FDA's Unapproved New Drug Letters: What Canadian Homeopathic and OTC Exporters Must Fix

On 1 October 2026, the United States Food and Drug Administration (FDA) signed a batch of warning letters that should stop every Canadian natural health product and over the counter exporter in their tracks. The letters, posted publicly on 6 October, target companies selling homeopathic and OTC topical products that claim to treat sexually transmitted infections, including genital herpes and chlamydia. One of the letters went to Amazon.com, Inc. itself, for products it ships through Fulfillment by Amazon on behalf of third party sellers.

For Canadian manufacturers and brand owners who sell into the United States, the message is blunt. A homeopathic label does not exempt a product from FDA drug approval. A disease claim turns a wellness product into an unapproved new drug. And selling through a marketplace does not move the risk off your shoulders, because FDA is now willing to name the marketplace too. This article explains what FDA cited, why it matters, and the concrete steps to protect your product before a letter lands in your inbox.

What FDA did, and to whom

In short: FDA issued warning letters on 1 October 2026, posted on 6 October, to companies marketing homeopathic and over the counter topical products with claims to treat sexually transmitted infections. The agency classed the products as unapproved new drugs and told each recipient to respond within 15 business days. The core problem was not the ingredient. It was the claim.

The letters came from FDA's Center for Drug Evaluation and Research (CDER), Office of Unapproved Drugs and Labeling Compliance. The office does not inspect a factory to write this kind of letter. It reads your website, your product label and your marketplace listing, then decides whether your intended use makes the product a drug. Three of the letters show the pattern clearly.

DesBio, also known as Deseret Biologicals, Inc., received a letter over a product labelled "Chlamydia 10M" and sold as homeopathic. FDA said the product was intended to relieve the symptoms of chlamydia, a disease, which made it a drug by intended use. Aidance Scientific, Inc. received a letter over "Terragen HG Formula," a homeopathic product sold with claims to relieve genital sores and the symptoms of genital herpes. Amazon.com, Inc. received a letter covering nine over the counter topical products, several of them homeopathic, all sold with herpes or STI relief claims and shipped to consumers through Fulfillment by Amazon.

The same four statutory sections appear in each letter. A product is a drug under section 201(g)(1) when it is intended to diagnose, cure, mitigate, treat or prevent a disease. It is a new drug under section 201(p) when it is not generally recognized as safe and effective for its labelled use. Section 505(a) prohibits marketing a new drug without an approved application, and section 301(d) makes it a prohibited act to introduce such a product into interstate commerce. None of the three letters cited good manufacturing practice. The violation was the claim and the lack of an approval, full stop.

Why a homeopathic or OTC label is not a shield

Many Canadian companies believe that calling a product homeopathic, or formatting a label in over the counter Drug Facts style, keeps it out of the drug approval system. FDA's letters say the opposite. Homeopathic drugs are subject to the same requirements on adulteration, misbranding and approval as any other drug. The label format does not change the legal test, and the disease claim is what the agency reads.

FDA regulates homeopathic products under a risk based policy set out in its December 2022 guidance on homeopathic drug products. A product can fall outside even that guidance. In the DesBio letter, FDA noted that "Chlamydia trachomatis 10M" is not listed in the Homeopathic Pharmacopoeia of the United States (HPUS), so the product was outside the scope of the guidance, and that even inside it the product would sit in a higher risk category FDA intends to prioritize for enforcement. In the Amazon letter, FDA made the same point about several products that contained lemongrass, which is not listed in the HPUS. A homeopathic label on an ingredient that is not even in the HPUS offers no protection at all.

The over the counter monograph system does not help either when the claim goes beyond what the monograph allows. In the Amazon letter, FDA said one product, Herstat GST, went beyond the permitted indications of OTC Monograph M017 and that there was no basis under section 505G of the Act to market it lawfully without an approved application. If your product claims to treat a disease that no monograph covers, the monograph route is closed.

