Once the formula is settled and before looking for a factory, many brands haven’t answered an earlier question: where will this product be sold? Depending on the market, the answers change completely: which ingredients are allowed, whether you need approval before launch, and which extra certifications apply. Here is how several common markets compare.
United States: no pre-approval, but old and new ingredients differ
US dietary supplement rules are built on the Dietary Supplement Health and Education Act of 1994 (DSHEA). Products don’t need FDA approval before sale, but ingredients fall into two groups. Ingredients marketed as dietary supplements in the US before October 15, 1994 are “old” dietary ingredients and can be used. Newer ones are “new dietary ingredients” (NDIs), and generally need an NDI notification filed with FDA at least 75 days before marketing.
Facilities that make, pack or hold the product must register with FDA as food facilities and renew in every even-numbered year. There is currently no mandatory product listing for supplements (bills have been introduced in Congress but not passed). Labels must say “Dietary Supplement” and carry a full Supplement Facts panel. Claims are limited to structure/function statements with the standard disclaimer; you can’t claim to treat or prevent disease.
European Union: no single pass, and new ingredients need their own check
The EU sets some common rules, such as which vitamins and minerals and which forms may be used, but member states enforce them. There’s no single registration that covers every country, and many member states require a notification to their own authority before a product goes on sale.
New ingredients may count as “Novel Foods”. The key test is whether the ingredient was consumed to a significant degree in the EU before May 15, 1997. If it was, it’s exempt. If not, an application goes to the European Commission and the European Food Safety Authority (EFSA) assesses its safety. Member states can also read the same ingredient differently, so check country by country instead of assuming that what works in one works in all.
Indonesia: registration before sale, and halal is now mandatory
Health supplements in Indonesia (“Suplemen Kesehatan”) are regulated by the food and drug agency BPOM. Whether made locally or imported, a product needs a marketing authorization before it can be sold.
Halal certification needs attention too. Under Indonesia’s Halal Product Assurance Law and Government Regulation 42 of 2024, mandatory halal certification for health supplements took effect on October 17, 2026. Imported products apply through a local representative in Indonesia, and the halal agency BPJPH’s official announcements are the reference for the exact process and any transition rules. If Indonesia is on your list, plan for halal certification early, not at customs.
Singapore: no pre-market approval, but sellers carry the responsibility
Singapore’s Health Sciences Authority (HSA) oversees health products. Health supplements currently don’t need pre-market approval or a license, and a voluntary product notification scheme has run since 2022. That doesn’t mean anything goes. Importers, wholesalers and sellers are responsible for safety and quality, and products must still follow HSA rules: no prohibited medicinal ingredients, heavy metals within limits, English labeling and no claims to treat disease.
HSA is also consulting on mandatory listing for “complementary health products”, including supplements, from 2028. Brands planning to sell in Singapore long term should keep an eye on it.
Pick the market first, then the formula and the factory
Your target market decides far more than label language and packaging. It decides which ingredients you can use, what has to happen before launch and which certifications you need. Moving a product from Indonesia to Singapore is a completely different regulatory path, and one set of documents won’t cover both. Settle the market before finalizing the formula and choosing a factory, and you’ll avoid a lot of detours.
Sources
- US FDA: Dietary Supplement Health and Education Act of 1994; New Dietary Ingredient notification (21 CFR 190.6).
- US FDA: Food Facility Registration requirements; Dietary Supplement Listing Act of 2026 (H.R. 8370), introduced, in committee.
- EU: Novel Food Regulation (EU) 2015/2283; Food Supplements Directive 2002/46/EC.
- Indonesia: Government Regulation 42 of 2024 (Halal Product Assurance); BPJPH and BPOM official notices.
- Singapore Ministry of Health and HSA guidance on health supplements; NutraIngredients, July 2026, on HSA’s proposed mandatory notification for complementary health products.