Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

Abstract

While fortification of staple foods and condiments has gained enormous global traction, poor performance persists throughout many aspects of implementation, most notably around the critical element of regulatory monitoring, which is essential for ensuring foods meet national fortification standards. Where coverage of fortified foods is high, limited nutritional impact of fortification programs largely exists due to regulatory monitoring that insufficiently identifies and holds producers accountable for underfortified products. Based on quality assurance data from 20 national fortification programs in 12 countries, we estimate that less than half of the samples are adequately fortified against relevant national standards. In this paper, we outline key findings from a literature review, key informant interviews with 11 fortification experts, and semi-quantitative surveys with 39 individuals from regulatory agencies and the food fortification industry in 17 countries on the perceived effectiveness of regulatory monitoring systems and barriers to compliance against national fortification standards. Findings highlight that regulatory agencies and industry disagree on the value that enforcement mechanisms have in ensuring compliance against standards. Perceived political risk of enforcement and poorly resourced inspectorate capacity appear to adversely reinforce each other within an environment of unclear legislation to create a major hurdle for improving overall compliance of fortification programs against national standards. Budget constraints affect the ability of regulatory agencies to create a well-trained inspector cadre and improve the detection and enforcement of non-compliant and underfortified products. Recommendations to improve fortification compliance include improving technical capacity; ensuring sustained leadership, accountability, and funding in both the private and the public sectors; and removing political barriers to ensure consistent detection of underfortified products and enforcement of applicable fortification standards. Only by taking concrete steps to improve the entire regulatory system that is built on a cooperative working relationship between regulatory agencies and food producers will a nutrition strategy that uses fortification see its intended health effects.

FIGURE 1

Critical Challenges Along the Food Value Chain That Present Barriers to Consistent Compliance Against National Fortification Standards

FIGURE 2

Top Regulatory Monitoring Priorities Requiring Improvements at the Regulatory Agency Level to Ensure Industry Compliance With Fortification, According to Rankings^a by Questionnaire Respondents From Regulatory Agencies (n=14) and Food Industries (n=20)^{b a} Respondents ranked each element as 1 of their top 3 priorities. ^b The 14 respondents from regulatory agencies came from 12 countries, and the 20 respondents from food industries came from 13 countries (a total of 16 countries represented). Four respondents from regulatory agencies and one from industry left this question blank.

FIGURE 3

Top Barriers^a Fortified Food Producers Face in Ensuring Fortification Compliance, According to Rankings by Questionnaire Respondents From Food Industries (n=20)^{b a} Respondents ranked each element as 1 of their top 3 barriers. ^b The 20 respondents came from 13 countries; 1 respondent left this question blank.

FIGURE 4

Greatest Challenges Faced in Creating a Legal and Regulatory Environment That Allows for High Compliance With Fortification Regulations, According to Open-Ended Responses From Regulatory Agency Respondents (n=16)^{a a} The 16 respondents came from 13 countries, with some respondents providing multiple answers; 2 respondents left this question blank.

FIGURE 5

Regulatory Monitoring Areas Lacking a Trained Cadre of Regulatory Inspectors and Analysts, According to Open-Ended Responses From Regulatory Agency Respondents About Key Challenges^{a a} The analysis was based upon the responses of 18 respondents from 15 countries. A range of 9 to 17 respondents provided answers in each regulatory monitoring area.

FIGURE 6

Relationship Between Regulatory Monitoring Elements in Ensuring Food Vehicles Are Adequately Fortified and Can Contribute to a Positive Health Impact