Inspections, Compliance, Enforcement, and Criminal Investigations
Regco Corporation, Inc. 29-Jun-06
Department of Health and Human Services
Public Health Service
New England District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
June 29, 2006
Regina A. Ragonese, President
Regco Corporation, Inc.
46 Rogers Road
Haverhill, MA 01835-6935
Dear Ms . Ragonese:
We inspected your food manufacturing and distribution facility, Regco Corporation, located at 10 Avco Road, Haverhill, MA, on February 14-15, 2006. During the inspection, we collected a physical sample of your product, Regenie's Thin Cut Crunchy Pita Chips, 2 oz. package (garlic parmesan flavor). We also collected labeling for your products, Regenie's Thin Cut Crunchy Pita Chips, 6 oz. packages (habanero salsa, garlic parmesan, tomato basil parmesan, and cinnamon maple sugar flavors). The inspection was conducted to determine your company's compliance ,with the Federal Food, Drug, and Cosmetic Act (the "Act") and its implementing regulations in Title 21 of the Code of Federal Regulations (21 CFR). You can find copies of the Act and FDA's regulations through links on FDA's Internet home page at http://www.fda.gov.
Your Regenie's Thin Cut Crunchy Pita Chip products 6 oz. packages (habanero salsa, garlic parmesan, tomato basil parmesan, and cinnamon maple sugar flavors) and Regenie's Thin Cut Crunchy Pita Chips, 2 oz. package (garlic parmesan flavor), are misbranded under section 403(r)(1)(A) of the Act [21 U.S.C. 343(r)(1)(A)] in that the labels bear nutrient content claims, namely "Low Fat" and "Low Calorie," but the products do not comply with the regulations that would allow them to bear such claims.
The amount of fat or calories a food may contain and still bear a "Low Fat" or "Low Calorie" nutrient content claim on its label or labeling depends on the reference amount customarily consumed (RACC) for the food [see 21 0FR 101 .60(b)(2) and 21 CFR 101.62(b)(2)]. The RACC for your products, snacks, is 30 g [see 21 CFR 101.12, Table 2]. For a food with a RACC less than or equal to 30 g, a nutrient content claim regarding low calories or low fat must be based on the RACC and 50 g of product [21 CFR 101.60(b)(2)(i)(B); 21 CFR 101 .62(b)(2)(i)(B)].
The labels for your pita chips declare a value of 6 g of fat per 28 g serving, or 10.7 g of fat per 50 g of your pita chips. The labels for your pita chips declare a value of 135 calories per 28 g serving, or 241 calories per 50 g of your pita chips. Your products contain greater than 3 g of fat and greater than 40 calories; therefore, they do not qualify for making a "Low Fat" claim [21 CFR 101.62(b)(2)(i)(B)] or a "Low Calorie" claim [21 CFR 101.60(b)(2)(i)(B)].
This letter is not meant to be an all-inclusive list of deficiencies for your products or their labeling. It is your responsibility to ensure that all of your products comply with the Act and implementing regulations.
You should take prompt action to correct the above-referenced violations. Failure to promptly correct these violations may result in regulatory action without further notice. The Act provides for the seizure of illegal products and/or injunction against the manufacturer and/or distributor of illegal products.
In addition to the violations described above, FDA has the following comments concerning your product labels.
For your information, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amended the Act to require any food product labeled on or after January 1, 2006 to declare all major food allergens present in that product. 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 the exception of highly refined oils. The presence of a major food allergen must be declared in the manner specified by section 403(w) of the Act. Failure to comply with section 403(w) causes a food to be misbranded. We note that your pita chips, made from pita bread, are labeled to contain unbleached enriched flour. If the flour is derived from wheat or any other major food allergen, the labels must declare the presence of the food allergen in accord with the requirements of section 403(w). A copy of FALCPA, including the specific labeling requirements of section 403(w), can be accessed on our website at http://www.cfsan.fda.gov/~dms/alrgact.html. Guidance and information on FALCPA and food allergens can be accessed on our website at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
We note that the information panel of the Regenie's Thin Cut Crunchy Pita Chip products (2 oz. and 6 oz. garlic parmesan flavor, and 6 oz. habanera salsa, tomato basil parmesan and cinnamon maple sugar flavors) list your internet address and telephone number. Your firm name and place of business are not listed as required by section 403(e)(1) of the Act [21 USC 343(e)(1)] and 21 CFR 101 .2(d)(1) and 101.5. In addition, you placed the internet and telephone information between the required nutrition label and ingredient list. Under 21 CFR 101.2(e), all required information on the information panel must appear in one place without intervening material.
You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time at which the corrections will be completed. Your reply should be directed to the Food and Drug Administration, One Montvale Ave., 4th Floor, Stoneham, MA 02180, Attention Ann Simoneau, Compliance Officer.
Gail T. Costello
New England District Office