May 10, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm Rockville, MD 20852

Transcription

1 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rm Rockville, MD Via Fax: RE: Use of the Term Natural in the Labeling of Human Food Products; Request for Information and Comments. 80 Federal Register (November 12, 2015). Docket No. FDA-2014-N Dear FDA Desk Officer, The Natural Products Association (NPA) appreciates the opportunity to respond to the Food and Drug Administration s (FDA s) notification of request for comments over use of the term natural in the labeling of human food products. Members of the NPA applaud FDA s latest notification for stakeholder comment. NPA is submitting this letter as formal comments to Docket No. FDA-2014-N-1207, Use of the Term Natural in the Labeling of Human Food Products; Request for Information and Comments published in the Federal Register on November 12, 2015 (80 FR 69905), regarding the agencies request for information and comments on the use of the term natural in the labeling of human food products.

2 Page 2 NPA was founded in 1936 to promote and protect the unique values and shared interests of retailers and suppliers of natural nutritional foods, dietary supplement, and other natural consumer products. NPA is a non-profit 501(c)(6) association whose mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health, and for the rights of retailers and suppliers to sell those natural products. We are the oldest and largest trade association in the natural products industry representing over 1,400 members accounting for almost 10,000 retail, manufacturing, wholesale, and distribution locations of natural products, including foods, dietary supplements, and health/beauty aids. The NPA was the first and only trade association to develop a natural certification program for personal and home care products and ingredients in the United States. Therefore, the NPA and its member companies, have a significant interest in the development of the definition of the term natural as well as how the Agency will regulate the term when made in claims on the labeling of food, dietary supplements and other consumer products (i.e., personal and home care products). The term food here in these comments refers to both conventional foods and dietary supplements. NPA is committed to advocating for the manufacture, distribution and retail sale of safe and wholesome conventional foods and dietary supplements that are in full compliance with all federal and state laws, while meeting the demand for healthy and innovative products and ingredients by consumers. NPA applauds FDA for taking on the task to define natural by subject matter experts and no Madison Avenue ad executives. While there are several courts waiting for FDA to define the term, we see the need for the federal government to develop one overarching definition for natural as it is the most litigated claim out there in the natural products industry today. American consumers are seeking foods manufactured without artificial preservatives or synthetic alternatives. Products with natural claims have even outpaced products with organic claims over the years. The food industry has a vital interest to meet consumer demand with natural products that are safe, healthy (nutritional), and affordable. Americans also have a right to know what is in the products they buy and having a universally accepted definition of what is and is not natural is a strong first step forward. At present, consumers

3 Page 3 believe organic and natural are one in the same. Many Americans do not know there is a federal standard in place for organic and a longstanding FDA policy in place for natural. NPA would like to comment on the need to create fundamentally distinct regulatory definitions for these two terms to educate consumers, increase clarity, provide guidance to industry, allow choice for consumers, meet consumer demand, and harmonize natural across multiple agencies. NPA believes that FDA should take a uniform position on natural that encompasses both FDA and the U.S. Department of Agriculture s (USDA s) Food Safety and Inspection Service (FSIS) when defining the term natural. Thank you for considering this request as FDA has a considerable amount on its plate at the moment and only limited resources. The decision to take this issue on could not have been taken lightly, given the agency s past history of respectfully declining requests from federal judges on three occasions to come to an administrative determination of whether Genetically Modified Organisms (GMOs) belong in allnatural foods. The NPA thanks the FDA and looks forward to participating in this important regulatory process.

4 Page 4 Executive Summary Organic is Non-GMO NPA Supports Natural as a Distinct Entity from organic Consumers Who Wish to Avoid Artificial and Synthetic Ingredients Should Be Able to Do So By Choosing Natural Products FDA Should Address and Define Natural Through the Public Rulemaking Process Current FDA Policy Contradicts Vermont State Law on Natural NPA Supports a National Natural Labeling Standard for All Foods Including Dietary Supplements to Avoid a Patchwork of Regulations from States on Natural Claims NPA Requests FDA to Incorporate Its Policies on Foods Developed from Biotechnology in its Definition of Natural NPA Requests FDA to Harmonize Its Definition of Natural with the Same Term Defined by USDA s FSIS NPA Requests the FDA to Amend the Federal Food, Drug & Cosmetic Act (FFDCA) and Sections of the Codified Regulations to Allow the Term Natural on Foods Derived from Biotechnology Minimally Processed NPA Supports the Development of an Illustrative List of Natural Processes NPA Requests that Natural Preservatives, Natural Colors, Incidental Additives and Some Processing Aids Be Included in the Development of a Positive Illustrative List of Natural Ingredients NPA Supports a Multi-Tier Approach on Natural Claims, akin to USDA s Organic Program, to Recognize Companies Who Only Use Natural Ingredients and Encourage Other Companies to Switch from Synthetic to Natural Alternatives NPA requests an Economic Impact Cost Analysis of Ignoring Natural Claims, a First Amendment Issue, and Placing It in the Hands of the States

