•   * What kind of evidence is needed?
•   * How much of this evidence is sufficient?
•   * Will a "reasonable basis" be adequate?

•   * What is a "win," and how much does it need to win by?
•   * Using additional data to bridge the gap
•   * The tension between statistical significance and consumer relevance
•   * The limitations of clinical data

Is Claim Substantiation Needed?

Without it you may subsequently have to change labeling and advertising and/or pay a fine related to an expressed or implied claim.

Vague, subjective, non-quantifiable language for which reasonable consumers expect no substantiation.

Exceptions on the Need for Substantiation?

Unlike fact claims which are verifiable and fact-based statements, puffery claims are opinion-based or non-specific statements that cannot be proven, e.g., Lighter than a Cloud..., Best choice..., etc. Claims consisting of puffery or obvious exaggeration may not require substantiation.

Do I need Substantiation If Not Making Claims?

Yes. Verifiable data about products is widely requested or required, for example from buyers such as Costco, or distribution platforms such as Amazon, or insurance underwriters.

Substantiation Source(s):

Substantiation should be developed independently (i.e., not self-generated or internal data). Further, independent data should be scientific and reflect typical or common uses of the product.

  Product Claim Types & Substantiation Needs