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WARNING LETTER

Bedessee Imports, Inc MARCS-CMS 536586 — 01/12/2017

Bedessee Imports, Inc - 536586 - 12/01/2017


Delivery Method:
UPS

Recipient:
Recipient Name
Verman Bedessee
Bedessee Imports, Inc

601 Wortman Avenue

Brooklyn, NY 11208
United States

Issuing Office:
New York District Office

United States


 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Food Operations East
Division 1 

 
 

 

WARNING LETTER
CMS # 536586
 
December 1, 2017
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Verman Bedessee, President
Bedessee Imports, Inc.
601 Wortman Avenue
Brooklyn NY 11208
 
Dear Mr. Bedessee:
 
On May 2, 2017 through May 16, 2017, the U.S. Food and Drug Administration (FDA) inspected your facility, located at 601 Wortman Avenue, Brooklyn, NY 11208. During the inspection we identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123); the juice Hazard Analysis and Critical Control Point regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120); and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). 
 
The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your Ready-to-eat Sardines in Tomato Sauce and Tomato Sauce with Chili and Ready-to-eat Mackerel in Water, Tomato Sauce, Hot Tomato Sauce and Soya Oil are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby theymay have been rendered injurious to health. 
 
In addition, we found that you have serious deviations from the FDA's juice processing regulation (21 CFR Part 120). As an importer of juice products, you must operate in accordance with the requirements of Part 120. In accordance with 21 CFR 120.14, there must be evidence that all juice products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 120. If assurances do not exist that the imported juice product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 120, the juice product will appear to be adulterated under Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 120, your Fruit of Life Coconut Water (No Pulp)(Diabetic Choice)(17.5 oz/ 520 ml) is adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that it has been prepared, packed, or held under insanitary conditions whereby itmay have been rendered injurious to health.
 
Further, we reviewed your website at the Internet address http://www.bedessee.com/ in July 2017 and determined that you take orders there for the products Fruit of Life Coconut Water 100% Frozen Pouch, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Based on our review of your website, we also determined that certain of your products are misbranded under section 403 of the Act [21 U.S.C. § 343]. 
 
You may find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at http://www.fda.gov.
 
The violations are described below.
 
Unapproved New Drug and Misbranded Drug Violations
 
FDA reviewed your internet address at http://www.bedessee.com/ in July 2017 and determined that you take orders there for the products Fruit of Life Coconut Water 100% Frozen Pouch, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen. The claims on your website establish that these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Examples of claims on your website at http://www.bedessee.com/ that provide evidence that your products are intended for use as drugs include:
  • “Other top nutrition values in coconut water [an ingredient in your Fruit of Life Coconut Water 100% Frozen Pouch, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen]: 
    • Lower your risk of heart attacks & high blood pressure
    • Help with preventing cancer
    • Contains trans-zeatin which has been used to treat Alzheimer’s disease or dementia” 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353 (b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your productsFruit of Life Coconut Water 100% Frozen Pouch, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen are intended for the treatment and prevention of one or more diseases that are not amenable to self-diagnosis or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Seafood HACCP Violations
 
You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR123.12(a)(2)(ii). However, your firm did not perform an affirmative step for your imported seafood products as follows:
  • Ready-to-eat Sardines in Tomato Sauce and Tomato Sauce with Chili imported by your firm and manufactured by (b)(4) located in (b)(4).
  • Ready-to-eat Mackerel in Water, Tomato Sauce, Hot Tomato Sauce and Soya Oil imported by your firm and manufactured by (b)(4) located in (b)(4)
Juice HACCP Violations
 
You must have and implement written procedures that describe the product specifications and affirmative steps for any juice you import into the United States to ensure that the juice has been processed in accordance with 21 CFR part 120 to comply with 21 CFR 120.14. However, you did not have such written procedures, nor did you have product specifications or affirmative steps for the Fruit of Life Coconut Water Diabetic Choice 100% Natural manufactured by (b)(4). located in (b)(4).
 