5 Page 5 Background The regulation of the entire food industry in the United States is covered by three federal agencies with unique jurisdictions and various state and local governments. The USDA, FDA, and Federal Trade Commission (FTC) have ultimate regulatory authority of interstate commerce when foods make any claims using the term natural. USDA is responsible for labels on meat, poultry, and processed eggs; 1 FDA s Center for Food Safety is responsible for labels on all other conventional foods, beverages, and dietary supplements, amounting to approximately 80% of the nation s food supply; 2 and the FTC is responsible for food advertising. 3 The historic role that each of these three agencies have taken in shaping natural will be discussed below. USDA. FSIS is the public health regulatory agency in the USDA responsible for ensuring that the nation s commercial supply of meat, poultry, and egg products is safe, wholesome, and truthfully labeled and packaged. In particular, FSIS develops and implements national policies to ensure that meat, poultry, and egg product labeling is truthful and non-misleading. To guide manufacturers in the development of labeling that FSIS was likely to determine to be truthful and not misleading with regard to the voluntary claim natural, FSIS published policy guidance in the form of Standards and Labeling Policy Memorandum 055 (Policy Memo), dated November 22, The policy guide states that the term natural may be used on labeling for meat products and poultry products provided that the applicant for such labeling demonstrates that: (1) The product does not contain any artificial flavor or flavoring, coloring ingredient, or chemical preservative (as defined in 21 CFR ), or any other artificial or synthetic ingredient; and 1 21 U.S.C. 453, 457, 601, , 1033, The USDA is also responsible for products that bear the label USDA Organic, though many USDA Organic foods also fall under the FDA s umbrella since food labeled USDA Organic is still regulated by the FDA in a traditional sense (ie. found to be adulterated or misbranded) U.S.C. 343(q)(1) U.S.C. 52, 55 (2012); Enforcement Policy Statement on Food Advertising, FED. TRADE COMMISSION (May 13, 1994),

6 Page 6 (2) The product and its ingredients are not more than minimally processed. The USDA defines minimally processed to include food processed in a manner that does not fundamentally alter the food. Minimal processing may include: (a) Those traditional processes used to make food edible or to preserve it or to make it safe for human consumption, e.g., smoking, roasting, freezing, drying, and fermenting, or (b) Those physical processes that do not fundamentally alter the raw product or that only separate a whole, intact food into component parts, e.g., grinding meat, separating eggs into albumen and yolk, and pressing fruits to produce juices. Relatively severe processes, e.g., solvent extraction, acid hydrolysis, and chemical bleaching, would clearly be considered more than minimal processing. Thus, the Policy Memo explained, the use of a flavor or flavoring, for example, that has undergone more than minimal processing would, in general, mean that a product in which the ingredient is used could not be called natural. The Policy Memo acknowledged, however, that there are exceptions to this general view, and that the presence of an ingredient that has been more than minimally processed would not necessarily preclude a product from being promoted as natural. The Policy Memo stated that exceptions of this type would be granted on a case-by-case basis if it could be demonstrated that the use of such an ingredient would not significantly change the character of the product to the point that it could no longer be considered a natural product. In such cases, the natural claim would have to be qualified to clearly and conspicuously identify the ingredient, e.g., all natural ingredients except dextrose, modified food starch, etc. The USDA FSIS Policy Memo further stated that all products claiming to be natural or a natural food should be accompanied by a brief statement that explains what is meant by

7 Page 7 the term natural, i.e., that the product is a natural food because it contains no artificial ingredients and is only minimally processed. This statement should appear directly beneath or beside all natural claims or, if elsewhere on the principal display panel of the label, an asterisk should be used to tie the explanation to the claim. According to the 1982 policy, the decision of the Agency to approve or deny the use of a natural claim may be affected by the specific context in which the claim is made. For example, claims indicating that a product is natural food, e.g., natural chili or chili a natural product would be unacceptable for a product containing beet powder which artificially colors the finished product. However, all natural ingredients might be an acceptable claim for such a product. The USDA also requires that the manufacturer include on the label a descriptive factor of what makes the food natural. 4 For example, if the label for frozen meatballs says all natural, the label must also state minimally processed and no added colors, artificial ingredients, or chemical preservatives. Making a natural claim without a more detailed description is a violation of USDA guidelines. The USDA also distinguished between food that is natural and food that comes from animals that are naturally raised, 5 and the two terms are separate. Agriculture Marketing Service (AMS) reiterated that the Naturally Raised Marketing Claim standard was independent of and district from the FSIS label approval policies governing use of natural claims. In a 2009 published notice, USDA defined naturally raised to include meat from animals that were raised with no growth hormones, no antibiotics, and no animal by-products. 6 USDA also incorporated an exception to the no antibiotics component because antibiotics were FR 3541, 3544 (2009). Notice, United States Standards for Livestock and Meat Marketing Claims, Naturally Raised Claim for Livestock and the Meat and Meat Products Derived From Such Livestock, (Jan. 21, 2009). 6 USDA AMS No (2009). USDA Establishes Naturally Raised Marketing Claim Standard. Available at ELPRDC &dID=106698&wf=false&docTitle=USDA+Establishes+Naturally+Raised+Marketing+Claim+St andard.

