Question: What do Sodium Reduction, FOP Labeling, and Medical Foods Have in Common?

By Ricardo Carvajal –

Answer:  They were all designated as high priority items in a Nutrition Program Review (NRP) Report prepared by CFSAN staff for the Center Director in December 2014.  (We compiled the report and its attachments into a single PDF, which we repaginated for the reader’s convenience.)  Unlike the highly publicized activities of CFSAN’s Chemical Safety Review, the activities of the NRP have stayed low on the radar, and the NRP Report was not made widely available to the public.  Our summary analysis of the Report is based on a copy obtained through the FOIA.

Commissioned by then-CFSAN Director Michael Landa, the NRP’s purpose was “to examine the nutrition and nutrition-related activities within CFSAN and recommend how they could be enhanced to more optimally benefit the public health,” in light of “reasonable resource constraints” and existing statutory authority.  The NRP was motivated in part by recognition that nutrition-related morbidity and mortality is estimated to far exceed morbidity and mortality associated with food contamination – historically the primary focus of FDA’s foods program, and almost certain to remain so with the advent of FSMA and associated funding.  The NRP was led by a Steering Committee (SC) comprised of key FDA personnel, and developed its recommendations based on interviews of agency staff and a range of external sources, including consumer advocates and the food industry. 

For purposes of the NRP, the SC broadly defined “nutrition and nutrition-related activities” to include “all activities intended to support growth, maintain health, and reduce the risk of chronic diseases, nutrient deficiencies, and other nutrition-related problems through a nutritionally healthy food supply and diet.”  Activities within the scope of the NRP included “assessments, education and outreach, economic analysis, food supply monitoring, research, and compliance.”  Covered chronic diseases and conditions included “obesity, nutrient inadequacy, inadequate growth, heart disease, site specific cancers, diabetes, hypertension, osteoporosis, age-related macular degeneration, neural tube defects, and dental caries.”

One of the principal objectives of the NRP was to develop a proposed strategic framework for FDA’s nutrition program.  The Report notes that CFSAN’s nutrition-related activities focus on providing information to consumers, with the assumption that they’ll use that information to make choices that contribute to better health, and encouraging product reformulation.  The NRP recommended that these activities be focused on achieving public health outcomes, notwithstanding the difficulty of ascertaining whether those goals are met.  Under the proposed strategic framework, the “top-level results” of CFSAN’s nutrition program over the next 10 years would be:

• Reduce rates of nutrition-related risk factors for chronic disease;
• Improve rates of optimal nutritional status among adults; and
• Ensure rates of optimal growth and development in infants and children.

Accordingly, the Report proposes the inclusion of the following nutrition-related objectives in the Office of Foods and Veterinary Medicine’s upcoming 10-year strategic plan: facilitate dissemination of information to help consumers choose healthier diets; monitor scientific developments, as well as changes in composition of marketed foods and their impact on consumers’ health; and encourage product reformulation “to promote a healthier food supply.”  In furtherance of those objectives, the Report includes the following “recommendations for improvement,” tiered in order of priority:

Tier 1

• Conduct a comprehensive evaluation of the nutrition program to establish a baseline against which to measure future evaluations;
• Reduce consumption of sodium through “voluntary and gradual” reduction, and of trans fat through revocation of GRAS status of PHOs (the Report also mentions engaging with industry “to consider how and whether foods could be reformulated to reduce saturated fats”);
• Begin planning to engage in FOP labeling to ensure that “labels are useful to consumers and not misleading regarding the healthfulness of the food,” perhaps through issuance of a regulation mandating a “single national system” or guidance establishing basic principles;
• Address the “growing and sometimes egregious problem of products making unsubstantiated therapeutic drug-type claims” by claiming medical food status – but without stifling “development of legitimate medical foods”;

Tier 2

• Address “growing concern” about the potentially misleading use of dietary guidance statements, such as the use of such statements on products that have “negative nutritional attributes” or “lack meaningful amounts of foods to which the statements pertain”;
• Develop a “regulatory structure” to ensure that structure/function claims are adequately substantiated, “given their great potential to mislead consumers”;
• Monitor scientific developments pertaining to “bioactive food components” such as probiotics and added fibers, and consider how to address the validity of related structure/function claims.

The Report includes other recommendations pertaining to consumer studies, consumer education, laboratory and clinical research, and collaboration with other government agencies and the private sector.

In looking back over the past year, it’s clear that FDA has pursued some activities consonant with the Tier 1 recommendations described above, such as revocation of GRAS status for PHOs and continued targeting of products the agency believes to be unlawfully marketed as medical foods – but those activities were underway when the NRP Report was generated.  At this point, the ultimate fate of the Report is unclear.  It may be that the Report’s recommendations will be incorporated into the next OFVM strategic plan, given that the benefits of the proposed initiatives are estimated to far outweigh the costs, and also far exceed the benefits of the agency’s food safety initiatives.  Alternatively, the Report might be shelved and forgotten – more time will tell.