Inspections, Compliance, Enforcement, and Criminal Investigations

Raymond-Hadley Corp. 6/26/15

  

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

Public Health Service
Food and Drug Administration
 
New York District
158-15 Liberty Avenue
Jamaica, NY 11433 

 

                                                                                                                                                                                                   
                                                                                                                                                               
  June 26, 2015
 
WARNING LETTER NYK-2015-40 
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Jacinto S. Maratea
Chief Executive Officer
Raymond-Hadley Corp.
89 Tompkins Street
Spencer, NY 14883-9759
                                   
Dear Mr. Maratea:
 
The U.S. Food and Drug Administration (FDA) inspected your facility located at 89 Tompkins Street, Spencer, NY 14883-9759 on October 20-29, 2014. During our inspection, FDA investigators obtained product labels for several of your products. We have reviewed these labels and concluded that your Pride of Africa brand Semo “Semolina,” Pride of Africa brand Enriched Farina, and New Hope Mills Gluten Free Chia Pancake & Waffle Mix products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 301 et seq.] and the applicable regulations found in 21 CFR Part 101. You can find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
 
We acknowledge your submission of a report to the Reportable Food Registry (RFR) and recall of your New Hope Mills Gluten Free Chia Pancake and Waffle Mix due to undeclared soy, however, this report was not submitted within 24 hours after you determined that a food was a reportable food as required by section 417(d)(1)(A) of the Act, [21 U.S.C. § 350f]. Specifically, your firm’s management was notified on 9/18/14 by an employee that a private label pancake and waffle mix contained soy flour but did not have soy declared on the label, but your firm did not initiate the submission of a reportable food report until 10/15/14. We also acknowledge the recall of your Pride of Africa Enriched Farina and Pride of Africa Semo “Semolina” products due to undeclared wheat. However, you have not reported specific corrective action and timeframes for the review of all your products and ingredients to assure that all allergens are accounted for in your production and packaging operations. Since 2004, your firm has recalled eight other products for undeclared sulfites, soy or milk.
 
Your significant violations are as follows:
 
1.    Your Pride of Africa brand Semo “Semolina”, Pride of Africa brand Enriched Farina, and New Hope Mills Gluten Free Chia Pancake & Waffle Mix products are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] in that the labels fail to declare the major food allergens, wheat and soy, as required by section 403(w)(1) of the Act. 
 
Section 201(qq) of the Act, 21 U.S.C. § 321(qq), defines a major food allergen as 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 certain exceptions, e.g., highly refined oils derived from a major food allergen.  A food is misbranded 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 word “Contains,” followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients [section 403(w)(1)(A) of the Act, 21 U.S.C. § 343(w)(1)(A)], or
  • 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, except that 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)].
 
Specifically, your New Hope Mills Gluten Free Chia Pancake & Waffle Mix product is manufactured using defatted soy flour; however, your labels fail to declare the major allergen soy.
 
Your Pride of Africa brand Enriched Farina product is manufactured using wheat; however, your label fails to declare the major allergen wheat.
 
Your Pride of Africa brand Semo “Semolina” product is manufactured using wheat; however, your label fails to declare the major allergen wheat. A single ingredient food that is, or contains protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, or soybeans, may identify the food source in the name of the food (e.g., "all-purpose wheat flour") or use the "Contains" statement format. FDA recommends that if a "Contains" statement format is used, the statement be placed immediately above the manufacturer, packer, or distributor statement. For single ingredient foods intended for further manufacturing where the "Contains" statement format is used, the statement should be placed on the principal display panel of the food.
 
2.    Your New Hope Mills Gluten Free Chia Pancake & Waffle Mix product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because 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 requirement pertaining to nutrient content claims for that nutrient causes the product to be misbranded under section 403(r)(1)(A) of the Act. 
 