8 Page 8 considered important for parasite control even before an animal becomes ill. USDA would later publish a withdrawal of this notice on January 11, 2016 with an effective date of January 12, The distinction by USDA does provide a window in the thinking of USDA, namely a clear division between natural claims and naturally raised claims. This is a major reason why NPA supports the term natural to start with post-harvest and so does not include how the seed was created or how the animal was raised. Any discussions involving traditional plant breeding vs. GMOs, harvesting, animal husbandry techniques, use of growth hormones and antibiotic use for livestock would apply to naturally raised claims and not natural claims. NPA supports the position that Organic is non-gmo. There would be no difference between the terms natural and organic if natural similarly encompasses non-gmo. NPA believes that any definition of natural emanating from the FDA will incorporate and should draw heavily upon USDA s definition and the regulatory guidance framework from FSIS in order to harmonize the term across all agencies. It is important to note that as of the date of these comments (May 2016); no further publications or rule-making on this subject has been published now over nine years after the period of public comment closed. 8 FDA Definition of Natural. Many mistakenly believe that FDA s foray into natural started with their 1991 advisory opinion, which adopted that natural means nothing artificial or synthetic [was] added to the product that would not normally be expected to be there. 9 On June 18, 1966, FDA announced a new and much stricter set of vitamin and mineral regulations in the Federal Register, which would go into effect on December 15, The proposed 1966 Vitamin and Mineral Regulations attempted to undo the statutory requirement from Congress, which held FDA responsible to prove as false and misleading any FR (December 5, 2006). Product Labeling: Definition of the Term Natural. On October 9, 2006, Hormel Foods submitted a petition to USDA s Food Safety and Inspection Service (FSIS) for rulemaking to codify in the Federal meat and poultry inspection regulations a definition of natural. The petitioner requested that FSIS begin rulemaking procedures to clarify the circumstances in which the claim may be used on the labeling of a meat or poultry product. FSIS announced receipt on December 5, 2006 of a petition from Hormel Foods to establish a definition for the voluntary claim natural and to delineate the conditions under which the claim can be used on the labels of meat and poultry products FR 60, 421 and (proposed Nov. 27, 1991). Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definitions of Terms.

9 Page 9 statements about dietary foods it opposed such as natural claims. In effect, FDA tried to ban use of the term natural and other truthful statements on foods and dietary supplements. In the June 1966 version of the regulations, FDA called for the full disclosure of sources, including natural or synthetic, on the labels of all vitamin and mineral supplements. The disclosure was meant to conform with other FDA policies theoretically aimed at insuring the consumer s access to the kind of information needed to evaluate the merits of different brands. Between June and December of 1966, the FDA changed its mind on the label requirement for food supplements and declared that future regulations would ban all mention of dietary supplement sources, whether natural or synthetic. The proposed rule prompted the Vitamin Hearings. The FDA s position was that vitamins from natural sources are identical to those made synthetically, and therefore a declaration of the source was unnecessary. The final Vitamin and mineral regulations were published on August 2, NPA (then NNFA) fought implementation of the regulation. The U.S. Court of Appeals ruled in favor of NPA, and Judge Friendly stated in his August 15, 1975 decision that the word natural could be used on labels as long as no unproven claims were made. Today the source ingredient that supplies a dietary ingredient is permitted within the meaning of 21 CFR (d) and may be identified within the nutrition label (ie. supplement facts box) or listed in an ingredient statement in accordance with 101.4(g) below the nutrition label. FDA previously attempted to define natural when used on the labels of human food. In its preamble of a proposed rule published in the Federal Register, 10 FDA placed only three stipulations on the term natural when used in food labeling. First, FDA stated natural was a term used to convey that a food is composed only of substances that are not manmade and therefore somehow more wholesome. Second, FDA did not restrict use of the term natural except for added color, synthetic substances, and flavors under 21 CFR Third, FDA considered natural to mean that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected FR FR at 60466

