Inspections, Compliance, Enforcement, and Criminal Investigations
Tws Marketing Group Inc. 11/10/10
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
5100 Paint Branch Parkway
NOV 10 2010
Mr. Tom Saltmarsh
Tws Marketing Group Inc.
P.O. Box 520104
Longwood, FL 32752
Dear Mr. Saltmarsh:
The Food and Drug Administration (FDA) has reviewed the label for your HomeMaker Premium 100% Pure Florida Squeezed Orange Juice, 64 fl oz. (2 QT/ 1.89L). Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (CFR) Part 101. You may find the Act and these regulations through links in the FDA's home page at http://www.fda.gov.
Your HomeMaker Premium 100% Pure Florida Squeezed Orange Juice is misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] because the label is false or misleading. The label statement "Made With Not From Concentrate Juice" is misleading because, according to the list of ingredients declared on the label, the product contains orange juice concentrate as well as juice that is expressed directly from oranges. The "Made With Not From Concentrate Juice" statement, which is featured in orange type in a prominent location on the top of the carton, fails to reveal the material fact that the product is made in part from orange juice concentrate. Under section 201(n) of the Act [21 U.S.C. § 321(n)], failure to reveal a fact that is material in light of representations made in labeling renders the labeling misleading. The label is also misleading because the statement "100% Pure Florida Squeezed" leads the consumer to believe that the product is made exclusively from expressed juice, when in fact it is not. According to the list of ingredients, the product contains water and orange juice concentrate in addition to "not from concentrate orange juice," which presumably refers to expressed juice. In addition, the label is misleading because it contains conflicting information, in that it states, in different places, "Made With Not From Concentrate Juice" and "From Concentrate and Not From Concentrate."
Your product is further misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that the label fails to bear the common or usual name of the food. The common or usual name of a food must accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients [21 CFR 102.5]. If one or more juices in a juice beverage is made from concentrate, the name of the beverage must include a term indicating that fact, such as "from concentrate" or "reconstituted" [21 CFR 102.5, 102.33(g)]. Your product label identifies the product as "100% All Florida Orange Juice." The term "From Concentrate" or a synonym such as "Reconstituted" is not included as part of the name of the product, as required by 21 CFR 102.33(g). The entire common or usual name of your product, including the term "From Concentrate" or a synonym, must be presented in bold type on the principal display panel of the product label in a size reasonably related to the most prominent print matter, as required by 21 CFR 101.3(d).
Your HomeMaker Premium 100% Pure Florida Squeezed Orange Juice product is also misbranded within the meaning of 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that it is fabricated from two or more ingredients, but the label fails to declare the common or usual name of each ingredient as required by 21 CFR 101.4(a)(1). Ingredients required to be declared on the label or labeling of a food must be listed by their common or usual names and without intervening material [21 CFR 101.2(e) and 101.4(a)(1)]. Extraneous modifiers such as those used in the ingredient list on your product label (e.g., "Pure Filtered," "100% Pure Premium," "Made with" and "100% Pure ... Squeezed Not From Concentrate") are not part of the common and usual name of the ingredient to which they refer; rather, they are considered intervening material and therefore may not be included as part of the ingredient statement.
In addition, your product is further misbranded within the meaning of section 403(i)(2) of the Act because it purports to be a beverage containing fruit juice, but the label fails to bear a percent juice declaration on the information panel, as required by 21 CFR 101.30(b)(1). The percent juice declaration must be placed near the top of the information panel with no other printed label information appearing above the statement except the brand name, product name, logo or universal product code [21 CFR 101.30(e)(1)]. The percent juice declaration must also be in easily legible boldface print, in a height not less than the largest type found on the information panel except that used for the brand name, product name, logo, universal product code or the title phrase, "Nutrition Facts" [21 CFR 101.30(e)(2)].
Your product is further misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that it bears unauthorized health claims associating folate, vitamin C, and calcium with reduced risk of high blood pressure and stroke. Your product label bears the following statements enclosed in a box: "Promotes Cardiovascular Health," "Potassium • Folate • Vitamin C • Calcium • Naturally Fat Free • Cholesterol Free • Sodium Free," and "Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke." In addition to the small heart symbols between the nutrient names, there are several larger heart symbols elsewhere in the box.
Although the health claim associating foods that are good sources of potassium and low in sodium with a reduced risk of high blood pressure and stroke has been authorized through the health claim notification provision of the Act [21 U.S.C. § 403(r)(3)(C)] (see http://www.fda.gov/Food/LabelingNutrition/LabelClaims/FDAModernizationActFDAMAClaims/ucm073606.htm), featuring other nutrients in your product (folate, vitamin C, calcium) directly above the authorized health claim and accompanying the nutrient names with heart symbols and a statement about promoting cardiovascular health suggests that the presence of these other nutrients in your product also helps reduce the risk of certain cardiovascular diseases, namely high blood pressure and stroke. These claims are implied health claims that misbrand your product because FDA has not authorized any health claims associating conventional foods that contain folate, vitamin C, or calcium with reduced risk of high blood pressure or stroke. Implied health claims include those statements, symbols (e.g., a heart symbol), vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition [21 CFR 101.14(a)(1)]. The nutrient names and heart symbols in the box on your product label, read in conjunction with the health claim about reduced risk of high blood pressure and stroke and the statement about promoting cardiovascular health, imply that the folate, vitamin C, and calcium in your product contribute to reducing the risk of high blood pressure and stroke. The authorized health claim "Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke" could appear alone on your label without misbranding your product; however, the boxed statements as a whole constitute an unauthorized health claim.
This letter is not intended to be an all-inclusive review of your products and their labeling. It is your responsibility to ensure that all of your products and labeling comply with the Act and regulations. You should take prompt action to correct the violations described in this letter. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.
Your written response should be directed to Latasha Robinson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, you may contact Ms. Robinson at 301-436-1890.
Office of Compliance
Center for Food Safety
and Applied Nutrition