LABELS
Information Panel. FDA permits additional required information to be displayed on either side of the PDP, known as the information panel. FDA identifies the information panel as “that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel….” Although permitted to be displayed on either the PDP or information panel, most of the following information required by FDA to be on the label is typically found on the information panel: •
Ingredients. For bottled water, an ingredients list is not required if nothing has been added to the water. However, if sodium fluoride or mineral salts are added, they must be listed under “Ingredients.” Ingredients are listed in descending order of predominance.
•
Name and place of business of manufacturer, packer, or distributor. If a manufacturer, packer, or distributor has a phone book or Yellow Pages listing, it is only required to list the company name with corresponding city, state, and zip code. If the manufacturer, packer, or distributor does not have a phone book or Yellow Pages listing, a full company name and street address is required. Bottlers may also opt for listing any combination of the three companies, but typically either the manufacturer or distributor is listed on the information panel. If the product is not manufactured by the company named on label, the label statement must be preceded by either “Manufactured for _____” or “Distributed by _____.”
•
Nutrition Facts label. For bottled water, FDA does not permit nutrition claims beyond hydration and variations of “healthy” for bottled water. However, any claim of sodium content will trigger the requirement for a nutrition facts panel. It is important to note that bottlers are not required to include a Nutrition Facts panel unless a claim of sodium content is included on the PDP or information panel. (Additional information on nutrition labeling is discussed below.)
FDA states that it considers bottled water to have no significant nutritional value. Thus, bottled water can make no nutrition claims other than touting the benefits of hydration. “Contains excessive lead” would be required on the label. Considering that consumers would probably not purchase such an adulterated product, one would not expect to see such a statement on a label of bottled water. All items listed above must appear on the label “prominently and conspicuously.” In no case may letters and numbers be less than 1/16 inch in height unless an exemption is granted by FDA. FDA has approved label exemptions specific to the bottled water industry. The name and place of business, nutrition information (which is not required if no nutritional claims are made on the label), and statement of ingredients are not required to be included on the cap label of 4- or 5-gallon containers if the information is located on the body of the container.
Nutrition Facts Labels
•
Nutrient content claims. As mentioned above, any claim of sodium content in bottled water may be included on either the PDP or information panel. Claims of sodium content are optional, not mandatory.
Sparing readers from a review of the complexities of the Nutrition Labeling and Education Act (NLEA), which has been a part of food labeling since the early 1990s, below we’ll focus on what triggers some NLEA requirements for bottled water. (To review the NLEA, visit bit.ly/ NLEArequirements.)
•
Food label warning and notice statements. As you may be aware, when a food product contains a contaminant that exceeds a regulatory limit or the product is otherwise adulterated, FDA requires warning and notice statements on the label. For example, if a bottled water product contains lead in excess of the FDA standard of quality of 5 ug/L, a statement such as
In the NLEA final rule’s preamble, FDA states that it considers bottled water to have no significant nutritional value. Therefore, bottled water can make no nutrition claims other than touting the benefits of hydration. However, because the sodium content of any food is important to people who are on restricted diets, any claims about sodium are addressed by NLEA. Regarding bottled water, NOV/DEC 2014
BWR
13