As advances in science have led conventional food manufacturers to offer products with added health value, the market for these "functional foods" (or "nutraceuticals") has blossomed. Recently, manufacturers of bottled water-considered a conventional food by FDA-have begun following suit. The introduction of "aquaceuticals" offers the bottled water industry an avenue for growth and a means of attracting new segments of the health conscious consuming public.

Functional foods, including aqua­ceuticals, are a cross between dietary supplements and conventional foods/beverages; they are foods that contain ingredients intended to promote health. The result is a line of products that may have an effect on the structure or function of the body, the classic example being margarines that claim an effect on cholesterol levels, such as McNeil Consumer Healthcare's "Benecol" and Unilever's "Take Control." Recent additions to the functional food marketplace have included juices, snacks, bars and soup products.

From a legal point of view, there is reason to believe that there are opportunities for bottled water manufacturers to enter this burgeoning marketplace. At the same time, the route to market is not obstacle free.

Labeling: Bottled Water Standards of Identity

In the first instance, bottled water manufacturers must ensure that the contents and labeling of any aquaceuticals abide by existing standards of identity contained in the Code of Federal Regulations (CFR). FDA's definition states, "Bottled water is water that is intended for human consumption and that is sealed in bottles or other containers with no added ingredients except that it may optionally contain safe and suitable antimicrobial agents" 21 CFR § 165.110(a)(1) (emphasis added).

Additional sections of these regulations contain specifications for the content and labeling of bottled water products. For example, section 21 CFR § 165.110(a)(2)(iii), setting the standard of identity for mineral water, states:

The name of water containing not less than 250 parts per million (ppm) total dissolved solids (TDS), coming from a source tapped at one or more bore holes or springs, originating from a geologically and physically protected underground water source, may be "mineral water." Mineral water shall be distinguished from other types of water by its constant level and relative proportions of minerals and trace elements at the point of emergence from the source, due account being taken of the cycles of natural fluctuations. No minerals may be added to this water.

Other sections present similarly rigid standards of identity for "Artesian Water," "Purified Water," "Bottled Sparkling Water," "Spring Water" and "Sterile Water." The net impact of the regulations is that a product may not use one of these label standards of identity unless it conforms exactly to the levels set out in the regulation.

Despite these carefully structured parameters, the regulations do leave an opening for bottled water manufacturers to include other ingredients, such as the dietary ingredients currently being added to functional foods, in their products. The key is that a manufacturer must ensure that the bottled water product is labeled in a way such that a consumer will not confuse it-in FDA's estimation-with standardized products. Thus, a product meeting the Mineral Water Standard of Identity that also contains Vitamin C, cannot be simply labeled "Mineral Water"; instead it must bear the statement, "Mineral Water with Vitamin C" or some similar variation. Similarly, a spring water containing caffeine would need to be labeled to reflect this, with a statement such as "Spring Water with Added Caffeine."

It should be noted that several states have regulations that further narrow labeling opportunities. Arizona, Georgia, Hawaii, Louisiana, Ohio, Texas and Wyoming have laws that prohibit labeling bottled water as a "natural" product if any dissolved solid has been added to it. As such, those states could argue that if dietary ingredients are added to products such as spring water, artesian water, mineral water or well water in their borders, the product would have to be labeled as "drinking water" or "bottled water" with a specific added ingredient rather than as one of the natural water products.

Safety: Food Additive Or GRAS Status Required

FDA regulations also require a demonstration of the safety of ingredients added to conventional foods, including bottled water. Thus, ingredients added to water must be either approved as food additives or be "generally recognized as safe" (GRAS) by qualified experts for their intended use.

While food additives and GRAS ingredients are subject to the same threshold standard of safety, the FDA review processes of the ingredients are quite different. In essence, a food additive petition relies primarily upon animal or clinical test data developed by the manufacturer, while GRAS determinations are based principally upon publicly available literature.

Gaining approval as a food additive is a lengthy process requiring extensive scientific testing to demonstrate safety for the intended use of the ingredient. FDA regulations require the submission of a petition containing extensive safety data. The petition is then subject to a public notice-and-comment rulemaking with final approval (or disapproval) often coming many months after submission. For approval, a food additive petition must show "reasonable certainty" that no harm will result from the proposed use of the additive.

