Publishing health-related books or products can quickly turn into a compliance nightmare. Many authors and entrepreneurs face unexpected removals from Amazon or aggressive scrutiny from the FDA and FTC. To successfully sell your health content without interruptions, you must master the overlapping regulations enforced by these powerful entities. This guide outlines exactly what you can—and can't—say, helping you build a secure and compliant brand. FDA compliance for supplements is not easy. Luckily, our Amazon lawyers are here to help.
You've poured your expertise into a book, a supplement, or a digital product—something designed to help people feel better, live better, be better. But if that content touches on health, you're entering one of the most highly regulated—and misunderstood—spaces in publishing and e-commerce.
We see it all the time: authors blindsided by Amazon takedowns. Sellers are losing revenue overnight because of a word choice. Entrepreneurs with the best intentions are suddenly facing warning letters or legal scrutiny. The common thread? They didn't realize the rules they were breaking until it was too late.
In today's marketplace, publishing health-related content isn't just about getting noticed. It's about staying alive. To do that, you need to understand the overlapping rules enforced by Amazon, the FDA, and the FTC—and how to work within them without losing your voice or momentum.
Let's break down what's at stake, what you can and can't say, and how to build a strategy that protects your content, brand, and bottom line.
Understanding the Compliance Trifecta: Amazon Guidelines, FDA Rules, and FTC Marketing Regulations
Publishing in the health space doesn't just demand compelling content—it requires navigating a complex and overlapping web of rules. If you're selling on Amazon, making wellness claims, or promoting health benefits in your books or products, you're operating under the scrutiny of three powerful entities: Amazon, the Food and Drug Administration (FDA), and the Federal Trade Commission (FTC). Each has its own mandate. Together, they form a compliance trifecta that every author and seller must understand. FTC marketing guidelines are available to help.
- Amazon: Zero Tolerance for Unverified Health Claims
Amazon is not a neutral marketplace when it comes to health content. Its policies explicitly prohibit unsubstantiated medical claims across all content touchpoints—including book titles, product descriptions, A+ content, and even cover designs. The platform's algorithmic enforcement means takedowns can happen instantly, often without prior notice or opportunity to revise.
Phrases like:
- "Cures depression"
- "Heals leaky gut in 30 days"
- "Clinically proven to reverse diabetes"
...are all likely to trigger automated removal or account suspension. Even if you believe your claims are grounded in scientific literature or personal experience, Amazon requires that all medical assertions be demonstrably supported—and comply with its internal content standards, which are often stricter than federal guidelines.
- FDA: When a Claim Turns Your Content into a Regulated Drug
The FDA doesn't just regulate pharmaceuticals. It also oversees how health-related products are marketed, including supplements, functional foods, and yes—books and digital content that make disease-related claims. Under FDA rules, stating that a product "treats anxiety" or "prevents cancer" can reclassify that product as an unapproved drug, subjecting it to regulatory action.
This applies even if:
- The product is natural or over-the-counter
- The claim appears in a testimonial
- The effect is implied, not directly stated
Once the FDA views your content or product as making a disease claim, you're operating in a completely different regulatory space—one with strict requirements most publishers and sellers aren't prepared to meet.
- FTC: Health Claims Must Be Truthful and Substantiated
While the FDA focuses on product classification and labeling, the FTC is squarely concerned with consumer protection. Its primary concern: Are your health-related claims truthful, not misleading, and backed by reliable scientific evidence?
The FTC's scope includes:
- Claims made on book covers and sales pages
- Marketing emails, webinars, and social media posts
- Product descriptions across Amazon and your website
For example, if you promote a detox protocol as something that "boosts immunity" or a supplement that "enhances focus and clarity," you need real, peer-reviewed scientific support. Not testimonials. Not personal belief. Not a single small study. The bar for substantiation is high—and enforcement is growing more aggressive.
Legal Note: The Statutes Behind the Standards
The compliance obligations described above aren't just platform policies—they're rooted in U.S. law:
- Amazon enforces its rules contractually through its Terms of Service and internal Healthcare Claims and KDP Content Guidelines, which are often more conservative than federal standards.
- The FDA derives its authority from the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321), which classifies products making disease claims as "drugs" requiring formal approval—even if the product is natural or content-based.
