Senate Report

submitted the following

REPORT ON COMMENTS

[To accompany, S. 1043]

The Committee on FDA Affairs has analyzed the proposed regulation and the accompanying comments, and recommends that the regulation do not pass. Due to significant evidence questioning the validity of the argument and data that the FDA uses to support their proposed changes, it is recommended that the rule should not be passed without further review and editing.

PURPOSE

In the proposed rule, titled ‘Food Labeling: Revision of the Nutrition and Supplement Facts Labels’, the Food and Drug Administration (FDA) is making revisions to nutrition and supplement facts labels in attempt to make the information provided on food labels more accurate and useful to the general public. The FDA will change several pieces of the labels. Among the changes included will be the altering of daily intake recommendations to more accurately represent the current state of nutrition and health in America. Additionally, the “calories from fat” section will be eliminated, and an “added sugars” segment will be included. The FDA is also changing which vitamins and minerals are featured, taking away values that have less relevance and replacing those with more significant values that will be of better use to consumers. The format will also be changed to improve readability and accessibility of the label, which includes font size changes and the relocation of percent daily values from the right side to the left side of the panel. Each of these changes proposed by the FDA aim to increase consumer understanding and improve the health of the nation.

ESTABLISHING THE DEBATE

Nutrition and supplement facts labels are topics that are of high concern and debate because of their effect on all consumers in the United States. The proposed rule attracted many comments, both for and against the rulemaking.

Many comments posted were in favor of the government intervention and the proposed changes. Individuals and organizations alike see value in changing the information provided on nutrition and supplement labels to improve the health of the nation and see that it is necessary for the government to intervene. The first comments that will be looked at are from Unilever, which is one of the world’s largest consumer product companies. Unilever includes many top consumer brands in the United States, such as Ben & Jerry’s, Klondike ice cream, Hellman’s mayonnaise, Promise and many more, each of which will be affected by the changes proposed. Unilever supports government intervention, which will provide consumers with an easier understanding of nutrition information in order to build healthy diet patterns. Their support aligns with the Unilver’s Sustainable Living Plan that aims to improve nutritional profiles of products through transparent communication of nutrition information.

The next organization, the Union of Concerned Scientists (UCS), is also in support of the proposed rule and believes that consumption of added sugars is closely linked with higher risk of heart disease, obesity, diabetes and dental issues and is in support of the FDA’s attempts to increase consumer’s understanding of these risks. They value scientific findings and data, and see the worth of the scientific data the FDA used to back up their work. Lastly, the Food Marketing Institute (FMI) shows their support of the rule. As FMI members in the United States operate over 40,000 retail food stores and represent almost $770 billion of annual sales, they clearly have a large stake in the food retail industry and see the need in the FDA’s proposed changes. The FMI represents supermarket chains and other retail food stores that all value providing consumers with an abundance of options that support healthy and nutritious lifestyles. The FMI believes that food choices are an extremely important factor in affecting consumer’s health and therefore support the FDA’s proposed rule.

However, there are also many informed citizens and organizations that submitted comments in disagreement with the government intervention and to express their hesitations and dismay for the rulemaking. The first comment comes from the Cape Cod Cranberry Growers’ Association (CCCGA), which represents more than 325 cranberry growers in Massachusetts. Cranberries are an agricultural commodity and have an annual value of $99.8 million, creating nearly 7,000 jobs and bringing millions of dollars to the Massachusetts economy (Wick, 2015). The CCCGA values the profitability of the cranberry industry and wants to keep thousands of jobs intact for the people who rely on cranberry farming, hence why they do not support the proposed regulation.

