Читать книгу Food Regulation - Neal D. Fortin - Страница 294

The label of a dietary supplement containing “X” uses the following claims: “The amino acid ‘X’ is the chemical precursor to nitric oxide. Blood vessel cells contain enzymes that produce nitric oxide. Nitric oxide is important in maintaining blood vessel tone.” Assuming this statement were supported by sound science so that each individual statement was substantiated, the “message” conveyed by the claims, when considered together, is that taking oral “X” will affect nitric oxide production and blood vessel tone. Therefore, we recommend in this case that the dietary supplement manufacturer have substantiation that taking the amount of “X” provided by the product affect nitric oxide production and blood vessel tone under the product’s recommended conditions of use.

The firm’s clear understanding of the meaning of the claim is useful in ensuring that the evidentiary basis for substantiation is appropriate for the claim. Understanding the claim’s meaning will help identify the appropriate study hypotheses and measurable endpoints, which can be used to ensure that the firm has appropriate studies to substantiate the claim. For example, a firm making a claim that a dietary supplement “helps maintain blood vessel tone” or “supports healthy immune system” should have a clear understanding of the claim’s meaning to develop endpoints that could be measured and replicated in studies used as a basis for substantiation.