- The FTC enforces Section 5 of the FTC Act (15 U.S.C. § 45), prohibiting deceptive or misleading marketing practices. Health-related advertising must be supported by "competent and reliable scientific evidence," typically defined as peer-reviewed clinical research.
Understanding these foundations is critical—not just for legal protection, but for building a business that lasts.
The Most Common (and Costly) Compliance Mistakes
If you're creating or selling health-related content, one of the fastest ways to get flagged—or worse, banned—is by unintentionally crossing regulatory lines. Many of the most frequent missteps aren't made with bad intent; they're the result of misunderstanding how language, storytelling, and marketing claims are interpreted by platforms and regulators. Here are a few pitfalls that consistently trip up even experienced authors and sellers.
- Using Absolute Medical Language
One of the most pervasive issues is the use of absolute medical language. Words like "cures," "eliminates," or "heals" may feel persuasive from a marketing perspective, but they can quickly draw the attention of Amazon's content moderators and even the FDA. These terms suggest clinical outcomes and imply that a product or book provides treatment—a major regulatory red flag.
- Making Disease-Specific Claims
Another risky tactic? Making disease-specific claims, especially in titles or product listings. A phrase like "The Natural Way to Beat Diabetes" might seem like a strong hook, but it could result in your content being treated as an unapproved drug promotion under FDA guidelines. And Amazon's algorithms are increasingly attuned to this kind of language.
- Using Anecdotes as Evidence
Anecdotal storytelling is another area where well-meaning creators can get into trouble. A personal account of overcoming depression or reversing autoimmune symptoms can feel like compelling proof—but regulators may interpret such stories as implied medical claims, especially if they're positioned as typical or achievable for the average reader.
- Linking to Off-Platform Sales
Some creators also attempt to extend their marketing reach by embedding URLs or QR codes in book covers or pages, directing readers to off-platform supplement sales. This kind of cross-promotion is particularly frowned upon by Amazon and can lead to swift enforcement actions.
- Overusing Buzzwords Without Substantiation
And finally, watch out for the allure of buzzwords like "proven," "miracle," or "secret." Without documented, peer-reviewed evidence, terms like these can be considered misleading—and both the FTC and Amazon view them as red flags for unsupported hype.
Each of these missteps may seem small in isolation, but together they signal a pattern that can erode trust, damage credibility, and put your business at legal risk.
Understanding the Spectrum of Risk—And Choosing Your Strategy
Publishing in the health space doesn't mean walking on eggshells—but it does mean being deliberate. There's a wide range of ways to communicate value to your audience without crossing into noncompliance. The key is understanding where your content sits on the risk spectrum, and how your brand's risk tolerance should guide your messaging.
- High-Risk: Promising Medical Outcomes
At the high end of the spectrum is explicit medical content. This includes language that suggests a product or book can prevent, diagnose, or treat a disease. Statements like "eliminates arthritis pain" or "treats depression naturally" carry the highest risk. Not only can they trigger automated content takedowns on Amazon, but they also expose you to potential regulatory scrutiny from the FDA or FTC. Unless you're operating under formal clinical validation and legal oversight, this approach is rarely worth the exposure.
- Moderate-Risk: Supportive, Not Prescriptive
A more strategic, moderate-risk approach focuses on supportive language that frames products or content in terms of promoting wellness rather than promising cures. For example, instead of saying a supplement "reverses liver disease," it might say it "supports liver health." This language is still persuasive but doesn't overpromise or mislead.
- Low-Risk: Lifestyle- and Wellness-Oriented
On the low-risk end of the spectrum is content that avoids medical language altogether and instead emphasizes lifestyle, education, or general wellness. Books in this category often focus on habit-building, nutrition, or personal growth. They provide value without triggering regulatory concerns, making them ideal for authors or brands looking to build trust and stay firmly in the safe zone.
- Aligning Your Language with Your Risk Tolerance
Choosing where you land on this spectrum depends on your business model, your audience, and your legal risk appetite. But no matter where you fall, it's critical to ensure your content aligns with not just your marketing goals—but with the evolving expectations of Amazon, the FDA, and the FTC.
