|Company:||Everything Spelt Company, Inc.|
|Subject:||False & Misleading Claims/Misbranded|
|Issuer:||New York District Office|
|Issued:||March 30, 2007||Closed:||
Department of Health and Human Services
Public Health Service
Food and Drug Administration
New York District
March 30, 2007
WARNING LETTER NYK 2007-14
RETURN RECEIPT REQUESTED
Simone Fried, President
Everything Spelt Company, Inc.
415 Spook Rock Rd.
Unit B 102
Suffern, NY 10901
Dear Ms. Fried:
On November 1 and 13, 2006, an investigator from the Food and Drug Administration (FDA) conducted an inspection of your facility located at 415 Spook Rock Rd., Unit B102, Suffern, NY. During this inspection, the investigator collected labels from several of your products. After reviewing the labels for your Spelt Challah Medium, Spelt Sandwich Loaf, Original Whole Spelt Bread, Whole Spelt Challah, and Pan Crust Pizza products, the information on your firm's website at http://www.everythingspelt.com, and other evidence collected during our investigation, FDA concludes that these products violate provisions of the Federal Food, Drug, and Cosmetic Act (the Act). In addition, your facility is not registered with FDA as required by the Act [21 U.S.C. 350d]. Regulations implementing requirements of the Act are found in Title 21, Code of Federal Regulations (21 CFR). You may find the Act and the FDA regulations through links in FDA's home page at http://www.fda.gov.
Spelt Challah Medium, Spelt Sandwich Loaf, Original Whole Spelt Bread, Whole Spelt Challah, and Pan Crust Pizza:
• These 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 presence of the major food allergen wheat, as required by section 403(w)(1).
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:
(1) 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
(2) 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)]).
Each of these products is manufactured with spelt, which is Triticum spelta L. The term "wheat" in section 201(qq) means any species in the genus Triticum. Thus, for the purposes of section 201(qq), wheat includes grains such as spelt.
• These products are misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labels bear false and misleading statements. For example, your Spelt Challah Medium, Spelt Sandwich Loaf, Original Whole Spelt Bread, and Whole Spelt Challah products claim that these products are a "Wheat Alternative" and are made "in a wheat free environment." Your Pan Crust Pizza label bears the statement "ideal for many who have allergies or intolerances to wheat." These statements are false and misleading because they suggest that the products do not contain wheat, when in fact they are made with spelt, which is a variety of wheat.
• These products are also misbranded under section 403(q) of the Act [21 U.S.C. 343(q)] because the nutrition information on their labels does not comply with the format and content requirements in FDA's regulations. For example:
1. Your Spelt Challah Medium, Spelt Sandwich Loaf, Original Whole Spelt Bread, and Whole Spelt Challah products fail to declare trans fat [21 CFR 101.9(c)(2)(ii)]. Your Pan Crust Pizza incorrectly declares the trans fat amount as "0%" rather than declaring the number of grams of trans fat in a serving. Regulations requiring the declaration of trans fat went into effect on January 1, 2006 (see 21 CFR 101.9(c)(2)(ii); 68 FR 41433). You should review all of your product labels to ensure they comply with these regulations. For additional information on trans fat labeling, go to http://www.cfsan.fda.gov/~dms/lab-cat.htm#transfat .
2. For your Pan Crust Pizza, the label fails to declare a percent Daily Value (DV) for Total Fat [21 CFR 101.9(d)(7)(ii)].
3. The labels of all five products state "spelt is also higher in B vitamins." In addition, the products bear the claim "more protein than wheat" or, in the case of Pan Crust Pizza, "more protein than regular wheat." However, the nutrition information on the product labels does not declare the percent DV for protein and the various B vitamins. When a claim about these nutrients is made, the amount of the nutrient present in a serving of the product must be declared as a percentage of the DV [see 21 CFR 101.9(c)(7)(i),(c)(8)(ii)].
