Health Claim Substantiation

Identify untapped potential and avoid expensive FDA and FTC fines with health claim substantiation services

Protect your bottom line with health claim substantiation

Many companies focus on the US Food & Drug Administration (FDA) when it comes to labeling compliance, but few realize that the US Federal Trade Commission (FTC) has jurisdiction over the health claims contained in your product’s labels, advertising, and marketing. Even if your product has a successful clinical trial, your marketing team must still comply with limitations regarding how you communicate those findings. How can you be sure your claims are sufficiently substantiated?

When you include a health claim on your labels, website, or other advertising methods, you are claiming that a relationship exists between your product and a specific health outcome. This claim must be substantiated with sufficient high quality scientific evidence. Companies with insufficient evidence to substantiate claims are at risk of adverse actions from regulatory authorities.

Health Claim Substantiation Services Include

Product Review & Literature Analysis

Formulation reviews to identify untapped health claims you can make based on existing scientific findings.

Comprehensive literature reviews and/or meta-analyses to determine whether or not sufficient evidence exists to support a new health claim.

Structure & Function Claim Doc Prep

Doc prep and submission of structure and function claim notifications and related health claim applications.

Literature Review

The scientific literature is a wealth of valuable information that might hold potential to support your product’s claims or to defend your product (or key ingredients) against risk-based claims. Our team has the expertise to conduct a comprehensive review of the literature and analyze the quality of existing evidence within the context of the specific methodology that has been used.

A systematic literature review can:

  • Raise awareness of the benefits of your ingredient or product in the scientific community
  • Substantiate claims regarding a key ingredient in your formulation
  • Evaluate existing claims regarding key ingredients
  • Generate new marketing opportunities for your product in the natural products market

A comprehensive literature review presents a complete and thorough summary of the entire body of scientific knowledge on the effects of your product or key ingredients within your product. This presents a wide range of marketing opportunities and boosts consumer confidence in the safety and efficacy of your product.

Our team has the ability to interpret the existing data within the context of its methodology, ensuring that scientific reviews are accurate and correctly reflect what has been discovered regarding your products and/or key ingredients.

Meta Analysis

A meta analysis is a systematic way to quantify the total effect size of an ingredient or product and to control for variables that may moderate that effect. Practically, this means the meta analytic methodology is able to produce a more generalizable effect of your product or ingredient across a wide range of markets. The research is also able to identify ways in which the total effect of your product or ingredient may be altered–both positively and negatively.

A meta analysis can:

  • Provide clarity when published studies have conflicting results
  • Identify populations, health conditions, or other factors that influence your product’s efficacy
  • Resolve confusion created by click-bait media headlines
  • Increase your product/ingredient’s scientific validation

Our team is highly skilled in conducting meta analysis and is among the most widely published researchers using this methodology in integrative health. Many natural product clinical studies are underpowered, reflect poor methodology, and use subclinical dosing.

A meta analysis can correct for these factors, cutting through the noise, and identifying the true potential of your product. Meta analysis does not require an IND or ethical authorization and can be completed in as little as 4-6 weeks.

When it comes to health claims, the FTC focuses on the overall impression, not semantics. You don’t have to explicitly state that your product treats arthritis to leave the overall impression that your product is making a health claim. The FTC can also take action if the studies you use to substantiate a health claim are not representative of the entire body of scientific evidence. You may also be at risk by disclosing insufficient information.

FTC fines are expensive, often 6-7 figures. Our team can evaluate your marketing, advertising, and labels to identify areas of risk, protecting your company from expensive fines, warning letters, and other regulatory actions.

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