the current claims keep the product in the food category under the Therapeutic Goods (Excluded Goods) Determination, or whether the claims need to be reworded to plain digestive-comfort language to stay clear of the Therapeutic Goods Act 1989 — selling with unpermitted therapeutic claims and no AUST L listing is a contravention of that Act. This review is not yet complete.

Food Standards Code obligations we do meet

Standard 1.2.4 — descending-order ingredient listingOur six botanicals are listed by proportion in the blend, most to least, as this standard requires.
Standard 1.2.3 — mandatory allergen and warning declarationsNone of the mandatory declared allergens are present in Cutting Drops; this is stated on our Allergen Statement and Ingredient Transparency pages.
Standard 1.2.7 — nutrition, health and related claimsGeneral-level health claims made about a food must be truthful, not misleading, and either drawn from the Code's pre-approved food–health relationships or self-substantiated by us before publication. We have not yet documented formal self-substantiation for every claim on our product and ingredient pages.
Australian Consumer Law, ss 18 & 29Ingredient, origin and manufacturing claims (made in Australia, batch-tested, allergen-free facility) must be accurate and not misleading — these reflect our actual formulation and manufacturing arrangements.
US
FDA (DSHEA) & FTC

United States

In the United States, Cutting Drops is regulated as a dietary supplement under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which the Food and Drug Administration (FDA) administers, alongside the Federal Trade Commission's (FTC) rules on truthful, substantiated advertising.

What DSHEA requires — and where we stand

No pre-market approval requiredUnlike a drug, a dietary supplement doesn't need FDA pre-approval before sale — the manufacturer is responsible for ensuring it's safe and truthfully labelled before it goes to market.
Supplement Facts panel (21 CFR 101.36)Liquid dietary supplements sold into the US must carry a compliant Supplement Facts panel (serving size, botanical blend weight, and the "other ingredients" statement for our carrier ingredients). We're confirming our current label artwork matches this format exactly for the US market.
Structure/function claims and the DSHEA disclaimerA claim describing how an ingredient affects the body's structure or function (for example, "supports smooth digestion") is permitted only where it is truthful, substantiated, and carries the DSHEA disclaimer, boldfaced and linked to the claim: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Following the FDA's December 2025 enforcement-discretion letter, this disclaimer no longer has to be repeated on every single label panel that carries a claim — but it must still appear on the label and be clearly linked (for example, by an asterisk) to each structure/function claim.
No disease claimsCutting Drops does not claim to diagnose, treat, cure or prevent any disease anywhere in its marketing, which keeps it out of "unapproved new drug" territory under the Federal Food, Drug, and Cosmetic Act.
FTC substantiationEvery claim we make — including the traditional-use botanical statements — needs to be backed by competent and reliable evidence before publication, per FTC guidance on dietary supplement advertising. We're compiling a substantiation file for each claim rather than relying on ingredient tradition alone.
UK
FOOD STANDARDS AGENCY (FSA) & MHRA

United Kingdom

Food supplements sold in the UK sit under the Food Supplements (England) Regulations 2003 (and the equivalent Scottish, Welsh and Northern Irish regulations), the retained Nutrition and Health Claims Regulation, and — where a product's claims start to look medicinal — the Medicines and Healthcare products Regulatory Agency's (MHRA) borderline products framework.

The claims problem for botanicals specifically

Only claims on the GB Nutrition and Health Claims Register may be used

Under the retained EU Nutrition and Health Claims Regulation, a food or supplement can only carry a health claim that's been formally authorised and added to the GB Register. There is currently no authorised claim on that Register for ginger, fennel, peppermint, dandelion, burdock root or elderberry — the assessment of botanical health claims has been "on hold" (neither authorised nor rejected) for over a decade, across the whole UK/EU botanicals category.

