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Enforcement Actions

Philemon Pty Ltd 7/26/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740 

 

July 26, 2013
 
 
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Mr. John Stanger
Technical Manager
Waterwheel Premium Foods Pty Limited
Gateway Corporate Park
Unit 6, 11 David Street
Dandenong, Victoria 3175, Australia
 
Re: 396837
 
Dear Mr. Stanger:
 
The United States Food and Drug Administration (FDA) conducted inspections of your facilities at Gateway Corporate Park, Unit 6, 11 David Street, and Unit 1, 5 Gladstone Road, Dandenong, 3175, Australia, on January 17-18, and January 21-22, 2013, respectively. During the inspections, labels of your Water Wheel Fine Wafer Crackers Original, Waterthins Cheese Twists Classic Cheddar, and Waterthins Grain Wafer Thins Original products were collected for review. FDA has reviewed the labeling for these products and, based on our review, we have concluded that these products are in violation of section 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 United States Code (U.S.C.) § 343], and the food labeling regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and these regulations through links in FDA’s home page at www.fda.gov.
 
Your significant violations were as follows:
 
1.    Your Water Wheel Fine Wafer Crackers Original and Waterthins Cheese Twists Classic Cheddar products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the product labels are false or misleading. Specifically:
 
a.    Your Water Wheel Fine Wafer Crackers Original label bears the claim “All Natural.” We consider use of the term “natural” on a food label to be truthful and non-misleading when “nothing artificial or synthetic … has been included in, or has been added to, a food that would not normally be expected to be in the food.” [58 FR 2302, 2407, January 6, 1993]. Your use of the claim “All Natural” on this product label is false and misleading because the product is made with artificial rye flavor.
 
b.    Your Waterthins Cheese Twists Classic Cheddar product label states, in the ingredient statement, that the product contains cheddar cheese; however, according to the recipe, the product does not contain cheddar cheese.
 
2.      Your Waterthins Grain Wafer Thins Original product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because the label bears several nutrient content claims, but the product does not meet the requirements to bear the claims. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act. Specifically:
 
a.    The label bears the claim “[Grain Wafer Thins] contain a range of Multigrains that includes Chia Seeds …. Chia seeds are known to be an important source of Omega3 … and Amino Acids.” Under section 403(r)(2)(A) of the Act, nutrient content claims may be made only if the characterization of the level made in the claim uses terms which are defined by regulation. However, FDA has not defined the characterization “important source” by regulation. Moreover, even if we determined that the term “important source” could be considered synonymous with the term “high” or the term “good source,” both of which are defined by regulation, this claim does not comply with the requirements for use of those terms in 21 CFR 101.54(b) (“high” claims) or 21 CFR 101.54(c) (“good source” claims) because there is no established Reference Daily Intake (RDI) or Daily Reference Value (DRV) for omega-3 fatty acids or for amino acids.
 
b.    The label bears the claim, “[Grain Wafer Thins] contain a range of Multigrains that includes Chia Seeds …. Chia seeds are known to be an important source of … Dietary Fibre.” As noted above, we have not defined the term “important source.” Even if we determine that the term “important source” could be considered a synonym for a term defined by regulation (e.g., “high” or “good source”), the product does not meet the requirements to bear this claim. Under 21 CFR 101.54(b) and (c), a food bearing a “high” claim must contain 20 percent or more of the RDI or the DRV per reference amount customarily consumed (RACC), while a food bearing a “good source” claim must contain 10 to 19 percent of the RDI or the DRV per reference amount customarily consumed. However, your label indicates that this product contains only seven percent of the DRV for fiber. Furthermore, under 21 CFR 101.54(d), if a nutrient content claim is made with respect to the level of dietary fiber and the product is not “low” in total fat as defined in 21 CFR 101.62(b)(2), the label must disclose the level of total fat per labeled serving. Such disclosure must be made in immediate proximity to the claim, in a type size no less than one-half the size of the claim. This product is not “low” in total fat as defined in 21 CFR 101.62(b)(2), but the label does not contain the required disclosure.
 
c.    The label bears the claim “[Grain Wafer Thins] contain a range of Multigrains that includes Chia Seeds …. Chia seeds are known to be an important source of … Protein.” As noted above, we have not defined the term “important source.” Even if we determine that the term “important source” could be considered a synonym for a term defined by regulation (e.g., “high” or “good source”), and even if your product contains the amount of protein required to make a claim associated with such term, your label would still be in violation of 21 CFR 101.9(c)(7)(i). That provision states that if a protein claim is made for a product, the product’s label must contain a statement of the corrected amount of protein per serving as determined in 21 CFR 101.9(c)(7)(ii), calculated as a percentage of the RDI or DRV for protein, and expressed as a Percent of Daily Value. Your label does not provide such a statement.
 