The label for the Chia Pancake & Waffle Mix product bears the claim “Exploding in antioxidants.” Nutrient content claims using the term “antioxidant” must comply with, among other requirements, the requirements listed in 21 CFR 101.54(g). Such a claim must include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term “antioxidant” or “antioxidants” may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity (21 CFR 101.54(g)(4)). Your claim “Exploding in antioxidants” does not include the names of all the nutrients that are the subject of the claim as part of the claim, or use a symbol to link the term “antioxidants” to a symbol that appears elsewhere on the same panel of the product label followed by the names of the nutrients. Hence, the claim fails to comply with 21 CFR 101.54(g)(4). Furthermore, it is unclear whether the product meets the requirements under 21 CFR 101.54(g)(1)-(3) for antioxidant nutrient content claims. The Nutrition Facts Panel of the chia pancake & waffle mix lists two antioxidants, Vitamin A and Vitamin C. However, the declared daily value of these nutrients is 0%. The labeling does not indicate whether the product contains any other antioxidants.  Therefore, we are unable to ascertain whether the claim “Exploding with antioxidants” applies to nutrients that have an established RDI (21 CFR 101.54(g)(1)) and recognized antioxidant activity (21 CFR 101.54(g)(2)). We also note that under 21 CFR 101.54(g)(3), the level of the nutrient subject to the claim must be sufficient to qualify for the 21 CFR 101.54 (b), (c), or (e) claim. “Exploding in” is not a defined term, and even if it was an authorized synonym for a defined term such a “good source” or “high” it is unclear if the product contains any antioxidant in an adequate level to bear those claims.
 
Your product label also bears the unauthorized nutrient content claim “rich in omega-3 fatty acids.” Under section 403(r)(l)(A) of the Act, a nutrient content claim in food labeling must be made in accordance with a regulation authorizing the use of the claim. FDA has issued a regulation specifying criteria for the use of the nutrient content claim “high” in food labeling, which also applies to the synonymous claim “rich in” (see 21 CFR 101.54(b)(1)). This regulation requires a food that bears these claims to contain 20 percent or more of the Daily Value (DV) of the nutrient per reference amount customarily consumed. However, this regulation does not authorize your claims because there is no DV for omega-3 fatty acids. Therefore, the use of the term “rich in” to characterize the level of omega-3 fatty acids misbrands your product under section 403(r)(1)(A) of the Act.
 
Your product label also bears the unauthorized nutrient content claims “Provides more calcium than 2% milk”, “Boasts more omega oils, protein, fiber and calcium than flax seed” and “Contains More Soluble Fiber than Bran Flakes.” These claims are not made in accordance with 21 CFR 101.54(e), as described below.
  • FDA considers a claim about an ingredient in a food to be an implied claim about the food itself. Therefore, although the above claims are made under the heading “Chia Facts,” they are only permissible if your Chia Pancake & Waffle Mix product meets the requirements to bear the claims.
o    Under 21 CFR 101.54(e)(1)(i), your Chia Pancake & Waffle Mix product cannot bear the claim “provides more calcium than 2% milk” unless a serving of the mix contains at least 10 percent more of the RDI for calcium (expressed as a percent of the Daily Value (%DV)) per reference amount customarily consumed (RACC) than 2% milk. Our review of nutrition information for this food and for 2% milk[1] indicates that the level of calcium in this food (15 %DV) is less than the level of calcium in a serving of 2% milk (29%DV). Therefore, this claim does not meet the requirements of 21 CFR 101.54(e).
o    Similarly, this product cannot bear the claim “Boasts more …, fiber and calcium than flax seed” unless a serving of the mix contains at least 10 percent more of the DV for fiber and calcium per RACC than flax seed. Below is a table for the two products:
 

Food
RACC
%DV Calcium
%DV fiber
Pancake/waffle mix
40 g
15
8
Flax seed nutrient values per USDA Database
30 g
7.5
32

 
Our review of the nutrition information for this food compared to flax seed indicates that the declared %DV of fiber on the pancake mix is less than the calculated %DV of fiber in flax seed. The declared %DV of calcium on the pancake mix is not at least 10% more than the calculated %DV for a RACC of flax seed. For these reasons, the claim does not meet the requirements of 21 CFR 101.54(e).
 
o   This product also cannot bear the claim, “Boasts more . . . protein . . . than flaxseed.” Under 21 CFR 101.9(c)(7), a statement of the corrected amount of protein per serving, expressed as a %DV, must be given if a protein claim is made for the product. Your product does not include such a statement.  Under 21 CFR 101.54(a)(3), a “more” claim can only be made if the food is labeled in accordance with 21 CFR 101.9.
 