Using Structure/Function Claims to Stay Compliant with FDA and Amazon
One of the biggest challenges for health-focused authors and sellers is how to communicate value without making risky claims. Fortunately, there's a regulatory-safe middle ground: structure/function claims. When used strategically, these claims allow you to highlight how a product or lifestyle approach supports general wellness—without suggesting that it treats or cures any specific condition. Done correctly, they offer a way to stay persuasive while avoiding the compliance pitfalls that plague more aggressive marketing tactics.
- What They Are—and Why They Matter
When it comes to communicating health benefits without running afoul of federal regulations, structure/function claims offer a strategic and compliant alternative. These are statements that describe how a product or nutrient supports the body's normal biological functions—without suggesting that it prevents, treats, or cures any disease.
Unlike disease claims, which can reclassify your book or supplement as a drug under FDA rules, structure/function claims stay safely within the bounds of regulatory acceptance. Phrasing such as "supports immune health" or "helps maintain healthy cholesterol levels" may still be persuasive, but they avoid the medical overreach that draws scrutiny from Amazon, the FDA, or the FTC.
- Why They're Safer Under FDA Rules
Structure/function claims are explicitly allowed under FDA regulations for dietary supplements—as long as they are truthful, substantiated, and accompanied by the required disclaimers. This makes them one of the few reliable tools available to authors and sellers seeking to communicate wellness benefits without triggering regulatory enforcement.
These claims work because they shift the focus away from curing disease and instead emphasize the body's natural processes. When used correctly, they can lend credibility to your message without overstating what your content or product can deliver.
- The Role of Disclaimers
Even compliant language needs guardrails. The FDA requires that any structure/function claim for a supplement be paired with the following disclaimer:
"These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
For authors and marketers, additional disclaimers can be just as important. A medical disclaimer makes it clear that your content is for informational purposes only and should not be interpreted as professional medical advice. A results disclaimer can help set expectations and clarify that outcomes will vary by individual.
Where and how you present these disclaimers matters. Ideally, they should appear early in your content—on the copyright page of a book, in the introduction of a guide, or near any section that shares testimonials or recommendations. Disclaimers aren't just legal safeguards—they're signals to your audience that you take compliance, transparency, and trust seriously.
- Strategic Content Choices That Protect Your Brand
Operating in the health and wellness space means more than just delivering value—it means doing so with foresight. Whether you're publishing a book, launching a product, or sharing your personal journey, every word you choose has legal and reputational implications. Compliance isn't just about checking boxes—it's about building a brand that can grow without interruption. The most successful creators in this space understand how to balance authenticity with accountability. That starts with intentional choices about what you say, how you say it, and how you position yourself in the eyes of regulators, platforms, and your audience.
- Reframing the Personal Health Journey
Many successful health-focused books and brands are built on personal transformation stories—and rightfully so. Lived experience can be compelling, relatable, and persuasive. But if your story includes overcoming illness, managing chronic conditions, or abandoning conventional treatments, the way you frame that narrative becomes critical.
Instead of positioning your experience as a blueprint or implied solution, focus on what worked for you. Emphasize personal lifestyle changes, mindset shifts, or routines—without suggesting that others should expect the same outcomes. Avoid language that sounds prescriptive or diagnostic. Framing your story with humility and individuality not only improves compliance—it builds credibility.
- Smart Placement of Disclaimers
Disclaimers aren't just legal formalities—they're strategic communication tools. When positioned properly, they clarify intent, set expectations, and mitigate regulatory risk. For authors, the copyright page or introductory chapter is a natural place to include a general medical disclaimer. For creators sharing success stories, placing a results disclaimer near the relevant content can help avoid the appearance of a guarantee.
The key is visibility. The disclaimers shouldn't be buried in fine print if your content includes wellness claims, testimonials, or mentions of supplements. They should be easy to find, understand, and tailored to your content.
- Discussing Supplements Without Triggering Scrutiny
Whether you're referencing your own supplements or someone else's, it's easy to accidentally cross a regulatory line. Mentioning a product in the context of treating a condition—or even implying a result—can reframe your content as advertising or a drug claim under FDA rules.
Instead, speak in general terms. Focus on the ingredients, the intended support function, or the role the supplement played in your personal routine. Avoid stating or implying that the product cures, prevents, or significantly alters a health condition. And never present supplements as a replacement for professional care. Even subtle wording shifts—like "supports energy" instead of "fixes fatigue"—can mean the difference between compliant content and a flagged product.
