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WARNING LETTER

CV. Arira Pangindo


Recipient:
CV. Arira Pangindo


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

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

JAN 27, 2016

WARNING LETTER 
 
VIA EXPRESS DELIVERY
 
Mr. Aria Budi Dharmawan, Owner/Commissioner
CV. Arira Pangindo
Jl. Sukaraja No. 51 Ciluar,
Bogor, Indonesia
 
Re: 484374
 
Dear Mr. Dharmawan:
 
The United States Food and Drug Administration (FDA) inspected your facility, CV. Arira Pangindo, located in Bogor, Indonesia on August 10, 2015. During the inspection, the labels of your “Indies Cassava Chips” and “Kusuka Cassava Chips”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 Federal Food, Drug, and Cosmetic Act (the Act) [21U.S.C. § 343], and its implementing regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101). You may find the Act and these regulations through links on FDA’s home page at www.fda.gov.
 
Your significant violations were as follows:
 
1.    Your “Indies Cassava Chips” and “Kusuka Cassava Chips” products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the labels bear nutrient content claims, but the products do 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 promulgated by the Secretary (or by delegation, FDA) authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling of a product 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. For example:
  • Your “Indies Cassava Chips” product label bears the claim “NO CHOLESTEROL;” however, it fails to meet the requirements to bear this claim. In accordance with 21 CFR 101.62(d) the term “no cholesterol” may be used on the label or in the labeling of food that contain 13g or less of total fat per reference amount customarily consumed (RACC), per labeled serving, and per 50 g if the RACC is 30 g or less, provided that the food contains 2 g or less of saturated fatty acids per RACC or, in the case of a meal product or main dish product, 2 g or less of saturated fatty acids per labeled serving. The RACC for snack chips such as your “Indies Cassava Chips” is 30 g.  The product label for your “Indies Cassava Chips” indicates that the product contains less than 13 g of total fat per RACC, labeled serving, and per 50 g. However, the product label also indicates that 30 g of “Indies Cassava Chips” contains more than the allowable amount of 2 g of saturated fat. Therefore, the labeling of this product fails to comply with the requirement in 21 CFR 101.62(d)(1)(i)(C) and therefore causes your product to be misbranded under section 403(r)(1)(A).  
  • Your “Indies Cassava Chips” product label bears the claim “With twice the fiber of regular potatoes” and your “Kusuka Cassava Chips” product label bears the claim “twice the fiber of regular potato chips, cassava…” These claims using the term “twice the” are nutrient content claims because they characterize the level of nutrients in your products [see section 403(r)(1)(A) of the Act and 21 CFR 101.13(b)]. However, FDA has not authorized the use of nutrient content claims using the term “twice the.” Further, even if we considered the term “twice the” to be synonymous with a term such as “more,” to qualify for a “more” nutrient content claim for fiber, a food product that is not “low” in total fat as defined in 21 CFR 101.62(b)(2), must disclose the level of total fat per labeled serving in accordance with 21 CFR 101.54(d). Per 21 CFR 101.62(b)(2)(1)(B), food with a RACC of 30 g qualifies as “low fat” if it contains 3 g or less of fat per RACC. Because your “Indies Cassava Chips” and “Kusuka Cassava Chips” both have a RACC of 30 g and contain more than 3 g of fat per 30 g of chips, they do not qualify as “low fat.”  However, their labels do not disclose that they contain 6g of total fat per serving. We note that 21 CFR 101.54(d)(2) requires this disclosure to appear in immediate proximity to the dietary fiber claim, be in a type size no less than one-half the size of the claim, and precede any disclosure statement required under 101.13(h) (e.g., “contains [x amount ] of total fat per serving. See nutrition information for fat content”).
Additionally, if we considered the term “twice the” to be synonymous with a term such as “more,” it would be considered a relative claim. In accordance with 21 CFR 101.54(e)(1), a relative claim may be used on the label or in labeling of food to describe the level of dietary fiber provided that (1) the food contains at least 10 percent more of the RDI or DRV for dietary fiber per RACC than an appropriate reference food; (2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20; and (3) the claim bears the required information for relative claims as described in 21 CFR 101.13(j)(2) and 101.54(e)(1)(iii). However, your “Indies Cassava Chips” and “Kusuka Cassava Chips” products contain less than 10% of the DRV per RACC of 30 g for your products and therefore could not meet the requirement in 21 CFR 101.54(e)(1)(i).  
  • The label of your “Indies Cassava Chips” product bears an implied nutrient content claim, because it bears a statement suggesting that the product may be useful in maintaining healthy dietary practices, and that statement is made in connection with claims or statements about nutrients. Specifically, your “Indies Cassava Chips” product label bears the claim “healthy alternative to regular potato chips” in connection with the statement “With twice the fiber of regular potatoes. ” However, your product does not meet the requirements for use of the nutrient content claim “healthy” that are set forth in 21 CFR 101.65(d)(2).  
In accordance with 21 CFR 101.65(d)(2), you may use the term “healthy” as an implied nutrient content claim on the label or in the labeling of a food provided that the food, among other things, is “low fat,” “low saturated fat,” and contains at least 10 percent of the RDI or DRV per RACC of one or more of vitamin A, vitamin C, calcium, iron, protein or fiber.   
 
