You’ve got the product. Your private label fiber capsules are ready to roll out. You’ve sourced a manufacturer, worked on branding, and maybe even nailed your packaging down to a science. But suddenly, exporting them across borders feels like stepping into a bureaucratic minefield. Regulations pop up like gophers on a golf course, and each country plays by its own rulebook. If you’re hoping to scale internationally, compliance isn’t just a box to tick—it’s your passport to the market.
Let’s be blunt: labeling laws can wreck your launch if you don’t read the fine print. Different countries define “dietary fiber” differently. The U.S. Food and Drug Administration (FDA) has one take. The European Food Safety Authority (EFSA) has another. Australia? A third. Your capsule may be acceptable in one place and flagged as misleading in another. For example, in the EU, you can’t claim a health benefit unless it’s been scientifically substantiated and approved by EFSA. In the U.S., structure-function claims are permitted, but you need to add that tiny, annoying disclaimer: “This statement has not been evaluated by the FDA…” You know the drill.
Then there’s ingredient disclosure. Let’s say you’re using psyllium husk sourced from India. Harmless, right? Japan may require additional documentation to validate purity. Canada might ask you to prove it’s non-GMO. In Saudi Arabia, it might need Halal certification. Suddenly, that globally “safe” ingredient turns into a dossier of forms, verifications, and laboratory test results. You’ll need traceability paperwork, and sometimes even batch-specific certifications. Sounds tedious? That’s because it is.
Now, let’s talk about Good Manufacturing Practices (GMP). Some countries require compliance with their specific GMP standards—not just the general ones. The U.S. uses 21 CFR Part 111. Australia sticks to the TGA’s PIC/S standards. If your manufacturer only complies with one, it could limit your reach. Think of it like having a driver’s license valid in only one state. You can drive, sure. Just not everywhere you want to go.
Documentation is another landmine. Certificates of Analysis (CoAs), Stability Testing Reports, Allergen Declarations, Safety Data Sheets—each region might want them formatted their way. China, for instance, requires full translations and official stamps. And don’t think Google Translate will cut it. You’ll need a certified translator who knows how to phrase chemical names so they don’t accidentally sound like controlled substances.
And then there’s the matter of import permits. Some countries—looking at you, Brazil—want you to register your supplement with their national health authority before you bring a single capsule across the border. Others may allow you to import a “first shipment” while your application is still in progress. You’ll need a local agent, and sometimes, a sponsor. It’s like dating the bureaucracy—just to meet their customs officer.
Packaging, too, becomes a hot topic. Does your label state “natural?” In Canada, that term is closely regulated. Use it incorrectly, and you’ll be slapped with a non-compliance warning. How about “gluten-free?” The U.S. allows it under certain limits. The EU? Similar, but with tighter enforcement. South Korea? Totally different animal.
Let’s not forget allergens. If your capsule is manufactured in a facility that also processes peanuts, shellfish, or soy—even if there’s no detectable trace—you might be obligated to disclose that. Some jurisdictions fine brands for what seems like an oversight. France, in particular, is tough on undeclared allergens. And in Germany, translations must be flawless or you risk delisting.
The cost of compliance isn’t just in dollars. It’s in time, energy, and missed market windows. Some supplement companies rush a launch, thinking they’ll “fix things later.” That’s a classic mistake. Your product can be pulled from shelves faster than you can say “recall.” A better move? Build regulatory research into your go-to-market strategy from day one.
Also, consider how e-commerce complicates things. Selling on Amazon or Shopify to global buyers might expose you to foreign laws—even if you’re based in one country. If you sell a batch of capsules to a customer in South Africa, and the product doesn’t meet their health labeling laws, you’re still liable. Geo-fencing can help, but it’s not foolproof.
Working with a consultant or regulatory affairs expert can make a massive difference. Someone who understands the maze, who’s been down that alley before, who can tell you if your claims will fly in Dubai or fall flat in Zurich. And no, your cousin who studied biology for one semester doesn’t count.
Laws change. Fast. The EU is currently tightening its novel foods regulation, while the U.S. has hinted at potential changes under the DSHEA framework. Asia is a mixed bag—Vietnam is moving toward stricter enforcement, while Thailand is trying to streamline. If you’re still working from that two-year-old PDF you downloaded from a trade forum, you’re already behind.