The GRAS self-affirmation process is less formal, but requires a similar level of scientific data demonstrating safety for intended uses. GRAS ingredients must be demonstrated to be "generally recognized as safe among the community of scientific experts knowledgeable about such substances, as well as ingredients commonly used in food prior to 1958."

Under a voluntary process proposed in 1997, FDA asks manufacturers to submit a notification of their GRAS determination with summaries of science and research. FDA then reviews the submission to ensure that the manufacturer has provided a basis for its GRAS determination, but does not give an approval as such. FDA has said that the notification is complete if the agency does not object to the submission within 90 (actually closer to 135) days of receipt.

Once food additive or GRAS status for an intended use is demonstrated (i.e. in a food additive petition, in a GRAS notification filed with the agency or through a GRAS self-determination by a manufacturer), other manufacturers may also rely on that information as long as the intended use of the ingredient is the same.

Importantly, food additive or GRAS status cannot be presumed for any dietary ingredients, including those that are widely present in the dietary supplement market. For example, in a warning letter sent to a juice company in February 2000, the agency identified the ingredients chromium picolinate, lycopene, echinacea, ginkgo biloba, guarana, St. John's Wort and gotu kola as inappropriate ingredients for a conventional food or beverage. FDA concluded that the agency is "not aware of a basis for concluding that [food use of the ingredients] is GRAS."

Claims: Nutritive Value Requirement

According to a January 2000 final rule by FDA, conventional foods are permitted to bear the full range of truthful and non-misleading structure/function claims (claims relating an ingredient to an effect on a structure or function of the body) available to dietary supplements, subject to one important limitation. That is, FDA states that the structure/function claim must relate to an ingredient that achieves its effect through "nutritive value." In the agency's view, a structure/function claim for a food that is not achieved through nutritive value renders the product a drug under the FFDCA.

Until recently, FDA has taken a narrow view of the range of ingredients having "nutritive value." FDA's best effort in defining this term came in the preamble to the proposed and final rules on labeling for health claims:

[an ingredient having] value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy.

Until recently, many companies in­correctly interpreted these definitions to mean that structure/function claims for foods were limited to sanctioned health claims, in that they must relate to a proven relationship between health and a specific nutrient. Thus, in practice, the majority of structure/function types of claims used for foods or beverages were sanctioned health claims, which address such nutrient-health links as calcium intake and a reduced risk of osteoporosis; low fat diets and a reduced risk of cancer; low sodium and reduced risk of high blood pressure and folate and decreased risk of neural tube defects.

This narrow approach to "nutrient" and nutritive value appears to be changing, however. The shift in policy began to appear in early 1999, when FDA permitted structure/function claims for new phytosterol ingredients added to margarine, a conventional food. These phytosterols were added solely for cholesterol lowering/maintenance purposes and do not fit FDA's traditional conception of nutrient or nutritive value.

In addition, at an April 26, 2000 conference sponsored by the Institutes of Medicine, Christine Lewis, director of FDA's Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS), said that despite FDA's insistence that structure/function claims for conventional foods "must derive from the nutritive value of the substance," the agency tends "to interpret [the term] rather broadly." Ms. Lewis also stated that the agency is currently struggling to define the dividing line "between when something stops being a nutrient and starts having pharmacological effects."

It is likely that the scope of claims available to functional foods will continue to expand. Nonetheless, in view of the shifting landscape, it is advisable to seek consultation on the status of an ingredient and planned claims prior to going to market.

It should also be noted that several states have regulations prohibiting label statements about the medicinal or health benefits of bottled water products. However, these restrictions arguably only apply to claims about the water itself and should not create a legal obstacle to claims about dietary ingredients added to the bottled water product.

In addition, it is important to recognize that bottled waters, whether containing naturally occurring or added ingredients, are subject to the Nutrition Labeling & Education Act of 1990 (NLEA), which requires detailed label listings of ingredients. NLEA also makes clear that the use of nutrient content claims detailing levels or presence of individual ingredients is limited to those ingredients having a Recommended Daily Intake (RDI) or Daily Reference Value (DRV). Thus, in a recent warning letter, FDA indicated that a statement such as, "Natural Mineral Contents: Calcium–Potassium–Magnesium–Selenium," can only be used for a water product containing RDI or DRV levels specified in FDA regulations. This limitation should be kept in mind when devising statements about a product's dietary ingredient content.

NW