10 Page 10 to be there. 12 NPA agrees with FDA that the term natural is used on a variety of products to mean a variety of things, and it is time that the agency define the term to remove ambiguity surrounding use of the term that results in misleading claims. 13 FDA suggested the idea to entertain a prohibition on natural claims entirely on the grounds that they are false or misleading; 14 however, that was already attempted 2 decades earlier. FDA has held a longstanding policy for using natural claims in food labeling when it was first articulated in that proposed rule in November FDA states that for foods to be called natural, nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. 15 FDA, however, has never formally defined natural, nor has FDA established requirements through regulation for the use of natural in food labeling. 16 In recent years, FDA has received a number of citizen petitions requesting that FDA define natural, and has received requests from federal courts asking it to respond to questions about natural claims being disputed in litigation. 1 On November 12, 2015, in response to these inquiries, FDA finally published a notice in the Federal Register requesting public comments and other information on use of the term natural in food labeling, including when, if ever, the term would be false or misleading. 17 FDA asked specifically for comments on: use of natural in the labeling of foods derived from Genetic Engineering (GE); whether and how consumers associate the term natural with the terms organic or healthy ; whether use of natural should be allowed only in the labeling of single ingredient foods; and other issues related to processing of foods and ingredients. Organic is Non-GMO USDA already has a standard for foods carrying organic claims. NPA supports USDA s definition of organic, which prohibits GMO ingredients. Since organic is heavily focused on pre-harvest, natural should be concerned with whether the food product was naturally FR at FR at FR at Fed. Reg , (Nov. 27, 1991). 16 FDA has defined what it constitutes as natural flavorings Fed. Reg

11 Page 11 sourced and whether natural processes were used in its refinement. NPA supports that natural should be evaluated after harvest and focus instead on whether ingredients were sourced naturally and further refined using natural processes. NPA hopes FDA will clarify the difference between natural and organic so that consumers will understand the two terms. NPA believes that FDA will clarify the difference between the two terms and that natural foods, which are products of the earth, can contain ingredients derived from biotechnology. If natural became synonymous with non-gmo, there would be no difference between the terms natural and organic, and it would be pointless for FDA to undertake defining natural through federal rulemaking. Foods derived from biotechnology are safe, sustainable practices. To best serve consumers, natural should remain distinct from organic. One difference that should remain between natural and organic is that organic foods should be the category of food which may not be allowed to contain any ingredients derived from biotechnology. 18 If as a result of litigation or state legislation, food manufacturers are precluded from using the term natural on foods from biotechnology, the two categories would become blended, and consumers would not have a distinct choice between natural and organic foods. Those consumers who simply wish to avoid artificial and synthetic ingredients should be able to do so by choosing natural products. They should not be forced into choosing between conventional foods and organic foods. This is especially true considering one of the largest barriers to consumers purchasing organic foods is price. 19 FDA Should Address and Define Natural Through the Public Rulemaking Process Federal rulemaking for defining natural is in the public interest for several reasons. First, this is a complex scientific issue that requires the nation s experts on food safety and regulations. FDA has agency expertise and resources to put it in the best position to address natural labeling for all foods, including those derived from biotechnology. Second, the 18 7 CFR Excluded methods. In contrast to natural, organic refers not only to the food itself but also to how it was produced (ie. without synthetic pesticides), including how the seeds were manipulated, the ground was fertilized, what livestock was fed, etc. Foods labeled organic can contain up to five percent non-organic ingredients, including synthetic ingredients, listed on the National List of Allowed and Prohibited Substances. 19

12 Page 12 plaintiff s bar has been particularly aggressive in going after products using the term natural in the absence of a single overarching definition of natural by the federal government. This has prompted the nation s courts to hear numerous cases in which claims have been made concerning natural labeling and foods derived from biotechnology. The lack of an express regulation addressing this issue has prompted predatorial practices, which has only served to take the issue away from the one agency that has the scientific expertise and authority to resolve it. Third, several state legislatures have passed legislation addressing natural terms and biotechnology in labeling, prompting other states to follow suit. 20 At present, Vermont s law 21 is the only one not to have trigger provisions, 22 while Maine and Connecticut GMO labeling laws do not go into effect until other states in the region also pass similar laws. 23 In particular, the Vermont labeling law prohibits manufacturers from calling their GMO products natural, naturally made, naturally grown, all natural, or any words of similar import that would have a tendency to mislead a customer. The problem with Vermont s law and others is that the statute does not define these terms. Even if these prohibitions on use of the term natural would be found permissible under Central Hudson, 24 they appear to offer no guidance to businesses and could be considered unconstitutionally vague. Fourth, Congress 20 Connecticut Governor Dannel Malloy signed a bill into law requiring labels on genetically modified foods, making it the first state to pass such a law, but the bill had three triggers. First, four other states must enact similar legislation. Second, one of the four states must share a border with Connecticut. Third, the combined population of the northeastern states that enact GMO-labeling laws must total more than 20 million, based on the 2010 census. Maine passed its own GMO-labeling law with the same trigger-clause provisions as Connecticut. 21 Vermont passed its own mandatory GE labeling law (Act 120), which will go into effect July 1, The state law establishes mandatory labeling and recordkeeping requirements that apply to all packaged foods that are produced with GE, as defined by that law, and offered for retail sale in Vermont. Primarily, unless an exemption applies, manufacturers must label GE foods as Produced with Genetic Engineering and cannot use many natural terms in labeling. More specifically, Act 120 prohibits GE manufacturers from labeling a product in signage, or in advertising as natural, naturally made, naturally grown, all natural, or any words of similar import, which are collectively termed Act 120 s natural restriction, regardless of where or how those activities take place. On April 27, 2015, Judge Christina Reiss denied the food industry s efforts to suspend enforcement of the Vermont law Vermont s law Act 120 will require food containing genetically engineered ingredients to be labeled. This law requires that any food offered for sale must be labeled a GMO if it is entirely or partially produced with genetic engineering. The law also prohibits such food from being labeled natural and sets out statutory damages of not more than $1, per day, per product. 24 As laid out by the Supreme Court in Central Hudson Gas & Electric Corporation v. Public Service Commission, commercial speech that is not false or deceptive and does not relate to illegal activities may be restricted only in the service of a substantial governmental interest, and [may be restricted] only through means that directly advance that interest.

