Todd Harrison09.01.03
The New Qualified Health Claims Process
Examining FDA’s new qualified health claim rating system.
By Todd Harrison
On July 10th, FDA announced the publishing of an interim guidance document regarding the qualified health claims process. The interim guidance is aimed at permitting a wide variety of qualified health claims that would have been considered by the Agency to be impermissible in the past. Before discussing the guidance, this column will first discuss what constitutes a health claim.
Health Claims in General
As a general matter, health claims discuss the relationship between a particular food, nutrient or dietary ingredient and a disease. Disease is defined in general terms as damage to an organ, part, structure or system of the body such that it does not function properly (i.e., cardiovascular disease) or a state of health leading to such dysfunctioning (i.e., hypertension), except that diseases resulting from essential nutrient deficiencies (i.e., scurvy, pellagra) are not considered diseases. It is important to remember that FDA considers health claims to be “disease reduction” claims. In other words, FDA will not permit any health claim, qualified or otherwise, that purports to treat a particular disease condition (e.g. saw palmetto as a means of treating benign prostatic hyperplasia—BPH). Companies that desire to make disease treatment claims should consider whether it would be more appropriate to market the product as a medical food.
Health claims are generally approved after the (1) submission of a health claims petition; (2) the FDA finds that there is significant scientific evidence to support the claim and (3) the FDA issues a regulation authorizing its use. The Authoritative Statement process for health claims augments the health claim petition process. Congress instituted this process as part of the Food and Drug Administration Modernization Act of 1997. Under this process, upon petition, FDA may permit a health claim based on an authoritative statement by a scientific body of the U.S. government or the National Academy of Sciences (NAS) or one of its subsidiaries. FDA has only permitted a few claims through this route and many believe that this process has had a chilling effect on government agencies, e.g., government agencies have generally been more tempered with their statements regarding the impact of a particular food or nutrient on a disease in order to avoid the statements from being used as a basis for an authoritative statement health claim.
In January 1999, the D.C. Circuit Court of Appeals, in Pearson v. Shalala, struck down FDA’s application of the “significant scientific agreement” standard to dietary supplements as “unconstitutionally vague.” More specifically, the court stated that FDA may be required to permit a health claim if adequate scientific evidence exists, i.e., the quality of scientific evidence in support of the claim is at least equal to the quality of the scientific evidence against the claim—i.e., the scientific evidence is inconclusive—and the use of a disclaimer is sufficient to communicate to consumers the level of scientific proof in support of the claims. It is important to note that the court never stated that FDA couldn’t deny a health claim or is required to permit a qualified health claim. Rather, the court stated that FDA must permit the health claim if a disclaimer is adequate to communicate the level of support for the claim.
Since the decision in 1999, FDA has been working to develop a workable solution to the issue of qualified health claims. In July, FDA finally issued interim guidelines for the use of health claims. These guidelines are not permanent and FDA will be conducting consumer surveys on the impact of disclosure statements on consumers’ ability to understand the meaning a particular qualified health claim conveys. Thus, it is possible that those qualified health claims that are being permitted on an interim basis may be withdrawn in the future because consumer perception studies indicate that the claims are inherently misleading.
The Rating System
Under the interim guidance, FDA intends to exercise its enforcement discretion to permit (not approve) qualified health claims based on an evidence-based rating system. The purpose is to rank the strength of evidence behind a proposed substance/disease relationship. The ranking system will have 3 ratings:
•Study design
•Study quality
•Strength of the entire body of evidence
In arriving at a ranking, FDA will institute the following six-part procedure:
(1) Define the substance/disease relationship.
(2) Collect all relevant studies (favorable and unfavorable).
(3) Classify and rate each study as to type:
(a) Study Design Type One-Randomized, controlled intervention trials
(b) Study Design Type Two-Prospective observational cohort studies
(c) Study Design Type Three-Non-randomized intervention trials with concurrent or historical controls and case-control studies
(d) Cross-sectional studies; analysis of secondary disease endpoints in intervention trials
(4) Rate each study for quality: Individual studies are assigned a designator of +, ø, -, or N/A to reflect the study quality.
(5) The strength of the total body of evidence: This rank is determined by taking into consideration the quantity, consistency and relevance to disease risk reduction of the aggregate study.
(6) The rank is reported
Based on the overall ranking assigned to the claim, FDA will give it a grade. The grade will correspond to the type of disclaimer that would be required. Under the grading system, a Grade A would indicate that the health claim meets the significant scientific agreement standard and that no qualifying language will be required. The remainder of the grades are summarized below:
• Second Level/Grade B/Qualified Language-” . . . Although there is scientific evidence supporting the claim, the evidence is not conclusive”
• Third Level/Grade C/Qualified Language-”Some scientific evidence suggest . . . however, FDA has determined that this evidence is limited and not conclusive”
• Fourth Level/Grade D/Qualified Language “Very limited and preliminary scientific research suggests . . . FDA concludes that there is little evidence supporting this claim”
Will the New Grading System Present New Opportunities?
Whether this process will open the doors to more health claims is a good question. It will be interesting to see how FDA applies these standards to the various qualified health claim petitions that will be filed. However, before flooding FDA with qualified health claim petitions, a company or industry group should consider the potential impact this review may have on structure/function claims. More specifically, while FDA is required to permit a structure/function claim, the FTC, as well as the FDA, would require that any implied meaning also be properly substantiated.
For instance, FDA has stated that it would exercise enforcement discretion on the qualified health claim “Consumption of phosphatidylserine (PS) may reduce the risk of dementia (or cognitive dysfunction in the elderly). Very limited and preliminary scientific research suggests that phosphatidylserine may reduce the risk of dementia (or cognitive dysfunction) in the elderly. FDA concludes that there is little scientific evidence supporting this claim.”
It is quite possible that a consumer perception study may reveal that consumers interpret the structure/function claim “helps support normal cognitive function” as an implied reduces the risk of dementia or cognitive dysfunction claim. If that were the case, it would likely be the position of the FTC, that FDA’s determination that there is little scientific evidence to support the unqualified health claim requires that structure/function claim be similarly qualified, e.g., “Very limited and preliminary scientific research suggests that PS may help maintain normal cognitive function. FDA has concluded that there is little scientific evidence supporting this claim.”
Thus, before submitting qualified health claim petitions to the FDA, a company or industry group should consider the impact of FDA’s review of the scientific literature on structure/function claims.NW