The marketplace trap: why Amazon received a letter

In short: FDA named Amazon because Amazon distributes these products to United States consumers on behalf of third party sellers, through Fulfillment by Amazon. The agency said that introducing or delivering the products for introduction into interstate commerce through that service is itself a prohibited act. For a Canadian seller, this is the most important single lesson in the batch.

Many Canadian brands reach United States buyers through a marketplace rather than their own website. The comfortable assumption is that the platform carries the compliance risk, or that a third party listing somehow separates the brand owner from the sale. FDA's Amazon letter dismantles both ideas. The agency quoted Amazon's own description of Fulfillment by Amazon, which lets sellers outsource order fulfillment and says Amazon will pick, pack and ship orders, along with customer service and returns. FDA treated that operational role as distribution of an unapproved new drug. If the platform is in scope, the brand owner whose product and claims created the problem is certainly in scope.

What counts as a drug claim

In short: a drug claim is any statement, express or implied, that a product is intended to treat, cure, mitigate, prevent or diagnose a disease. FDA builds intended use from the whole record, not one sentence. In these letters, the evidence came from product names, website condition categories, Drug Facts labels and marketing copy. The following are all claims FDA has treated as evidence of intended use:

• Product names that reference a disease, such as a herpes or chlamydia name built into the brand or SKU.
• Website navigation that sorts products by disease, such as a "Shop by Condition" menu with a herpes category.
• Drug Facts or label text promising relief of symptoms tied to a named disease, such as genital sores, pain or swelling from herpes.
• Implied claims through metadata, search keywords, testimonials and reviews that the seller publishes or allows to stand.
• Before and after imagery, dosing instructions for a condition, or comparisons to an approved prescription treatment.

The line that keeps a lawful natural health product on the right side of the test is the difference between a permitted structure or function statement and a disease claim. "Supports a healthy immune response" is a structure or function statement. "Treats genital herpes outbreaks" is a disease claim and, without an approved application, an unapproved new drug claim in the United States.

What Canadian exporters must do now

In short: run a claims and classification review across every product you sell, or plan to sell, in the United States, and fix the listings as carefully as the labels. The practical sequence is below.

• Inventory every product and every United States channel, including your own site, each marketplace listing and any reseller pages you control or influence.
• Classify each product. Decide whether it is intended as a dietary supplement, a cosmetic, an OTC monograph drug or a product that needs an approved drug application. The intended use you communicate, not the formula alone, drives the answer.
• Strip disease claims from products you intend to keep as supplements or cosmetics. Remove disease based product names, condition navigation, symptom relief statements and any testimonial or review that makes the claim for you.
• For homeopathic products, confirm each active is listed in the HPUS and map the product against FDA's December 2022 risk based guidance. Treat anything outside the HPUS, or in a higher risk category, as high exposure.
• For OTC monograph products, confirm the indications stay within the relevant monograph and that your product meets the conditions for marketing under section 505G.
• Audit marketplace content directly. Export your live listings, read them as FDA would, and correct the title, bullets, structured content and condition tags.
• Build a claims approval SOP so no new listing or label goes live without a documented regulatory sign off, and keep the evidence that supports each remaining claim.

A claims review is also a good moment to confirm what is actually in the bottle. FDA and Health Canada both act on undeclared drugs hidden in herbal products, and robust identity and adulterant testing in your finished product specifications is the control that keeps a compliant claim honest.

Compliance checklist

• Every United States product is classified in writing as supplement, cosmetic, OTC monograph drug or approved drug.
• No product name, SKU or brand references a disease.
• No label, website or listing claims to treat, cure, mitigate or prevent a disease unless the product has the required approval.
• Homeopathic actives are confirmed against the HPUS and mapped to FDA's risk based guidance.
• OTC monograph products stay within the monograph indications and meet section 505G conditions.
• Marketplace listings, condition categories, metadata and displayed reviews are audited and corrected.
• A claims approval SOP requires documented regulatory sign off before any new label or listing goes live.
• A monitored mailbox and a 15 business day response plan are in place in case a warning letter arrives.

