Consistent evaluation will enhance the value of health claims

by Keith Nunes
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Food and beverage companies that market products featuring health claims have come under additional scrutiny during the past few years from regulatory bodies like the Federal Trade Commission and Food and Drug Administration as well as by the courts via lawsuits initiated by consumers. As the F.D.A. seeks to develop a more consistent health claim evaluation process, the food industry will continue to be challenged by actions taken by regulators and the courts. But in the long term, efforts that truly mean better regulation will lend credibility to the health claims of food and beverage companies.

The popularity of using health claims, in the face of regulatory hurdles, may be seen in research from companies such as Mintel International Ltd., which tracks claims most frequently used by food and beverage companies. The two most popular claims relate to cardiovascular health and digestive health, but the rapid growth of the “Other” category, which is used by Mintel to track less common claims, speaks to the value being placed on health claims in order to differentiate products in the marketplace.

Unfortunately, the list of companies that have faced challenges to their health claims is long and runs the gamut of product types. Most recently, the F.D.A. sent warning letters to two beverage manufacturers, the Dr Pepper Snapple Group and Unilever, regarding claims made about the benefits of green tea in some of their beverages (see story on Page 12).

Most warnings are settled by the alteration or withdrawal of a claim or the presentation of additional scientific evidence to support the claim. In a few instances, especially when a lawsuit is involved, companies have faced judgments that have forced them to adjust or withdraw their claim and pay a financial penalty.

Increasing calls are heard from the public health community to make health claim standards more uniform and stringent than now is the case. In May, the Institute of Medicine recommended a new framework it said the F.D.A. should use when evaluating health claims. The I.O.M. asserted there are no scientific grounds for the F.D.A. to use different standards of evidence when evaluating the health benefits of food ingredients or drugs.

In its report, the I.O.M. said the F.D.A. has been slowed in its ability to assess the proliferation of health claims being made by food and beverage manufacturers because it lacks a process accepted across the regulatory, food, and medical communities to evaluate biomarkers as valid measurements that substitute for clinical outcomes. For example, the report said blood level of harmful cholesterol is often used as a biomarker for the risk of heart disease, and food companies make claims about the heart health benefits of their products based on their ability to lower cholesterol levels, even if the products have not been shown to actually decrease heart disease.

The I.O.M. is proposing a framework that will give the F.D.A. a way to assess the selection and use of biomarkers across the food, device and drug markets. The proposed framework includes validating that a biomarker may be accurately measured, ensuring that it is associated with the clinical outcome of concern, and confirming that it is appropriate for the proposed use.

Short-term efforts to improve the health claim evaluation process will further challenge food and beverage companies. But eventual consistency in the evaluation and approval process has been needed for some time and a standardized framework should minimize future regulatory challenges and lawsuits.

Gaining an advantage in the food and beverage marketplace is difficult without the benefit of a proprietary technology or the investment in research that allows a company to substantiate a health claim and differentiate its product in the market. While the industry will continue to be challenged in the near future, the development of a more uniform evaluation process will do much to minimize future regulatory actions and add value to those products that qualify.

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