Inspections, Compliance, Enforcement, and Criminal Investigations
Chocolate Cottage, Inc. 25-Apr-06
Department of Health and Human Services
Public Health Service
Denver District Offices
April 25, 2006
RETURN RECIEPT REQUESTED
Ref. # DEN- 06-15
Kimberly A. Smart, Owner
Chocolate Cottage, Inc.
720 East 10600 South
Sandy, UT 84094
Dear Mrs. Smart:
The Food and Drug Administration (FDA) conducted an inspection of your candy manufacturing facility located at 720 East 10600 South, Sandy, Utah on December 20 and 21, 2005. Labeling for your products was collected and a review of that labeling found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA's implementing regulations in Title 21 of the Code of Federal Regulations, Part 101- Food Labeling (21 CFR 101). You can find the Act and FDA regulations through links on FDA's Internet homepage at http://www.fda.gov.
Your Rocky Road, Cherry Cordial, and Haystack 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 and fail to declare the common or usual name of each ingredient as specified under 21 CFR 101.4. Some examples are as follows:
The ingredient statement for these products declares "light or dark chocolate", which is not an appropriate common or usual name for the type of chocolate used in the three products. According to formula information you provided during this inspection, the Rocky Road, Cherry Cordial, and Haystack products contain milk chocolate.
Milk chocolate is a food for which a definition and standard of identity has been prescribed by regulation (21 CFR 163.130); furthermore, it is an ingredient which contains two or more component ingredients. Each of the ingredients used to make milk chocolate must be declared on the label as specified under 21 CFR 101.4(b)(2) and 163.130(d). According to the labeling of your milk chocolate ingredient, it consists of sugar, milk, cocoa butter, chocolate liquor, soy lecithin and vanillin (an artificial flavor); however, the ingredient statement for your products do not include all of these component ingredients. 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.
The ingredient statement on the labels declares "fruits." This collective term is not an appropriate common or usual name for the fruit ingredient(s). The label must declare the name of the specific fruit or fruits being used in the product.
Your Cottage Fudge, Cherry Cordial, Haystack and Rocky Road products are also misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that their labeling is false or misleading because their ingredient statements do not accurately represent the ingredients used in these products. For example, the ingredient statements for your Cherry Cordial, Haystack and Rocky Road products declare that these products may contain, in addition to other ingredients, brazils, black walnuts, and cashews. According to formula information you provided during this inspection, however, none of these three products is made with any of these types of nuts. Additionally, your Cottage Fudge label declares that it contains, in addition to other ingredients, dark chocolate, dextrose, cream, pecans, walnuts, water, invertase, coconut oil; however, the formula information for this product does not include any of these ingredients.
Many of these deviations were noted in our January 21, 2005, letter to you regarding labeling deficiencies for these same four products. While you have corrected some of the deficiencies in your Cottage Fudge label, our review of your current labels finds that you have failed to correct the majority of the deviations noted in our January 2005 letter.
The above violations are not meant to be an all-inclusive list of deficiencies in your labeling at your facility. You should take prompt action to correct these violations, to establish procedures whereby such violations do not recur, and to review your operations and your product labels to ensure compliance with all applicable laws and regulations. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure and/or injunction.
In addition to the violations described above, FDA has the following comments concerning your product labels.
Some of your labels declare "U.S. certified food colors" as an ingredient. If certified colors are used in any of your products, they must be declared individually in accordance with sections 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] and 21 CFR 101.22(k).
On your Cherry Cordial, Haystack, and Rocky Road labels, your ingredient statement: begins with the phrase "May contain any or all of the following ingredients." This phrase should be removed from the ingredient statement because the Act and FDA regulations require the ingredient statement to list the specific ingredients used in each product, as explained in detail above.
With regard to your assortment packages, we refer you to Compliance Policy Guide Section 505.100 (CPG 7102.01) for guidance on how some candy assortment packages may be able to bear "catch all" ingredient labeling. (See www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg505-100.html)
For your information, the Food Allergen Labeling and Consumer Protection Act (FALCPA) amended the Food, Drug, and Cosmetic Act to require food labels to clearly disclose ingredients that are or contain a protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, effective January 1, 2006. Any food product labeled on or after this date must be in compliance with FALCPA. Failure to comply with FALCPA causes a food to be misbranded under section 403(w) of the Act [21 U.S.C. 343(w)]. A copy of FALCPA, including its specific labeling requirements, can be accessed on our website at http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106187.htm and additional guidance for industry can be accessed at http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm2006884.htm.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the steps you have taken to correct the above-cited violations to the Act. In addition, we request that you come to our Denver District Office the week of May 15, 2006 to discuss the steps you have taken to correct the above-cited violations of the Act. Please bring copies of the revised labels you have completed. For those labels that are not completed, be prepared to discuss the reason for the delay and when you plan on having the labels completed.
Finally, be prepared to discuss your plan for preventing such violations in the future. Please contact Mr. William H. Sherer at (303) 236-3051 to arrange a meeting time. If you have questions regarding the issues in this letter, please contact Mr. Sherer and he will assist you.
B. Belinda Collins