Market rules by country

Supplements

Supplements are regulated as a category of food under DSHEA. There is no pre-market approval for the finished product, but the facility must register and follow cGMP rules, and structure/function claims must carry a specific disclaimer.

Cosmetics

Cosmetics are regulated by the FDA. Under MoCRA, cosmetic facility registration and product listing obligations now apply, with a responsible person and adverse-event reporting.

Devices

Most health devices are Class I or II and need 510(k) clearance or an exemption; a De Novo route exists for novel low-risk devices.

Tea & infusions

Tea and herbal infusions are foods, and a tea marketed as a supplement is a dietary supplement. Cascara is not permitted for food use. Stimulant-laxative 'detox' teas have attracted warning letters for unapproved drug claims. Caffeine must be declared on dietary supplement labels and on conventional foods where it is added.

Ask the supplier for

• cGMP certificate for the facility plus the FDA registration number
• For any ingredient marketed after 15 October 1994: an NDI notification and the FDA's response
• Structure/function claim wording with the mandatory disclaimer
• For cosmetics: facility registration and product listing confirmation under MoCRA

Where launches stall

The lack of pre-market approval for supplements makes US claims a common enforcement area. Marketing copy, not the formula, is where most importers get into trouble.

US FDA — verify the current rules here.

Supplements

Regulated under the Food Supplements Directive 2002/46/EC: the vitamin and mineral forms allowed are harmonised at EU level, but maximum levels and notification duties are set nationally — so a formula legal in Germany is not automatically legal in Ireland.

Cosmetics

Cosmetics follow Regulation (EC) No 1223/2009, require a Responsible Person established in the EU, a Cosmetic Product Safety Report and a Product Information File, plus CPNP notification before sale.

Devices

Medical devices fall under Regulation (EU) 2017/745 (MDR), with Notified Body involvement for most classes.

Tea & infusions

Tea is a food. Hydroxyanthracene derivatives — senna, cascara, aloe latex, rhubarb root — are restricted in food with a daily intake limit, and in several member states senna is a herbal medicine instead. Botanicals without a consumption history before 1997 need a novel-food authorisation, which is the usual trap for tulsi and newer adaptogens. Estragole limits apply to fennel and anise, and EU pesticide MRLs for tea are enforced at import, so residue testing is a commercial necessity rather than a formality.

Ask the supplier for

• Which EU member state you are selling into and what its national notification requires
• Whether every vitamin and mineral form appears in the permitted annex
• The Responsible Person's details and the CPNP notification reference
• A CPSR prepared against the current annexes, including the recent changes to retinol-type ingredients

Where launches stall

The EU is not one market in practice. National notification, language requirements on the label and maximum-level rules differ by country, and botanicals are largely regulated at member-state level.

European Commission / EFSA / national competent authorities — verify the current rules here.

Supplements

Retained EU law with national differences, plus FSA rules on claims and novel foods. A UK-based establishment requirement applies for placing these products on the market.

Cosmetics

Cosmetics require a UK Responsible Person and SCPN notification. A CPNP notification does not cover Great Britain, which is a frequent and costly oversight.

Devices

Devices are regulated as UKCA-marked products, with separate rules for Great Britain and Northern Ireland.

Tea & infusions

Retained EU rules with UK-specific maximum levels, and the FSA maintains the novel food register. The same hydroxyanthracene restrictions apply, and caffeine above defined thresholds requires a warning.

Ask the supplier for

• UK Responsible Person details and the SCPN notification reference
• Confirmation the claims are on the Great Britain register of authorised claims
• A UK or EU legal address on the label, as required

Where launches stall

Post-Brexit divergence is real. Assumptions based on EU compliance are the most common reason a UK launch stalls.

Food Standards Agency / Office for Product Safety and Standards — verify the current rules here.

Supplements

Most supplements are 'listed' complementary medicines on the ARTG with an AUST L number, largely self-assessed against permitted ingredients, indications and label wording. Higher-risk products require registration.

Cosmetics

Cosmetics are regulated as therapeutic goods only when they make therapeutic claims; otherwise they are covered by industrial chemicals rules.

Devices

Devices are included on the ARTG and follow conformity assessment procedures for their class.

Tea & infusions

A tea making a therapeutic claim becomes a listed complementary medicine with an AUST L number, and the permissible ingredient limits apply — several laxative herbs are restricted. Imported tea is checked for pesticide residues and contaminants.

Ask the supplier for

• AUST L number and the ARTG listing record, including the stated indications
• Evidence that the label complies with the TGA's labelling order, including any required warnings
• A local sponsor's details, which are legally required for the ARTG listing

Where launches stall

TGA label compliance is checked closely, and the 'listed' status means the sponsor carries the responsibility for the evidence — not the TGA.

Therapeutic Goods Administration — verify the current rules here.

Supplements

Products need a product licence before sale, with an NPN or DIN-HM number, an approved label and a named Canadian importer. Many products are approved against published monographs.

Cosmetics

Cosmetic notification is required within 10 days of first sale, with ingredient disclosure under the Cosmetic Regulations and the Hotlist of prohibited and restricted ingredients.

Devices

Devices require an establishment licence and, for higher classes, a medical device licence.

