Bottled water is fully regulated as a food by the United States Food and Drug Administration (“FDA”) under the Federal Food, Drug,and Cosmetic Act (“FFDCA” or the “Act”), 21 U.S.C. § 301et seq. The FFDCA defines food as “articles used for food or drink for man or other animals. . . .” FFDCA § 201(f). This includes packaged water sold in smaller containers at retail outlets as well as larger containers distributed to the home and office market. In contrast, municipal water is regulated not as a food by FDA but as a commodity by the Environmental Protection Agency (“EPA”) pursuant to the Safe Drinking Water Act, 42 U.S.C. § 300f et seq. Like all food except meat and poultry products, bottled water is subject to FDA’s extensive food safety and labeling requirements. In addition, bottled water is one of only several food product categories that is subject to additional specific FDA Good Manufacturing Practice (“GMP”) requirements. Between the general food provisions and the provisions specific to bottled water, bottled water is one of the most extensively regulated food products under FDA’s jurisdiction. Indeed, the federal requirements applicable to bottled water include:
- full application of far-reaching food adulteration and misbranding provisions of federal law;
- full application of FDA’s general food GMP regulations;
- full application of FDA’s specific bottled water GMP regulation
- full application of FDA’s standard of identity and quality for bottled water; and
- full application of both civil and criminal penalties for non-compliance with the above-mentioned FDA requirements.
Section 402(a)(1) of the Act / deems a food to be adulterated if it contains an added “poisonous or deleterious substance which may render it injurious to health” or a substance which is not added that would “ordinarily render” the product injurious to health. Section 402(a)(2) of the Act deems a food to be adulterated if it bears an added poisonous or deleterious substance which is unsafe within the meaning of section 406 of the Act. Bottled water may be deemed adulterated under these provisions if it contains industrial contaminants, unapproved pesticides, or other substances harmful to health. Section 402(a)(3) deems a food to be adulterated “if it consists in whole or in part of any filthy, putrid or decomposed substance, or if it is otherwise unfit for food.” Bottled water could be deemed adulterated under this provision if it becomes contaminated during processing by dirt or other debris.
Section 402(a)(4) deems a food to be adulterated if it has been “prepared, packaged, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” Bottled water may be deemed adulterated under this provision if it was not manufactured in substantial compliance with good manufacturing practices, which are detailed below. Section 402(a)(6) of the Act deems a food adulterated if a bottled water container “is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.” Bottled water is also adulterated if: any valuable constituent has been removed from the product; any substance has been wholly or partially substituted; damage or inferiority has been concealed in any manner; or if any substance has been added to the product or its packaging to increase the product’s weight or value or reduce its quality or strength. FFDCA §§ 402(a), (b). As discussed below, FDA has multiple tools available to it to enforce these food adulteration provisions.
The food misbranding provisions require that food labeling both affirmatively contain certain information, such as the name of the manufacturer, and avoid containing certain types of prohibited information, such as false or misleading statements. Accordingly, in order to avoid being misbranded, bottled water labeling must contain a statement of identity (FFDCA § 403 (h)), the name and place of business of the manufacturer (FFDCA § 403(e)),a statement of the net weight of the contents (FFDCA § 403(e)),and ingredient labeling if the product contains more than one ingredient(FFDCA § 403(i)). Further, section 403(q) of the Act deems a food misbranded if the product is required to bear nutrition labeling and it does not. Depending on what claims are made for the product and/or what nutrients and/or minerals are present and/or added to the product, some bottled waters have to bear nutrition labeling while others do not. Section 403(r) of the Act requires that all nutrient content claims (such as “sodium free”) and health claims comply with specific FDA definitions contained in regulations. If such a claim on a bottled water product does not conform to these regulations, the product is misbranded.
In addition to being required to contain certain information on its labeling, bottled water is misbranded if its labeling contains certain prohibited statements. Section 403 (a)(1) of the Act deems a food to be misbranded if”its labeling is false or misleading in any particular.” For instance, a label that falsely states that the product is free from a certain contaminant would be misbranded under this provision. Section 403 (g) of the Act deems a food misbranded if it purports to be or is represented as a food for which a standard of identity has been prescribed and it fails to conform to the definition, statement of identity or other specific requirements contained therein. Section 403 (h) of the Act deems a food to be misbranded if it purports to be or is represented as a food for which a standard of quality has been prescribed and its quality falls below that standard, unless this is disclosed in the label.