- Avoiding the Appearance of Medical Advice
One of the most important ways to protect your brand is also one of the simplest: don't offer—or appear to offer—medical advice unless you're licensed to do so. It's a common trap, especially for authors with deep research or personal experience. But regardless of your expertise, giving prescriptive health recommendations to the general public can cross ethical and legal lines.
To avoid this, be clear about your role. Use language like "this worked for me" or "based on my research" rather than "you should do X." Encourage readers to consult with healthcare professionals before making any health decisions. And resist the urge to frame your content as an alternative to medical care. That clarity protects both your readers—and your business.
Amazon Compliance Best Practices for Health-Related Productss
While federal agencies like the FDA and FTC oversee broader consumer protection, Amazon operates as its own regulator—and plays by its own rules. For many authors and health-focused brands, Amazon is both the most accessible platform and the most unforgiving. Understanding how its enforcement systems work is critical to long-term success.
- Why Amazon Flags Content
Amazon's algorithm is designed to detect unsubstantiated medical claims and redirect liability away from the platform. That means books and products can be flagged automatically for violating its medical content policy—often without any manual review. Common triggers include disease names in titles, promises of specific health outcomes, or before-and-after imagery in product listings.
- Best Practices for Titles, Covers, and A+ Content
When designing your Amazon presence, subtle changes can make all the difference. Book titles and subtitles should avoid referencing specific medical conditions. Instead of "The Cancer Cure Protocol," consider language like "A Natural Approach to Cellular Health." Cover imagery should be neutral—avoid medical symbols, prescription bottles, or before-and-after comparisons.
For A+ content, focus on educational or lifestyle narratives, not claims. Use compliant language ("supports focus," "promotes balance") and steer clear of medical charts, diagnostic terms, or anything resembling a treatment plan.
- Avoiding External Sales Links
One of the fastest ways to lose your Amazon listing is by directing traffic off the platform—especially to supplement or health product sales pages. Embedded URLs, QR codes, or even brand names that imply a separate site can lead to takedowns. Keep your marketing channels cleanly separated, and don't try to work around Amazon's rules.
- Structuring Your Listings for Long-Term Viability
Think of your Amazon listing as a legal document—not just a sales pitch. Write copy that educates and engages, while steering clear of clinical promises. Use bullet points to focus on product features, benefits framed as structure/function claims, and avoid superlatives unless they're backed by verifiable third-party evidence.
Working with a Compliance Attorney—Why It Matters
You don't need to be a regulatory expert to publish in the health space—but you do need someone in your corner who is. A qualified compliance attorney can be the difference between building a lasting brand and watching it vanish overnight due to a misstep in language, labeling, or cross-channel marketing.
- Navigating a Complex Regulatory Landscape
Amazon, the FDA, and the FTC each enforce different rules—but they often intersect. A compliance attorney helps you interpret these overlapping frameworks and make smart decisions about your content, product claims, and customer communications. It's not just about staying out of trouble—it's about building a strategy that aligns with your business goals while minimizing legal exposure.
- Tailoring Your Strategy to Your Business Model
A one-size-fits-all approach doesn't work here. If you're publishing a book and nothing more, your strategy will look different from someone using content to drive supplement sales or coaching programs. A compliance attorney can help you map your marketing journey—book pages, sales funnels, product labels, and ad copy—and ensure every touchpoint is aligned with the appropriate regulations.
- Risk Tolerance, Market Strategy, and Long-Term Planning
Do you want to play it safe, or are you willing to take calculated risks? Are you aiming for thought leadership, or product conversion? Compliance strategy isn't just a defensive move—it's part of your broader positioning. An attorney who understands both regulatory risk and business growth can help you make informed decisions that protect your brand and drive results.
Build With Confidence, Not Just Caution
If you're in the business of helping people live healthier lives—through books, supplements, or educational content—you're also in the business of risk management. Because in this space, what you say (and how you say it) can mean the difference between growing your brand and getting shut down.
Compliance isn't about limiting your message. It's about making sure your message reaches people—and stays there. A few small changes to language, structure, and disclaimers can prevent the bigger, more expensive problems we've seen too many creators face.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