13 Page 13 may direct FDA to define natural in the very near future. 25 Although FDA has declined to define natural with respect to food derived from biotechnology, 26 it is in the public interest for the agency to undertake this task through the Administrative Procedures Act, the public rulemaking process and stakeholder notice/comment and officially define its position to allow GE and GMO food ingredients in products made with natural claims. It is important for FDA to address natural in a deliberate manner and do so in an open and transparent process that can ensure a voice to all interested stakeholders. Using the federal rulemaking process ensures public participation and results in national, uniform standards. Consumers and the food industry would all benefit from uniform legal requirements and the consistent outcomes that result from federal regulation with preemptive effect. Current FDA Policy Contradicts Vermont State Law on Natural It should be noted that the FDA policy on natural contradicts with Vermont s labeling law. FDA states that for a food to be called natural, it will not object as long as the food contains nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. Therefore, a GE manufacturer could adhere to those rules surrounding natural and use the term. Vermont s law currently forbids GE manufacturers from labeling a product as natural. This guidance would be better served as an implementing regulation, which is legally binding, to preempt any current or future state laws over natural or non-gmo. FDA policy on natural never intended to address food production methods. In its 1993 non-binding guidance, FDA stated that natural means nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food. It did not clarify the status of foods, for example, containing high fructose corn syrup, GMOs and a litany of other ingredients that many 25 The Safe and Accurate Food Labeling Act of 2015, would establish national standards for voluntary claims that a food is or is not derived from GE, direct FDA to define the term natural, and preempt any existing (Vermont s Act 120), and future state and local GE labeling requirements. This bill passed the House but has yet to be introduced into the Senate. 26 Letter from Leslie Kux, Assistant Commissioner for Policy, Food and Drug Administration, to the Honorable Yvonne Gonzalez Rogers, The Honorable Jeffrey S. White, The Honorable Kevin McNulty (Jan 6, 2014).

14 Page 14 believe do not belong in a product labeled as all-natural. In their own words, FDA has stated the following regarding the term natural : This policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term natural should describe any nutritional or other health benefit. From a food science perspective, it is difficult to define a food product that is natural because the food has probably been processed and is no longer the product of the earth. That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances. NPA Supports a National Natural Labeling Standard for All Foods Including Dietary Supplements State v. Federal Interests in Regulating. The issue of states and the federal governing defining natural for consumers is a case of concurrent authority. While, it is clear that both the states and the federal government have authority to regulate food labeling, the resources, scientific expertise, and interstate jurisdictional authorities suggest that defining natural should reside with the federal government. The core of states so-called police power is the authority to secure the health, safety and morals of their citizens, and all state have consumerprotection laws to achieve those goals. 27 The federal government is most likely authorized to regulate food labeling in interstate commerce under the current understanding of the Commerce Clause [C]onsumer protection is a field traditionally subject to state regulation. SPGGC v. Blumenthal, 505F.3d 183, 194 (2 nd Cir. 2007). However, it is true that state constitutions could limit the authority of state governments to regulate consumer protection. 28 The Congress shall have Power to regulate Commerce among the several States Article I, Section 8, Clause 3 of the U.S. Constitution. The Commerce Among the States Clause operates both as a power delegated to

