FDA: Labeling It Right Will Take a Community Effort

On April 1, 2013, the U.S. Food and Drug Administration (FDA) released its proposed rule for revision of nutrition and supplement labels (FDA 21 CFR Part 101).

The American Society of Nephrology, together with the National Kidney Foundation and 17 other organizations, developed a joint comment letter to the FDA regarding its proposed modifications (Table 1). The organizations agreed that most of the proposed changes have the potential to improve diets and overall health for millions of Americans. However, the letter focused not on what the FDA included in the proposed rule but rather on changes the agency omitted.

The proposed rule lists several important chronic diseases that constitute the leading causes of death and disability in the United States. But the FDA chose not to include chronic kidney disease on its list with other diseases like cardiovascular disease, cancer, obesity, and hypertension in its proposed rule. Given that kidney disease is the eighth leading cause of death in the United States—and that the kidney is critical in the metabolism and regulation of many nutrients in the human body—the FDA should give greater attention to this public health concern in this and other proposed rules, the letter argued.

The FDA made no mention of dietary phosphorus intake in the proposed rule, and the agency did not propose any changes with regard to how phosphorus content is reflected on the nutrition label.

“If FDA finalizes the proposed rule as is, it could be a significant missed opportunity to help people with kidney disease understand and better control their diet—and ultimately their health,” said ASN President Sharon M. Moe, MD, FASN. The letter recommended that the FDA switch phosphorus content from voluntary to mandatory listing. The phosphate labeling could be further subdivided into natural content of phosphorus versus added phosphates, similar to a change that FDA proposed in this rule for distinguishing between natural sugar content of food versus added sugar.

Restricting dietary phosphorus intake is an important therapeutic strategy in patients with kidney disease. However, the increasing use of additives and the lack of mandatory labeling of phosphorus content pose significant—and often insurmountable—challenges to patients and their families who are trying to adhere to these important recommendations. In the United States, more than 45 percent of the best-selling grocery items contain phosphorus additives, and these items typically cost less and are eaten more often. Therefore, the search for foods that do not contain high amounts of phosphorus so they can maintain a healthful diet can make patients feel as if they are fighting an uphill battle.

ASN, NKF, and the other signing organizations hope that this joint letter will help the FDA recognize that diet management is critical in preventing progression of kidney disease and, for those whose kidneys have failed, that diet can have a monumental effect on maintaining the best possible quality of life.

These organizations will continue to advocate that the FDA include kidney disease on its list of chronic diseases and that the agency make the labeling of phosphorus content mandatory in the final rule.

The FDA’s proposed rule states that when FDA is determining if mandatory versus voluntary labeling is indicated, “First we consider whether there is evidence of a relationship between the nutrient and a chronic disease, health-related condition, or health-related physiological endpoint. Second, we consider whether there is evidence of a problem related to health in the general U.S. population.”

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