For example, a bottle of water with more than 0.3 mg/L of iron would be misbranded unless its label disclosed the substandard nature of the product by stating “Contains Excessive Chemical Substances” or “Contains Excessive Iron.” 21 C.F.R. § 165.110 (c). (Of course, if their iron is at a level considered injurious to health, the product would be adulterated regardless of whether the label bore such a statement. 21 C.F.R.§ 165.110 (d)). Bottled water is also misbranded if: it is offered for sale under the name of another food; if it is an imitation of another food and it is not so labeled; if its container is so made, formed or filled as to be misleading; and if information required to be on the label is not sufficiently prominent. FFDCA §§ 403(b); (c); (d); (f). As will be discussed below, FDA has multiple tools available to it to enforce the food misbranding provisions.
General Food GMPs
The general GMPs applicable to foods, including bottled water,contain rules governing:
- plant and grounds maintenance, including drainage and waste disposal requirements;
- plant construction and design;
- sanitary maintenance of buildings and fixtures;
- sanitary facilities including water supply, plumbing, sewage disposal, etc.;
- design and maintenance of equipment and utensils;
- production and process controls of raw materials and manufacturing operations, including sanitation and quality control of receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging and storage of food; and
- defect action levels.
21 C.F.R. Part 110.
Failure to comply with these regulations may render the bottled water product adulterated and subject to enforcement action.
Bottled Water GMPs
In addition to a comprehensive array of facility, sanitation, product quality and testing, and record keeping requirements, which will be highlighted below, a fundamental requirement of the bottled water GMPs is that all product water be obtained from a source that has been “. . . inspected and the water sampled, analyzed and found to be of a safe and sanitary quality according to applicable laws and regulations of state and local government agencies having jurisdiction. The presence in the plant of current certificates or notifications of approval from the government agency or agencies having jurisdiction constitutes approval of the source and the water supply.”21 C.F.R. § 129.3(a). Further the GMPs specific to bottled water processing and bottling contain rules governing:
1. plant construction and design, including separation of the bottling room, protection of processing operations, adequate ventilation, and enclosure of washing and sanitizing operations;
2. sanitary facilities, including
- approved sources of both product water and operations water;
- minimum once a year analysis of source water for chemical contaminants;
- analysis once every four years of source water for radiological contaminants;
- once a week sampling and analysis of source water for microbiological contaminants;
- use of approved test and sample methods;
- control of air under pressure; and
- separation and maintenance of locker and lunch room areas.
3. sanitary operations including
- adequate sanitization of all product water contact surfaces;
- adequate drainage and protection from contamination of multi-service containers, utensils, disassembled piping and equipment;
- protection of single service containers, caps and seals; and
- sanitary filling, capping, closing, sealing and packaging of containers;
4. equipment design and construction, including materials of construction;
5. production and process controls specific to the production and processing of bottled drinking water, including
- sampling and inspection of containers and closures;
- product sample analysis as follows:
- bacteriological analysis once a week of each type of water produced during a day’s production;
- chemical, physical and radiological analysis at least annually of a representative sample from a batch or segment of a continuous production run for each type of water produced during a day’s production
6. record keeping
- maintenance and retention of records of product sample analysis;
- maintenance and retention of source approvals;
- maintenance and retention of other GMP records;
- availability of required records for official review.
21 C.F.R. Part 129.
Failure to comply with these regulations may render the bottled water product adulterated and subject to regulatory action.
Bottled Water Standard of Identity
Bottled water manufacturers also now must ensure that their products meet the FDA established standard of identity for bottled water products.21 C.F.R. § 165.110(a). A bottled water product bearing a particular statement of identity (e.g., mineral water) must meet the requirements of the standard of identity in order to avoid being misbranded. For example, under the standard of identity regulations bottled water may only be labeled”mineral water” if it: (1) contains not less than 250 ppm total dissolved solids; (2) comes from a source tapped at one or more bore holes or springs; (3) originates from a hydrogeologically protected source; and(4) contains no added minerals. 21 C.F.R. § 165.110(a)(2)(iii).There are similar definitions for bottled water, drinking water, artesian water, ground water, distilled water, deionized water, reverse osmosis water,purified water, sparkling bottled water, spring water, sterile water and well water. 21 C.F.R. § 165.110(a). A bottled water product must bear the appropriate name as reflected in the applicable standard of identity definition or it is misbranded. FFDCA § 403(g).