• Finally, the products are misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] because they bear nutrient content claims but fail to meet the requirements for making such claims. The labels of your Spelt Challah Medium, Spelt Sandwich Loaf, Original Whole Spelt Bread, and Whole Spelt Challah products state "spelt is a healthy and delicious wheat alternative containing more fiber, more protein and more iron than wheat ." The label of your Pan Crust Pizza states "spelt is a healthy and delicious wheat, containing more fiber, more protein and more iron than regular wheat ." These claims represent that the products contain more fiber, protein, and iron than products made with other varieties of wheat. The regulation defining the nutrient content claim "more" [21 CFR 101.54(e)] limits the use of this claim to foods that contain at least 10% more of the DV for the nutrient than a reference food identified in the claim and that provide quantitative information comparing the level of the nutrient in the food that bears the claim with the amount of the same nutrient in the reference food. Your Spelt Challah Medium, Spelt Sandwich Loaf, Original Whole Spelt Bread, Whole Spelt Challah, and Pan Crust Pizza do not qualify for making "more" claims about fiber, protein, or iron because the product labels fail to provide comparisons of nutrient content by weight and by percentage or fraction of the DV, as required by 21 CFR 101.54(e). Further, based on your labels, these products do not qualify for making a "more" claim about iron because they provide less than 10% of the DV for iron per reference amount customarily consumed (reference amount). Finally, the Spelt Challah Medium and Spelt Sandwich Loaf do not qualify for a "more" claim about fiber because they provide less than 10% of the DV for fiber per reference amount.
Pan Crust Pizza:
• This product is 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 its label fails to declare the common or usual name of each ingredient as required by 21 CFR 101.4. Specifically, the label declares the multi-ingredient, standardized food mozzarella cheese [see 21 CFR 133.155], but fails to declare the component ingredients of this food. As specified in 21 CFR 101.4(b)(2), the requirement to list these component ingredients may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
• Your Pan Crust Pizza product is misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that its label bears the claims "healthy" and "no sugar added," but your product does not qualify to make these claims. Your product fails to meet the requirements for a "healthy" claim because it is not a "low fat" and "low in saturated fat" food [21 CFR 101.65(d)(2)(i)]. The product also fails to meet the requirements for a "no sugar added" claim because (1) the product does not bear a statement that the food is not "low calorie" or "calorie reduced," and (2) the claim is not accompanied by a statement directing consumers to the nutrition panel for further information on sugar and calorie content [21 CFR 101.60(c)(2)(v)].
• Your Pan Crust Pizza product is fu rther misbranded under section 403(q)(1)(A) of the Act [21 U.S.C .343(q)(1)(A)] in that the product bears incorrect serving size information. Your product bears a serving size of 1 slice (76 g); however, the reference amount for this product is 140g under "Mixed Dishes, Not measurable with cup" [21 CFR 101.12(b)]. In accordance with 21 CFR 101.9(b)(6), a product that is packaged and sold individually and that contains less than 200% of the applicable reference amount shall be considered to be a single serving container, and the entire contents of the package shall be labeled as one serving, except that for products that have a reference amount of 100 g (or ml) or larger, such as your Pan Crust Pizza, the manufacturer may decide whether a package that contains more than 150% but less than 200% of the reference amount is 1 or 2 servings. The Pan Crust Pizza weighs 227 grams and contains 3 slices (76 g each). Thus, because the package contains 162% of the reference amount, under 21 CFR 101.9(b)(6) the product must be labeled as either 1 serving [3 slices (227 g)] or 2 servings [2 slices (152 g)]. Because the labeled serving size for Spelt Pan Crust Pizza is smaller than the serving size regulations allow, the values for the declared nutrients are only 1/3 of the amount they should be if the pizza were labeled as a single serving, or 1/2 the amount they should be if the pizza were labeled as 2 servings.
Spelt Challah Medium and Spelt Sandwich Loaf:
Your Spelt Challah Medium and Spelt Sandwich Loaf products are also misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear the nutrient content claim "good source of fiber", but the products do not qualify to make this claim. The term "good source of fiber" may be used in the labeling of foods only if the food contains 10 to 19 percent of the Daily Reference Value (DRV) of fiber per reference amount [21 CFR 101.54(c)]. The reference amount for these bread products is 50 grams . Based on the information declared on the Nutrition Facts panels of the product labels, these products contain 4% of the DRV per 28 gram se rvings, which is only about 7% of the reference amount. We note that your website also states that the Spelt Sandwich Loaf is a "Good Source of Fiber."
Additionally, the Food and Drug Administration has determined that your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. 350d], and our implementing regulation at 21 CFR Part 1, Subpart H. During our inspection of your facility, you were advised of this requirement. The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. 331(dd)]. Our records indicate that, to date, this facility has not been registered with FDA.
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.
The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, must register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov/ . We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.
Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or (301) 575-0156, or by writing to the agency at the following address:
U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857
When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.
This letter is not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility as top management to ensure that your establishment complies with all requirements of the Act and FDA regulations. Failure to promptly correct the violations described above may result in regulatory action without further notice. Such actions may include seizure and injunction.
Please respond to this office in writing within 15 working days of receipt of this letter and describe any steps you have taken or will take to correct the noted violations and to prevent their recurrence. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
In addition to the labeling violations above, we have several additional comments. First, we noticed that your website at www.everythingspelt coin claims that spelt is a "wheat alternative," "an alternative to wheat," and "ideal for most people with allergies or intolerances to wheat." As explained above, such claims are false and misleading because spelt is a variety of wheat.
We also draw your attention to the requirements for relative nutrient content claims, which are label claims that compare the level of a nutrient in the labeled food to the level of the same nutrient in another food, the "reference food" [see 21 CFR 101.13(j)]. These requirements apply to the claim "spelt is also higher in B vitamins," which appears on the labels of all five of your products discussed above, because the claim compares the level of B vitamins in spelt to the level of B vitamins in an unnamed reference food. From the context of the claim, it appears that the reference food is intended to be one or more other varieties of wheat that are not specified. By regulation, relative nutrient content claims are required to include certain key information to facilitate accurate comparisons between products and prevent consumer confusion. Among other things, a relative claim must identify the reference food, must state the percentage or fraction by which the amount of the nutrient in the labeled food differs from that in the reference food, and must include a clear and concise quantitative comparison of the amount of the nutrient per labeled serving in the labeled food with the corresponding amount in the reference food [21 CFR 101.13(j)(2).
After reviewing the required information on your product labels, we note that the manufacturer address on your Spelt Challah Medium, Spelt Sandwich Loaf, Original Whole Spelt Bread, Whole Spelt Challah, and Pan Crust Pizza does not include a zip code [21 CFR 101.5(d)]. In addition, the name and address are separated by intervening material. Under 21 CFR 101.2(e), all required statements on the information panel of a food label must appear in one place without other intervening material. We also note that the ingredient statement for your Spelt Challah Medium label declares "For Coating: Fresh Eggs." The terms "Fresh" and "For Coating" are considered intervening material under 21 CFR 101.2(e).
We have two observations about the format of the Nutrition Facts on your product labels. First,under 21 CFR 101.9(d)(1)(v), the "Amount Per Serving" heading must be separated from the calorie statements by a hairline centered between the lines of text. In addition, the regulation requires each nutrient and its corresponding percent DV to be separated from the nutrient and percent DV above and below it by a hairline. On your product labels, the hairlines between the vitamin and mineral nutrients are missing, as is the hairline under "Amount per Serving."
Second, the ingredient statement on your products appears within the Nutrition Facts panel, immediately below the nutrition information. Under FDA regulations, the nutrition information on the label of a food must be set off in a box by hairlines [21 CFR 101.9(d)(1)(i)], and no food components other than the nutrients listed as mandatory or voluntary in 21 CFR 101.9(c) may be included within the box [see 21 CFR 101.9(c)]. Therefore, your ingredient statement should be moved outside the Nutrition Facts panel.
We acknowledge receipt of your written response to the Inspectional Observations Form FDA-483 issued to you at the close of the inspection; however, the response does not provide information concerning corrections specific to the above labeling and registration deficiencies. It also does not address what your intentions are concerning misbranded products still in the marketplace or the disposition of violative labels still in stock.
Your reply should be directed to Compliance Officer Richard T. Trainor, U.S. Food & Drug Administration, 300 Hamilton Avenue, White Plains, NY 10601.
Otto D. Vitillo
New York District