⚠️ Important Legal Notice
This guide provides general information about FDA and FTC regulations for educational purposes. It does not constitute legal advice. Always consult with qualified legal counsel for specific compliance questions regarding your products and marketing claims.
Marketing wellness products while staying compliant with FDA and FTC regulations can feel like navigating a minefield. Make one wrong claim, and you could face regulatory action, fines, or worse—damage to your brand's reputation and customer trust.
The wellness industry operates under a complex web of federal regulations that govern everything from product labeling to advertising claims. Understanding these rules isn't just about avoiding legal trouble—it's about building a sustainable business that customers can trust.
Understanding the Regulatory Landscape
Two primary federal agencies oversee wellness marketing: the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). They share jurisdiction through the FDA-FTC Liaison Agreement, with each agency focusing on different aspects of marketing compliance.
FDA vs. FTC: Who Regulates What
- Product labeling and packaging
- Product inserts and point-of-sale materials
- Structure/function claims on labels
- Nutritional labeling requirements
- Good Manufacturing Practices (GMPs)
- All forms of advertising (print, digital, TV, radio)
- Website claims and social media marketing
- Influencer partnerships and testimonials
- Email marketing and promotional materials
- Substantiation evidence for advertising claims
Types of Legal Claims for Wellness Products
Understanding what you can and cannot claim is fundamental to compliant marketing. The FDA recognizes three main categories of allowable claims:
| Claim Type | What It Covers | Requirements |
|---|---|---|
| Structure/Function Claims | How a product affects normal body functions or structure | FDA notification within 30 days, substantiation required, disclaimer required |
| Nutrient Content Claims | Level of nutrients in the product (e.g., "high in vitamin C") | Must meet FDA-defined criteria for specific nutrients |
| Health Claims | Relationship between food/supplement and reduced disease risk | Pre-approval by FDA required, very limited approved claims |
Structure/Function Claims: The Safe Harbor
Most wellness brands rely on structure/function claims because they offer the most flexibility while remaining compliant. These claims describe how a product supports normal body functions without claiming to treat, cure, or prevent disease.
✅ Compliant Structure/Function Claims
"Supports immune system function"
"Helps maintain healthy energy levels"
"Promotes healthy digestion"
"Supports muscle recovery after exercise"
❌ Non-Compliant Disease Claims
"Cures arthritis pain"
"Prevents heart disease"
"Treats depression"
"Eliminates inflammation"
Required Disclaimers and Language
When making structure/function claims, the FDA requires specific disclaimer language to appear prominently on your labeling:
Required FDA 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."
Disclaimer Requirements
- Prominence: Must be displayed prominently and in boldface type
- Placement: Must accompany each structure/function claim
- Timing: Required on all labeling, not just advertising
- Clarity: Cannot be hidden in fine print or obscured
Substantiation Requirements: Proving Your Claims
Both the FDA and FTC require that you have evidence to support your marketing claims before you make them. This is called "prior substantiation," and it's one of the most critical aspects of compliance.
FTC Standard: Competent and Reliable Scientific Evidence
The FTC defines competent and reliable scientific evidence as tests, analyses, research, or studies that:
- Have been conducted and evaluated objectively by experts in the relevant field
- Are generally accepted in the profession to yield accurate and reliable results
For health-related benefits, the FTC typically requires randomized, controlled human clinical testing. This means:
- Human subjects (not just animal or in-vitro studies)
- Randomized assignment to treatment and control groups
- Blinded design when possible
- Statistically significant results
- Peer-reviewed publication preferred
Substantiation Factors
The level of substantiation required depends on several factors:
- Type of claim: Health claims require more evidence than general wellness claims
- Product category: Dietary supplements face different standards than cosmetics
- Consequences of false claims: Claims about serious health conditions require stronger evidence
- Cost of substantiation: Balanced against potential benefits and risks
- Expert consensus: What level of proof experts in the field consider reasonable
Common Compliance Mistakes to Avoid
Learning from others' mistakes can save your brand from costly regulatory issues. Here are the most common compliance pitfalls:
1. Inadequate Qualifying Language
Vague terms like "may help" or "supports" don't automatically make claims compliant if the underlying claim is still a disease claim.
❌ Still Non-Compliant
"May help reduce depression symptoms"
"Supports cancer recovery"
"Helps treat diabetes"
2. Relying on Testimonials and Surveys
The FTC considers consumer testimonials and surveys as anecdotal experiences that cannot adequately substantiate health-related claims. Even if you have thousands of positive reviews, this doesn't constitute scientific evidence.
3. Cherry-Picking Studies
Using only favorable studies while ignoring contradictory research violates substantiation requirements. Your evidence must represent the overall body of scientific research.
4. Making Claims Beyond Your Evidence
If your study tested a specific dosage or formulation, you cannot make claims about different products or dosages without additional evidence.
Digital Marketing Compliance
Online marketing presents unique compliance challenges. Every claim made on your website, social media, or in email marketing must meet the same standards as traditional advertising.
Website Compliance
- Homepage claims: Must be substantiated and include appropriate disclaimers
- Product pages: All benefit claims require evidence and FDA disclaimers
- Blog content: Educational content cannot make implied product claims
- Customer reviews: Cannot be edited to remove negative experiences
Social Media Guidelines
- Influencer partnerships: Must disclose relationships and ensure compliant claims
- User-generated content: Cannot encourage non-compliant claims from customers
- Hashtag compliance: #ad and #sponsored required for paid partnerships
- Story highlights: Permanent content must meet same standards as posts
Building a Compliance Program
Sustainable compliance requires systems and processes, not just one-time reviews. Here's how to build a robust compliance program:
1. Legal Review Process
- Establish legal review for all marketing materials
- Create approval workflows for new claims
- Maintain substantiation files for all claims
- Regular training for marketing teams
2. Documentation Requirements
- Maintain complete substantiation files
- Document all claim reviews and approvals
- Keep records of FDA notifications
- Archive marketing materials with approval dates
3. Ongoing Monitoring
- Regular audits of marketing materials
- Monitor competitor enforcement actions
- Stay current with regulatory guidance
- Review and update policies annually
Recent Regulatory Updates and Trends
2024-2025 Enforcement Trends
The FTC has increased enforcement activity significantly, with over $472 million in refunds to consumers in 2021 for deceptive marketing. In 2023, more than 700 beauty and personal care brands received warning letters about questionable marketing claims.
Updated "Healthy" Definition
The FDA has finalized updates to the "healthy" nutrient content claim, with an effective date of April 28, 2025. This affects how wellness brands can use "healthy" in their marketing and labeling.
Increased Scrutiny of Digital Claims
Regulators are paying closer attention to online marketing, including social media influencer partnerships, subscription models, and auto-ship programs.
Working with Legal Counsel
While this guide provides a foundation for understanding compliance requirements, working with experienced legal counsel is essential for:
- Product-specific claim reviews
- Substantiation strategy development
- FDA notification submissions
- Enforcement action response
- International compliance requirements
💡 Pro Tip: Invest in compliance from the start. It's much more expensive to fix compliance problems after launch than to build compliant marketing from the beginning.
FDA and FTC compliance isn't just about avoiding regulatory trouble—it's about building a trustworthy brand that customers can rely on. By understanding the rules, investing in proper substantiation, and building robust compliance processes, wellness brands can market effectively while maintaining the trust that's essential for long-term success.
Remember: when in doubt, be conservative. It's better to make fewer claims that you can fully substantiate than to risk regulatory action with aggressive marketing that can't be proven.