d.    The label bears the claim “[Grain Wafer Thins] contain a range of Multigrains that includes Chia Seeds …. Chia seeds are known to be an important source of … antioxidants.” As noted above, we have not defined the term “important source.”  Furthermore, nutrient content claims using the term “antioxidant” must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, an RDI must have been established for each of the nutrients that are the subject of the claim (21 CFR 101.54(g)(1)), and these nutrients must have recognized antioxidant activity (21 CFR 101.54(g)(2)). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) (21 CFR 101.54(g)(3)). In addition, such a claim must include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term “antioxidant” or “antioxidants” may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity (21 CFR 101.54(g)(4)). Your claim “important source of . . . antioxidants” does not include the names of the nutrients that are the subject of the claim as part of the claim, or use a symbol to link the term “antioxidants” to a symbol that appears elsewhere on the same panel of the product label followed by the names of the nutrients.
 
e.    The label bears the nutrient content claim “healthy” in connection with the above claims; however, it does not meet the requirements in 21 CFR 101.65(d)(2) to bear this claim. To bear the nutrient content claim “healthy” under 21 CFR 101.65(d)(2), a product such as this one must, among other things, be “low fat” as defined in 21 CFR 101.62(b)(2) and contain at least 10% of the RDI or DRV per RACC of one or more of the following: vitamin A, vitamin C, calcium, iron, protein, or fiber. As is noted above, this product is not “low fat” as defined in 21 CFR 101.62(b)(2). Furthermore, the product does not appear to contain at least 10% of the Daily Value per RACC of vitamin A, vitamin C, calcium, iron, protein, or fiber. (We note that the label does not provide a percent daily value for protein.)
 
More information about nutrient content claims can be found at: http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm2006880.htm
 
3.    Your Water Wheel Fine Wafer Crackers Original product is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] in that the product contains artificial rye flavor but fails to bear labeling stating that fact, in accordance with 21 CFR 101.22(h).
 
4.    Your Waterthins Cheese Twists Classic Cheddar product is 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. Specifically, your product is made with natural cheddar cheese flavor but it contains no cheddar cheese. As required by 21 CFR 101.22(i)(1)(i), if the food is one that is commonly expected to contain a characterizing food ingredient (e.g., cheddar cheese) and the food contains natural flavor derived from such ingredient and an amount of characterizing ingredient insufficient to independently characterize the food, or the food does not contain the characterizing ingredient, the name of the characterizing flavor shall be immediately followed by the word “flavored” in letters not less than one-half the height of the letters in the name of the characterizing flavor (e.g., “cheddar cheese flavored cheese twists”). If the flavor is natural, the name of the flavor may be immediately preceded by the word “natural” (e.g., “natural cheddar cheese flavored cheese twists).
 
5.    Your Water Wheel Fine Wafer Crackers Original and Waterthins Cheese Twists Classic Cheddar products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients and each ingredient is not declared on the label using the common or usual name, as required by 21 CFR 101.4. Specifically:
 
a.    Your Water Wheel Fine Wafer Crackers Original product fails to declare water and artificial rye flavor, in accordance with 21 CFR 101.4(a)(1).
 
b.    Your product labels fail to list some ingredients using their common or usual names, in accordance with 21 CFR 101.4(a)(1). For example:
 
  • The ingredient declared as “unbleached wheat flour” on your Water Wheel Fine Wafer Crackers Original product and “wheat flour” on your Waterthins Cheese Twists Classic Cheddar labels is not the appropriate common or usual name [21 CFR 101.4(a)(1)]. The ingredient cannot be called by these names because flour is a food for which a standard exists [21 CFR 137.105] and the ingredient does not meet the standard. According to the supplier’s ingredient declaration, the ingredient contains thiamine mononitrate and folic acid. These enrichments are not permitted by the standard for flour.

 

c.    Your product labels fail to list the sub-ingredients of all ingredients in your products, in accordance with 21 CFR 101.4(b)(1). For example:
 
  • Your Water Wheel Fine Wafer Crackers Original product contains the ingredient Cheese Powder. According to the supplier’s ingredient declaration, Cheese Powder contains the following sub-ingredients: milks solids, maltodextrin, cheese solids (pasteurized milk, salt, starter culture, enzymes), salt, mineral salts (E339, E331), hydrolyzed vegetable protein and food acids (E330). These sub-ingredients are not listed in the ingredient statement on the Water Wheel Fine Wafer Crackers Original product label.

