Inspections, Compliance, Enforcement, and Criminal Investigations
Jes-Made Bakery 5/15/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
RETURN RECEIPT REQUESTED
May 15, 2009
Michael Jess Nugent, President
52 Concord Road
Aston, PA 19014-2935
Dear Mr. Nugent:
During inspections of your baked goods manufacturing plant at 52 Concord Road, Aston, PA, and a follow-up investigation, the Food and Drug Administration (FDA) documented serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). First, your packaged muffins, packaged doughnuts, and other, packaged bakery products made from doughnut dough are misbranded under sections 403(e), 403(i), and 403(w) of the Act [21 U.S.C. 343(e), 343(i), and 343(w)] and FDA's implementing regulations in Title 21, Code of Federal Regulations (CFR), Part 101. (b)(3).You may find the Act and regulations through links in FDA's home page at www.fda.gov.
During inspections of your Aston, PA plant on January 28 - February 1, 2008 and April 10-11, 2008, our investigator collected evidence regarding the labeling of your packaged muffins, doughnuts, and other bakery products made from doughnut dough. The inspections revealed that these packaged bakery products are unlabeled except for product identifier codes on the cardboard boxes that serve as the product packaging.
On January 22 and 23, 2009, FDA visited one of your wholesale customers. That investigation confirmed that the packaged bakery products sold to the customer were not labeled with the information required by the Act and FDA regulations, including information on major food allergens present in the products.
The label of a product is defined in section 201(k) of the Act [21 U.S.C. 321(k)] as "a display of written, printed, or graphic matter upon the immediate container of any article ...." The cardboard boxes containing your bakery products are the immediate containers of these products, and therefore the cardboard box must bear the label statements required under the Act.
Based on our inspections at your facility and the investigation conducted at your customer's facility, the labeling violations we noted are as follows:
1. Your packaged muffins, doughnuts, and other bakery products made from doughnut dough are misbranded within the meaning of section 403(w) of the Act [21 U.S.C. 343(w)] in that the labels of these products fail to declare the major food allergens present in these products 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:
• 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, 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)].
During the inspections, our investigator observed that your packaged muffins, doughnuts, and other doughnut dough bakery products are made from ingredients that contain major food allergens, including wheat, soy, milk and eggs. However, none of these major food allergens are declared on the labels of your finished products.
2. Your packaged muffins, doughnuts, and other bakery products made from doughnut dough are misbranded under section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] in that they are fabricated from two or more ingredients, but their labels fail to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, as required by 21 CFR 101.4.
3. Your packaged muffins, doughnuts, and other bakery products made from doughnut dough are misbranded under section 403(e)(1) of the Act [21 U.S.C. 343(e)(1)] in that they fail to bear the name and place of business of the manufacturer, packer, or distributor [see 21 CFR 101.5]; under section 403(e)(2) of the Act [21 U.S.C. 343(e)(2)] in that they fail to bear a net quantity of contents statement [see 21 CFR 101.105]; and under section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] in that they fail to bear the common or usual name of the food [see 21 CFR 101.3].
You should take prompt action to correct these violations. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure or injunction.
This letter may not list all the violations at your facility and on your product labels. You are responsible for ensuring that your processing plant operates in compliance with the Federal Food, Drug, and Cosmetic Act and all applicable regulations, including the Good Manufacturing Practice regulations (21 CFR Part 110). You are also responsible for ensuring that all of your products are labeled in compliance with the laws and regulations enforced by FDA. In addition to consulting the Act and Title 21 of the CFR, you may find it useful to visit our website at http://www.cfsan.fda.gov when reviewing your labels. For your information, we are enclosing a copy of FDA's Compliance Policy Guide 505.100, entitled "Bakery Products, Candy- 'Catch-All' or 'Shotgun' Ingredients Declaration." This guidance discusses FDA's current thinking on using a single "catch-all" ingredient statement for an assortment of baked goods or candies.
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. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and when you will complete the corrections.
Your response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions with regard to this letter, Ms. Bonner can be reached at 215-717-3074 or Lynn.Bonner@fda.hhs.gov.
Kirk D. Sooter
Acting District Director
Enclosure: CPG 7102.01
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Assistant Director, Bureau of Food Safety and Laboratory Services