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Compliance Gets Real – FDA, FTC, and Amazon Testing Rules

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The Compliance Landscape in 2025

The U.S. nutraceutical market is thriving, but with growth comes greater scrutiny. The FDA and FTC continue to monitor supplement brands closely for mislabeling, false claims, and cGMP violations. At the same time, major retailers—especially Amazon—have implemented stricter testing and verification requirements.

In 2025, compliance isn’t just about avoiding penalties. It’s a competitive advantage. Brands that can demonstrate transparency, testing, and adherence to regulations are more likely to gain consumer trust and remain on retail shelves.

FDA & FTC: Focus Areas

Claims Substantiation

  • Structure/function claims (“supports heart health,” “promotes digestive balance”) are acceptable.
  • Disease claims (“treats diabetes,” “cures anxiety”) are prohibited.
  • FTC requires competent and reliable scientific evidence for marketing claims.

Label Accuracy

  • Supplements must list accurate potency at expiration, not just at manufacture.
  • Labels must disclose allergens, excipients, and added sugars (in gummies and liquids).

Manufacturing Standards

  • cGMP compliance is mandatory.
  • FDA inspections continue to cite facilities for incomplete batch records, poor testing practices, and misbranded products.

Amazon’s New Rules

Cross-Category Innovation Expands Market Reach

Amazon has become a dominant supplement channel—and one of the strictest. As of 2024–2025,

Amazon requires:

  • Third-party testing by ISO/IEC 17025-accredited labs
  • Certificates of Analysis (COAs) uploaded for each SKU
  • Verification of label claims, including potency and purity
  • Adherence to U.S. FDA supplement labeling guidelines

 

Failure to comply can result in delisting or permanent account suspension.

FDA supplement compliance checklist

The Rising Cost of Non-Compliance

The risks are real:

  • FDA warning letters can damage a brand’s reputation overnight.
  • Retailer delistings cut off vital revenue streams.
  • Class-action lawsuits are increasingly targeting brands with misleading claims or adulterated products.

 

Compliance is no longer optional—it is the foundation of long-term success.

Strategies for Success

Invest in Third-Party Testing

COAs from accredited labs are essential for Amazon and consumer trust.

Build Claims Substantiation Files

Document evidence supporting all claims to satisfy FDA and FTC.

Partner With Certified Manufacturers

NSF, Organic, Halal, and Kosher certifications provide credibility and open distribution channels.

Educate Your Team

Marketing, sales, and customer service staff should understand compliance basics to avoid overpromising.

How Health Genesis Supports Compliance

At Health Genesis, compliance is built into our process:

  • FDA-registered, cGMP-certified facilities inspected and audited regularly
  • NSF, Organic, Halal, and Kosher certifications for credibility
  • COA management and testing partnerships to support Amazon requirements
  • In-house compliance review for labels, claims, and marketing assets

 

In 2025, compliance is the line between growth and risk. Brands that prioritize testing, transparency, and regulatory alignment will not only stay in business—they’ll thrive in a competitive landscape.

This article is for informational purposes only and does not constitute medical advice. Always consult with a qualified healthcare professional before starting any new supplement regimen.

Need Help With Supplement Compliance?

Health Genesis is your partner in compliant, innovative formulation and manufacturing. Our expertise in botanical supplements, combined with state-of-the-art production capabilities and regulatory knowledge, positions your brand for long-term success in the adaptogen and mushroom market.

Contact Health Genesis today to discuss your formulation ideas and discover how we can bring your vision to market with quality, compliance, and innovation.