July 12, 2002
Mr. Paul Tierney
Division of Food and Drugs
Department of Public Health
305 South Street
Jamaica Plains, MA 02130-3597
Subject: Legal Issues Regarding Bottled Water Labeling Proposal
This letter follows up on testimony provided at the June 26, 2002 hearing regarding proposed revisions to the bottled water regulations of the State of Massachusetts Department of Public Health, which are codified in chapter 570.000 of title 105 of the Code of Massachusetts Regulations. I apologize for being so late in providing the requested information on the preemption of bottled water labeling by the Food and Drug Administration to you after the public hearing. I have not had access to a computer until this past Wednesday.
You asked that we provide information regarding our basis for concluding that the Federal standard of identity for bottled water (21 C.F.R. § 165.110) preempts state laws or regulations that require specific source labeling for bottled water products. The provision of interest is proposed section 570.012(C)(2) (“Additional labeling requirements for bottled water”; “Source”), which would require the labels of bottled water products marketed in Massachusetts to identify “the location of the water source: municipality, state, and country if not the U.S.” An identical provision also appears in the current version of 105 C.M.R. § 570.006(A)(2)(b).
As described more fully below, the State’s source labeling requirement is preempted by section 403A of the Federal Food, Drug, and Cosmetic Act (FFDCA or “the act”), section 401 of the FFDCA, and 21 C.F.R. § 165.110. Section 403A(a)(1) of the FFDCA provides that a state may not establish or continue in effect any requirement for a food that is subject to a standard of identity unless the requirement is “identical to” the applicable Federal standard. Because the Federal standard of identity for bottled water contains a narrow source labeling requirement, and this requirement followed careful consideration by the Food and Drug Administration (FDA) of the circumstances under which source labeling should be required, the Federal standard preempts state labeling laws or regulations that impose additional or different requirements.
I. ffdca preemption: section 403a
A. National Uniformity Framework
To promote national uniformity of certain food labeling requirements, Congress established preemption for numerous provisions of the FFDCA in the Nutrition Labeling and Education Act (NLEA) of 1990. FFDCA § 403A; 21 U.S.C. § 343-1. In doing so, Congress recognized the disruptive impact that conflicting state labeling laws could have on the interstate commerce of foods, and wished to ensure that food products may be marketed in all 50 states in an efficient and cost-effective manner. 136 Cong. Rec. H5840 (daily ed. July 30, 1990) (statement of Rep. Waxman); 60 Fed. Reg. 67492, 67497 (Dec. 29, 1995) (“One of Congress’ goals . . . was to provide industry with some relief from State requirements that interfere with its ability to market products in all 50 States in an efficient and cost effective manner.”)
Federal standards of identity are among the Federal requirements to which the FFDCA national uniformity provisions give preemptive effect. Specifically, in section 403A(a)(1) of the act, Congress provided in pertinent part that “no State or political subdivision of a State may directly or indirectly establish . . . or continue in effect as to any food in interstate commerce . . . any requirement for a food which is the subject of a standard of identity under section 401 that is not identical to such standard of identity.” FFDCA § 403A(a)(1); 21 U.S.C. § 343-1(a)(1). Under section 401, FDA is authorized to promulgate regulations “establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity.” FFDCA § 401; 21 U.S.C. § 341. In addition to establishing compositional requirements and the common or usual name that must be used for labeling purposes, standards of identity may also require specific information that must appear on the product label to inform consumers of key product characteristics. 60 Fed. Reg. 67492, 67494 (Dec. 29, 1995).
In regulations to implement section 403A of the act, FDA has identified the circumstances under which a state requirement will be considered “not identical to” a requirement set forth in a Federal statutory provision or regulation that has preemptive effect, including a standard of identity. FDA has advised that a state requirement is deemed “not identical to” an applicable Federal requirement if it— directly or indirectly imposes obligations or contains provisions concerning the composition or labeling of food . . . that are not imposed by or contained in the applicable provision (including any implementing regulation) of section 401 or 403 of the act; or differ from those specifically imposed or contained in the applicable provision. 21 C.F.R. § 100.1(c)(4).
B. Preemptive Effect of FDA’s Bottled Water Standard
FDA has established standard of identity regulations for bottled water in 21 C.F.R. Part 165. The standard of identity encompasses (1) a general description of bottled water; (2) names that may be used to identify bottled water products (e.g., “bottled water,” “drinking water,” or alternative terms such as “spring water”); and (3) FDA requirements for “other label statements” specific to bottled water products. 21 C.F.R. § 165.110(a)(1)-(3). Among the requirements for “other label statements” is a narrow source labeling provision, which addresses the extent to which bottled water must bear source labeling. The source labeling provision of the Federal standard provides that bottled water from a community water system must, unless expressly exempt, bear a label that states “from a community water system” or “from a municipal source,” as appropriate. 21 C.F.R. § 165.110(c)(3)(ii). Thus, the source labeling requirement imposed by the Federal standard is generic, not specific, and applies only to water from a community water system.
