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May 6, 2016 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Submitted electronically via www.regulations.gov Re: Docket No. FDA-2014-N-1207 Dear Sir/Madame: The Animal Welfare Institute (AWI) is pleased to submit comments on the notification of request for comments, Use of the Term Natural in the Labeling of Human Food Products, published in the Federal Register on November 12, 2015. Our comments apply only to use of the claim on foods derived from animals meat, poultry, dairy, and eggs or multi-ingredient foods containing one or more of these animal products. AWI has no position regarding use of the claim on other foods. I. Background Since its founding in 1951, AWI has sought to reduce the sum total of pain and fear inflicted on animals by people. We seek to abolish factory farms and achieve humane transport and slaughter for all animals raised for food. AWI supports policy initiatives that offer independent family farmers who utilize humane and sustainable animal agricultural practices greater opportunity to promote and sell their products, and that help consumers make better informed food choices. AWI has long been concerned about use of the natural claim in the labeling of food products from animals. We consider the claim, as currently defined by the US Department of Agriculture (USDA) for meat and poultry, to be misleading and the cause of much confusion and misunderstanding among consumers. Moreover, no definition currently exists under federal regulation or policy regarding use of the claim on dairy and eggs. Products labeled as natural are not being produced in a manner that meets public expectations of the term (as will be described below). Given the current popularity of the claim, we believe it is imperative that use of the term for animal food products (meat, poultry, dairy, and eggs) be either eliminated or modified as soon as is practical. II. Problems with Existing Natural Claim In 2009, the USDA solicited comments on the advance notice of proposed rulemaking, Product Labeling: Use of the Voluntary Claim Natural in the Labeling of Meat and Poultry Products (Docket No. FSIS-2006-0040A). In its comments, AWI identified five serious concerns regarding use of the claim on meat and poultry: 1) the claim is not understood by consumers, 2) the current definition does not meet

Docket No. FDA-2014-N-1207 / Page 2 consumer expectations, 3) the USDA s application of the definition is not consistent, 4) the claim s definition may be obscured or missing altogether from product packaging, and 5) confusion exists over the similar-sounding natural and naturally raised claims. More than six years later, all of these concerns remain, with the exception of the issue related to the claim naturally raised. Several years ago, the USDA halted approval of the claim and it was recently officially removed from the list of claims addressed by the USDA Process Verified Program. However, AWI s other concerns regarding the natural claim remain; in fact, public opinion surveys suggest that consumer confusion over the claim has only grown since the USDA first proposed establishing a regulatory definition for meat and poultry products. III. AWI Response to Issues for Comment Should we prohibit the term natural in food labeling? Why or why not? In October 2009, AWI commissioned a survey of consumer views of the natural claim on meat and poultry. One question asked the respondents to identify the meaning of the natural label from a list of criteria. Only two people or 1 percent of the survey sample correctly identified natural as indicating no artificial ingredients and minimally processed. A majority (51 percent) of the respondents said they believed natural meant the product came from animals who were not administered hormones or antibiotics. 1 Similarly, in a 2015 survey commissioned by Consumer Reports National Research Center, 59 percent of respondents said natural meant no genetically modified organisms (GMOs) in the animals feed, and 57 percent thought it meant the animals did not receive antibiotics or other drugs. 2 It is clear from the above survey results that consumers have a very low level of understanding of the natural claim. Most surveys suggest that consumers view natural has having a meaning similar to organic. Consequently, AWI recommends prohibiting the term natural, which will have the effect of driving consumers toward organic products that are produced in a manner more consistent with their expectations for the claim natural. Should we define, through rulemaking, the term natural? Why or why not? According to consumers surveys, natural is one of the most trusted and sought after claims on food products. 3 If use of the claim for animal food products is not prohibited, then the claim s definition should be clearly stated in regulation. This way, all parties producers, retailers, and consumers would know what to expect from the claim. If we define the term natural, what types of food should be allowed to bear the term natural? As previously stated, AWI does not have a position on use of the term natural on food products other than those derived from animals. For products from animals, we encourage the USDA and the Food and Drug Administration (FDA) to collaborate on a definition that applies to meat, poultry, dairy, and eggs. If 1 Harris Interactive QuickQuery for the Animal Welfare Institute, fielding period: October 12-14, 2009. 2 Natural Foods Label Survey, Consumer Reports National Research Center, 2015. 3 Fresh Chicken Study Final Report, Russell Research, October 2015; Food Labels Survey, Consumer Reports National Research Center, 2014; S. Muirhead, Natural Claims Cause a Stir, Feedstuffs, November 12, 2011.

