Public Health Service Food and Drug Administration
College Park, MD 20740
NOV 24, 2014
VIA OVERNIGHT DELIVERY
Mr. John Heily
President and CEO
18100 Andover Park W
Tukwila, WA 98188-4703
Dear Mr. Heily:
The Food and Drug Administration (FDA) reviewed the label for your TrueBliss Confections Dark Chocolate Covered Coconut product in June 2014. Based on our review, we have concluded that this product is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.
The label for the TrueBliss Confections Dark Chocolate Covered Coconut product bears the claim “Experience a healthy temptation with the truly indulgent taste of TrueBliss Confections.” This claim renders the product misbranded because the assertion that the Dark Chocolate Covered Coconut product is “healthy” is misleading under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)]. As declared on the product label, your Dark Chocolate Covered Coconut product contains 7 g of saturated fat per labeled serving of 30 g of food. FDA considers the use of the term “healthy” to be misleading under section 403(a)(1) of the Act for foods for which the level of a nutrient exceeds the level established in 21 CFR 101.13(h)(1) [see 58 FR 2944, 2945 (Jan. 6, 1993)]. The level for saturated fat provided in 21 CFR 101.13(h)(1), 4.0 g of saturated fat per reference amount customarily consumed (RACC) or per labeled serving, is the amount of that substance in a food that increases the risk of disease or health-related conditions. Therefore, this product is misbranded within the meaning of section 403(a)(1) of the Act because it is misleading for this product label to include the term “healthy” when the food contains saturated fat at a level that would increase the risk of disease or health-related conditions.
Your TrueBliss Confections Dark Chocolate Covered Coconut product is also misbranded within the meaning of section 403(e)(1) of the Act because the statement of the name and the place of business does not meet the requirements in 21 CFR 101.5. Specifically, the statement “Prepared For: True Bliss Confections, P.O. Box 1493, Owasso, OK 74055, U.S.A” is on the label, but the label does not include the street address. FDA is unable to determine the physical location of the firm based on this address.
Your TrueBliss Confections Dark Chocolate Covered Coconut product is also misbranded within the meaning of section 403(q) of the Act because the serving size (“6 pieces (30 g)”) is incorrect. In accordance with 21 CFR 101.12(b), the RACC for this type of candy is 40 g, which would be 8 pieces. Therefore, all information in the nutrition label that is based on the labeled serving size is incorrect because it is based on the incorrect serving size for this type of product.
The above violations are not intended to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with all applicable laws and regulations. You should take prompt action to correct the violations. Failure to promptly correct the violations may result in regulatory action without further notice, such as seizure or injunction.
In addition, we offer the following comments:
The ingredient statement contains the ingredient “sulfite,” which is not an appropriate common or usual name. An appropriate common or usual name for “sulfite” could be sodium sulfite or sodium bisulfite (21 CFR 101.4).
The statement “Contains: Milk, Soy, Sulfites, Coconut” does not meet the requirements of the Act, as amended by the Food Allergen Labeling and Consumer Protection Act (FALCPA). “Sulfites” is not one of the eight major food allergens.
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 violations and prevent similar violations. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within 15 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 Carrie Lawlor, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance (HFS-608), Division of Enforcement, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835.