  • Your product label also bears the unauthorized nutrient content claim “Contains More Soluble Fiber than Bran Flakes.” Comparative claims that use the term “more” are discussed in relation to the difference in the Daily Reference Value (DRV) or Reference Daily Intake (RDI) established for the nutrient in the claim. There is no DRV for soluble fiber. 
  • Similarly, the claim “Boasts more omega oils . . . than flax seed” is an unauthorized nutrient content claim. The reference to “omega oils” is an implied claim about omega-3 fatty acids. As discussed above, there is no DV for omega-3 fatty acids.
3.    Your New Hope Mills Gluten Free Chia Pancake & Waffle Mix product is misbranded within the meaning of section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that the labeling bears a health claim that was not authorized by FDA. Your product label bears a claim that suggests a relationship exists between a nutrient in the food and a disease or health-related condition. Specifically, your product label bears the following claim: “Heart Health – Soluble fiber may help lower total and LDL (bad) cholesterol.”
 
A health claim expressly or by implication characterizes the relationship between a substance and a disease or health-related condition (21 CFR 101.14(a)(1)). Substance means a specific food or component of food (21 CFR 101.14(a)(2)). The soluble fiber that is a component of your product is a substance within the meaning of 21 CFR 101.14(a)(2), and your label characterizes the relationship of this substance to a disease or health-related condition (i.e., coronary heart disease[2]). Because the product label bears a health claim that is not authorized by FDA either by regulation (see section 403(r)(3)(A)-(B) of the Act [21 U.S.C. § 343(r)(3)(A)-(B)]) or under authority of the health claim notification provision of the Act (see section 403(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)]), the product is misbranded within the meaning of section 403(r)(1)(B) of the Act.

 

4.    Your Pride of Africa brand Enriched Farina and Semo “Semolina” 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 presented in the appropriate format in accordance with 21 CFR 101.9. For example:

  • Folic acid is not declared on your Pride of Africa brand Enriched Farina product label, as required by 21 CFR 101.9(c)(8)(ii).
  • Your Pride of Africa brand Semo “Semolina” product label fails to declare a serving size based on the reference amount customarily consumed (RACC) and in a common household measure as required by 21 CFR 101.9(b)(5) and 21 CFR 101.12(b). The product label declares 10g; however, the appropriate RACC for “Flours or cornmeal” is 30g. The serving size shall be the amount in household measure that most closely approximates the reference amount of 30g in accordance with 21 CFR 101.9(b)(2)(iii).

5.    Your firm’s Pride of Africa brand Enriched Farina product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it is fabricated from two or more ingredients, however the label fails to bear a complete list of all ingredients by common or usual name, as well as all sub-ingredients, as required under 21 CFR Part 101.4. Your Pride of Africa Enriched Farina flour product label does not bear an ingredient statement, as required in 21 CFR 101.4(a)(1).

 
The above is not intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that all of your products are in compliance with the Act and all applicable regulations. You should take prompt action to correct the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action, including seizure and injunction, without further notice.
 
We also offer the following comments:
  • New Hope Mills Gluten Free Chia Pancake & Waffle Mix product label declares an “Auburn, New York” address. In accordance with 21 CFR 101.5(c), where the food is not manufactured by the person whose name appears on the label, the name must be qualified by a phrase that reveals the connection such person has with such food; such as “Manufactured for ___”, “Distributed by___”, or any other wording that expresses the facts.  We note that the statement of the place of business does not include a street address for your Pride of Africa brand Enriched Farina and Semo “Semolina” products. The street address may only be omitted if it is shown in a current city directory or telephone directory as required by 21 CFR 101.5(d).
 
Please respond in writing within fifteen working days from your receipt of this letter.  Your response should outline the specific steps you are taking to correct the violations noted above. You should include in your response documentation and any 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 re-inspection related costs. A re-inspection 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. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection 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 re-inspection 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 re-inspection related costs. 
 
Please send your written response to Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) 662-5576 or Email at Lillian.Aveta@fda.hhs.gov.
 
 
Sincerely yours,
/S/ 
Ronald M. Pace
District Director
New York District


[1] USDA Nutrient Data Base Standard Reference for 1 cup 2% milk vitamin A and D added (http://ndb.nal.usda.gov/ndb/foods/show/72?fgcd=&manu=&lfacet=&format=&count=&max=35&offset=70&sort=&qlookup=)
[2] High blood total- and low density lipoprotein (LDL)-cholesterol levels are associated with increased risk of developing coronary heart disease.

 

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