CGMP Violations
 
The FDA investigator observed the following significant violations of the Current Good Manufacturing Practice regulation for foods (21 CFR Part 110):
 
1.    You failed to provide, where necessary, adequate screening or other appropriate protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the FDA investigator observed 13 plastic strips in the loading dock that barred birds from entering the facility were cut and/or torn and three pigeons were observed roosting in the loading bay while the overhead door was open.
 
2.    Your firm failed to provide sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1). Specifically, the FDA investigator observed pallets were stored directly against walls and in aisles hampering cleaning and inspection.
 
3.    Your firm failed to store and dispose of rubbish to minimize the potential for waste becoming an attractant and harborage or breeding place for pests, as required by 21 CFR 110.37(f).  Specifically, your firm was storing numerous empty boxes just inside the overhead door in the loading dock, just beyond an overhead door left ajar. Empty boxes and other debris may contribute to pests and pest harborage sites within food storage areas of your facility.
 
Misbranding
 
1.    Even if your Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen products were not unapproved new drugs and misbranded drugs, they would be misbranded within the meaning of section 403(r)(1)(A) of the Act because the product website, http://www.bedessee.com, bears a nutrient content claim, but the products fail to meet the requirements to bear the claim.
 
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], 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 on the labeling of a food 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 website states, “[C]oconut water has . . . low levels of . . . calories.” Under 21 CFR 101.60(b)(2)(i)(A), the label or labeling of foods that have a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons may use the terms “low calorie,” “low source of calories,” and “low in calories” if they do not provide more than 40 calories per reference amount customarily consumed. Coconut water has a RACC greater than 2 tablespoons, and based on the levels of calories declared on the coconut water labels, your Fruit of Life Coconut Water with Pulp, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen products do not qualify for a low in calories claim. Therefore, these products are misbranded under section 403(r)(1)(A) of the Act.
 
2.    Your Fruit of Life Coconut Water and Marshall’s Sardines in Tomato Sauce product are 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 Label) does not meet the requirements of 21 CFR 101.9. Specifically,
  • The Marshall’s Sardines in Tomato Sauce product label fails to declare the serving size in a household measure in accordance with 21 CFR 101.9(b).
  • The saturated fat and transfat declarations on the Marshall’s Sardines in Tomato Sauce product label are not expressed in the format of 21 CFR 101.9(c) and (d).
  • The Fruit of Life Coconut Water labels bear nutrition information but fail to include the nutrients that are the subject of claims. For example, the website labeling bears the claims “Coconut water contains a unique combination of vitamins B and vitamin C” and “[R]ich in Nutrients: coconut water contains…magnesium, phosphorus, potassium.” However, the Nutrition Facts label for the frozen coconut water product label fails to list any of the B vitamins, phosphorous, magnesium or potassium and the remaining coconut water product labels fail to list any of the B vitamins, vitamin C, phosphorous or magnesium. When a claim about these nutrients is made, the amount of the nutrients present in a serving of the product must be declared in accordance with 21 CFR 101.9(c). We further note that to bear nutrient content claims, the food will also need to meet the nutritional requirements in the corresponding definition for the claims in 21 CFR 101.54. In addition, the declarations for most of the nutrients on the frozen coconut water label are not in the increments specified in 21 CFR 101.9(c) and the serving size is not based on fluid measure (e.g. fl. oz.). Additionally, the saturated fat and transfat declarations are not expressed in the format of 21 CFR 101.9(c) and (d).
3.      Your Fruit of Life Coconut Water frozen juice product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)] in that it purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food in accordance with 21 CFR 101.30.
 
This letter is not intended to be an all-inclusive list of the violations that may exist in connection with your products or their labeling. You are responsible for ensuring that your products are in compliance with the Act and its implementing regulations.  You should take prompt action to correct the violations in this letter. Failure to promptly correct the violations may result in legal action without further notice, including seizure and/or injunction.
 
