Salve regulatory status reference

Salve shows a product's regulatory status with fixed wording. You choose the status values; the theme prints the matching chip and statement. This page lists every value, what it prints and how to limit statuses to one region.

Salve helps you present product information clearly. It does not make your store, products or content compliant with any law or regulation. You are responsible for your product claims, labeling and regulatory obligations. Take professional advice.

Where statuses come from

Statuses come from the health.regulatory_status metafield, a list of values. Four other fields complete the statements:

health.regulatory_reference: a list of reference numbers, in the same order as the statuses. The first reference goes with the first status, and so on.
health.device_class: the device class, for example "Class II".
health.notified_body: the notified body number for CE statuses.

To create these fields, see the Health data setup guide. You can also type status values into the Custom statuses setting of the Regulatory status block, separated by commas. That setting applies to every product that uses the template and replaces each product's own statuses, so leave it empty in most cases.

The device class is shared by the US (510(k) exempt), EU and UK statements. If a product's class differs between markets, leave the device class empty, or use Custom statuses on a template you use only for that market.

Only set a status that applies to your product. Enter reference numbers exactly as they appear in the official record.

Status values and what they print

A chip is the short label shown in the Regulatory status block (with Style set to Chips) and on product cards. A statement is the longer line shown with Style set to Statements. In the table, {reference} is the matching regulatory reference, {device class} is the device class and {number} is the notified body number.

Value	Region	Chip	Statement	Without the optional data
`us_510k_cleared`	United States	FDA cleared	FDA 510(k) cleared: {reference}	FDA 510(k) cleared
`us_pma_approved`	United States	FDA approved	FDA premarket approval (PMA): {reference}	FDA premarket approval (PMA)
`us_de_novo_granted`	United States	FDA De Novo	FDA De Novo classification granted: {reference}	FDA De Novo classification granted
`us_510k_exempt`	United States	510(k) exempt	{device class} device, exempt from FDA 510(k) premarket notification	Exempt from FDA 510(k) premarket notification
`us_otc_drug`	United States	OTC drug	Over-the-counter drug. Read the Drug Facts label before use.	Not applicable
`us_dietary_supplement`	United States	Dietary supplement	Dietary supplement.	Not applicable
`eu_ce_mdr`	European Union	CE marked	CE marked under Regulation (EU) 2017/745 (MDR), notified body {number}. {device class}.	CE marked under Regulation (EU) 2017/745 (MDR).
`eu_ce_ivdr`	European Union	CE marked (IVD)	CE marked under Regulation (EU) 2017/746 (IVDR), notified body {number}.	CE marked under Regulation (EU) 2017/746 (IVDR).
`uk_ukca`	United Kingdom	UKCA marked	UKCA marked medical device. {device class}.	UKCA marked medical device.
`ca_mdl`	Canada	Health Canada licensed	Health Canada medical device licence: {reference}	Health Canada licensed medical device
`au_artg`	Australia	ARTG included	Included in the Australian Register of Therapeutic Goods: {reference}	Included in the Australian Register of Therapeutic Goods
`general_wellness`	All regions	No chip	General wellness product. Not a medical device.	Not applicable
`cosmetic`	All regions	No chip	No statement	Not applicable

Notes:

The wording "FDA approved" is used only for us_pma_approved.
There is no "FDA registered" status. Establishment registration and device listing with the FDA are not a clearance or approval, so the theme doesn't print them as a status.
CE and UKCA appear as text. The theme never shows agency logos or conformity mark artwork.
The cosmetic value is accepted so you can record it, but it prints nothing.
Values the theme doesn't recognize are ignored.
Product cards show only the first chip that passes the region filter. The Regulatory status block shows up to the number set in Maximum items.
Shoppers see this wording in your store's language. You can adjust the translations in Online Store > Themes > Edit default theme content. If you do, keep the meaning exact.

Dietary supplements

When a product has the us_dietary_supplement status, Salve can show the dietary supplement statement:

"These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

With Show the dietary supplement statement automatically turned on in theme settings, the statement shows in the Highlights block, or in the Price block when the template has no Highlights or Disclaimer block.
The statement is a US requirement, so it shows only when Show regulatory statuses for is All regions or United States.
The Disclaimer block shows the statement when its Text setting is empty.
The wording is set in theme settings under Health data > Dietary supplement statement. Change it only on legal advice. It's a setting, so translate it with Shopify's Translate & Adapt app. See Markets and languages.
For food supplements sold in the EU or the UK, which need different statements, connect the Disclaimer block's Text to a product metafield. See Theme settings under Health data.

Show statuses for one region

If you sell in one market, you can hide statuses for other regions. Go to theme settings, open Health data and choose an option in Show regulatory statuses for:

Option	Statuses shown
All regions	Every status.
United States	Values starting with `us_`.
European Union and United Kingdom	Values starting with `eu_` or `uk_`.
Australia	Values starting with `au_`.
Canada	Values starting with `ca_`.

general_wellness and cosmetic apply to all regions, so they're never filtered out. The filter applies everywhere statuses appear: product pages, product cards and product comparison.

Your responsibility

The theme prints what you enter. It doesn't check whether a status, reference number or device class is correct, current or allowed in the markets you sell to. Review your product pages with someone who knows the rules for your products and markets.

Country/region