Tea & infusions

Herbal teas are foods unless a health claim is made. Marketing with a health claim or in a dosage form brings the product under the natural health product framework with a product licence. Caffeine labelling rules apply to products with added caffeine.

Ask the supplier for

• The NPN/DIN-HM number and the authorised label text
• Confirmation the licence holder is the Canadian importer of record
• Cosmetic notification number and the ingredient disclosure list

Where launches stall

Label text is approved as part of the licence. Changing claims, ingredients or dosage means a new or amended licence application.

Health Canada — verify the current rules here.

Supplements

Three routes: Foods with Function Claims (notification, evidence-based, not individually pre-approved), Foods for Specified Health Uses (individually approved), and general foods (no function claims). Ingredients also face additive and novel-food rules.

Cosmetics

Cosmetics have a licensing and notification framework with a defined ingredient list, and quasi-drugs sit in a separate, more restrictive category.

Devices

Devices are classified by risk and generally require a marketing authorisation held by a Japanese entity.

Tea & infusions

Tea is a beverage. Functional claims require either Foods with Function Claims notification or FOSHU approval, so a 'fat-burning' or 'detox' claim cannot simply be printed. Laxative slimming teas are a recurring enforcement target.

Ask the supplier for

• Which of the three routes the product is aimed at, and who holds the marketing authorisation
• Japanese-language labelling, which must be prepared for the market rather than translated from the English pack
• Confirmation the ingredients are permitted additives for the intended category

Where launches stall

Japan is not a 'translate the label' market. The regulatory route determines everything, and a local partner is usually essential.

Consumer Affairs Agency; MHLW — verify the current rules here.

Supplements

Health foods need registration or filing, and imported products must have a Chinese registration holder plus GACC importer registration. Cross-border e-commerce is a separate, lighter route with its own product list.

Cosmetics

Cosmetics need notification (imported general cosmetics) or registration (special cosmetics), with an in-country responsible person and animal-testing requirements that differ for imported products.

Devices

Devices are registered with NMPA by class, with clinical evaluation requirements.

Tea & infusions

代用茶 (substitute tea) is a defined food category with its own national standard, and functional claims move the product into health food territory, which requires registration or filing. Botanicals must sit on the approved lists — the 药食同源 list or the health food ingredient list. Imported tea needs GACC registration and a Chinese label.

Ask the supplier for

• Whether you are selling via general trade or cross-border e-commerce — the requirements are entirely different
• The in-country registration holder and the filing or registration number
• Chinese label and packaging files prepared by a local agent

Where launches stall

The cross-border e-commerce route is much faster, but it restricts where and how the product can be sold. Choose the route before you design the packaging.

SAMR; GACC for imports — verify the current rules here.

Supplements

Health supplements are treated as food-like products with no pre-market approval, but prohibited substances and Chinese proprietary medicine rules apply, and the importer holds responsibility.

Cosmetics

Cosmetics must be notified with the ASEAN Cosmetic Directive framework, with a product information file held by a responsible company.

Devices

Devices are registered by class with HSA, with an in-country registrant.

Tea & infusions

Tea is treated as a food. Claims are restricted, certain substances are prohibited outright, and imported products must carry compliant labelling. Health supplements have a low barrier to entry but the importer carries responsibility.

Ask the supplier for

• Confirmation that no ingredient appears on the prohibited list
• ASEAN Cosmetic Directive notification confirmation for skincare
• A local importer or registrant for device products

Where launches stall

A relatively open market, which makes it a good first test market — but enforcement focuses on prohibited substances and therapeutic claims.

Health Sciences Authority — verify the current rules here.

Supplements

Supplement registration is generally required per product, with an in-country agent, Arabic labelling and certificate attestation of the manufacturing site.

Cosmetics

Cosmetic products are registered through the Emirates Conformity Assessment Scheme with product notification and Arabic labelling.

Devices

Devices are registered with MOHAP by risk class, with an authorised representative.

Tea & infusions

Tea is a food product requiring registration for import, with Arabic labelling and shelf-life rules. Health claims are restricted, and any functional positioning needs to be cleared as part of registration.

Ask the supplier for

• The registered in-country agent and the product registration number
• Attested GMP and free-sale certificates from the country of manufacture
• Arabic label artwork approved by the authority

Where launches stall

Document attestation takes time and is a common bottleneck. Start it before the stock is ready, not after.

Ministry of Health and Prevention (MOHAP); municipal authorities — verify the current rules here.

Supplements

Most supplements are notified, with a defined permitted ingredient and claim list; higher-level claims require registration. Brazilian Portuguese labelling and local responsibility are mandatory.

Cosmetics

Cosmetics are registered or notified by risk grade, with a local legal representative and Portuguese labelling.

Devices

Devices are registered with ANVISA, with technical documentation for higher classes.

Tea & infusions

Tea is a food. ANVISA permits or restricts specific botanicals, claims are restricted, and Portuguese labelling with a local legal representative is mandatory.

Ask the supplier for

• Notification or registration number, and which grade the product falls into
• Portuguese language label and the local legal representative's details
• Confirmation the ingredients and claims appear in the permitted lists

Where launches stall

Brazil applies local-language and local-responsibility rules strictly, and import taxation adds significant landed cost — run the numbers before pricing.

ANVISA — verify the current rules here.