Another organization that disagrees with the FDA’s rulemaking is The Juice Products Association (JPA), which consists of processors and distributors of fruit juices and drinks. Fruit juices and drinks typically have high values of added sugars and the sales of these products could be deeply affected by the new added sugars requirements on labels. The JPA values their profits and their business will see significant losses if the rulemaking is passed. Lastly, the Sugar Association represents sugar cane farmers and refiners and promotes the safe consumption of sugar in moderation as part of a balanced diet. The Sugar Association advocates for the healthy consumption of sugar, which quite actively goes against the ideas of the proposed regulation. The Sugar Association is in disagreement with the proposed rules’ percent daily values for added sugars and disagrees with the FDA’s scientific evidence that it is using to support its changes regarding added sugars. The Sugar Association values their profits and success of their business, just like the CCCGA and the JPA, and will see great losses if the regulation is passed.

COMMENTS FOR PROPOSED RULE

The three comments published by Unilever, UCS and FMI are in support of government intervention, reinforcing the proposed rule’s attempt at providing consumers with more complete knowledge. To start, Unilever offers the perspective of a consumer food and beverage brand. The brand supports providing consumers with improved knowledge of nutritional elements of their products because they hope to “assist consumers in developing healthy diets” (Balentine, 2015). They acknowledge the dangerous effects of elevated sugar intake and think it is critical that the FDA improve the information on nutrition labels to make consumers more aware. Unilever cites evidence from empirical studies in their comment to reinforce their support of government intervention. Moreover, Unilever could be motivated to support this rulemaking so that they can keep up their public image as a brand that cares about their consumers and cares about producing healthy food and beverages. Their concerns are geared toward the general public in offering a perspective that is in agreement with the government and which expresses concern for the health of their consumers.

Next, the Union of Concerned Scientists (UCS) fully endorses the FDA’s proposed rule, specifically because of its focus on sugars. The UCS recognizes the increased risk of heart disease, weight gain, and diabetes for people who consume high rates of added sugars, and believes that consumers have the right to be fully informed about these risks and the sugars they are eating (Phartiyal, 2015). The UCS represents scientists, public health professionals, doctors, and other concerned individuals, all of whom value empirical data, which is in agreement with the FDA’s evidence. Their concerns are viable, but may be limited in their representation of the general public, as the UCS represents a more targeted group.

Furthermore, The Food Marketing Institute (FMI) submitted a comment in support of the rule, however they were more skeptical and constructive about certain aspects, such as added possible customer confusion due to new added values. As a group that advocates for the places (grocery stores, supermarket chains and retail stores) that sell food products, the FMI has a different perspective than the previous two comments analyzed. The group is motivated to speak out though because although they believe the revisions could cause significant cost increases, the labeling initiative will inform consumers about important nutrients in their foods (Barnes, 2014).

COMMENTS AGAINST PROPOSED RULE

Among the hundreds of comments advocating against government intervention, the comments by the CCCGA, the Juice Products Association and the Sugar Association all make solid arguments supporting their side. The CCCGA, which represents more than 325 cranberry growers, makes the argument that the proposed changes will dramatically impact the cranberry industry. Cranberries are a naturally tart fruit that are very nutritious but unpalatable in their raw form. The CCCGA is concerned that the new ruling will negatively affect the sales of all cranberry products, causing a greater impact on the greater economy through eliminating jobs and jeopardizing the livelihood of the thousands of people who rely on cranberry agriculture. The CCCGA writes, “Many of our growers are already facing significant economic hardships and with the prospect of these proposed labeling changes, their very existence as farmers is in jeopardy” (Wick, 2015). The association proposes that accommodations be made for cranberry products and other similar products on the new labels to allow consumers to be able to understand the complicated background about the cranberry (Wick, 2015). The CCCGA’s concerns are mainly geared toward protecting the specific group of cranberry farmers and other people who rely on the cranberry industry.

Furthermore, the Juice Products Association (JPA) uses two external studies to support their argument against the FDA’s proposed changes, with specific attention to the possible format changes. By citing results from an eye-tracking study, the JPA found that there was not enough evidence to support that changing the format of the nutrition facts panel will help consumers better understand the label (Faison, 2014). The JPA’s comment also uses data from an experimental study, which shows that consumers saw no apparent difference in levels of understanding between labels with the new format versus the old format. By citing these studies, the JPA appeals to the concerns of the general public and uses logical and viable studies to concretely back up their argument against government intervention.

