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.

Substantiation Services Include:

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

Results that make a difference

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. If the average consumer understands your images, marketing, or overall message to indicate that your product is capable of producing some effect on the body, you’ve made a health claim and must substantiate the 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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