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Supplement Health Claims Compliance: How FTC and FDA Rules Shape Your Merchant Account Approval

7 min read·Karma Card Payments·Published ·Updated
Supplement Health Claims Compliance: How FTC and FDA Rules Shape Your Merchant Account Approval

Your supplement application didn't get declined because of your ingredients. It got declined because an underwriter opened your product page, read one sentence, and decided the bank couldn't defend it.

For nutraceutical brands, the claims on your site are the risk profile. This post explains the federal rules behind those claims, why free-trial offers raise the stakes, and exactly what a reviewer looks for before saying yes.

Why underwriters read your marketing like regulators do

A processor's sponsor bank carries the risk of every merchant it approves. If a supplement brand gets hit with an FTC action or a wave of "this didn't work" chargebacks, the bank absorbs losses and reputational damage it never priced in.

That's why supplement underwriting looks so much like a compliance review. The underwriter isn't judging whether your product works. They're judging whether your claims would survive a regulator, a consumer protection attorney, or a cardholder's dispute.

The good news: the rules are public. If your site follows them, you look like a different category of merchant from the ones causing the losses.

The FTC's Health Products Compliance Guidance in plain language

In December 2022, the FTC replaced its 1998 dietary supplement advertising guide with broader Health Products Compliance Guidance. It covers supplements, foods, devices, and health apps, and it is the clearest statement of how the agency evaluates health marketing.

Every claim needs competent and reliable scientific evidence

Health claims must be backed by competent and reliable scientific evidence. For most health benefit claims, the guidance says that generally means randomized, controlled human clinical trials. Animal studies, lab studies, and testimonials alone don't qualify.

Implied claims count as much as stated ones

The FTC looks at the net impression of the entire ad, including images, product names, and layout. A "natural immune support" product pictured next to someone recovering from a cold is making a cold-related claim, even if the copy never says "cold."

Testimonials don't substantiate anything

Customer stories can't substitute for evidence, and testimonials describing results better than typical users get are deceptive even with a "results not typical" note. Advertisers are also responsible for what their endorsers and influencers say.

The FDA disclaimer isn't a shield

The guidance is explicit that the standard dietary supplement disclaimer won't rescue an ad that makes unsupported disease claims.

The FTC has backed this up. In April 2023, it sent notices of penalty offenses about substantiation to almost 700 companies, putting them on notice that unsupported claims could bring civil penalties.

FDA structure/function claims: the line you can't cross

The FDA side of the picture is narrower but just as decisive. Dietary supplements may make structure/function claims, statements about how a nutrient or ingredient affects the normal structure or function of the body. They may not claim to diagnose, treat, cure, mitigate, or prevent a disease.

FDA's own example captures it: "supports joint flexibility" is a structure/function claim, and "treats arthritis" is a disease claim. Cross that line and the product is being marketed as an unapproved drug.

Structure/function claims carry two obligations. The manufacturer must notify FDA within 30 days of first marketing the claim, and the label must carry this disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

In December 2025, FDA said it would use enforcement discretion on the requirement that the disclaimer appear on every label panel where a claim appears, while still requiring the disclaimer on the label and linked to each claim. Underwriters will still look for it on your site and product pages.

Underwriters don't approve supplements. They approve claims. If your claims can't survive the FTC and FDA, your account can't survive the first wave of disputes.

Free trials and negative option offers: where most supplement accounts die

"Just pay shipping" trials that roll into monthly charges built the supplement industry's bad reputation with banks. They also generate exactly the disputes card networks track most closely: customers who never understood they agreed to recurring billing.

The federal picture

The FTC's broader "click-to-cancel" negative option rule was vacated by the Eighth Circuit in July 2025, but that didn't open the door. The Restore Online Shoppers' Confidence Act still requires clear disclosure of material terms, express informed consent before billing, and a simple way to stop recurring charges. The FTC restarted subscription rulemaking with an advance notice in March 2026, and many states have their own automatic renewal laws.