We offer you the following labeling comments:
  • The 17.5 fl. oz. labels of your Fruit of Life Coconut Water With Pulp, Fruit of Life Coconut Water No Pulp, and Fruit of Life Coconut Water Diabetic Choice 100% Natural products appear to have been updated to comply with the new nutrition facts label format as set forth in the final rules titled Revision of the Nutrition and Supplement Facts Labels (81 Fed. Reg. 33742, May 27, 2016) and Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (81 Fed. Reg. 34000, May 27, 2016), which amended 21 CFR 101.9. However, your product labels are not in an appropriate format in accordance with the revisions to 21 CFR 101.9. The nutrition information on the 17.5 fl. oz. labels of the coconut water does not contain an additional column for nutrient values for the entire container. The new nutrition label format includes, in part, requirement that products that are packaged and sold individually and that contain at least 200 percent and up to and including 300 percent of the applicable reference amount must provide an additional column within the Nutrition Facts label that lists the quantitative amounts and percent Daily Values for the entire package, as well as a column listing the quantitative amounts and percent Daily Values for a serving that is less than the entire package (i.e., the serving size derived from the reference amount). The first column would be based on the serving size for the product, and the second column would be based on the entire contents of the package [21 CFR 101.9(b)(2)(i)(D)]. The RACC for coconut water is 8 fl. ounces. Your 17.5 oz. packages contain 200-300 percent of the RACC and therefore will be subject to the requirements of 21 CFR 101.9(b)(2)(i)(D). The final rules established compliance dates for the new requirements for nutrition labeling of July 26, 2018, for manufacturers with $10 million or more in annual food sales, and of July 26, 2019, for manufacturers with less than $10 million in annual food sales. We note, however, that FDA published a proposed rule on October 2, 2017, that would extend the compliance dates by approximately 1.5 years, to January 1, 2020, and January 1, 2021, respectively (see 82 Fed. Reg. 45753). We are currently reviewing and considering comments on the extension of the compliance date, and pending completion of this rulemaking we intend to exercise enforcement discretion with respect to the current July 26, 2018, and July 26, 2019, compliance dates. Although a conclusion about the applicable compliance date is pending, manufacturers may begin revising labels now to meet the new requirements. 
  • Your website states, “Other top nutrition values in coconut water . . . Rich in Nutrients: coconut water contains calcium, magnesium, phosphorus,. . . potassium and sodium . . . .”   Under 21 CFR 101.54(b)(1), the term “rich in” may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 20 percent or more of the Reference Daily Intake (RDI) or the Daily Reference Value (DRV) per reference amount customarily consumed (RACC). To the extent that you assert that your products are rich in calcium, magnesium, phosphorus, potassium, and sodium, we note that the declared values for calcium, potassium, and sodium on your Fruit of Life Coconut Water With Pulp, Fruit of Life Coconut Water No Pulp, Fruit of Life Coconut Water Diabetic Choice 100% Natural, and Fruit of Life Coconut Water 100% Natural Frozen labels are not at adequate levels to qualify for the products to be “rich in” these nutrients. Additionally, the product labels for these products fail to provide information about the magnesium and phosphorus content. 
  • The metric values declared for the serving size are not based on fluid measure. In addition, we question the accuracy of the declared values, for example on one of the 17.5 fl. oz. containers, the declared level of carbohydrates is less than the declared level of total sugars.
Please respond in writing within fifteen (15) working days from your receipt of this letter with the actions you plan to take in response to this letter. You should include in your response documentation such as revised SOPs, revised product labels and website labeling, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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 re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic 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.
 
Your written response should be sent to: Lillian C. Aveta, Compliance Officer, New York District Office, Office of Human and Animal Food Operations East, Division 1, Food and Drug Administration, 158-15 Liberty Ave., Jamaica, NY 11433. If you have any questions about the content of this letter please contact Ms. Aveta at 718-662-5576 or E-mail at lillian.aveta@fda.hhs.gov.
 
                                                           
Sincerely,
/S/ 
Ronald M. Pace
Program Division Director 
Office of Human and Animal Food Operations East – Division 1