Health Claims – FDA’s Evidence-Based Pathway to Success

Lately, grocery shoppers are less inclined to select the cheapest item on the shelf or purchase on the basis of brand or label recognition. Now, consumers are focused on how a particular food may affect their health, and are guided by Health Claims or Qualified Health Claims on the labels. These claims, describing the relationship between a specific food or food component and a disease or health-related condition, are now becoming the “tipping point” for the decision to purchase.

When the Nutrition Labeling and Education Act (NLEA) was established in 1990, mandatory nutrition labeling and restrictions on the use of food label claims characterizing the health benefits of the food were put in place. However, because the original guidelines for making these claims have been met with so many exceptions (and Court-mandated changes), the guidelines have grown in complexity and depth. Notwithstanding the evolving nature of the guidelines, they work to both level the playing field for food manufacturers and allow consumers to make informed choices when selecting items based on health and nutrition information.

To use any type of health claim, a company must submit a petition to the FDA for evaluation either as a “Health Claim” (i.e, “significant scientific agreement” or SSA) or “Qualified Health Claim (QHC)” standard. The SSA standard (the highest of the two) is derived from 21 U.S.C. 343 (R)(3)(B)(i), which provides that FDA shall authorize a health claim to be used on conventional foods if the agency “determines based on the totality of the publicly available evidence that there is significant scientific agreement… that the claim is supported by such evidence.” While both Health Claims and Qualified Health Claims must have supporting scientific documentation of the ability of the substance to reduce the incidence of the disease, the claims are categorized based on the strength of the supporting scientific evidence. According to this criterion, the scientific evidence supporting a Health Claim is near universally acknowledged as being conclusive (i.e., the origin of the term, “Significant Scientific Agreement”). On the other hand, a QHC is supported only by emerging evidence and has not quite reached the point of the universality of agreement on the supporting science. QHCs are additionally qualified as to the type of claim allowed on the label, with a range of 3–4 levels of acceptance, with the resulting claim permitted by FDA having some very obtuse qualifying wording.

The scientific review and evaluation process for determining QHC standards and the SSA standard have been described in previously issued documents. Because of the similarity between the review and evaluation processes for SSA and QHC claims, however, the FDA has consolidated its thinking into a single guidance document representing the current thinking for evaluation of health claim petitions. The document, released on July 9, 2007, is entitled Evidence-Based Review System for Scientific Evaluation of Health Claims and is in a “Draft” form. This “evidence-based review system” is an attempt to level the playing field by describing several key points integral to study and calim evaluation. The FDA will sort through the supporting documentation by study type and assign each study a high, moderate, or low rating. The rating would be based on criteria such as relevance, sound scientific method, statistical methods, length of study, location of study, type of outcome, etc. Studies without any clear scientific conclusion or containing deficiencies will be eliminated from further review. To simplify, the overall ratio of high/moderate/low ratings contributes to a rating of the totality of scientific evidence to determine if the claim meets the SSA standard or if the supports only emerging evidence for a qualified health claim. The evidentiary threshold to meet the standards is left to the judgment of the expert reviewers and their assessment that the substance/disease relationship “is not likely to be reversed by new and evolving science.” Additionally, the strength of the QHC language would then be reflective of the scientifically-based rating. Importantly, FDA will also use this systematic method to reevaluate an existing health claim in response to new information.

This pathway for a “healthy” label claim affords opportunities for entrepreneurial food companies to use innovative ingredients, however, they will have both the “burden of proof”, to generate relevant data that meets the threshold, and they will have the “burden of persuasion” to show that the evidence generated supports the proposed claim.