DEPARTMENT OF HEALTH & HUMAN SERVICES
August 14, 2012
Mr. Gilles Duault
President and CEO
17 Rue Gustave Eiffel
Dear Mr. Duault:
The Food and Drug Administration (FDA) conducted an inspection of your facility on January 19, 2012. During the inspection, our investigator collected labels of a number of your products. The labels we reviewed are:
- 24 Jars PET 110g Lemon and Orange Slices
- 12 Jars 170g Lemon and Orange Slices
- 12 Jars 180g Berlingot Fruit Hard Candy
- 12 Jars 170g Verbena
- 12 Jars 160g Seashells & Fish Candy
- 4 bags x 3kg (6.6lbs) Verbena
- 4 bags x 3kg (6.6lbs) Violets
- 4 bags x 3kg Seashells & Fish Candy
- 4 bags x 3kg Apple and Calvados KB 155
Based on our review, these products are in violation of sections 402 and 403 of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. §§ 342 and 343], and the food labeling regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find these regulations through links in FDA’s home page at www.fda.gov.
Your labeling deviations are as follows:
- Your products are adulterated within the meaning of section 402(c) of the Act [21 U.S.C. § 342(c)] because the products bear or contain color additives which are unsafe within the meaning of section 721(a) of the Act [21 U.S.C. § 379(a)].
Section 721(a) deems a color additive to be unsafe unless its use conforms with the color additive’s listing regulation. A color additive’s listing regulation specifies the name that must be used on the product label and may limit use of a color additive to a specific product or type of product.
Your products listed below do not comply with the color additive listing regulations because they do not declare the color additives using the terms required in the listing regulations, they contain color additives that are not permitted in the product, or both. Sodium copper chlorophyllin (declared on your labels as chlorophyllin or chlorophylline) is only permitted in citrus-based dry beverage mixes (21 CFR 73.125). Curcumin and paprika extract are not the correct names for these color additives (21 CFR 73.600 and 21 CFR 73.340, respectively). Specifically,
24 Jars PET 110g Lemon and Orange Slices and 12 Jars 170g Lemon and Orange Slices product labeling declares in part “curcumin, paprika extract.”
12 Jars 180 g Berlingot Fruit Hard Candy product labeling declares in part “curcumin, chlorophylline, paprika extract.”
12 Jars 170 g Verbena and 4 bags x 3 kg (6.6 lbs) Verbena product labeling declares in part “chlorophyllin, curcumin.”
12 Jars 160 g Seashells & Fish Candy and 4 bags x 3 kg Seashells & Fish Candy product labeling declares in part “curcumin, chlorophylline, paprika extract.”
4 bags x 3 kg Apple and Calvados KB 155 product labeling declares in part “curcumine, chlorophylline.”
The above products are also misbranded within the meaning of section 403(i) of the Act because the product labels do not bear the common or usual names of color additives. As required in 21 CFR 101.22(k)(2), the color additives above must be declared 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 24 Jars PET 110g Lemon and Orange Slices, 4 bags x 3 kg (6.6lbs) Verbena, and 4 bags x 3 kg (6.6lbs) Violets products are misbranded within the meaning of section 403(q) of the Act [21 U.S.C. 343(q)] in that the labels fail to bear nutrition labeling (“Nutrition Facts” panel), in accordance with 21 CFR 101.9.
Your 24 Jars PET 110g Lemon and Orange Slices, 4 bags x 3 kg (6.6lbs) Verbena, and 4 bags x 3 kg (6.6lbs) Violets product labels do not declare the place of business of the manufacturer, packer, or distributor, in accordance with 21 CFR 101.5. The labels list the importer name and phone number, but must also declare the address to be in compliance with the regulation.
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 regulations.
Please notify this office, in writing, within thirty (30) business 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. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within thirty business days, state the reason for the delay and the time within which the corrections will be completed.
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 firstname.lastname@example.org.
Jennifer A. Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition