Navigating Amazon & Walmart Import Compliance for Health & OTC Brands

Let me guess, you're here because you've either had a shipment stuck in customs limbo, or you're terrified it might happen to you.

Trust me, I get it. When I first started working with health and OTC brands trying to sell on Amazon and Walmart, I watched too many entrepreneurs learn about compliance the hard way.

Here's what usually happens: You create an amazing vitamin supplement or pain relief cream. You've done your research, found your suppliers, and you're excited to get your products in front of millions of customers.

Then reality hits. Your perfectly good products get rejected at the border, or Amazon suddenly deactivates your listings because of some documentation you didn't even know existed.

It's disappointing, isn't it? You are trying to create a business and help people with your products, but instead, you are drowning in paperwork and rules that blink the eyelid every time.

The thing is that Amazon and Walmart are not trying to make your life difficult (even if it seems like that). They are protecting themselves and their customers. When someone buys health products from their platforms, they have to know that it is safe, valid, and, in fact, what it claims to be.

But no one here tells you: Once you crack the compliance code, it really becomes easier than you. It is like learning to ride a bike at first, but once you get it, you wonder why you were so worried.

I've seen brands go from constant compliance headaches to smooth, predictable operations. The difference? They stopped treating compliance as an afterthought and started building it into their business from day one.

In this guide, I'm going to share everything I've learned about navigating import compliance for health and OTC products on Amazon and Walmart.

We'll cover what documents you really need, how to avoid the most common mistakes, and how to build a system that keeps you compliant without driving you crazy.

Ready to turn compliance from your biggest fear into just another part of your routine? Let's get started.

Understanding the Regulatory Landscape

Okay, before we dive into the specific requirements for Amazon and Walmart, let's talk about the bigger picture.

Think of regulatory compliance like a three-layer cake: you've got federal regulations at the bottom, platform policies in the middle, and import requirements on top. Miss any layer, and the whole thing falls apart.

FDA Regulations for Health and OTC Products

First things first, the FDA. If you're selling anything that goes in, on, or near the human body, the FDA wants to know about it. And honestly? That's a good thing. But it does mean you need to understand where your products fit in their world.

Here's the breakdown: Dietary supplements, vitamins, and herbal products fall under one set of rules. Over-the-counter drugs like pain relievers, cold medicines, or acne treatments? That's a whole different ballgame. The FDA treats OTC drugs much more strictly because they're making specific health claims.

For dietary supplements, you'll need to follow Good Manufacturing Practices (GMPs) and make sure your labels don't cross the line into drug claims. Does your supplement "support immune health"? You're probably fine. Claim it "prevents colds"? Now you've got a problem.

OTC drugs need to follow specific monographs (think of them as FDA-approved recipes), register their facilities, and list their products with the FDA. It sounds complicated, but once you know which category you're in, the path becomes clearer.

Import Requirements and Documentation

When your products hit U.S. borders, customs agents aren't just checking for contraband; they're making sure your health products meet all federal requirements. You'll need your commercial invoice, packing list, and bill of lading (the basics), but that's just the beginning.

For health and OTC products, add these to your must-have list:

FDA Prior Notice (basically telling them your shipment is coming)
Certificates of Analysis from your manufacturer
Product labels that meet FDA requirements
Facility registration numbers
For OTC drugs, your National Drug Code (NDC) numbers

Pro tip: Missing even one document can mean your shipment sits in customs for weeks. I've seen $50,000 worth of inventory expire in a warehouse because of a single missing certificate. Don't let that be you.

Key Differences Between Amazon and Walmart Policies

Now here's where it gets interesting. While both Amazon and Walmart have to follow FDA rules, they each add their own requirements on top. It's like how different teachers might have different rules for the same subject.

Amazon tends to be more automated but also more rigid. They'll ask for specific documents in specific formats, and their bots don't negotiate. Get it right, and you're golden. Get it wrong, and you might spend weeks trying to reach a human who can help.

Walmart, on the other hand, takes a more relationship-based approach. They want to know you're a serious supplier who can meet their standards consistently. They might require facility audits, additional insurance, and more detailed quality control documentation. It's more work upfront, but once you're in, you typically have more support.

The key is understanding that compliance isn't one-size-fits-all. What works for getting your vitamins on Amazon might not be enough for Walmart, and vice versa. But don't worry, in the next sections, we'll break down exactly what each platform needs so you can prepare accordingly.

Remember, all these regulations exist for a reason. They protect consumers, protect the platforms, and ultimately, they protect your business too. Because when customers trust that products are safe and legitimate, everyone wins.

Amazon’s Import & Compliance Requirements

Amazon has some of the strictest compliance rules for health and OTC brands. Because the platform prioritizes customer safety and legal accountability, every product sold must pass through multiple checks before (and after) listing.

Here are the key areas to focus on:

1. Required Documentation

Amazon often requests proof that your products meet U.S. regulatory standards. For health and OTC brands, this may include:

FDA Registration & Compliance – Proof that your products fall under FDA guidelines (for dietary supplements, OTC drugs, or medical devices).
Certificates of Analysis (CoA) – Third-party lab tests verifying product safety, purity, and potency.
Product Labels & Packaging – Must clearly display ingredients, dosage instructions, warnings, and country of origin.

2. Restricted & Prohibited Products

Amazon maintains a strict list of restricted categories. For example, certain supplements, controlled substances, or OTC drugs may not be sold without prior approval. Attempting to list restricted products without authorization can lead to immediate suspension.

3. Common Pitfalls Sellers Face

Incomplete Documentation: Missing CoAs or vague labeling can trigger compliance holds.
Improper Health Claims: Marketing your supplement as a “cure” or “treatment” for a disease is a fast track to delisting.
Ignoring Renewals: Amazon may re-verify documents periodically, so staying proactive is key.

Guidance Tip: Always maintain a “compliance folder” with up-to-date certifications, FDA registrations, and labeling templates. This makes it easier to respond quickly to Amazon’s verification requests.

Walmart’s Import & Compliance Requirements

Like Amazon, Walmart enforces strict compliance rules for health and OTC products, but its approach is slightly different. Walmart positions itself as a trusted retailer, so it holds vendors to a “big-box” retail standard, even in its online marketplace.

Here’s what you need to know:

1. Vendor Setup & Approval

Application Process: Unlike Amazon’s open marketplace, Walmart Marketplace requires sellers to apply and get approved. Health and OTC brands must show a proven compliance record to even get accepted.
Insurance Requirements: Walmart typically requires sellers to carry product liability insurance with Walmart named as an additional insured party.

2. Safety & Testing Standards

Product Testing: Walmart often asks for lab testing or certificates proving that your health and OTC products meet FDA, FTC, or state-level regulations.
Label Accuracy: Labels must be fully compliant with FDA guidelines, ingredients, dosage, disclaimers, and expiration dates must be accurate and legible.
Supply Chain Transparency: Walmart may require proof of where your products are manufactured and how they are imported.

3. Key Differences from Amazon

Stricter Vetting: Walmart approves fewer sellers, meaning compliance is a barrier to entry.
Retail-Like Expectations: Documentation requirements often mirror those of selling to a major retail chain, not just an online marketplace.
Ongoing Audits: Walmart conducts regular compliance checks to ensure ongoing adherence, not just at the time of listing.

Guidance Tip: If you’re preparing to sell on Walmart, treat the process like pitching to a national retailer. Organize compliance documents, test results, and insurance coverage before applying; this can speed up approval and reduce costly delays.

Shared Challenges Across Platforms

While Amazon and Walmart have their own unique rules, health and OTC brands often face similar hurdles across both marketplaces. Understanding these shared challenges can help you prepare a compliance strategy that works everywhere, not just on one platform.

1. Packaging & Labeling Consistency

Labels must meet FDA guidelines across the board. That means:

Accurate ingredient lists
Proper dosage and usage instructions
Mandatory disclaimers (“This product is not intended to diagnose, treat, cure, or prevent any disease.”)
Clear country of origin

Even small mistakes, like missing a warning statement, can cause product rejection at both Amazon and Walmart.

2. Customs Clearance & Tariffs

Since many health and OTC products are manufactured overseas, customs compliance is critical. Missing import documents, incorrect tariff codes, or misclassified ingredients can delay shipments or result in seizure at the border.

3. Quality Assurance & Testing

Both platforms expect ongoing verification that products are safe and authentic. This includes:

Routine Certificates of Analysis (CoAs)
Batch testing for supplements and OTC products
Maintaining traceability from raw material to finished product

4. Constantly Changing Regulations

The FDA, FTC, and state agencies frequently update their requirements. What’s compliant today may need adjustments tomorrow. Sellers who fail to track these changes risk product suspension or penalties.

Guidance Tip: Build compliance into your operations workflow, not just as a one-time checklist. That way, every new product launch automatically includes label review, testing, and import documentation.

