- Chocolates Garoto S.A.
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
August 3, 2015
VIA EXPRESS DELIVERY
Mr. Fabio Battistella, Factory Manager
Chocolates Garoto S.A.
Praca Meyerfreund, 1 -Gloria
Vila Velha, Espirito Santo, Brazil 29122-900
Dear Mr. Fabio Battistella:
The United States Food and Drug Administration (FDA) inspected your facility, Chocolates Garoto S.A., Vila Velha, Espirito Santo, Brazil, on March 26-27, 2015. The inspection was conducted to determine your compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and regulations that apply to the food that you ship to the United States. Based on our review, we have concluded that your Talento brand White Chocolate with Crunchy Cereals and Raisins product is in violation of the Act and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and these regulations through links in FDA's home page at www.fda.gov.
1. Your Talento brand White Chocolate with Crunchy Cereals and Raisins product is misbranded within the meaning of Section 403(w) of the Act [21 U.S.C. § 343(w)], in that the finished product labels fail to declare the major food allergen, wheat, as required by section 403(w)(l) of the Act. Specifically, your Talento brand White Chocolate with Crunchy Cereals and Raisins product is manufactured using "Crunchy cereals" that contain wheat.
Section 201(qq) of the Act [21 U.S.C. § 321(qq)], defines milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well as any food ingredient that contains protein derived from one of these foods, with the exception of highly refined oils as "major food allergens." A food is misbranded under section 403(w) of the Act 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)(l)(A)]; or
• The common or usual name ofthe 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 (e.g., "Whey (Milk)''), except 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)(l)(B) of the Act [21 U.S.C. § 343(w)(l)(B)].
We note that listing "gluten" in the "Contains" statement is not provided for in the Food Allergen Labeling and Consumer Protection Act (FALCPA) because gluten is not one of the major food allergens. The label states "Contains traces of peanut, hazelnut, cashew nut and brazil nut," and "Contains traces of gluten and peanuts, hazel nuts, cashew nuts and almonds" (Arabic translation). The "Contains" statement must include the food sources of all major food allergens that are ingredients or are contained in ingredients used to make the finished food. FALCPA does not permit the use of a "Contains" statement for major food allergens that are not intentionally added to the food. In addition, FDA has not defined the term "traces." Advisory statements should not be used as a substitute for adherence to current Good Manufacturing Practices and statements made on the label must be truthful and not misleading.
2. Your Talento brand White Chocolate with Crunchy Cereals and Raisins product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition information (e.g., Nutrition Facts Panel) is not in a correct format, as required by 21 CFR 101.9. For example:
• The declared serving size is 1/3 bar; the bar weighs 100 grams. The Reference Amount Customarily Consumed for "all other candies" is 40 grams. Therefore your serving size should be 1/2 bar or an entire bar if the whole unit can reasonably be consumed at a single-eating occasion [21 CFR 101.9(b)(2)(i)(D)]. All nutritional information must be adjusted to reflect this change. [21 CFR 101.12, Table 2, and 101.9(b)(2)(i)(C)]
• The Nutrition Facts panel should be offset from the balance of the label statements by a box as required in 21 CFR 101.9(d)(l)(i).
3. Your Talento brand White Chocolate with Crunchy Cereals and Raisins product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. For example:
• Your product is manufactured using the ingredient "crunchy cereals," which is a multicomponent ingredient in that it contains two or more ingredients; however, you fail to list all sub-ingredients on your finished product label.
• Your label fails to identify the common or usual name for "Vegetable fat," and fails to identify the vegetable from which the oil is obtained (for example, com oil or canola oil).
• "Soya lecithin (322) and polyglycerol polyricinoleate (476) - emulsifiers and synthetic identical to natural flavouring (sic)" do not meet our requirements for listing each ingredient by its common or usual name, and using the designations "(322)" and"(476)" in the ingredient statement is not provided for in 21 CFR 101.4.
• We note that the Arabic translation of the ingredient information is different than the ingredient information provided for the Portuguese, Spanish and English translations, and that the "crunchy cereals" ingredient is not in this ingredient statement. Also, in the Arabic translation, "emulsifying agents made from soy (322), poly cholesterols (476)" does not meet the requirements in 21 CFR 101.4 for listing each ingredient by its common or usual name.
According to 21 CFR 101.4(b )(2), 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.
4. Your Talento brand White Chocolate with Crunchy Cereals and Raisins product is misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the label contains information in multiple languages (Portuguese, Spanish, Arabic and English); therefore, all required information must be in all languages (i.e., the English language as well as the foreign language). For example, the statement of identity and the nutritional information must be declared in each foreign language represented on the label as required by 21 CFR 101.15(c)(2).
5. Your Talento brand White Chocolate with Crunchy Cereals and Raisins product is further misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the label information is not prominent and conspicuous as required by 21 CFR 101.15(a)(6) due to the smallness of type and crowding with other printed and graphic material.
6. Your Talento brand White Chocolate with Crunchy Cereals and Raisins product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. §343(f)] because the label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. The statement of the place of business shall include the street address, city, state, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The distributor, Joya Industries, is listed with a city only.
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations.
We also have the following comments:
• The statement of identity of the product "White Chocolate with Crunchy Cereals and Raisins" is not reasonably related (considered at least half the type size) to the most prominent printed matter on the principal display panel (21 CFR 101.3 (d)).
• The net quantity of contents statement is not placed within the bottom 30 percent of the area of the principal display panel in lines generally parallel to the base of the package when displayed (21 CFR 101.105(f)). Also, the letters and numbers in this statement must meet the type size requirements in 21 CFR 101.105(h).
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
We request that you respond to this office in writing, within 15 working days ofreceipt of this letter. Your response should include, in English, the specific steps you have taken to correct the violations. If you cannot complete all of the corrections within 15 working days, your response should state the reason for the delay and the time within which 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 take further action to refuse admission of your imported products under Section 80l(a) ofthe 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 allergen labeling requirements is 99-22 while the Import Alerts that convey information specific to foreign firms that are not in compliance with nutritional labeling and basic labeling requirements are 99-20 and 99-39, respectively. You may view these alerts at: http://www.accessdata.fda.gov/cms_ialialist.html
You should direct your written reply to: Tyra Wisecup, Compliance Officer, Division of Enforcement (HFS-608), Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions regarding this letter you may contact Ms. Wisecup via email at firstname.lastname@example.org
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
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