Wednesday 24 January 2018

FDA Proposes New Study on Fortified Foods; Agency Concerned Industry Misleading Consumers

The US  Food and Drug Administration (FDA) submitted to the White House’s Office of Management and Budget (OMB) the required paperwork to launch a study into whether artificially adding vitamins to snack foods and carbonated drinks causes consumers to believe that substituting them for more nutritious foods ensures a healthier diet.  The Nutrition Labeling and Education Act (NLEA) already gives the FDA authority to issue regulations that require almost all packaged foods to bear nutrition labeling. The law also allows manufacturers to provide other nutrition information on labels in the form of various types of statements, including claims, as long as such statements comply with the regulatory limits that govern the use of each type of statement. There are three types of claims that the food industry can voluntarily use on food labels: (1) Health claims, (2) nutrient content claims, and (3) structure/function claims. The FDA expressed concern the use of these voluntary claims is used by industry to mislead consumers.

FDA’s policy on fortification (21 CFR 104.20) establishes a set of principles that serve as a model for the “rational addition” of nutrients to foods. In its submission to the OMB, the FDA states it “has an interest in the American public achieving and maintaining diets with optimal levels of nutritional quality, wherein healthy diets are composed of foods from a variety of nutrient sources.” The proposal goes on to explain the “FDA does not encourage the addition of nutrients to certain food products (including sugars or snack foods such as [cookies] candies, and carbonated beverages).” Out of this rationale the FDA seeks to study whether fortification of these foods could cause consumers to believe that substituting fortified snack foods for more nutritious foods would ensure a nutritionally sound diet.

Under the NLEA and other regulations the FDA already enforces labeling claims. Typically enforcement of labeling claims by the FDA is focused on dietary supplements and some functional foods. Fortified foods, however, are largely ignored. One aim of the study is to assess whether greater enforcement is needed by the Agency. This could mean greater scrutiny of brand’s websites, product labels, and social media sites. As dietary supplement firms know all to well the FDA leaves no stone unturned when reviewing claims – even looking and product testimonials. The watchful eyes of the FDA wouldn’t be the only worry.

Enforcement of fortified foods largely comes from plaintiffs and the study could sustain the surge of labeling litigation. Some brands, like Nutella and Yoplait, already know the pinch of consumers who complain the label mislead them. Nutella for example was successfully sued on a class action basis for misleading consumers to believe the snack was healthy when it contained high levels of fat and sugar. New enforcement by the FDA along with new findings through the study will encourage more plaintiffs to file labeling lawsuits. Also, expect new defenses and disclaimers to emerge on the labels. For example, dietary supplements making structure/function claims must bear a disclaimer provided in the regulations stating the FDA has not evaluated the claim and the claims is not intended to treat or mitigate a disease. Food labels may come to bear a similar, but voluntary, disclaimer as a defense to labeling litigation.

The FDA study would use a short web-based questionnaire to collect information from 7,500 adult members of an online consumer panel. Potential conditions for the study include : (1) A mock snack product with a claim similar to “[a]s much [nutrient] as a serving of [food product];” (2) a mock candy with the claim “[g]ood source of [nutrient];” and (3) a mock carbonated beverage with the claim, “product name] plus [nutrient].” The FDA proposal explains “Each participant in each study will be randomly assigned to view a label image. Each participant in each study will also be randomly allowed or disallowed to access the Nutrition Facts label of the product. All label images will be mock products resembling actual food labels found in the marketplace.” Based on the participants review of the label they will then answer questions about their perceptions and reactions to the product. The FDA will assess the response for “Product perceptions (e.g., healthiness, potential health benefits, levels of nutrients), label perceptions (e.g., helpfulness and credibility), and purchase/choice questions.” To help understand the data, the study will also collect information about participants’ background, such as purchase and consumption of similar products; nutrition knowledge; dietary interests; motivation regarding label use; health status and demographic characteristics.

As the study rolls out food facilities using fortification should begin to review their labels and assess the risk of their claims for both regulatory enforcement and litigation exposure.

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