The card network picture

Visa's rules for merchants offering free trials or introductory offers that convert to subscriptions require express consent to future charges at checkout, an immediate receipt with cancellation instructions, a reminder before the trial converts, and a statement descriptor that identifies the first post-trial charge. Mastercard has its own requirements for trial-to-subscription offers. Merchants that can't prove those steps tend to lose disputes in this category.

A processor reviewing a trial-based supplement offer will walk through your checkout to confirm every one of those steps exists. If your model is subscription-based, our guide to cutting subscription chargebacks covers the operational side, and subscription merchant accounts explains how recurring billing is underwritten.

Product categories that draw a closer look

Not every supplement gets the same scrutiny. A basic multivitamin with modest claims reads very differently from a product whose entire pitch sits one step from a disease claim.

Categories where the natural marketing language drifts toward disease or dramatic results tend to get the hardest review:

Selling in these categories doesn't rule you out. It means your claims file has to be stronger and your copy more disciplined, because the reviewer starts from a more skeptical place. Expect more questions about substantiation and more attention to your refund and dispute numbers.

What underwriters flag on your website

A supplement site review usually takes minutes, and it follows a predictable pattern. These are the items most likely to stop an application or trigger a reserve:

Clean these up before you apply, not after a decline. A site that passes this review signals that the merchant behind it understands the risk, which is half of what an underwriter is trying to learn.

How to build a claims file that speeds approval

The fastest supplement approvals come from brands that hand the underwriter answers before questions arise. Put together a short claims file:

  1. A claims inventory. Every health-related claim on your site, labels, and ads, listed in one document.
  2. Substantiation for each claim. The studies or evidence behind it, with a note on whether they involve your formula, your dose, and human subjects.
  3. FDA notification records. Copies of structure/function claim notifications where applicable.
  4. Checkout screenshots. Every step of a trial or subscription flow, showing disclosures, consent, and cancellation.
  5. Affiliate rules. Your written policy on what partners may and may not claim, and how you monitor it.
  6. Chargeback history. Recent statements and dispute ratios, with an explanation of anything unusual.

A file like this changes the conversation from "is this merchant dangerous?" to "how should we set this account up?" It is how we approach processing for supplement and nutraceutical brands, and it makes a stable approval far more likely wherever you apply.

Ongoing protection matters too. Even compliant supplement brands face disputes from customers who expected miracles. Chargeback protection with alerts gives you a chance to refund before a complaint turns into a dispute on your ratio.

Audit one product page today

Open your best-selling product page and read it like an underwriter would. Highlight every claim, check it against the structure/function line, confirm the disclaimer is there, and make sure any trial terms sit right next to the order button. Talk to an advertising attorney about anything you're unsure of, since this is general information, not legal advice.

When your claims file is ready, put it in front of a team that underwrites nutraceutical and supplement merchants regularly, and start your application with Karma Card Payments.

Frequently asked questions

What health claims can supplements legally make?

Dietary supplements can make structure/function claims, such as supporting normal joint flexibility or healthy digestion, if the claims are truthful and substantiated. They can't claim to diagnose, treat, cure, mitigate, or prevent a disease. Structure/function claims require FDA notification within 30 days and the standard DSHEA disclaimer. This is general information, not legal advice.

What does the FTC require to substantiate a supplement claim?

The FTC's 2022 Health Products Compliance Guidance requires competent and reliable scientific evidence for health claims. For most health benefit claims, that generally means randomized, controlled human clinical trials. Animal studies, lab results, and customer testimonials alone don't meet the standard, and the FDA disclaimer doesn't cure an unsupported claim.

Why do processors decline supplement merchants with free trial offers?

Trial offers that convert to recurring billing generate high dispute rates when customers don't realize they agreed to future charges. Card networks such as Visa require express consent, receipts, pre-billing reminders, and clear descriptors for these offers. Processors decline or add reserves when a checkout can't show those safeguards clearly.

Is the FTC click-to-cancel rule still in effect?

No. The Eighth Circuit vacated the FTC's negative option rule in July 2025. The Restore Online Shoppers' Confidence Act still requires clear disclosures, express consent, and simple cancellation for online recurring charges, and the FTC restarted subscription rulemaking in March 2026. Many states also have their own automatic renewal laws.

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