Inspections, Compliance, Enforcement, and Criminal Investigations
Awesome Foods, Inc. 12/15/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
December 15, 2009
Bruce S. Weinstein President
Awesome Foods, Inc.
30 E. 4th Street
Bridgeport, PA 19405-1420
Dear Mr. Weinstein:
We inspected your food manufacturing facility located at 30 E. 4th Street, Bridgeport, PA, on May 6, 2009 through May 7, 2009. A review of your product labels and website
(http://awesomefoods.com) revealed violations that cause several of your products to be misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (the Act) and Title 21, Code of Federal Regulations (CFR) Part 101. You may find the Act and the food labeling regulations through links in the FDA's home page at www.fda.gov.
The labeling violations are as follows:
1. Your Raw Essene Bread is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that its label fails to declare all major food allergens present in the product.
Section 201 (qq) of the Act [21 U.S.C. 321 (qq)] defines as "major food allergens" milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient containing proteins derived from one of these foods, with the exception of highly refined oils. A food is misbranded if it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen, unless either
• the word "Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients [section 403(w)(1)(A) of the Act; 21 U.S.C. 343(w)(1)(A)], or
• The common or usual name of the major food allergen in the list of ingredients is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when either the common or usual name of the ingredient uses the name of the food source or the name of the food source appears elsewhere in the ingredient list (unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of an ingredient that is not a major food allergen) [section 403(w)(1)(B) of the Act; 21 U.S.C. 343(w)(1)(B)].
According to the ingredient list on the product label, your Raw Essene Bread contains "Sprouted Kamut" as an ingredient, but the product label fails to declare the major food allergen "wheat." The botanipal name of kamut is Triticum polonicum L. The term "wheat" in section 201 (qq) of the Act means any species in the genus Triticum, including Triticum polonicum L.
2. Your Raw Coconut Spread and Raw Zucchini Bread products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] because the nutrition information on their labels does not comply with the format and content requirements in FDA's regulations.
• The serving size declared on the label of your Raw Zucchini Bread is incorrect, and consequently the nutrient values declared for the product are also incorrect. Serving sizes are determined based on the Reference Amounts Customarily Consumed (RACCs), which are provided in 21 CFR 101.12(b). Your product label declares the serving size as 42g and states that the package contains two servings; however, under FDA's serving size regulations, the package contains only one serving. The RACC for "Bakery products: Coffee cakes... sweet quick type breads... " is 55g. Under 21 CFR 101.9(b)(6), a product that is packaged and sold individually and contains less than 200 percent of the applicable RACC shall be considered to be a single-serving container, and the entire content of the product shall be labeled as one serving. Because the Raw Zucchini Bread is labeled as containing 30z (approximately 90g) of product, which is less than 200 percent of the RACC of 55g, it must be labeled as a single serving.
• The serving size for your Raw Coconut Spread is not declared in a common household measure that is appropriate to the food (21 CFR 101.9(b)(1)). Your product label declares the serving size as 57g. However, for a spread, "common household measure" means tablespoons (see 21 CFR 101.9(b)(5)(i)). The serving size for nondiscrete bulk products, including spreads, is the amount in common household measure that most closely approximates the RACC for the product category (21 CFR 101.9(b)(2)(iii)). Because the RACC for "Nuts and Seeds: Nut and seed butters, pastes, or creams," is 2 tbsp (21 CFR 101.12(b), Table 2), the correct serving size for your product is also 2 tbsp. The serving size in common household measure must be followed by the equivalent metric quantity in parentheses (21 CFR 101.9(b)(7)), so the serving size on the label of the Raw Coconut Spread should be declared as "2 tbsp (_g)".
• The labels for your Raw Coconut Spread and Raw Zucchini Bread products fail to declare the cholesterol content of the products (21 CFR 101.9(c)(3)) and the percent Daily Values for several of the nutrients listed (e.g., total fat) (21 CFR 101.9(d)(7)(ii)).
The Nutrition Facts panels on your Raw Coconut Spread and Raw Zucchini Bread products fail to meet many of the rounding and formatting requirements specified under 21 CFR 101.9 (i.e., rounding nutrient amounts and percent Daily Values as required in 21 CFR 101.9(c) and printing "Nutrition Facts" and certain nutrient names in boldface type as required in 21 CFR 101.9(j)(13)(ii)(A)).
3. Your Raw Parmesan Cheeze product is misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because the statement of identity on the label, "raw parmesan cheeze," is not the common or usual name of this food. The common or usual name of a food must accurately describe the basic nature of the food, and may not be confusingly similar to the name of another food. 21 CFR 102.5(a). The basic nature of cheese is that it is a food made using milk as the starting ingredient. According to the ingredient statement for Raw Parmesan Cheeze on your website, your Raw Parmesan Cheeze product does not contain milk. Moreover, "Raw Parmesan Cheeze" is confusingly similar to the name "parmesan cheese," which describes the dairy product parmesan cheese (see 21 CFR 133.165).