Why we use "traditionally used to" wording, not authorised health claims

Because generic wording like "supports digestion" or "supports detox" can read as an unauthorised health claim if phrased as a direct benefit statement, we frame our UK-facing ingredient copy as historical/traditional use ("traditionally used to settle the stomach") rather than as an authorised nutrition or health claim. A UK court ruling in 2025 reaffirmed that sellers can still sell botanical supplements during the "on hold" period, but can't advertise them using health-claim wording that hasn't been scientifically assessed and approved — so this distinction matters and we haven't yet had every product page checked line-by-line against it.

MHRA borderline risk

The MHRA's October 2025 updated borderline products guidance confirms that a food supplement can be reclassified as a medicine — requiring a marketing authorisation before it can be sold at all — based on its claims, its ingredients' properties, and how it's presented, not just its ingredient list. If a claim implies Cutting Drops works through a pharmacological, immunological or metabolic effect (rather than simply supplementing the diet), it risks being treated as an unlicensed medicine in the UK. We recommend a UK regulatory or MHRA borderline-status opinion before any UK-specific marketing copy is finalised.

CA
HEALTH CANADA — NATURAL HEALTH PRODUCTS REGULATIONS

Canada

Canada regulates products like Cutting Drops as Natural Health Products (NHPs) under the Natural Health Products Regulations, made under the Food and Drugs Act, and administered by Health Canada's Natural and Non-Prescription Health Products Directorate. This is the most restrictive of the five markets on this page for a botanical liquid blend like ours.

Why an NPN matters, and what happens without one

Current status: Cutting Drops does not hold a Natural Product Number

All six botanicals in our blend — ginger, fennel, peppermint, dandelion, burdock root and elderberry — fall under Schedule 1 of the Natural Health Products Regulations as NHP ingredients. Any product making a health-related claim and containing these ingredients generally needs a Natural Product Number (NPN), issued once Health Canada has reviewed a Product Licence Application, before it can be legally sold or commercially imported into Canada. Cutting Drops has not yet been through that licensing process and does not currently carry an NPN.

The practical risk

Without an NPN, shipments into Canada risk being held or seized at the border, and continuing to sell into the Canadian market without a licence carries genuine legal exposure under the Food and Drugs Act, separate from any advertising-platform or marketplace-level restrictions. Several of our ingredients (ginger, fennel, peppermint, dandelion, elderberry) already have existing Health Canada compendial monographs, which can shorten the licensing pathway compared to starting from a blank application — but a licence still has to be obtained before sale.

Urgent action flagged

We recommend an urgent legal and regulatory review of Canadian sales and shipping before continuing to advertise or ship Cutting Drops to Canadian customers, covering: whether a Natural Product Number application should be filed against existing monographs for our botanicals, and whether Canadian orders should be paused in the meantime. This has not yet been actioned.

NZ
MEDSAFE, MINISTRY FOR PRIMARY INDUSTRIES & FAIR TRADING ACT

New Zealand

New Zealand regulates dietary supplements under the Dietary Supplements Regulations 1985. That regime was previously set to be replaced by the Therapeutic Products Act, but the New Zealand Government repealed that Act in December 2024 before it took effect, and reissued the 1985 Regulations under the Food Act 2014 to keep them in force. A standalone natural health products law is still being developed, with no confirmed commencement date as at the date of this notice — so the 1985 Regulations are the current law, not a stopgap that has already lapsed.

What this means for Cutting Drops

No pre-market approval requiredThere's no pre-approval process for dietary supplements in New Zealand — the responsibility sits with us, as the sponsor, to ensure the product is safe, accurately labelled, and compliant before sale.
Regulation 11 — no therapeutic claimsThe 1985 Regulations expressly prohibit therapeutic claims on a dietary supplement. If a claim states or implies that Cutting Drops will treat, prevent or diagnose a condition — including "detox the liver" or "repair organs"-style wording, which Medsafe has specifically flagged as pushing a product into medicine territory — the product risks being reclassified as a medicine under the Medicines Act 1981 and would then need full Medsafe assessment before it could be supplied or advertised at all.
Maximum daily dose limitsThe Regulations set maximum daily doses for certain vitamins and minerals; Cutting Drops does not currently include any of the scheduled vitamins or minerals subject to those limits.
Fair Trading Act 1986All origin, manufacturing and ingredient claims — including "Made in Australia" — must be accurate; the Fair Trading Act applies to every claim on this page and on our other policy pages regardless of which supplement-specific regime is current.
HOW WE FRAME OUR CLAIMS

One product, five different rulebooks — so the wording changes by market.