In enacting this source labeling provision, FDA considered and specifically rejected a more stringent approach advocated by many comments submitted in response to FDA’s bottled water proposal. FDA was asked to require declaration of more specific information concerning the location of the water source, such as the address of the municipal source. 60 Fed. Reg. 57076, 57104 (cmt. 79). FDA was also asked to require all bottlers—not simply those using a community or municipal source—to provide specific source information such as a well number or a spring’s legal name. Id. The agency, however, declined to do so, concluding that such information was not a “material fact” for which disclosure is required under the FFDCA:
Under section 201(n) of the act, the agency must consider whether the information is a material fact whose nondisclosure will render the labeling misleading. Under this standard, it is difficult to see why the name of the specific source, be it a public water supply, spring, or well, would be a material fact. The agency requires that the product water supply for each bottled water plant be from a source that is inspected and approved by the government agency having jurisdiction (§ 129.3(a)). The product water supply must be properly located, protected, and operated, and must be easily accessible, adequate, and of a safe, sanitary quality that is in conformance at all times with the applicable laws and regulations of the government agency having jurisdiction (§ 129.35(a)(1)). Thus, the specific name of the source is not material to ensure the safety of the product. In addition, the water must meet the requirements of the quality standard in § 165.110(b) or be labeled as substandard. Thus, the identity of the specific source is not material to ensure the quality of the product. Id.
Accordingly, the source labeling provision set forth at 21 C.F.R. § 165.110(a)(3)(ii) represents FDA’s determination as to the extent to which bottled water must bear source labeling. A Massachusetts requirement that bottled water specifically identify the municipality, state, and country (if not the United States) of a water source is contrary to this determination. A State requirement of this type is preempted by Federal law because (1) it imposes an obligation concerning the labeling of a standardized food in an area that is specifically covered by the applicable Federal standard (i.e., the source labeling requirement of 21 C.F.R. § 165.110(a)(3)(ii)), and (2) it is “not identical to” the Federal standard in that it imposes an obligation that is not imposed by the Federal standard. The Massachusetts geographic source provision, therefore, is preempted by sections 403A(a)(1) and 401 of the FFDCA and 21 C.F.R. § 165.110(a)(3)(ii).
II. Commerce clause
The above-described source labeling mandate also raises concern under the Commerce Clause of the U.S. Constitution. As interpreted by the Supreme Court, the Commerce Clause prohibits states from enacting measures that expressly discriminate against or otherwise unduly burden interstate commerce. See, e.g., Pike v. Bruce Church, 397 U.S. 137 (1970). A state law or regulation constitutes an undue burden on interstate commerce if either of the following criteria are met: (1) the state law or regulation does not advance a legitimate state interest; or (2) the burden the requirement imposes on interstate commerce clearly exceeds the putative local benefit. Id. at 142. The source labeling mandate is problematic under these constitutional criteria.
With respect to the first criterion, the geographic source requirement does not further a legitimate State interest. Although FDA has stated that it would not object to the voluntary disclosure of specific source information, the agency has determined that such information is not necessary to ascertain the safety or quality of bottled water products. The agency requires that the product water supply for each bottled water plant be from a source that is inspected and approved by the government agency having jurisdiction. The product water supply must be properly located, protected, and operated, and must be easily accessible, adequate, and of a safe, sanitary quality that is in conformance at all times with the applicable laws and regulations of the government agency having jurisdiction. In addition, the water must meet the requirements of the quality standard in § 165.110(b) or be labeled as substandard. Consumers, therefore, do not need specific source information to be provided on the product label to ascertain product safety or quality. Although consumers may have a general interest in having such information on the label, FDA and the courts have long distinguished between material information that must be provided on food labels and information merely desired by consumers. See, e.g., Alliance for Biointegrity v. Shalala, 116 F. Supp.2d 166, 179 (D.D.C. 2000) (upholding FDA’s determination that the FFDCA does not authorize the agency to require special labeling of products solely on the basis of consumer demand).
Specific source information also is unnecessary to further other State interests that may be presumed, such as an interest in ensuring consumer access to information such the addition of fluoride or ensuring traceability for recall purposes. By law, labels must provide the name and place of business of a product’s manufacturer, packer, or distributor so that consumers or regulators may obtain information concerning the product’s production or content. The bottled water industry is generally able to provide information pertaining to content or traceability in response to appropriate requests of consumers or regulators. Specific source labeling, therefore, provides no information that is not already available through other means.
Even assuming, for the sake of argument, that the source labeling requirement were found to be based upon a legitimate state interest, the measure remains problematic because the burden imposed by the requirement is clearly excessive to the putative local benefit. A state source labeling law dramatically expands the number of labels needed, and requires substantial time, money, and other resources to ensure compliance. Such burdens are excessive in relation to any local benefit that may be derived from source labeling, which, as discussed above, would simply provide information that is already obtainable through alternative channels of information. The nature of the burden imposed by this law is particularly apparent when one considers that the approach is wholly inconsistent with that taken by FDA and many other states.
It is for the reasons stated above that IBWA respectfully requests the deletion of the state’s geographic source requirement. If you have any questions or need more information, please do not hesitate to contact IBWA.
Vice President, Government Relations
1700 Diagonal Road, Suite 650
Alexandria, VA 22314
(703) 683-5213 ext. 108
(703) 683-4074 (fax)