Lastly, the Sugar Association, an organization representing over 90 percent of sugar/sucrose producers in the United States, argues that the FDA does not properly justify their changes regarding added sugars and daily sugar intake values. The association itself is based upon the foundation of supporting and promoting sugar in moderation as part of a balanced diet, a value that comes into play throughout their argument against the FDA’s proposal (Briscoe, 2014). The Sugar Association states, “the FDA arbitrarily selected from general dietary guidance, science of low evidentiary value and selective reports… to support its proposal for ‘added sugars’ labeling and to set a DRV for ‘added sugars’” (Briscoe, 2014). The comment also directly attacks other evidence that the FDA uses, criticizing its validity and pointing out various contradictions in the FDA’s evidence. The Sugar Association clearly represents people and organizations that depend on sugar production so it is obvious that they are looking out for the best interests of the sugar industry.

FINAL RECOMMENDATION

Based upon the comments received and analyzed, it is recommended that the government does not intervene. The three comments by the CCCGA, JPA and Sugar Association all make strong points questioning the validity of the evidence that the FDA uses to support their changes regarding added sugars and formatting. It is necessary that the FDA use complete and accurate data to support their proposed changes so that they can completely justify the rulemaking and satisfy the views of the general public. The CCCGA mentions the economic hardships that the proposed rule changing could inflict upon cranberry growers, jeopardizing the livelihoods of thousands of farmers. The FDA must consider the lives they are putting at stake with this rule, as many industries will suffer significant losses with the passing of the rule. Additionally, the JPA uses significant data from two respected studies citing the lack of validity behind the format changes of the proposed nutrition facts labels. The JPA states that there is no observable difference in consumer nutritional understanding with the new format versus the old panel formatting. Furthermore, the Sugar Association justifies their argument through questioning the data that the FDA uses, pointing out holes and the lack of complete information in the FDA’s claims that contributed to their changes regarding added sugars and daily sugar intake values. The three organizations make diverse points that create a solid argument against the FDA’s current proposed rule. The FDA must consider the comments discussed, along with hundreds of other comments, before they pass this regulation to address the many concerns consumers and organizations have regarding the rule.

References

Balentine, D. (2015). Unilever Comments Nutrition Labeling Proposed Rules. fffffffComment on Food Labeling: Nutrition and Supplement Facts Labels; fffffffRevision. Retrieved from regulations.gov. fffffffhttps://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1210-0410

Barnes, S. (2014). Food Marketing Institute FMINFP comments. Comment on fffffffFood Labeling: Nutrition and Supplement Facts Labels; Revision. Retrieved ffffffffrom regulations.gov. fffffffhttps://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1210-0503

Briscoe, A. (2015). Comment from the Sugar Association. Comment on Food fffffffLabeling: Nutrition and Supplement Facts Labels; Revision. Retrieved from fffffffregulations.gov. https://www.regulations.gov/#!documentDetail;D=FDA-fffffff2012-N-1210-0805

Faison, P. (2015). Comment from the Juice Products Association. Comment on fffffffFood Labeling: Nutrition and Supplement Facts Labels; Revision. Retrieved ffffffffrom regulations.gov. fffffffhttps://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1210-0682

Food Labeling: Revision of the Nutrition and Supplement Facts Labels. Vol. 79. fffffff11880. (March 3, 2014).

Phartiyal, P. (2015). Comment from Union of Concerned Scientists. Comment on fffffffFood Labeling: Nutrition and Supplement Facts Labels; Revision. Retrieved ffffffffrom regulations.gov. fffffffhttps://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1210-0711

Wick, B. (2015). Comment from the Cape Cod Cranberry Growers Association. . fffffffComment on Food Labeling: Nutrition and Supplement Facts Labels; fffffffRevision. Retrieved from regulations.gov. fffffffhttps://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1210-0852