 

We note that these sub-ingredients must be declared using their common or usual name and not by number. Additionally, the sub-ingredients of all other ingredients must be identified on the label.
 
  • Your Waterthins Cheese Twists Classic Cheddar product contains the ingredients Mineral Salt 450, butter, and parmesan cheese, among others. However, the sub-ingredients of these ingredients are not declared.

 

The requirement to list these component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
 
6.    Your Water Wheel Fine Wafer Crackers Original, Waterthins Cheese Twists Classic Cheddar, and Waterthins Grain Wafer Thins Original products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example:
 
a.    The declared serving sizes for your Water Wheel Fine Wafer Crackers Original product is 10 g (6 crackers). However, this serving size is not appropriate. Title 21 CFR 101.9(b)(2) requires that serving size be determined from the Reference Amounts Customarily Consumed (RACC) at 21 CFR 101.12(b). There are two RACCs that may fit your product; the RACC for “Crackers that are not usually used as a snack, melba toast, hard bread sticks, ice cream cones” in Table 2 of 21 CFR 101.12(b) is 15 g, and the RACC for snack crackers is 30 g. The declared serving size for your product is less than either RACC that would be appropriate for this product; therefore, all nutrition facts information is incorrect for each nutrient.
 
b.    The serving size on your Waterthins Cheese Twists Classic Cheddar label is not declared in common household units as required by 21 CFR 101.9(b)(7).
 
c.    The nutrients declared on your Waterthins Cheese Twists Classic Cheddar product label include the numeric value but fail to identify the unit of measure. You must declare all nutrients using the appropriate unit of measure in accordance with 21 CFR 101.9(c).
 
We acknowledge receipt of your response dated February 14, 2013; however, we are unable to determine the adequacy of your response because you failed to provide revised labels addressing the violations listed above.
 
The above violations are not meant to be an all-inclusive list of violations that exist in connection with your products and labeling. It is your responsibility to ensure that the products you market are in compliance with the Act and all applicable regulations.
 
You should notify this office, in writing, within 15 working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
 
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may refuse admission of your products under section 801(a) of the Act (21 U.S.C. §381(a)), including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the Nutritional Labeling and Education Act (NLEA) is Import Alert #99-20. This alert can be found on FDA's web site at: http://www.accessdata.fda.gov/cms_ia/importalert_264.html.
 
In addition to the above violations, we also offer the following labeling comments:
 
  • Several of your products contain statements that are considered intervening material [21 CFR 101.2(e)].
 
o    Your Water Wheel Fine Wafer Crackers Original product label contains the terms “May contain sesame seed. For production/expiry (Best Before) Date, See Pack. Made in Australia” and “Consumer Guarantee Waterwheel Industries guarantee the quality of their product.” These statements are not part of the ingredient statement or name and place of business and therefore may not be part of these elements.
 
   Your Waterthins Cheese Twists Classic Cheddar product label contains “Rye’ in the “contains” statement; however, “rye” is not a major food allergen in the U.S. and should not be listed in the “contains” statement.
 
  • Your Waterthins Cheese Twists Classic Cheddar product label contains the statement “Contains less than 2% of the daily value of this nutrient”; however, we question the meaning of this statement because it does not appear to be linked to any nutrient.

 

  • We note that your Waterthins Grain Wafer Thins Original label bears the name of the old firm “Philemon Pty Ltd”; however, the new name of your firm is Waterwheel Premium Foods Pty Limited.

 

  • The declaration of the name and place of business on your Waterthins Cheese Twists Classic Cheddar label does not appear on the same panel as other required information. Under 21 CFR 101.2(d)(1), all information required to appear on the principal display panel or on the information panel under this section must appear on the same panel unless there is insufficient space. In determining the sufficiency of the available space, except as provided by 21 CFR 101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and other non-mandatory label information must not be considered.

 

  • The ingredient liquid sour dough on your Waterthins Cheese Twists Classic Cheddar product label is declared as “natural sour dough.” We question whether this is the appropriate common or usual name. Also, the sub-ingredients of the liquid sour dough declared on the finished product label do not match the ingredient label or the ingredient specification sheet. Your ingredient declaration must accurately reflect the ingredients in the product.

 

  • The calories, nutrients, and percent daily values declared on your product labels are not all rounded to the nearest reference increment as required [21 CFR 101.9(c)].
 
Your response should be directed to Carrie Lawlor, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, 5100 Paint Branch Parkway (HFS-608), College Park, Maryland 20740. If you have any questions regarding any issues in this letter, please contact Ms. Lawlor at (240) 402-0315 or via e-mail at carrie.lawlor@fda.hhs.gov.
 
Sincerely,
/S/ 
Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition