Marjon Specialty Food, Inc 07-Nov-07

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-08-01

November 7, 2007

John D. Miller, President
Marjon Specialty Food, Inc.
3508 Sydney Road
Plant City, Florida 33566-1185

Dear Mr. Miller:

The U.S. Food and Drug Administration (FDA) inspected your firm, located at 3508 Sydney Road, Plant City, Florida 33566-1185, on June 19 and 20, 2007. We conducted this inspection, in part, to determine your compliance with current Good Manufacturing Practices, cGPM (Title 21, Code of Federal Regulations (21 CFR) part 110. During the inspection we also collected samples of your labels. Based on our review of your labels, your Marjon® Tofu Grills Mesquite Pepper Rub, Marjon® Edamame in Pods, and Marjon® Edamame Shelled products violate provisions of the Federal Food, Drug and Cosmetic Act (the Act): Regulations implementing requirements of the Act are found in 21 CFR. You may find the Act and the FDA regulations through links in FDA's home page at http.www.fda.gov.

The labeling violations we noted are as follows:

1. Your Marjon® Tofu Grills Mesquite Pepper Rub is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the label fails to declare the presence of the major food allergen milk, as required by section 403(w)(1). Specifically, the [redacted] Pepperoni Sprinkle," an ingredient in Marjon® Tofu Grills Mesquite Pepper Rub, contains whey powder, which contains milk protein.

Section 201(qq) of the Act [21 U.S.C. 321(qq)] defines as "major food allergens" 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. 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 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 (e.g., "whey [milk]"), 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)].

2. Your Marjon® Tofu Grills Mesquite Pepper Rub is also misbranded under section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and fails to declare the common or usual name of each ingredient (see 21 CFR 101.4). For example the label for the [redacted] Pepperoni Sprinkle," which is used as an ingredient in the Marjon® Tofu Grills Mesquite Pepper Rub, identifies the sub-ingredients whey powder, dextrose and citric acid; which are not listed on your finished product label.

3. Your Marjon® Tofu Grills Mesquite Pepper Rub is further misbranded under Section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling is false and misleading. The term "NO PRESERVATIVES" is found on the finished product package when in fact the ingredient listing declares "sodium benzoate less than 1/10 of 1% as a preservative."

4. Your Marjon® Edamame in Pods and Marjon® Edamame Shelled products are misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. 343(r)(1)(B)] because the labels bear unauthorized health claims. Although these claims concern substance-disease relationships for which certain health claims are authorized by regulation, they do not meet the requirements of the authorizing regulation in 21 CFR Part 101, Subpart E. The following are examples of such claims:

The product label bears the claim "Health researchers have long noted that Asian countries (where soy foods have been a staple part of the diet), show lower rates of heart disease, breast cancer. . . than in the U.S."

The breast cancer portion of the statement is an unauthorized implied health claim because there is no authorized health claim for soy foods and its relationship to breast cancer.

The statement concerning lower rates of heart disease, as written, does not contain all of the elements required in order to make an authorized health claim for soy protein and coronary heart disease (CHD) under 21 CFR 101.82. For example, (1) the claim on your product does not make the association that diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease, and (2) the claim does not indicate that such a diet "may" or "might" reduce the risk-of CHD, and (3) this claim does not include the contribution one serving of the product makes to the specified daily intake level of 25 g or more per day of soy protein. [21 CFR 101.82(c)(2)(A) and (G)]. We also note that since saturated fat and cholesterol are two different food components, these two terms should be separated by the word "and."

You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure and injunction.

The above violations concern certain labeling requirements and are not meant to be an all-inclusive list of deficiencies in your products and their labeling. Other violations can also subject the food to legal action. It is your responsibility to assure that all of your products are in compliance with all applicable statutes and regulations enforced by FDA.

Please notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific things that you are doing to correct the violations described above. You should include in your response documentation of your corrective actions, such as revised labels, revised procedures or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.

In addition to the violations described above, we have the following concerns about your product labels:

1. Your Marjon® Tofu Grills Mesquite Pepper Rub ingredient listing has intervening information, which should not be included Under 21 CFR 101.2(e), all information required to appear on the information panel shall appear without intervening material. Your ingredient statement, in part, includes the following intervening material (see underlined words): Organic Soy Beans (GMO free), Natural Nigari (an extract of seawater), and Naturally Brewed soy sauce.

2. Single ingredient foods must comply with the allergen declaration requirements in section 403(w)(1). Consistent with our allergen labeling guidance document [see http://www.cfsan.fda.gov/~dms/alrguid4.html (see question 28)], a single ingredient food, such as your Marjon® Edamame Shelled product, that is or contains protein derived from soybeans, may identify the food source either in the name of the food or by use of the "Contains" statement format. The labels for your Marjon® Edamame Shelled product and Marjon® Edamame In Pods do not include the allergen declaration "soybean" as either part of the name of the food on the Principal Display Panel (PDP) or as a "Contains" statement. While we recognize that the term soybean appears in a number of places on the label, it does not appear in the name of the food or in a "Contains" statement.

3. The declaration of "Calories" in, the nutrition information for Marjon® Tofu Grills Mesquite Pepper Rub, Marjon® Edamame In Pods, and Marjon® Shelled Edamame is not in 10 calorie increments. In accordance with 21 CFR 101.9(c)(1), calories above 50 calories must be declared in 10-calorie increments.

4. The declaration of Trans Fat and Saturated Fat in the nutrition information for Marjon® Edamame in Pods, and Marjon® Shelled Edamame are not declared in the correct order. In accordance with 21 CFR 161.9(c)(2), Trans Fat follows the declaration of Saturated Fat.

During "our inspection, our Investigator provided you with a copy of the FDA 483, Inspectional Observations, which delineated sanitation deficiencies. We acknowledge receipt of your letter dated June 22, 2007, stating your completed and intended corrections to the sanitation deficiencies listed on the FDA, 483 issued to your firm on June 20, 2007. We do not consider this response adequate because you did not provide supporting documentation.

You are responsible for ensuring that your processing plant operates in compliance with the Act and the Current Good Manufacturing Practices Regulation (21 CFR Part 110)According to your records, you sample irrigation water for pathogen testing once per week. FDA recommends that you test for pathogens by collecting a sample of spent irrigation. water from each production lot or batch. The provisions of part 110 as well as FDA guidance for sprouts, which can be found at http://vm.cfsan.fda.gov/~dms/sprougdl.html and http://vm.cfsan.fda.gov/~dms/sprougd2.html are designed to assist you in reducing the risks of pathogen contamination and growth in your product. You have a responsibility to use procedures to prevent violations of the Act and all applicable regulations.

Please send your reply to the U.S. Food and Drug Administration, Attention: Matthew B. Thomaston, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issue. in this letter, please contact Mr. Thomaston at (407) 475-4728.

Sincerely,

/S/

Emma R. Singleton
Director, Florida District