Bottled Water Standard of Quality
Bottled water manufacturers also must ensure that their products meet the federally mandated standard of quality set forth in 21 C.F.R. § 165.110(b).The bottled water standard of quality establishes allowable levels for substances in bottled water, such as those for coliform and lead. This regulation includes levels related to microbiological quality, such as the limit on the number of coliform organisms; physical quality, such as turbidity, color and odor; chemical quality, such as the limits on organic and inorganic chemicals;and radiological quality, such as the limit on radium 226. FDA has now completed review of the contaminants for which EPA has established maximum contaminant levels (“MCLs”) for municipal water and established corresponding allowable levels in the standard of quality for bottled water where appropriate.This has resulted in over 75 substances for which FDA has established allowable limits pursuant to the FDA standard of quality for bottled water products. See 21 C.F.R. § 165.110(b). If a bottled water product exceeds the standard of quality, for example, the 0.3 mg/L limit on iron, it will be misbranded under section 403(h)(1) unless it bears the label statement regarding non-compliance with the applicable standard of quality. Further, it may be considered adulterated if this level constitutes adulteration.
As discussed above, the bottled water GMP regulations set forth appropriate testing methodology and testing time frames to determine compliance with the standard of quality. Both source water and product water are subject to these GMP requirements. Source water must, of course, be obtained from an approved source and conform with applicable state and local laws and regulations. 21 C.F.R. § 129.35(a)(2). Bacteriological analysis of source water must be done at least once per week. 21 C.F.R. § 129.35(a)(3). Chemical analysis of source water must be done at least annually. Id.Radiological analysis must be performed at least once every four years.Id. Test and sample methods used must be those recognized and approved by the government agency of jurisdiction. Operations water, if different from source water, must also be obtained from an approved source and conform with applicable state and local laws and regulations. Id. at § 129.35(a)(2).
Product water also is subject to strict GMP requirements. Bacteriological analysis of product samples must be done at least once per week for each type of water produced during a day’s production. 21 C.F.R. § 129.80(g). Chemical, physical and radiological analysis must be done at least annually on a representative sample from a batch or segment of a continuous production run for each type of water produced during a day’s production. Id.Again, test and sample methods used must be those recognized and approved by the government agency of jurisdiction. Product water, of course, also must comply with the bottled water standard of quality under 21 C.F.R. § 165.110(b).
Bottled water plants must retain all GMP records as well as government approvals of source water for at least 2 years and must make these documents available for official review. 21 C.F.R. § 129.80(h).
FDA Enforcement/Regulatory Action
FDA has a wide range of enforcement tools available to it. If a product is violative (meaning it is either adulterated or misbranded as discussed above) and a company declines to comply with applicable requirements or declines to take action to correct violative conduct, FDA may take either civil or criminal action or both. Generally, FDA first seeks voluntary compliance through use of Warning Letters and requests for voluntary recalls. If these mechanisms do not work, FDA may ask the Department of Justice to bring either a civil seizure or an injunction against the products and/or company involved. If the violative conduct warrants criminal prosecution, FDA may seek such action from the Department of Justice as well. These criminal cases maybe either misdemeanors or felonies, depending on the circumstances involved,and may result in substantial monetary penalties and jail sentences for culpable individuals. Lastly, FDA may use its authority to warn the public as a means to both protect the public and effectuate compliance. This maybe accomplished through the issuance of press releases or other similar means.
Finally, as with the entire food industry, FDA randomly inspects bottled water facilities. Pursuant to section 704 of the Act, FDA may inspect any food manufacturing facility, including a bottled water plant.
Bottled water is fully regulated at the federal, state and industry levels.There are extensive and specific FDA requirements that must be met. Failure to comply will subject the manufacturer and/or product to regulatory action. Further, there are state requirements that must be met as well as self-imposed industry requirements. All of these combine to ensure that bottled water remains a high quality, safe product.
Prepared by Hogan & Hartson L.L.P.