15 Page 15 FDA Has Primary Jurisdiction Over Natural Claims Made on Labels and in Labeling. When there is a conflict over concurrent authority, as could be the case with natural and GMO labeling, there are numerous federal laws that might preempt state laws already in place. They include the FFDCA, the Nutrition Labeling and Education Act (NLEA), the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Plant Protection Act, and the Federal Insecticide, Fungicide and Rodenticide Act. These laws create such a complicated web of provisions, they render it difficult to determine whether the federal government has preempted state law and thereby preclude the states from regulating this area. For example, NLEA has been interpreted by the federal courts explicitly to preempt any state labeling requirement that is not parallel to or identical with FDA labeling requirements in a variety of areas. As a result, many states have adopted Title 21 of the federal code regarding food and nutrition labeling standards. Labeling claims related to nutritional value or health effects has been preempted by NLEA. 29 The states cannot impose additional nutritional-labeling requirements on manufacturers beyond the requirements on manufacturers beyond the requirements imposed by the federal government under the NLEA. 30 In the end, it is unclear as to what extent GMO and natural labeling laws would be preempted. It depends on whether the state laws are premised on the need to provide information related to nutrition or safety, or whether these laws are simply requiring disclosure of a manufacturing process or providing other consumer information. Additional state legislatures addressing biotechnology in food and natural claims will certainly create a patchwork of rules that could not only be inconsistent with each other, but would be directly at odds with FDA s science-based policies on foods derived from biotechnology and the labeling of such foods. These differing state laws and judicial decisions will serve to confuse consumers, disrupt the free flow of goods in interstate commerce, and impose unnecessary costs on the food industry. These costs will ultimately be passed from Congress and as a constraint upon state legislation. No clause in the 1787 Constitution has been more disputed, and it has generated more cases than any other U.SC (a)(5); 21 U.S.C. 343(r)(1). 30 In New York State Restaurant Association v. New York City Board of Health (509F.Supp.2d 351 (2 nd Cir. 2007), the U.S. Court of Appeals for the Second Circuit held that a New York City regulation requiring restaurants to include calorie content information on menus was expressly preempted by the NLEA.

16 Page 16 manufacturer to retailer and retailer to consumer. As a result, NPA prefers one overarching labeling standard over terms involving GE, GMO and natural as opposed to multiple iterations from the states. FDA is the agency with primary jurisdiction over whether foods that contain ingredients derived from biotechnology may be labeled natural. The FFDCA provides FDA with the statutory authority to regulate food labeling claims, including the term natural. 31 Section 403(i) of the FFDCA requires that the food product as a whole, as well as each ingredient, with a few exceptions, be identified by its common and usual name. 32 The agency has the statutory authority to oversee foods derived from biotechnology both their safety and labeling. 33 FDA is in position to issue a regulation clarifying that statements such as natural may appear on a food if it is or contains a food derived from biotechnology. FDA should reinforce its longstanding position that there is no material difference between foods derived from biotechnology and their traditionally bred counterparts. It is important for FDA to affirm that because the method of planet breeding is not material information, it is irrelevant in a natural analysis. Such a regulation would be consistent with the agency s clear, concise, and wellsupported views about these foods. Whether foods derived from biotechnology can be labeled as natural is an important issue to consumers and the food industry and is one that warrants FDA s immediate and direct involvement. NPA Requests FDA to Incorporate Its Policies on Foods Developed from Biotechnology in its Definition of Natural NPA supports a regulation consistent with FDA s longstanding views. NPA believes the following points, many already made by the Agency throughout the years, should be incorporated in its definition of natural. It is neither false nor misleading to label a food as natural or similar terms solely because the food is or contains a food derived from biotechnology. 31 FFDCA 403; 21 U.S.C. 343, U.S.C. 343(i)(1) and (2). 33 FDA regulates food/crops derived from biotechnology in conjunction with the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA).

17 Page 17 FDA should take the necessary steps to clarify that whether a food has been derived through biotechnology is immaterial in a natural analysis. The fact that a food has been developed from biotechnology does not, in and of itself, mean there is a material difference in the food. Foods derived from biotechnology do not, as a class, exhibit attributes different from foods derived by other methods of plant breeding. Foods developed from biotechnology do not differ from their traditional counterparts in any meaningful or uniform way. Biotechnology does not change the essential nature of the plant. New techniques involving biotechnology are simply extensions at the molecular level of traditional methods and will be used to achieve the same goals as pursued with traditional plant breeding. NPA Requests FDA to Harmonize Its Definition of Natural with the Same Term Defined by USDA s FSIS A single, uniform natural definition that captures the common elements of the current FDA and FSIS policies would provide consistency for consumers and food manufacturers over the large variety of foods that bear a natural claim. A definition which incorporated both of these agencies thoughts on natural would meet each Agency s statutory obligation for ensuring that food labeling is neither false nor misleading and represent yet another instance in which the Agencies act in concert to advance the mutual goal of consumer protection. The value of a unified policy is evident from the significant number of FDA-regulated foods/ingredients that are used in FSIS-regulated products. FDA and FSIS-regulated products are intricately commingled and forever inextricably linked in the marketplace. Very few consumers would be expected to differentiate between foods subject to the respective Agency s jurisdiction, and do not expect that natural would be regulated pursuant to different policies. Over the years, the Agencies have sought harmonized food regulatory ground, when appropriate, to advance their shared consumer protection goals. Natural is similar to many