A single global product description can't simultaneously satisfy the TGA's food/medicine line, DSHEA's structure/function rules, the UK's on-hold botanical claims, Health Canada's NHP licensing regime, and Medsafe's ban on therapeutic claims. Rather than write one claim and hope it holds up everywhere, our approach — where it has been implemented — is:

01 — TRADITIONAL-USE FRAMING, NOT DISEASE CLAIMS
We describe what each botanical has traditionally been used for (for example, "traditionally used to ease bloating"), rather than promising a therapeutic outcome. This wording is not intended to diagnose, treat, cure or prevent any disease, and hasn't been evaluated by the TGA, the FDA, the MHRA, Health Canada, or Medsafe.
02 — NO PROPRIETARY-BLEND HIDING
Every botanical and carrier ingredient is disclosed by name and listed in descending order of proportion, as required in every market on this page — see our Ingredient Transparency page for the full list and amounts.
03 — REGIONAL DISCLAIMER, ADAPTED BY REGULATOR
Regulatory classification and the health claims a supplement is permitted to carry vary by country. Cutting Drops is sold as a food-type dietary/wellness supplement in accordance with the regulations that apply in your region. Claims on this website refer to the traditional use of the listed botanical ingredients and have not been evaluated by the Therapeutic Goods Administration (Australia), the Food and Drug Administration (United States), the Medicines and Healthcare products Regulatory Agency or Food Standards Agency (United Kingdom), Health Canada, or Medsafe (New Zealand). This product is not intended to diagnose, treat, cure or prevent any disease.
04 — OPEN ABOUT WHAT'S STILL UNDER REVIEW
Where we've identified a claim, ingredient or market that needs a regulatory consultant's or lawyer's sign-off before we're confident it's fully compliant — the AU detox/liver wording, the Canadian NPN position, the UK botanical claims check — we've said so directly on this page rather than presenting it as settled.
COMPLIANCE STATUS AT A GLANCE

Where each market currently stands.

i

This table reflects our own internal review as at 6 September 2026. It is not a substitute for advice from a qualified regulatory consultant or lawyer in each market, and several rows below are marked "under review" for exactly that reason.

AustraliaSold as a food-category wellness product; ingredient-order and allergen labelling compliant. Detox/liver-support wording flagged for TGA regulatory consultant review.
United StatesSold as a dietary supplement under DSHEA; DSHEA disclaimer in use. Supplement Facts panel format and per-claim FTC substantiation file are being finalised.
United KingdomSold as a food supplement using traditional-use wording rather than authorised health claims, in line with the "on hold" status of botanical claims. Full page-by-page wording check against MHRA borderline guidance is outstanding.
CanadaNo Natural Product Number currently held. Urgent legal/regulatory review of continued sale and shipping into Canada is outstanding.
New ZealandSold as a dietary supplement under the 1985 Regulations (now continued under the Food Act 2014); no therapeutic claims made; no scheduled vitamins/minerals present.
Currently compliant, as reviewed internally
Compliant on current wording; formal sign-off outstanding
Action required before continuing as-is

Questions about how this applies to your order or your country?

If you need more detail on how a specific claim, ingredient or regulation applies in your country, or you're a regulator, retailer or advertising platform reviewing our compliance, contact our small team and we'll respond within 1 business day.

URBAN CLOTHING PTY LTD (ABN 78 671 782 111), trading as The Minerals Lab · 66 Windemere Road, Alexandra Hills, Queensland 4161, Australia · Page last updated / effective: 6 September 2026