Inspections, Compliance, Enforcement, and Criminal Investigations
Goetze's Candy Company Inc 3/4/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|5100 Paint Branch Parkway |
College Park, MD 20740
March 4, 2011
VIA OVERNIGHT MAIL
Executive VP & COO
Goetze's Candy Co., Inc.
3900 E. Monument St.
Baltimore, MD 21205-2980
Dear Mr. Goetze:
The U.S. Food and Drug Administration (FDA) has reviewed the label for your Goetze's Caramel Creams Double Chocolate, 9 oz package product. Based on our review, we have concluded that this product is misbranded within the meaning of section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim but does not meet the requirements to make the claim under Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find copies of the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov.
Your Goetze's Carmel Creams Double Chocolate product bears the phrase “Fortified With Calcium” on the principal display panel of the product label. The phrase “Fortified With Calcium” is a nutrient content claim under 21 CFR 101.13(b), because this phrase characterizes the product's level of calcium, which is a nutrient of the type required to be in nutrition labeling under 21 CFR 109(c)(8).
Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a FDA regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(1)(A) of the Act.
Your product is not eligible to bear the “Fortified with Calcium” nutrient content claim under 21 CFR 101.54(e)(1)(ii), which requires: “Where a the claim is based on a nutrient that has been added to the food, that fortification is in accordance with the policy on fortification of foods in [21 CFR] 104.20.” Because the product is candy, it does not comply with the policy on fortification of foods in 21 CFR 104.20. The policy on fortification in 21 CFR 104.20(a) states that the FDA does not consider it appropriate to fortify snack foods, such as candy. Therefore, the “fortified” claim on the product label does not meet the requirements of 21 CFR 101.54(e)(1).
The above violation is not meant to be an all-inclusive list of deficiencies in your product or its labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violation. Failure to promptly correct this violation may result in regulatory actions without further notice, such as seizure and/or injunction.
In addition to the violation discussed above, we have the following comments:
• The serving size and the nutrition information on the label are not based on the established Reference Amount Customarily Consumed (RACC) for this food. FDA has promulgated regulations under section 403(q) of the Act that require nutrition information to be based on any appropriate serving size that is derived from the established RACC. The RACC established for “Sugars and Sweets: All other candies” is 40 grams (g) [21 CFR 101.12(b), Table 2]. According to your Goetze's Double Chocolate Caramel Creams label, the serving size for this product is “3 pieces” (34g). We calculate that four caramel creams would weigh 45 grams. The weight of four caramel creams appears to be closer to the 40 g RACC than the weight of three caramel creams. As a result, the nutrition information on your package of Goetz's Double Chocolate Caramel Creams should be based on four caramel creams.
• Your product label declares 7.5 servings per container of Goetze's Double Chocolate Caramel Creams (9 oz). The number of servings should be rounded to the nearest whole number for a product with more than five servings in accordance with 21 CFR 101.9(b)(8)(i).
•Your product bears the term “Double Chocolate” and “chocolate” as a characterizing flavor. However, the product is flavored only with cocoa. Because a consumer could reasonably expect there to be a chocolate ingredient in a chocolate candy product, but this product contains cocoa as the sole source of chocolate flavoring, the term “chocolate” should be qualified with the word “flavored” on the product label. FDA Compliance Policy Guide 515.800; 38 FR 33287 (Dec. 3, 1973).
Please respond to this letter within 15 working days from receipt with the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violation and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.
You should direct your written reply to Rob Genzel Jr., Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition