Inspections, Compliance, Enforcement, and Criminal Investigations
Paul Meserve Distributor 24-May-05
Department of Health and Human Services
Public Health Service
New England District
VIA FEDERAL EXPRESS
May 24, 2005
Paul J . Meserve, Owner
Deanna Meserve, Owner
Paul Meserve Distributor
209 Mosher Road
Gorham, ME 04038-5838
Dear Mr. and Mrs. Meserve,
The Food and Drug Administration (FDA) conducted an inspection of your facility, Paul Meserve Distributor, located at 209 Mosher Road, Gorham, ME on February 2 and 9, 2005. During the inspection, physical samples and representative product labeling for your product "Original Squire Mountain Sharp Cheddar Tub Cheese" were collected. Review of the labeling for this product found serious violations of Section 403 of the Federal Food Drug and Cosmetic Act (the Act)(21 U.S.C.343), and Title 21 Code of Federal Regulations Part 101 (21 C.F.R. Part 101).
Your "Original Squire Mountain Sharp Cheddar Tub Cheese" is misbranded within the meaning of Section 403(i)(2) of the Act (21 U.S.C. 343(i)(2) because the ingredient statement fails to bear the common or usual name of each of the component ingredients of several main ingredients which themselves contain two or more ingredients, as required by 21 CFR 101.4(b)(2). For example, the label for the [redacted] main ingredient lists VEGETABLE MONO AND DIGLYCERIDES" and "SOY LECITHIN" among its ingredients; however, your product's ingredient statement does not include these ingredients. This requirement may be met either by parenthetically listing all the component ingredients after the common or usual name of the main ingredient or, by listing all the component ingredients without listing the common or usual name of the main ingredient. Under the first alternative, the component ingredients must be listed in descending order of predominance in the main ingredient; under the second alternative, the component ingredients must be listed in descending order or predominance in the finished food. Declaration of the soy lecithin is of particular concern because soy is an allergenic substance. For sensitive individuals, the presence of allergens in food is potentially life-threatening.
The above violations are not intended to be an all-inclusive list of deficiencies. 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.
You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure of these misbranded products and/or injunction of your facility to prevent continued violation of the Act.
We also note that the statement of identity "SHARP CHEDDAR TUB CHEESE" does not adequately describe your product as required by 21 CFR 101.3(b) and 102.5. Based on the information you provided us during the inspection, your product is manufactured by [redacted].Your product does not satisfy the requirements for a "cheddar cheese," as set out by 21 CFR 133.113. Further, your product does not appear to be a "cheese" at all under the terms of 21 CFR Part 133. "Tub cheese" is not a sufficiently descriptive term for your statement of identity as required by 21 CFR 101.3(b)(3). We are not aware of "tub cheese" as a usual or common name for any food permitted by 21 CFR 101.3(b)(2), nor is it fanciful term commonly used by the public, as permitted by 21 CFR 101.3(b)(3)).
FDA has regulations that govern the labeling of foods whenever the label makes any representation or designation of the type of flavor(s) in a food (e.g ., cheddar cheese flavor), other than in the ingredient statement. You should look to FDA's regulations to determine how to properly describe your product in the statement of identity. If a food contains no artificial flavor that simulates the characterizing flavor, then the name for the food on the principal display panel must simply be accompanied by the common or usual name of the characterizing flavor (e.g ., Cheddar Cheese Flavored Cheese Spread) [21 CFR 101.22(i)(1)]. However, different rules apply if the characterizing flavors are derived from artificial flavors. When artificial flavors are used, the name of the food must be accompanied by the name of the characterizing flavors and the word(s) "artificial" or "artificially flavored" (e .g ., Artificially Flavored Cheddar Cheese Spread) [21 CFR 101.22(i)(2)].
In addition, we note that the ingredient statement on your product "Original Squire Mountain Sharp Cheddar Tub Cheese" lists "FLAVOR AND COLOR INGREDIENTS" and "PRESERVATIVE INGREDIENTS," but that listing does not comply with the regulations governing the listing of colors, flavors, and preservatives on ingredient labels. Non-certified colors, such as [redacted] must be declared in the manner required by 21 CFR 101.22(k)(2) (e.g ., "artificial color" or "colored with [redacted]. Flavors must be declared in the manner required by 21 CFR 101.22(h). As required by 21 CFR 101.22(j), preservatives must be listed by stating both the common or usual name of the ingredient and a separate description of its function (e.g., EDTA as a preservative).
Further, we note that the ingredient statement on your product "Original Squire Mountain Sharp Cheddar Tub Cheese" lists "SOYBEAN OILS," but the ingredient statement for the [redacted] which is an ingredient in your product and the source of its soybean oil content, identifies this oil as "PARTIALLY HYDROGENATED SOYBEAN OIL ." Fats or oils that are ingredients in food must be declared on the statement of ingredients in the manner required by 21 CFR 101.4(b)(14), including identification of hydrogenated or partially hydrogenated oils as such.
Additionally, the product label does not include the full name of your company and your current place of business as required by 21 CFR 101.5(a).
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you will take to correct these violations, including an explanation of steps that will be taken to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Please send your reply to the Food and Drug Administration, Attention: Anthony P. Costello, Compliance Officer, 1 Montvale Avenue, Stoneham, MA 02180.
Gail I. Costello
New England Officer