Under 21 CFR 101.62(b)(2)(i)(B), a food that has a RACC of 30 g or less is considered “low fat” if it contains 3 g or less of fat per RACC and per 50 g. However, according to the product label for your “Indies Cassava Chips,” the product contains more than 3 g of fat per RACC of 30 g for your product. Therefore, the product does not qualify as “low fat.” Further, under 21 CFR 101.62(c)(2) a food has “low saturated fat” if the food has a saturated fat content of 1 g or less per RACC and no more than 15 percent of the calories are from saturated fat. However, according to the product label for your “Indies Cassava Chips,” the product contains more than 1 g of saturated fat per RACC of 30 g for your product. Therefore, the product does not qualify as “low saturated fat.” Finally, according to the product label for your “Indies Cassava Chips,” the product does not contain at least 10 percent of the RDI or DRV per RACC of 30 g for your product of one or more of vitamin A, vitamin C, calcium, iron, protein or fiber. Accordingly, your product does not meet the requirements for use of the nutrient content claim “healthy” on a food label. Your product is thus misbranded within the meaning of section 403(r)(1)(A) of the Act.
 
2.    Your “Indies Cassava Chips” and “Kusuka Cassava Chips” 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. For example:
  • Your “Indies Cassava Chips” and “Kusuka Cassava Chips” product labels fail to declare the appropriate common household measure or unit as required by 21 CFR 101.9(b)(5).
  • Your “Indies Cassava Chips” product label declares a percent daily value for transfat which is not in accordance with 21 CFR 101.9(d)(7)(ii).
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.
 
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 imported 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 #99-39. This alert can be found on FDA’s website at: http://www.accessdata.fda.gov/cms_ia/importalert_264.html.
 
In addition to the above violations, we also have the following comments about your labels:
  • The “Indies Cassava Chips” product label states “may contain one or more of canola oil, corn oil, or palm oil.” The use of “may” in this statement suggests that none of these ingredients may be present. Under 21 CFR 101.4(b)(14) you must list the common or usual name of your oil ingredient(s), and may also list oil ingredients that are not present in the product but may sometimes be used. 
  • Both product labels fail to list the ingredients and name and place of business statements together in the same information panel as required by 21 CFR 101.2.
  • The “Kusuka Cassava Chips” product labels fail to include a street address of the distributor as required by 21 CFR 101.5(d). However, the street address may be omitted if it is shown in a current city directory or telephone directory.
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 15 working days, state the reason for the delay and the time within which the corrections will be completed.
 
You should direct your written reply to: Dehlia Young, 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 any issues in this letter you may contact Ms. Young via email at dehlia.young@fda.hhs.gov.
 
 
Sincerely,
/S/                                                           
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
        and Applied Nutrition

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