Common mistakes

• Assuming a homeopathic label removes a product from FDA drug rules. It does not.
• Treating the Canadian NHP licence as proof of United States compliance. The two systems are separate, and a Health Canada product licence number means nothing to FDA.
• Cleaning the label but leaving disease claims live in the marketplace listing, the metadata or the reviews.
• Believing a marketplace shields the brand owner. FDA named the marketplace itself in October 2026.
• Letting testimonials and customer reviews make the disease claim the label avoids. FDA reads those as intended use.
• Ignoring the 15 business day response window, or responding without a corrective action plan that FDA will accept.

Frequently asked questions

What is an unapproved new drug?

An unapproved new drug is a product that is intended to treat, cure, mitigate, prevent or diagnose a disease, is not generally recognized as safe and effective for that use, and is marketed without an approved FDA application. Under the Federal Food, Drug, and Cosmetic Act, a disease claim makes a product a drug, and a drug that is not generally recognized as safe and effective is a new drug that needs approval before it can be sold.

Does a homeopathic label exempt my product from FDA approval?

No. FDA has stated that homeopathic drugs are subject to the same requirements on adulteration, misbranding and approval as other drugs. FDA applies a risk based policy from its December 2022 guidance, but products with disease claims, or actives that are not listed in the HPUS, fall outside that policy and are enforcement targets.

Can I sell a homeopathic or OTC product from Canada on a United States marketplace?

Yes, if the product is lawfully marketable in the United States and the listing carries no disease claim. The October 2026 Amazon letter shows that the marketplace listing is part of the regulatory record, and that FDA will act on the listing content. Treat every marketplace page with the same care as the physical label.

Is the marketplace or the seller responsible?

Both can be. FDA treated Amazon as a distributor because it shipped the products to consumers through Fulfillment by Amazon. That does not relieve the brand owner, whose product, label and claims created the violation. Expect FDA to pursue the party whose conduct it can document, which usually includes the seller.

How long do I have to respond to an FDA warning letter?

The October 2026 letters gave 15 business days from receipt to respond in writing. A strong response confirms the violations you accept, sets out the corrective actions taken and planned, gives completion dates, and provides evidence. Ignoring the letter invites further action, including seizure or injunction.

My Canadian NHP is fully licensed by Health Canada. Is it compliant in the United States?

Not automatically. A Health Canada product licence does not carry any status with FDA. In the United States a comparable product is usually a dietary supplement with its own labelling and manufacturing rules, including 21 CFR Part 111 good manufacturing practice, and it cannot carry a disease claim without an approved drug application.

How MFLRC can help

MF License and Regulatory Consultants (MFLRC) helps Canadian natural health product, homeopathic and over the counter companies enter and stay in the United States market without stepping on an enforcement trap. We run claims and classification reviews that read your labels and your marketplace listings the way FDA does, map homeopathic products against the HPUS and the risk based guidance, and confirm whether an OTC monograph or an approved application is the right route. We also build the quality and documentation systems that keep a compliant claim defensible, from finished product specifications and identity testing to inspection findings that catch Canadian supplement exporters and the Canadian NHP compliance foundation that underpins your home market. Our services include gap assessments, SOP development, labelling and claims review, licensing support, QAP services and audits.

Selling a Canadian NHP or homeopathic product into the United States? Book an MFLRC claims and classification review before FDA does it for you.

Conclusion

FDA's October 2026 letters are a clear signal to Canadian exporters. The agency is reading websites and marketplace listings, it treats a disease claim as the thing that creates a drug, and it will name a marketplace as a distributor. A homeopathic or OTC format does not change the test. The defence is disciplined claims control across every channel, honest classification, and careful labelling practice. Fix the claim, fix the listing, and keep the evidence, and you can sell into the United States with confidence rather than waiting for a letter.

Sources and references

• FDA Warning Letter, DesBio / Deseret Biologicals, Inc., reference 735464, 1 October 2026
• FDA Warning Letter, Amazon.com, Inc., reference 736006, 1 October 2026
• FDA Warning Letter, Aidance Scientific, Inc., reference 735346, 1 October 2026
• FDA, Homeopathic Products (information and December 2022 guidance)
• FDA, Warning Letters database