Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flechard-sas-10202015
Timestamp: 2019-07-17 09:31:40
Document Index: 112534328

Matched Legal Cases: ['art 101', '§ 343', '§ 321', '§ 343', '§ 343', '§ 343', '§ 343', '§ 343', '§343', '§ 343', '§ 381', '§ 379', '§ 379']

FLECHARD S.A.S. - 10/20/2015 | FDA
FLECHARD S.A.S. - 10/20/2015
FLECHARD S.A.S. Oct 20, 2015
FLECHARD S.A.S.
Mr. Guy Flechard, General Director/CEO
Laiterie Du Pont Morin
Re: 472109
Dear Mr. Guy Flechard:
The United States Food and Drug Administration (FDA) inspected your facility, Flechard S.A.S., located in La Chapelle D’andaine, France, on February 19-20, 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 you ship to the United States. Based on our review, we have concluded that your Pure Butterghee (33 pounds), Butter Ghee Natural Milk (56 ounces), Butter Ghee Natural Milk (28.2 ounces), Frentel Bueurre Demi-Sel, and Bessofier unsalted butter products are 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 Bessofier unsalted butter and Frentel Bueurre Demi-Sel products are 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, milk, as required by section 403(w)(1) of the Act. Specifically, your Bessofier unsalted butter and Frentel Bueurre Demi-Sel products are manufactured using buttermilk, butterfat, or cream from cow’s milk.
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 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 (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)(1)(B) of the Act [21 U.S.C. § 343(w)(1)(B)].
2. Your Frentel Bueurre Demi-Sel product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is 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. The product does not have an ingredient statement. We further note that the statutory definition of butter does not provide for the use of “lactic starters” (bacterial cultures). Butter products with lactic starter cultures must be labeled in a way to sufficiently differentiate them from butter, and they must be labeled with a complete ingredient declaration. We also point out that the term “lactic starters” is not an appropriate name for the culture ingredient. Appropriate names to be listed in the ingredient statement may be “cultures,” “bacterial cultures,” or “lactic starter cultures.”
3. Your Frentel Beurre Demi Sel and the Bessofier products are misbranded within the meaning of section 403(b) of the Act [21 U.S.C. § 343(b)] because they are offered for sale under the name of another food, butter, but do not conform to the statutory definition of butter. Under 21 U.S.C. 321a, “’butter’ shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and containing not less than 80 per centum by weight of milk fat, all tolerances having been allowed for.” Your products contain bacterial cultures, which are not included in the definition of “butter,” and therefore the products do not conform to this definition.
4. Your Frentel Beurre Demi Sel and the Bessofier products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because “Butter,” “Unsalted butter,” or “Salted Butter” are not appropriate statements of identity for butter products made with lactic starter cultures. Under 21 C.F.R. 101.3(a), the principal display panel of a food in package form shall bear as one of its principal features a statement of identity of the commodity. Under 21 C.F.R. 101.3(b), such statement of identity shall be in terms of (1) the name specified by law, or (2) the common or usual name of the food, or (3) an appropriately descriptive term or fanciful name commonly used by the public. A possible statement of identity for butter products with lactic starter cultures is “cultured butter.”
5. Your Pure Butterghee (33 pounds), Butter Ghee Natural Milk (56 ounces), Butter Ghee Natural Milk (28.2 ounces), Frentel Bueurre Demi-Sel, and Bessofier unsalted butter 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, as defined in 21 CFR 101.9. For example:
The nutrition information is not provided in the FDA format in all languages shown on the labels [21 CFR 101.9(d)(14)].
The quantitative amounts for the nutrients and the percent DV’s are not rounded in accordance with 21 CFR 101.9(c) for your Pure Butterghee (33 pounds), Butter Ghee Natural Milk (56 ounces), and Butter Ghee Natural Milk (28.2 ounces) products.
Your Bessofier unsalted butter is not in the correct format in that the Nutrition Facts panel fails to have the required bold bars and the nutrients are in the incorrect order (Sodium is listed after Total Carbs). Further, the quantitative amount for trans fat is not rounded in accordance with 21 CFR 101.9(c)(2)(ii).
Your Frentel Bueurre Demi-Sel Nutrition Facts label does not meet the requirements in 21 CFR 101.9. It appears that you are attempting to create a bi-lingual simplified format; however, there appear to be at least 3 languages represented on the label. In addition, presenting the nutrition information in yellow type on a red background does not meet the requirements in 21 CFR 101.9(d)(1)(i). Furthermore, the label does not meet the requirements in 21 CFR 101.9(d) for headings, bolding of certain nutrients, and hairlines.
6. Your Pure Butterghee (33 pounds), Butter Ghee Natural Milk (56 ounces), Butter Ghee Natural Milk (28.2 ounces), Frentel Bueurre Demi-Sel, and Bessofier unsalted butter products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because required statements are written in a foreign language, not in English as required by 21 CFR 101.15(c)(1). Further, the product labels include labeling in multiple languages but do not include all of the required information in all of the other languages in accordance with 21 CFR 101.15(c)(2).
7. Your Frentel Bueurre Demi-Sel product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). Additionally, the Bessofier unsalted butter, Butter Ghee Natural Milk (28.2 ounces), Butter Ghee Natural Milk (56 ounces), and Pure Butterghee (33 pounds) product labels do not include a street address in accordance with 21 CFR 101.5(d).
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 vegetable 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 allergen labeling requirements is Import Alert #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 Import Alert #99-20 and #99-39, respectively. You may view these alerts at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
The above violations are not meant to be an all-inclusive list of violations that may exist in connection with your products. 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.
You told our investigator that your product does not contain milk protein, however, all of the ghee products declare “Pure Butterghee” and “Natural Milk” on the Principal Display Panel. Under Section 201(qq) of the Act [21 U.S.C. 321(qq)], milk and any food ingredient that contains protein derived from milk are major food allergens, unless subject to an exception (Section 201(qq)(2)). Under Section 403(w)(1) of the Act [21 U.S.C. 343(w)(1)], a food is misbranded if it contains a major food allergen and does not declare the major food allergen on its labeling, e.g., “Contains milk.”
While English language labels which include required information are provided for the Bessofier, Butter Ghee Natural Milk (28.2 ounces), Butter Ghee Natural Milk (56 ounces), and Pure Butterghee (33 pounds) products, it is our understanding that these labels are applied to the Butter Ghee labels covering the foreign nutrition information. We do not know where the sticker labels are applied to the Bessofier product labels. Note that the statement of identity and net quantity of contents information must be provided on the principal display panel in accordance with requirements in 21 CFR 101.3 and 101.105 respectively, and that nutrition labeling in another country’s format is not allowed [21 CFR 101.9(a)(1)].
You informed the investigator that the butter ghee products for the U.S. are made from cream from cow’s milk; however, we note that these labels include images of cows and a sheep. This may be confusing to some consumers in that it may lead them to believe that these products also contain sheep’s milk.
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 of receipt 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.
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