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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Pallas S.A. Confections 11/27/12

  

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

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

 

November 27, 2012
 
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Mr. Andreas Spanos
Plant Manager
Pallas S.A. Confections
Industrial Area of Gastouni
Ilia Prefecture
Greece
 
Re: 375081
 
Dear Mr. Spanos:
 
We inspected your facility Pallas S.A. Confections, located at Industrial Area of Gastouni, Ilia Prefecture, Greece, on July 23rd and 24th, 2012. The inspection was conducted to determine compliance with the Federal Food, Drug, and Cosmetic Act (the Act). During the inspection, FDA collected labels for several of your products. Based on our review, we have concluded that these products are adulterated and misbranded within the meaning of sections 402 and 403 of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342; 21 U.S.C. § 343], and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and FDA regulations through links in FDA’s home page at http://www.fda.gov.
 
Your Ross Ouzo, Galaxy Tangerine, Gelo Mixed, Galaxy Ouzo, Gelino Mixed, Fourre Candies filled with Jam, Hard Ouzo Candy, Fourre Mix Candy, Caramels ouzo flavour, Gelo Candies with Fruit Juices, and Gelo Strawberry Candies with Fruit Juices and Vitamin C products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] because the labels fail to declare the nutrition facts information in an appropriate format as defined within 21 CFR 101.9. For example:
 
  • Your products do not declare appropriate serving sizes. For example, your Ross Ouzo product declares a serving size of “3,7 gr”, and your Galaxy Tangerine product declares a serving size of “7,7 gr”. In accordance with 21 CFR 101.9(b)(7), a label statement regarding a serving shall be the serving size expressed in common household measure and shall be followed by the equivalent metric quantity in parenthesis. The reference amount customarily consumed per eating occasion for this product category (Sugars and Sweets: All other candies) is 40g according to 21 CFR 101.12(b) Table 2, therefore the product serving size for your product must be declared as “____pieces(s) (___g)”.

 

  • The labels for your Ross Ouzo, Galaxy Tangerine, Gelo Mixed, Galaxy Ouzo, Gelino Mixed, Fourre Candies filled with Jam, Hard Ouzo Candy, Fourre Mix Candy, and Caramels ouzo flavour products fail to provide a declaration of nutrition information for the appropriate specified nutrients in accordance with 21 CFR 101.9(c), and fail to provide nutrition information properly formatted in accordance with 21 CFR 101.9(d).
 
Your Galaxy Tangerine, Gelo Mixed, Gelo Candies with Fruit Juices, and Gelo Strawberry Candies with Fruit Juices and Vitamin C products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because they contain color additives which are unsafe within the meaning of section 721(a) of the Act. Your product labels declare the presence of E 100 (also known as Curcumin); Cochineal; Carminic acid; E 120 (also known as Carmines); E 150d (also known as Sulphite ammonia caramel); E 163 (also known as Anthocyanins); and “Colouring (FD&C).”
 
  • Curcumin (E 100) and Anthocyanins (E 163) are non-permitted color additives in food products.
  • Cochineal extract and carmine (E 120) are required to be declared on food product labels using the terms “cochineal extract” or “carmine” under 21 CFR 73.100(d)(2).
  • It appears that the color additives declared as “Colouring (FD&C)” were not certified as required in 21 CFR Part 74.
 
Your Ross Ouzo, Galaxy Tangerine, Gelo Mixed, Galaxy Ouzo, Gelino Mixed, Fourre Candies filled with Jam, Hard Ouzo Candy, Fourre Mix Candy, Caramels ouzo flavour, Gelo Candies with Fruit Juices, and Gelo Strawberry Candies with Fruit Juices and Vitamin C products are misbranded within the meaning of Section 403(k) of the Act [21 U.S.C. 343(k)] in that they do not properly declare the presence of artificial flavors and/or colors. Specifically,
 
  • Your Ross Ouzo, Galaxy Tangerine, Gelo Mixed, Galaxy Ouzo, Gelino Mixed, Fourre Candies filled with Jam, Hard Ouzo Candy, Fourre Mix Candy, Caramels ouzo flavour, Gelo Candies with Fruit Juices, and Gelo Strawberry Candies with Fruit Juices and Vitamin C product labels declare “flavours” as an ingredient; however, their labeling fails to state if the flavor is natural or artificial in accordance with 21 CFR 101.22(h)(1). 

 

  • Your Galaxy Tangerine, Gelo Mixed, Gelo Candies with Fruit Juices, and Gelo Strawberry Candies with Fruit Juices and Vitamin C products declare the presence of artificial coloring in the ingredient listing through declaring “Colourings:” followed by the EU designation for color additives. However, the color additives are not declared according to FDA's requirements. Under 21 CFR 101.22(k)(1), color additives that are subject to FDA certification are required to be declared by their listed names or appropriate abbreviations. Under 21 CFR 101.22(k)(2), color additives that are not subject to FDA certification and not otherwise required by applicable regulations in 21 CFR part 73 are required to be declared either by their listed names or as “Artificial Color,” “Artificial Color Added,” or “Color Added” or by an equally informative term that makes clear that a color additive has been used in the food. Alternatively, such color additives may be declared as “Colored with _____” or “_____ color,” the blank to be filled in with the name of the color additive listed in the applicable regulation in 21 CFR part 73.
 
Your Gelo Strawberry Candies with Fruit Juices and Vitamin C product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] in that the label bears 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, your “Gelo Strawberry Candies with Fruit Juices and Vitamin C” product label bears the nutrient content claim “Enriched with Vitamin C and fruit juice.” As required by 21 CFR 101.54(e), the term “enriched” may only be used if the product contains at least 10 percent more of the recommended daily intake (RDI) for the referenced vitamin per reference amount customarily consumed than an appropriate reference food. The label does not include an appropriate reference food, and the nutrition facts information indicates that the product contains only 4% of the RDI for Vitamin C. Additionally, the term “enriched” may only be used to describe the level of protein, vitamins, minerals, dietary fiber, or potassium in a product, and therefore cannot be used to describe the level of fruit juice in the products.
 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the Good Manufacturing Practice regulation (21 CFR 110) and labeling regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. Your response should include documentation, such as a copy of any revised labels, and any other useful information that would assist us in evaluating your corrections.   If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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 candy 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. 
 
During the inspection, the investigator provided your firm with an FDA-483, in which the investigator described observations made during the inspection. We acknowledge receipt of your response to the FDA-483, received on August 3, 2012, and find the response to adequately address the observations.
 
Please send your reply to Lara Snyder, Consumer Safety Officer, Food and Drug Administration, Office of Compliance, Division of Enforcement, Labeling and Dietary Supplement Compliance Team (HFS-608), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Snyder via email at lara.snyder@fda.hhs.gov.
 
Sincerely,
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
    and Applied Nutrition