Docket No. FDA-2014-N-1207 / Page 3 the claim is to be allowed on animal products, then it should also apply to multi-ingredient foods that contain one or more animal product. We are interested in any data or other information to suggest that consumers associate, confuse, or compare the term natural with organic. We are interested in data and other information about consumers understanding of foods labeled natural versus organic. Is the term natural on food labels perceived by consumers the same as organic? Or is natural perceived by consumers to be better than (or not as good as) organic? Please provide consumer research or other evidence to support your comment. Several surveys have documented significant consumer confusion regarding the differences between natural and organic foods. For example, in a 2015 survey on consumer attitudes toward fresh chicken products conducted by Russell Research, 44 percent of respondents said they trust natural claims when grocery shopping, while only 36 percent said they trust organic claims. 4 Similarly, in a 2014 survey conducted for the Consumer Reports National Research Center, 59 percent of respondents said they look for the natural claim when shopping, while 49 percent said they look for the organic claim. Two additional surveys conducted by Context Marketing in 2009 and 2010 showed that more consumers value the term natural than organic. While 50 percent of consumers said the natural label on food was either important or very important to them, only 35 percent assigned the same value to the organic label. 5 In the results of an online study conducted by the Organic and Natural Health Association in 2015, 36 percent of consumers said they do not believe there is a difference between natural and organic foods. That survey also showed that 46 percent of consumers believe the US government regulates food labeled as natural. 6 If we were to revise our policy regarding the use of the term natural or engage in rulemaking to establish a regulatory definition for natural, should certain production practices used in agriculture, for example, genetic engineering, mutagenesis, hybridization, the use of pesticides, or animal husbandry practices, be a factor in defining natural? Why or why not? As mentioned above, AWI supports prohibiting use of the claim natural on human foods derived from animals. However, if the natural claim is to be retained, the term s definition must cover animal husbandry practices, because that is the expectation of most consumers. A number of public opinion surveys have questioned consumers about what a natural label on meat and poultry should mean. In AWI s 2009 survey conducted by Harris Interactive, 66 percent of respondents said natural should mean that the product came from animals who were not administered hormones or antibiotics, and 45 percent said the claim should mean animals were raised in a pasture where they could engage in normal behaviors. 7 Purdue University researchers found that 60 4 Fresh Chicken Study Final Report, Russell Research, October 2015. 5 S. Muirhead, Natural Claims Cause a Stir, Feedstuffs, November 12, 2011. 6 M. Crane, What s the Difference Between Natural and Organic Foods? Don t Ask Consumers, Nutritional Outlook Magazine, November 6, 2015. 7 Harris Interactive QuickQuery for the Animal Welfare Institute, fielding period: October 12-14, 2009.

Docket No. FDA-2014-N-1207 / Page 4 percent of consumers believe that the natural label means improved animal welfare. 8 A 2015 survey conducted for the Organic and Natural Health Association found that 86 percent of consumers believe natural labeling on meat should mean no added hormones, 72 percent said no antibiotics should be administered, and 46 percent said the animals should be humanely raised. 9 In a 2011 survey of parents conducted for the meat processor Applegate, 70 percent of respondents said that the use of a natural claim on meat and poultry from animals treated with antibiotics is misleading, and 78 percent said they favor a change in regulations that would prevent companies from labeling meat and poultry sourced from animals treated with antibiotics, as natural. 10 Consumer Reports has surveyed consumers regarding the claim natural on multiple occasions over the past decade. In 2007, 83 percent of those surveyed said natural on meat should mean that it came from an animal who was raised in a natural environment. 11 In 2008, 85 percent of respondents said natural should mean that the animal was raised in a natural environment, and 77 percent said that the animal should have had access to the outdoors. 12 In response to the outdoor access question in 2014 13 and 2015 14, 66 percent and 69 percent of respondents, respectively, said the animals should have the opportunity to go outside. In the 2015 Consumer Reports survey, the use of artificial growth hormones in animals raised for the natural label was opposed by 87 percent of respondents, while 81 percent opposed GMOs in feed, and 82 percent said no antibiotics should be administered. 15 These results make it clear that most consumers expect that natural on meat products means that, at a minimum, animals received no artificial hormones or antibiotics 16 and had the opportunity to go outdoors. Although AWI has not seen any survey results on use of the claim on dairy or eggs, we suspect that consumer views on these products would be in line with those for meat and poultry. We are interested in any data or other information to suggest that consumers associate, confuse, or compare the term natural with healthy. AWI is aware of at least two surveys that suggest consumers believe food labeled as natural is more healthy or nutritious than comparable products without the claim. For example, in a Gate-to-Plate survey of more than 1,000 mothers commissioned by CommonGround, 53 percent of respondents agreed with the following statement: It s important to purchase food labeled all natural, whenever 8 S. Muirhead, Deficit of Trusted Sources, Conflicting Values Cause Disconnect, Feedstuffs, July 9, 2013. 9 M. Crane, What s the Difference Between Natural and Organic Foods? Don t Ask Consumers, Nutritional Outlook Magazine, November 6, 2015. 10 Survey Says: Parents Are Concerned About Overuse of Antibiotics in Animal Agriculture Creating Superbugs, Applegate, December 12, 2011. 11 Food Labeling Poll, Consumer Reports, July 11, 2007. 12 Food Labeling Poll 2008, Consumer Reports National Research Center, November 11, 2008. 13 Food Labels Survey, Consumer Reports National Research Center, 2014. 14 National Food Labels Survey, Consumer Reports National Research Center, 2015. 15 National Food Labels Survey, Consumer Reports National Research Center, 2015. 16 While AWI supports the principles of the Certified Organic program, it disagrees with the program s position on the use of antibiotics. We believe that the organic regulations should be amended to allow producers to treat sick animals with antibiotics and still maintain the ability to market products from the animal as organic (as long as the appropriate withdrawal period is observed).

