The FDA?s system of qualified health claims was meant to make life easier for consumers by providing them with information they could trust. But, Clare M Hasler believes, the current setup is still confusing and at times inconsistent
In December 2002, the Food and Drug Administration announced the Consumer Health for Better Nutrition Initiative. Two major goals of this initiative included: encouraging accurate, up-to-date science-based claims about the health benefits of foods and dietary supplements; and eliminating false or misleading claims about the benefits of such products.
As part of this initiative, a regulatory framework for qualified health claims on conventional foods was announced in order to improve consumer understanding of diet-disease relationships and assist them in making wise dietary choices that will optimise health. But will qualified health claims really help consumers make better nutritional choices?
Qualified health claims utilise a standard based on the ?weight of the scientific evidence.? Petitioners must provide a body of data that is sufficiently and scientifically persuasive to demonstrate to expert reviewers that the weight of the evidence supports the proposed claim. However, the data supporting the diet-disease relationship need not rise to the level of ?significant scientific agreement.?
In evaluating whether claims used in labelling are truthful and not misleading, the FDA will use a ?reasonable consumer? standard rather than the ?ignorant, unthinking or credulous consumer,? which reflects the agency?s belief that consumers are active partners in their own health care. There is no doubt more consumers than ever before are taking control of their health.
For the first time in food history, health will rival convenience as the most important new food product attribute. According to Shopping for Health 2002—Self Care Perspectives, the number of consumers treating themselves before seeing a physician has increased from 31 per cent in 1998 to 68 per cent in 2002.
The weight-of-the-scientific-evidence standard is a radical departure from the standard of evidence required for health claims under the Nutrition Labelling and Education Act of 1990 (NLEA). Under that standard, which was outlined in a December 1999 guidance document, health claim petitioners are required to demonstrate, based on a review of the ?totality of publicly available evidence? that there is significant scientific agreement (according to experts qualified by training and expertise to make such an evaluation) that a relationship exists between a substance and a disease or diet-related condition. This ?gold? standard is very high and, as such, only five unqualified health claims have been approved for conventional foods since 1997 under the NLEA:
- Fibre from whole oat products and reduced risk of coronary heart disease (CHD)
- Psyllium fibre and reduced risk of CHD
- Soy protein and reduced risk of CHD
- Sterol esters and reduced risk of CHD
- Stanol esters and reduced risk of CHD
In July 2003, the FDA announced it will use, on an interim basis, an evidence-based system to rank qualified health claims. The agency will categorise qualified health claims into one of three levels as outlined in the table. The ranking system does not apply to unqualified claims (category A), which still must meet the significant-scientific-agreement standard of evidence.
There is active debate about qualified health claims and not all public health organisations are in support of them. The American Dietetic Association feels that health and nutrient content claims should be based on the significant-scientific-agreement standard and should not be preliminary or speculative. The National Academy of Science?s Institute of Medicine has also cautioned against permitting claims based on preliminary scientific studies, stating that ?claims about nutrient-disease relationships are more easily made than scientifically supported. Because the implications for public health are so important, caution is urged prior to accepting such claims without supportive evidence from appropriately designed clinical trials.?
In a lawsuit challenging the policy, consumer groups argued that the FDA violated the NLEA by permitting the use of claims that do not meet the significant-scientific-agreement standard set forth in the act. Consumer groups also maintained that the policy violates NLEA procedural requirements because qualified health claims would not be subject to the rule-making proceedings specified by Congress.
Does the science justify the claim?
Six qualified health claims have been authorised for dietary supplements:
- Selenium and cancer
- Antioxidant vitamins and cancer
- Omega-3 fatty acids and CHD
- B vitamins and vascular disease
- 0.8mg folic acid and neural tube birth defects
- Phosphatidylserine and cognitive dysfunction and dementia
The scientific substantiation supporting these claims varies dramatically. For example, numerous epidemiologic reviews and several large-scale clinical intervention trials support the role of omega-3 fatty acids in reducing CHD risk. In contrast, however, little evidence exists for the role of phosphatidylserine in cognitive dysfunction. Although 16 studies were identified for review by the FDA during the petition process for this claim, six were excluded due to problems with study design. The remaining 10 intervention studies were seriously flawed or limited in some way. Yet for dietary supplements, a qualified health claim exists for phosphatidylserine, as well as for omega-3 fatty acids.
What about qualified health claims for foods? In July 2003, the first qualified health claim for conventional foods was approved for certain tree nuts (almonds, walnuts, hazelnuts, pecans, some pine nuts and pistachio nuts) and a reduction of CHD.10 The FDA concluded that there was not significant scientific agreement that consumption of nuts may reduce the risk of CHD. Rather, they concluded that there was sufficient basis for a qualified health claim and so approved the following claim and disclosure:
?Scientific evidence suggests but does not prove that eating 1.5 ounces per day of (name of specific nut) as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. See nutrition information for fat content.?
Nine additional qualified health claims were published for public comment between March 16 and April 26, 2004:
- Lutein and eye disease
- Soy protein and cancer
- Chromium picolinate and diabetes
- Green tea and cancer
- Calcium and bone fractures
- Calcium and kidney/urinary stones
- Calcium and menstrual disorders
- Calcium and various cancers
- Calcium and hypertension
Once again, the scientific substantiation supporting these proposed claims varies tremendously. For example, while the role of calcium in reducing bone fractures is well established, there is little clinical data supporting the role of dietary calcium in menstrual disorders, particularly in reducing the symptoms of premenstrual syndrome. In fact, only two randomised, placebo-controlled clinical intervention trials have confirmed an association between calcium deficiency and premenstrual dysphoric disorder.
In addition to the issue of the strength of scientific evidence, I have concerns that the FDA will be inundated with qualified health claims proposals.
Given today?s regulatory environment, I truly wonder whether the health claim for soy and CHD (which I was very much involved with in the mid- to late 1990s) would have been granted ?unqualified? status.
Although 43 clinical intervention trials were submitted to the FDA as part of the petition process, soy has a relatively modest effect on lowering blood total and LDL cholesterol of about 5-7 per cent compared to other functional components, such as the plant stanol esters, which can lower LDL cholesterol up to 14 per cent.
The FDA needs to ensure that claims on labels are supported by adequate scientific evidence and are not otherwise misleading in order to truly benefit consumer health.
Clare M Hasler, PhD, MBA, is the executive director of the Robert Mondavi Institute for Wine and Food Science at the University of California, Davis.
All correspondence will be forwarded to the author.