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Product Claim Risk Assessment for Dietary Supplement Industry


Product Claim Risk Assessment

To ensure compliance and mitigate risks in manufacturing vitamins and supplements, it is crucial for brands to implement best practices and standard operating procedures. A label claim risk assessment can assist in identifying and addressing non-conformities, conducting root cause analysis, implementing corrective actions, and safeguarding the brand's reputation.


Here's a breakdown of the product claim risk analysis:

  1. Product Claim: "Clinically Proven" Risk Level: Low Rationale: For claims supported by high-quality, randomized, controlled human clinical trials (RCTs), the brand can demonstrate compliance with the FTC's "competent and reliable scientific evidence" standard. Large-scale RCTs conducted by subject matter experts and published in peer-reviewed journals satisfy these requirements. How to Ensure Compliance: Maintain a copy of the RCT and consider conducting additional independent studies to strengthen the claim. Having multiple studies published in peer-reviewed journals helps remove bias and reinforces the original findings.

  2. Product Claim: "Clinically Proven Ingredient" Risk Level: Medium Rationale: While an ingredient supported by RCTs meets the standard, it is essential to consider the language used and the quantity of RCT-evaluated ingredients in the finished formulation. Consumer perception and potential ingredient interactions in unstudied formulations can elevate the risk. How to Ensure Compliance: Conduct a thorough review of the product label and consider independent consumer surveys to understand how claims are perceived. This can help align the packaging with FTC guidance. Additionally, understanding ingredient interactions is crucial for product safety and quality.

  3. Product Claim: Health Claims without RCTs Risk Level: Elevated Rationale: FTC requires RCTs or high-quality epidemiologic evidence to substantiate health-related benefits. In cases where RCTs are not feasible, subject matter experts may accept epidemiologic evidence as an alternative. How to Ensure Compliance: Evaluate the availability of robust epidemiologic evidence and have it reviewed by subject matter experts. If neither RCTs nor epidemiologic evidence is available, immediate label revision may be necessary.

Dietary supplement brands must stay informed about the FDA and FTC guidance interpretations to ensure truthful, non-misleading, and substantiated labeling and advertising claims. By proactively mitigating risks, brands can avoid penalties and uphold regulatory compliance.

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