Docket No. FDA-2014-N-1207 / Page 5 possible, because it is a more nutritious choice for our family. 17 In addition, work by researchers at Purdue University revealed that 64 percent of consumers responding to a survey said they believe all natural means improved food safety. 18 What can be done to ensure that consumers have a consistent and accurate understanding of the term natural in food labeling to ensure that it is not misleading? Current USDA policy allows flexibility in the definition of natural on meat and poultry, as long as the applicable definition is provided on the label. AWI believes that the practice of allowing natural to mean different things when used on different products adds to consumer confusion regarding the term. This flexibility is not allowed with other label claims such as organic. Natural is also frequently used on meat and poultry products in combination with a number of other claims, such as no antibiotics administered or all vegetarian feed. This also leads to confusion, as consumers who see natural used in a particular context on one label may mistakenly assume that it is being used in the same context on another label. Consumers typically say they prefer to receive information about food products at the point of sale, particularly on the food package itself. In a survey of fresh chicken products conducted by Russell Research in 2015, 76 percent of consumers said they were somewhat, very much or extremely influenced by large claims on the front of a package. However, only 49 percent of consumers in that survey said that they always or usually read the fine print on the back of packages when buying chicken. 19 In 2009, AWI conducted a survey of natural meat and poultry products offered in major supermarket chains in the Washington, DC area. AWI found several instances where the definition of the term was difficult to locate on the package due to the cluttered design of the label or the font size being too small. In addition, no definition whatsoever could be located on the labels of one major supermarket s store brand of natural meat and poultry products. AWI staff experienced difficulty locating the information, and we knew what we were looking for, as opposed to most consumers who are unaware that they must determine how the term is being defined for each particular product they are considering for purchase. Because consumers are extremely misinformed about the definition of natural on food products from animals, we believe it is essential that use of the claim is prohibited. However, if the FDA and the USDA decide to continue to allow the claim, we strongly recommend that the claim be strictly defined in regulation. While we are not opposed to the definition of the claim appearing on packaging, natural should always mean the same thing when it appears on a specific type of food product, such as eggs. Natural should not mean one thing on a particular brand of eggs and something else on a different brand, regardless of whether a definition is included on the package. 17 5 Things Moms Get Wrong at the Grocery Store, CommonGround, April 2013. 18 S. Muirhead, Deficit of Trusted Sources, Conflicting Values Cause Disconnect, Feedstuffs, July 9, 2013. 19 Fresh Chicken Study Final Report, Russell Research, October 2015.

Docket No. FDA-2014-N-1207 / Page 6 How might we determine whether foods labeled natural comply with any criteria for bearing the claim? In our opinion the best way to ensure that foods from animals that are labeled natural comply with the definition for the claim is to require third-party certification. We believe third-party verification is necessary, particularly if a decision is made to include animal husbandry practices in the definition of natural. Research conducted by AWI has documented that the USDA Food Safety and Inspection Service is inconsistent in its approval process for animal husbandry claims, such as humanely raised 20 and free range 21. Surveys suggest that consumers support third-party verification of claims, and, moreover, a sizable proportion of consumers already assume that natural claims are verified. In a 2015 survey conducted for Consumer Reports National Research Center, nearly half of the respondents said they think the natural label is verified. 22 In a 2015 survey by Russell Research, 77 percent of consumers indicated they are highly likely or somewhat likely to purchase a fresh chicken product with third-party verification of various claims. 23 IV. Recommendation and Conclusion Given the extreme level of consumer confusion over the meaning of the claim, AWI recommends that natural not be approved for use on meat, poultry, dairy, or eggs. Instead, companies should be allowed to label these products as no artificial ingredients and/or minimally processed, if they meet the appropriate criteria. However, if the natural claim is to be retained, its use should be limited to producers participating in USDA Certified Organic or other independent certification programs with equivalent standards. (Third-party certification programs that may be considered equivalent to Certified Organic include Certified Naturally Grown, Demeter Certified Biodynamic, and Food Alliance Certified.) In addition, the claim natural should not be allowed on any product containing artificial or synthetic ingredients. Thank you for the opportunity to comment on the natural label. We look forward to seeing our concerns addressed by publication of a proposed rule on the claim, drafted jointly by the FDA and the USDA. Sincerely, Dena Jones Director, Farm Animal Program 20 Label Confusion: How Humane and Sustainable Claims on Meat Packages Deceive Consumers, AWI, May 2014. 21 USDA Gives Producers Free Reign Over Free Range Product Labels, AWI, December 2015. 22 Natural Foods Label Survey, Consumer Reports National Research Center, 2015. 23 Fresh Chicken Study Final Report, Russell Research, October 2015.