The product is also misbranded under section 403(g) of the Act [21 U.S.C. 343(g)] in that it purports to be a food for which a definition and standard of identity has been prescribed by regulation, but it fails to conform to such definition and standard. FDA regulations prescribe a definition and standard of identity for parmesan cheese. 21 CFR 133.165. Among other things, that standard requires a parmesan cheese product to contain milk, an ingredient that is not present in your product. Simply changing the letter "s" in cheese to a "z" is not adequate to distinguish your product from the standardized food.
4. Your Blueberry Cashew Bar is misbranded within the meaning of section 403 of the Act [21 U.S.C. 343] because of the following violations:
• The information for the Blueberry Cashew Bar on your website (under "Ingredient Benefits") states that blueberries are "high in antioxidants." FDA considers a claim about an ingredient in a food to be an implied claim about the food itself. A product that claims to be "high" in a nutrient must contain at least 20 percent of the Reference Daily Intake (RDI) per RACC for the nutrient. 21 CFR 101.54(b). Further, whenever such a claim is made in the product's labeling, the nutrient that is the subject of the claim must be declared in the Nutrition Facts panel on the label. 21 CFR 101.9(c)(8)(ii) and 101.13(n). To make a "high" claim about the level of antioxidants in a food, the nutrient that is the subject of the claim also must be recognized as an antioxidant. 21 CFR 101.54(g)(2). In addition, the name of the antioxidant nutrient must be included in or linked to the claim (e.g., "high in antioxidant vitamins A and C"). 21 CFR 101.54(g)(4). However, the "high in antioxidants" claim for the Blueberry Cashew Bar does not specify which antioxidant nutrient is the subject of the claim. Moreover, according to the label of the Blueberry Cashew Bar, neither of the declared nutrients that are generally considered antioxidants, Vitamin A and Vitamin C, is present at the minimum 20 percent of the RDI per RACC. 21 CFR 101.54(g)(3). (Vitamin A is listed as 0% of the RDI per RACC, and Vitamin C is listed as 4% of the RDI per RACC.) The only other permissible basis for an antioxidant claim would be Vitamin E content. If the claim were based on the level of Vitamin E, the level of that nutrient in the product would have to be declared on the label. 21 CFR 101.9(c)(8)(ii). However, the Vitamin E content of the Blueberry Cashew Bar is not declared. Therefore, the Blueberry Cashew Bar is misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)].
• The information for the Blueberry Cashew Bar on your website also states that blueberries are "high" in manganese and Vitamin K. However, the levels of those nutrients in the Blueberry Cashew Bar are not declared on the product label as required under 21 CFR 101.9(c)(8)(ii) and 101.13(n). Therefore, the product is misbranded under section 403(q) and 403(r)(1)(A) of the Act. Further, because the
• nutrient levels are not declared, it is not clear whether the product has the required minimum 20 percent of the RDI per RACC of these nutrients as required under 21 CFR 101.54(b).
The preceding is not intended to be an all-inclusive list of labeling claims that cause your products to be misbranded, but represents the type of violative claims found in your product labeling.
You should take prompt action to correct the violations described above. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
We note that your Raw Zucchini Bread contains "Wheat-Free Tamari" Tamari is generally made from soybeans, which are a major food allergen under section 201 (qq) of the Act. Therefore, if this product contains proteins derived from soybeans, "soy" or "soybeans" must be declared on the product label in the manner prescribed for major food allergens in section 343(w)(1) of the Act.
We also note that during our May inspection, you promised some corrective actions. For example, you stated that you would remove the words "Wheat-Free" from the labeling for Raw Essene Bread because the product contains kamut. Although the labels collected from your firm during the inspection contained the false claim "Wheat-Free," we note that the labeling of product observed on June 2, 2009, at a retail store no longer contained this claim.
We acknowledge that you submitted letters to FDA dated January 2, 2008, February 6, 2009, and May 15, 2009. In the letters, you stated that, in the phrase "Raw Healthy Carb Food," which is used as a tagline on your product labels, the term "healthy" refers to the types of carbohydrates in your products, and is not intended to make a "healthy" claim about the foods as a whole. In the most recent letter, you proposed changing the tagline on your labels from "Raw Healthy Carb Food" to "Raw 'Right Carb' Food" when new labels are printed. We also note that, as of August 18, 2009, the tagline on your website was similarly changed to remove the word "healthy" and now states "Raw 'Right Carb' Food." We do not object to the "Raw 'Right Carb' Food" statement.
This letter may not list all the violations in your product labeling or at your facility. You are responsible for ensuring that your firm operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations. You are also responsible for ensuring that all of your products and their labeling are in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, you may find it useful to visit our website at http://www.cfsan.fda.gov when reviewing your labels.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Assistant Director