18 Page 18 other areas of food labeling where consistency across all product categories yields consumer benefits. FDA and FSIS have greatly advanced their common, respective consumer protection goals in numerous instances by adopting parallel policies and requirements. For example, nutrition labeling regulations by the Agencies are identical. While NLEA mandated new requirements for nutrition labeling and nutrient claims for FDA-regulated foods, FSIS on its own initiative adopted parallel regulations. FSIS stated: [h]armonization will ensure consistency of format and content for consumers and thereby, will encourage use of the new labels, while minimizing the cost of compliance on the food industry. 34 A decade later, FSIS made further refinements to its nutrition labeling rules to provide for nutrient content claims on multiple-serve meal-type products and to adopt the FDA definition of main dish products in the interest of maintaining consistency between FSIS and FDA. 35 More recently, FSIS announced its intentions to require allergen labeling pursuant to the Food Allergens Labeling and Consumer Protection Act (FALCPA). This amendment to the FFDCA to require allergen labeling did not apply to FSIS-regulated foods. In its own guidance to industry, FSIS states the following: The FALCPA passed by Congress did not amend or implement regulations and policies for meat, poultry, and egg products in the acts related to them; the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA). FSIS encourages the use of allergen statements, consistent with FALCPA, and other statements that highlight the presence or absence of ingredients of public health concern; particularly the big eight allergens. FSIS will consider rulemaking to require allergen statements if it does not continue to observe, through its prior label approval system, widespread voluntary compliance with the use of allergen statements on meat, poultry, and egg product labels FR 632, 637 (Jan 6, 1993) FR 58799, (Oct 1, 2004).

19 Page 19 FSIS announced its Agency s plans to engage in rulemaking regarding trans fat declarations in the nutrition facts panel. Not only does the Agency plan to enact regulations that are consistent with those adopted by FDA, but in the interim, the Agency announced it will not object to the voluntary declaration of trans fatty acids in Nutrition Facts panels if the declaration is made in accordance with FDA regulations Food standards reform is another area where the Agencies have worked together to foster consistency. FSIS noted that this consultation is necessary to avoid inconsistency [and] possible impairment of the coordinated effective administration of FSIS and FDA food labeling requirements. 36 Over the past decade, FDA and FSIS have jointly solicited comments on the modernization of these standards and developed a common set of principles to guide their respective processes. 37 In its advance notice of public rulemaking, FDA noted the following: [FDA] recognizes the need for consistency between FDA and FSIS in the development and implementation of food standards that set forth minimum compositional requirements. The agency believes that manufacturers will be better able to comply with the requirements of both agencies if similar approaches are used. Thus, to the extent possible, one of the agency s goals is to harmonize its regulations with those of FSIS. 38 FDA and FSIS repeatedly have recognized that advancing their respective consumer protection responsibilities over food labeling are best achieved through the development of harmonized labeling policies when appropriate and consistent with their distinct statutory responsibilities. NPA believes that regulating the term natural warrants the need for a single, harmonized definition across all agencies. A definition of natural that reflects the core elements of both agency s longstanding policies would also reduce the cost of compliance by subjecting food manufacturers and markets to a single regulatory scheme for all foods U.S.C. 607(c), 457(b) FR (May 20, 2005) FR 67492, (Dec 29, 1995).

20 Page 20 FDA s longstanding natural policy focuses on 1) the nature of the ingredients added to the food and FSIS policy discusses to some degree 2) the processing. NPA urges FDA to incorporate these two principles into its definition of natural, based upon its own longstanding policy on natural and the definition of natural from FSIS. 1) Natural should focus on the nature of the ingredients added to the food or the attributes or objective characteristics of the food itself. The development of the plant from which a plant is derived is not an objective characteristic of the food itself. FDA should focus on whether the ingredients are fauna and flora and therefore product of the earth, as opposed to a synthetics and petrochemicals. 2) Natural should focus on the processing of the ingredients or the food. FDA should define minimally processed. NPA requests the FDA to Amend the FFDCA and the Following Sections of the Codified Regulations to Allow the Term Natural on Foods Derived from Biotechnology. NPA requests 21 CFR General Provisions; Identity labeling of food in packaged form be amended with the following addition: The term(s) 100% natural, natural, made with X% natural ingredients or any natural terms of similar import, can accompany the name of a standardized food on the principal display panel or appear elsewhere on the label or in labeling of the food as long as they are truthful and not misleading. The food shall not be deemed to be misbranded solely because the food is or contains a food derived from biotechnology. NPA requests 21 CFR Food Standards: General; Definitions and interpretations be amended with the following addition: The term(s) 100% natural, natural, made with X% natural ingredients or any natural terms of similar import, can accompany the name of a standardized food on the principal display panel or appear elsewhere on the label or in labeling of the food as long as they are

21 Page 21 truthful and not misleading. The food shall not be deemed to be misbranded solely because the food is or contains a food derived from biotechnology. NPA requests 21 CFR 102 Common or Usual Name For Nonstandardized Foods be amended with the following addition: The term(s) 100% natural, natural, made with X% natural ingredients or any natural terms of similar import, can accompany the common or usual name of a food or on the principal display panel or appear elsewhere on the label or in labeling of the food as long as they are truthful and not misleading. The food shall not be deemed to be misbranded solely because the food is or contains a food derived from biotechnology. Minimally Processed NPA Supports the Development of an Illustrative List of Natural Processes FDA must first define what is meant by minimal processing. Food processing is any deliberate change in a food that occurs before it is available for ingestion. FSIS is the agency which calls for the need of natural foods to be minimally processed. Unfortunately, there is no definition or illustrative list which speaks to minimal processing. Food processing can be thought of as a continuum along a spectrum between minimal processed and foods packaged to stay fresh and save time (ie. frozen pizzas, pot pies, entrees, and other frozen meals). NPA believes the Agency should look to determine whether the process is natural or not and Figure 1. Common Natural Processes Encountered in Manufacturing Washing Drying Preserving with salt, Addition of natural preservatives Crushing/milling Gentle mixing/homogenization /puree Straining Course filtering, steam distillation, concentrating Cold pressing (expression), heating/pasteurization Freezing/freeze drying/flash freezing Desiccation (i.e. animal glandulars used in supplements) Extraction (CO 2, water, alcohol) Fat-splitting hydrolysis of oils using water/high pressure steam Fermentation

22 Page 22 develop a positive illustrative list for allowed processes under its national natural standard. NPA supports the development of an illustrative list of natural processes as long as it does not exclude longstanding, common sense practices of food handling and preparation. For example, people have been heating their foods for thousands of years. Figure 1 demonstrates common processes encountered in preparing food prior to ingestion. Common or natural processes include washing, drying, preserving with salt, addition of natural preservatives, crushing/milling, gentle mixing/homogenization /puree, straining, course filtering/concentrating, steam distillation, cold pressing (expression), heating/pasteurization, freezing/freeze drying/flash freezing, desiccation (ie. animal glandulars used in supplements), extraction (CO2, water, alcohol), fat-splitting hydrolysis of oils using water/high pressure steam, and fermentation (ie. pre- and pro-biotics). NPA believes that many of these processing practices are common sense. For example, heating foods, while it may cause denaturation of proteins, has been practiced for thousands of years, and heating/pasteurization help remove harmful bacteria. Both are hygienic practices performed out of safety considerations and should be allowed as natural processes. NPA Requests that Natural Preservatives, Natural Colors, Incidental Additives and Some Processing Aids Be Included in the Development of a Positive Illustrative List of Natural Ingredients Natural Preservatives. In adopting a new definition of natural, FDA and FSIS should recognize natural preservatives and other traditional preservative ingredients that would be consistent with making natural claims. Natural preservatives are often derived from plants, animals, and/or microflora and thus are natural or naturally sourced ingredients. That some of these ingredients may also provide a functional effect (ie. antimicrobial) or other preservative effect is a food safety benefit and not a means to classify them as chemical preservatives. Rosemary extract, for example, which contain rosmarinic acid and carnosic acid, can help prevent fats and oils from going rancid. Since these two compounds are not responsible for the flavor of rosemary, they should be considered as natural preservatives. Sodium lactate, sourced from corn,

23 Page 23 should also be considered a natural preservative. There are also traditional preservative ingredients, including salt, vinegars, spice extracts, vegetable extracts, which serve a preservative function and should not be excluded from inclusion in a natural federal standard. In contrast, many other preservative ingredients would not be compatible with claims to be natural. For example, butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) are known chemical preservatives that are derived from petrochemicals such as 4-methoxyphenol, isobutylene, and p-cresol. BHA and BHT are safe and suitable for use in foods, but their synthetic nature prohibits their inclusion as natural ingredients. Under FDA s current definition of natural, these ingredients would not normally be expected in a natural food. Natural Flavorings. In title 21 of the Codified Federal Regulations (CFR), FDA has defined the boundaries of a natural flavor or natural flavoring. According to the CFR, the term natural flavor or natural flavoring means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional. Natural flavors include the natural essence or extractives obtained from plants listed in , , , and and part 184 of this chapter, and the substances listed in of this chapter. Natural Colors. NPA disagrees with FDA s current position to exclude colors, regardless of whether they are natural or synthetic, from its working definition of natural. Manufacturers around the world are demanding more natural colors and abandoning synthetic alternatives. In 1991, when FDA opined on natural, the manufacture of natural colors in foods was not a very large industry and consumer demand was not significant. Today, consumers look for these colors as they represent a significant part of their purchasing behaviors. As many as 85% of consumers place color as a primary reason for why they purchase