Best Practices for Health & OTC Brands

Navigating compliance may feel overwhelming, but breaking it down into repeatable steps makes the process manageable. Here are proven best practices to help health and OTC brands stay compliant while scaling on Amazon and Walmart:

1. Create a Compliance Checklist

Develop an internal checklist that covers:

FDA registration or notification (if applicable)
Certificates of Analysis (CoA) for each batch
Label review (ingredients, warnings, expiration dates)
Packaging verification (country of origin, lot numbers, safety seals)
Import documents (customs forms, tariff codes)

2. Partner with Compliance Experts

Consider working with:

Regulatory consultants who specialize in health & OTC products
Customs brokers to handle import paperwork and border clearance
Third-party labs for ongoing product testing and certification

3. Build Documentation Systems

Keep all compliance records in one place, digitally if possible. This makes it easy to respond quickly when Amazon or Walmart asks for verification. Some brands use compliance management software to track renewals and testing schedules.

4. Train Your Team

Educate your staff on compliance basics so they understand what can and cannot go on product labels, listings, and marketing. Miscommunication between marketing and regulatory teams is a common cause of compliance issues.

5. Monitor Regulations Proactively

Set up alerts or subscribe to FDA, FTC, and CBP updates. Regulations shift often, especially around supplements and OTC products. Staying proactive reduces the risk of last-minute product suspensions.

Guidance Tip: Treat compliance as a brand advantage. Consumers trust products that are properly tested, certified, and clearly labeled. Highlighting compliance in your listings can actually improve conversions.

Building a Long-Term Compliance Strategy

Compliance isn’t just a hurdle to clear; it’s a foundation for long-term growth. Health and OTC brands that take a proactive approach not only avoid penalties but also position themselves as trustworthy, professional, and reliable in the eyes of both consumers and retailers.

Here’s how to think about compliance as an ongoing strategy:

1. Make Compliance Part of Your Brand Culture

Instead of treating it as a one-time task, embed compliance into every stage of your operations, from product development to marketing. This ensures every new SKU launches with the right approvals, documentation, and testing.

2. Use Compliance as a Trust Builder

Shoppers are more likely to purchase health and OTC products when they see transparency. Highlight certifications (FDA-registered, third-party tested, GMP certified) in your product listings and packaging. This reassures customers and strengthens your brand credibility.

3. Stay Ahead of Regulatory Changes

Regulations are always evolving. Set up quarterly compliance reviews and assign a team member (or external advisor) to monitor FDA, FTC, and marketplace updates. Staying ahead of changes keeps you from scrambling when rules shift.

4. Leverage Technology for Monitoring

Invest in tools that track expiration dates, batch testing schedules, and document renewals. Automation reduces human error and helps you keep all compliance-related tasks on schedule.

5. Build Marketplace Relationships

Strong communication with Amazon or Walmart support teams (or even account managers if available) can give you early insight into changing requirements and help you resolve compliance issues faster.

Guidance Tip: Think of compliance as insurance for your brand’s reputation. A single violation can cost you your marketplace account, but a strong compliance strategy will help you scale safely for years to come.

Conclusion

Selling health and OTC products on Amazon and Walmart is one of the fastest ways to reach millions of customers, but success depends on more than just great products. Compliance with FDA, CBP, and marketplace requirements is the foundation that keeps your listings active, your shipments moving, and your brand reputation intact.

By building a proactive compliance strategy, complete with documentation systems, regular testing, and regulatory monitoring, you not only avoid costly setbacks but also position your brand as trustworthy and professional in a crowded market.

Now is the time to:

Audit your current compliance process and close any gaps.
Organize your documentation so you can respond quickly to Amazon or Walmart requests.
Seek expert support if you’re unsure about import, labeling, or testing requirements.

Compliance is not a barrier; it’s your pathway to long-term growth in the health and OTC space. Treat it as part of your brand story, and you’ll build customer trust while scaling confidently on the world’s largest marketplaces.

FAQs

1. Do I need FDA approval to sell supplements on Amazon or Walmart?

Yes. Supplements must comply with FDA labeling and safety guidelines, and you may need to provide Certificates of Analysis (CoAs) or third-party lab results.

2. What documents are required to import OTC products into the U.S.?

Typical documents include FDA registration, Certificates of Analysis, customs entry forms, tariff codes, and accurate product labels.

3. Can I sell the same health product on both Amazon and Walmart?

Yes, but each platform has its own compliance checks. Be prepared to provide documentation separately to both marketplaces.

4. What happens if my product fails compliance checks?

Your listing may be suspended, shipments delayed, or products seized by customs. Repeat violations can lead to permanent bans.

5. How can I simplify ongoing compliance management?

Keep all certifications and documents in a central system, partner with compliance experts, and schedule regular product audits to stay ahead of changing regulations.