Qalitex Advises Brands on Amazon's Heightened Scrutiny of Unsubstantiated Structure/Function Claims

Qalitex advises supplement brands as Amazon steps up claim reviews, focusing on unsubstantiated structure/function claims that trigger compliance actions.

IRVINE, CA, UNITED STATES, June 13, 2025 /EINPresswire.com/ -- Qalitex Laboratories, a provider of product testing and compliance services, has issued an industry advisory addressing Amazon's increasing enforcement against unsubstantiated structure/function claims made by dietary supplement and wellness brands.

As Amazon continues to align its policies with regulatory standards, brands are facing stricter compliance reviews targeting improper health benefit statements.

Understanding Structure/Function Claims in Dietary Supplements
Structure/function claims describe the role of a nutrient or ingredient in maintaining normal structure or function in the human body.

Under FDA guidelines, such claims are distinct from disease treatment or prevention statements, which require formal drug approval. Permitted structure/function claims might reference general support for immune health, digestion, or energy metabolism, provided they are truthful and not misleading.

However, claims that imply disease treatment, prevention, or cure—such as reducing risk of cancer, reversing arthritis, or treating depression—fall outside permitted boundaries. Brands must carefully distinguish between legally permissible claims and prohibited therapeutic statements.

Amazon’s Expanding Role in Enforcing Structure/Function Claim Compliance
As part of its compliance obligations, Amazon requires all sellers to ensure that product listings meet FDA and FTC regulations. The platform has invested in internal compliance teams and automated screening tools that regularly monitor listings for violations.

Amazon’s review processes now scrutinize both new and existing listings, flagging claims that may violate federal regulations or platform policies.

Sellers whose listings contain unsupported or misleading health claims may face immediate enforcement actions, including listing removals and account suspensions.

Common Types of Claims Now Triggering Amazon Enforcement
Among the claims most frequently cited in Amazon compliance actions are:

Statements suggesting prevention, treatment, or cure of diseases.
Language implying therapeutic outcomes without clinical substantiation.
Vague or exaggerated health benefits that overstate product effects.
Use of unapproved medical terms in product titles, bullet points, or marketing descriptions.

Regulatory Background Driving Amazon’s Stricter Enforcement
The FDA has maintained long-standing rules prohibiting disease claims on dietary supplements without approved drug applications. In parallel, the FTC enforces truth-in-advertising laws, requiring that any health-related claims be supported by competent and reliable scientific evidence.

Amazon’s policy updates reflect growing pressure to ensure platform-wide compliance with these federal regulations. Recent public attention on misinformation related to supplement marketing has further contributed to heightened scrutiny.

Potential Consequences for Brands Violating Amazon’s Claim Policies
Brands that fail to comply with Amazon’s policies face serious consequences. These may include:

Immediate removal or suppression of non-compliant product listings.
Temporary or permanent suspension of seller accounts.
Delays in reinstating listings until full documentation is provided.
Permanent account deactivation for repeat violations or failure to resolve compliance issues.

Documentation Amazon May Require to Substantiate Claims
In response to claim violations, Amazon may request extensive documentation to verify product statements. Required materials may include:

Scientific substantiation for all structure/function claims.
Certificates of Analysis verifying ingredient identity and potency.
Clinical study data, where applicable.
Third-party laboratory reports validating product composition and safety.

The Role of Qalitex in Assisting Brands with Compliance Preparation
Qalitex provides compliance support services that help brands prepare defensible product documentation in alignment with regulatory standards. This includes third-party laboratory testing, document preparation, and claim reviews.

By ensuring that structure/function claims are appropriately substantiated and presented, Qalitex assists brands in minimizing their exposure to Amazon compliance actions and regulatory inquiries. All services are conducted according to existing scientific and legal standards.

Recommendations for Brands to Minimize Risk
To maintain compliance and reduce enforcement risks, Qalitex advises brands to:

Carefully review all marketing claims against FDA structure/function guidelines.
Avoid language that suggests disease treatment or prevention.
Retain comprehensive scientific substantiation for all product statements.
Conduct routine audits of Amazon listings for ongoing compliance.
Seek guidance from qualified regulatory professionals when preparing product documentation.

Proactive Claim Management Is Now Critical for Amazon Sellers
As Amazon intensifies its review of product claims, dietary supplement and wellness brands must exercise heightened diligence in managing their listings. Unsubstantiated structure/function claims represent a growing compliance vulnerability that can lead to significant operational disruptions.

With this advisory, Qalitex reaffirms its commitment to helping brands navigate the evolving intersection of regulatory oversight and marketplace enforcement, while promoting compliant and science-based product marketing practices.

Nour Abochama
Qalitex Laboratories
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