Inspections, Compliance, Enforcement, and Criminal Investigations
Aunt Lizzie's Cheese Straws, Inc 17-May-05
Department of Health and Human Services
Public Health Service
New Orleans District
May 17, 2005
Warning Letter No . 2005-NOL-21
Aunt Lizzie's Cheese Straws, Inc.
Ann H. Randalls, Co-Owner
1531 Overton Park Avenue
Memphis, Tennessee 38112-5138
Dear Ms. Randalls :
On December 8 - 9 and 16, 2004 and January 28, 2005, a Food and Drug Administration (FDA) investigator inspected your cheese and lemon straw manufacturing facility, located at 1531 Overton Park Avenue, Memphis, Tennessee. During the inspection, copies of your labeling were collected. Review of your product labels revealed your firm's finished packaged cheese and lemon straws are not labeled in compliance with Title 21 of the Code of Federal Regulations Part 101 (21 CFR 101), Food Labeling, and the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and the CFR through links in FDA's home page at http://www.fda.gov.
The violations of the Act and FDA regulations are as follows:
1) AUNT LIZZIE'S ZERO CARB CHEESE STRAW BITES (7.5 oz) AUNT LIZZIE'S ZERO CARB JALAPENO FLAVORED CHEESE STRAW BITES (7 .5 oz & 20 oz)
Your products are misbranded under Section 403(q)(1) of the Act [21 U.S.C. 343(q)(1)] because they fail to bear nutrition labeling, as required by 21 CFR 101.9. These products are not exempt from this requirement under Section 403(q)(5)(D) or (E) of the Act [21 U.S.C. 343(q)(5)] because the label bears the nutrient content claim "Zero Carb."
2) AUNT LIZZIE'S ZERO CARB CHEESE STRAW BITES (7.5 oz), AUNT LIZZIE'S ZERO CARB JALAPENO FLAVORED CHEESE BITES (7.5 oz & 20 oz), AUNT LIZZIE'S SUN DRIED TOMATO CHEESE STRAWS (6 oz), AUNT LIZZIE'S LEMON STRAWS (6 oz), AUNT LIZZIE'S CHEESE STRAWS (2oz, 4 oz, 7 oz, & 8 oz), and AUNT LIZZIE'S BITE SIZE CHEESE STRAWS (7 oz & 20 oz).
Your products are misbranded under Section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to bear the common or usual name of each ingredient, as required by 21 CFR 101.4(b)(2). Specifically, the ingredients "flour", "margarine," and "cheese" are multi-component ingredients, in other words, ingredients which themselves contain two or more ingredients. However, the ingredient statement does not include the components of these ingredients. The requirement to list component ingredients may be met by either parenthetically listing the component ingredients after the common or usual name of the main ingredient [21 CFR 101.4(b)(2)(i)], or by listing the component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. Under the first alternative, the component ingredients must be listed in descending order of predominance in the main ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food.
Some of your products contain milk as an undeclared ingredient. Undeclared ingredients known as allergens are of particular concern to the agency. FDA has received an increasing number of reports concerning consumers who have experienced adverse reactions following exposure to an allergenic substance in foods. For sensitive individuals, the presence of allergens in food is potentially life threatening. Ingredients are among the most commonly known to cause serious allergic responses are milk, eggs, fish, crustaceans, tree nuts, wheat, peanuts, soybeans, and derivatives of these products
The above violations are not meant to be an all-inclusive list of deficiencies on your labels. 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 the violations. Failure to promptly correct violations may result in regulatory action without further notice, including seizure and/or injunction. Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, explain the reason for your delay and state when any remaining deviations will be corrected. Please include copies of any labeling demonstrating that corrections have been made.
In addition, some of your products bear a claim suggesting the absence of genetically modified organisms, such as "Non-GMO." As explained in the FDA Draft Guidance for Industry regarding "Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering," the claims "GMO free" and "Non-GMO" are not technically accurate and may be misleading. This Draft Guidance may be viewed through the following link on FDA's web page: http://www.cfsan.fda.gov/~dms/biolabgu.html.
We note that "AUNT LIZZIE'S ZERO CARB CHEESE STRAW BITES" package includes the label statement "Zero Carb" and the additional statement "This product contains zero net carbs based on the total carbohydrates less fiber." The claim "zero carb" would be false and misleading on this product label if the product does not contain less than 0.5 grams of total carbohydrate (including fiber) per reference amount customarily consumed. According to the nutrition labeling regulations [21 CFR 101.9(c)(6)], less than 0.5g of Total Carbohydrate is the level to be declared as "0" in nutrition labeling.
Please send your reply to the Food and Drug Administration, Attention: Kimberly L. McMillan, Compliance Officer, 297 Plus Park Boulevard, Nashville, Tennessee 37217. If you have any questions concerning the violations noted, please contact Ms. McMillan at (615) 781-5380, extension 138.
H. Tyler Thornburg
New Orleans District