If you want to sell successfully in the US market for the next 10 to 20 years, here are some of the common mistakes that most first-time businesses entering the US make, and how to avoid them. I’m a US and FDA expert who’s helped over 500 businesses enter the US over the past decade. Recently I spoke at Amazon Global Selling Vietnam, and here’s what I shared there.

Mistake number one: using OTC drug claims on your beauty products. In the US, cosmetics, beauty and personal care products are regulated by the FDA. A common mistake for first-time entrants is loading their products with treatment claims. The FDA regulates cosmetics as products that only affect outer appearance, without changing any bodily function. A shampoo that simply cleanses the scalp is a cosmetic. A shampoo marketed for dandruff or hair loss treatment is an OTC drug claim. A moisturiser that improves skin appearance is a cosmetic; one that claims to stimulate collagen production or treat dark spots or acne is an OTC drug claim. A foundation used purely to beautify skin is a cosmetic; the moment it includes SPF — a sunscreen ingredient — it becomes an OTC drug. So the first common mistake is having treatment-result claims on a product without realising it crosses that line. Before we help clients file with the FDA, we review their ingredients and label design specifically to catch these violations, and where we find them, we advise revising the advertising statements to something compliant with cosmetic regulations instead.

That leads to the second mistake: choosing a treatment product as your first SKU. A lot of Amazon sellers and e-commerce brands doing keyword or category research see that treatment products — acne care, dark spot care, scar care — are in high demand, and naturally gravitate to them as a first product. From a compliance standpoint, I’d actually advise a first-time US entrant to choose a more forgiving SKU — hair care, or a cosmetic without specific treatment claims. The reason: going the OTC drug route gives you very little room to innovate on active ingredients. A lot of recent R&D and newer technology isn’t reflected in US regulation yet — sunscreen regulation, for instance, hasn’t materially changed in 20 years, so a newer active ingredient common in, say, Korean sunscreen formulations may not be permitted in the US at all. Under OTC, you’re generally restricted to following an existing FDA monograph — an established formulation you must match, not deviate from. And even once you’re following the monograph correctly, licensing costs to get an OTC drug approved through the FDA run roughly $100,000 to $500,000 a year, plus additional cost for introducing new active ingredients or formulas. Given that, if you’re a first-time brand entering the US, it’s worth thinking about what your actual competitive advantage is, and whether you can apply that to an easier product line instead.

One client we worked with recently had a popular acne skin treatment line they wanted to bring into the US. Fortunately they talked to us during their formulation and R&D process. We found that bringing that specific product into the US under cosmetic rules would mean stripping out the active ingredients and the acne-treatment claims — making it far less appealing to consumers than their original product. What they did instead was switch their first US SKU entirely to a hair care line. Their actual competitive advantage was social media and digital marketing, which they could apply to a different product line just as effectively, without being tied to one specific regulated product.

Speaking of social media, that leads to the third common mistake: overlooking FTC regulations and Proposition 65. The FTC is the US agency that regulates advertisements, claims and statements. Even with a fully compliant label, you’re still obligated to make sure every advertisement — your website, your influencer campaigns — follows FTC rules. This is an ongoing duty, especially important once you’re trying to scale. Social media platforms enforce FDA and FTC regulations strictly, so if you’re spending real money on influencer marketing, you don’t want your ads restricted or banned for violating platform or US regulation rules. To avoid this, understand FTC advertising regulations, and if you plan to sell in California specifically, Proposition 65 as well. California is one of the largest state markets in the US, so most brands entering the US will end up there. FDA rules are federal and apply nationwide, but for beauty and personal care specifically, California layers Prop 65 requirements on top.

Our compliance team helps review labels and advertising campaigns for exactly this. As a thank-you for watching this far, there’s a free checklist available — guidance for your influencers and content creators on what they can and can’t say in advertisements, based on current FDA and FTC advertising rules. It’s linked in the description.

The last, and most serious, mistake: betting on flying under the radar. By the time most clients come to us for FDA filing, they’ve usually already finished their R&D, product line and marketing materials — FDA compliance ends up last on the checklist. When they discover a violation in their labels or application, a lot of brands are hesitant to revise, given how much time and money has already gone into the marketing they now can’t use as-is. At that point there are two paths. Some accept the issue and revise, exactly like the client I described earlier. Others, even after being advised that their claims or label have a real violation, decide not to follow that advice and ship anyway.

I had one client, a supplement brand manufactured in Egypt. When we advised them to revise their label, or do additional work to bring it into compliance, they shipped the product as originally submitted instead. What they were betting on was not getting inspected — these agencies handle hundreds of thousands, millions, of shipments daily, so they can’t inspect everything. But routine inspection still happens, and this shipment was unlucky: FDA inspected it, took samples, reviewed the label, and found the claims were inaccurate. By that point the product was already on US soil. They had to destroy the entire shipment — a loss of roughly $10,000 in shipping value — and discontinued their US market entry permanently. This isn’t an isolated case; it’s one of many similar outcomes over the past few years. FDA and US Customs have been increasing inspection rates since 2025, driven partly by rising violations and partly by reciprocal tariff enforcement. If you want to be in this market long-term and actually enjoy the results for the next 10 or 20 years, the advice is simple: do it right from the beginning.

A better example of the alternative comes from Swisse, a well-known Australian-grown supplement brand, before they were acquired by a Hong Kong firm. When entering the US, they invested heavily in checking their labels for compliance. During that process they identified a potency issue with their active ingredients that risked significant losses. Instead of shipping that batch to the US, they redirected it to the Australian market instead and delayed their US launch. That single decision likely saved them millions of dollars in potential fines, reformulation costs, and recall expenses they would otherwise have faced.

Those are the most common mistakes first-time businesses make entering the US market. If this was useful and you’d like help planning and executing your US compliance paperwork, our website is linked in the description. My team looks forward to working with you. Thanks for watching, and subscribe for more content like this.