Inspections, Compliance, Enforcement, and Criminal Investigations
Masterfoods USA 31-May-06
Department of Health and Human Services
Public Health Service
College Park, Maryland
May 31, 2006
Refer to CFSAN-OC-06-W01
RETURN RECEIPT REQUESTED
Mr. John Helferich
Vice President, Research & Development
& Quality Assurance
800 High Street
Hackettstown, NJ 07840-1503
Dear Mr. Helferich:
The Food and Drug Administration (FDA) has reviewed the labels for several candy bar products in your Cocoa Via™ product line. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and regulations. You can find the Act and regulations at www.fda.gov.
Your Cocoa Via™ Original Chocolate Bars, Chocolate Blueberry Crunch Bar, and Blueberry & Almond Chocolate Bars are adulterated under section 402(a)(2)(C) of the Act [21 U.S.C. 342(a)(2)(C)], in that they contain a food additive, namely folic acid, which is unsafe within the meaning of section 409 of the Act (21 U.S .C. 348).
Any substance intentionally added to a conventional food, such as candy, must be used in accordance with a food additive regulation approving the substance for that use, unless the substance is generally recognized as safe (GRAS) among experts qualified by scientific training and experience to evaluate its safety under the conditions of intended use, or is otherwise exempt from the food additive definition in section 201(s) of the Act [21 U.S.C. 321(s)].
Folic acid is an ingredient for which there is a food additive regulation (21 CFR 172.345). The food additive regulation for folic acid does not provide for the addition of folic acid to candy products. The restrictions in the regulation are important. The foods to which folic acid can be added are designed to keep total folic acid intake under the 1 mg level. See 21 CFR 172.345; 61 FR 8797 (March 5, 1996). The consumption of higher levels of folic acid can mask anemia in persons with vitamin B 12 deficiency. Under those circumstances, the consequences of the anemia (i.e., severe and irreversible neurological damage) would go undetected .
In addition, your Cocoa Via™ Original Chocolate Bars and Blueberry & Almond Chocolate Bars are misbranded under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because their labels bear false or misleading claims that the products promote heart health. For example, the labels of these products bear the claims "Promotes a Healthy Heart" and "Now you can have real chocolate pleasure with real heart health benefits." These claims are false or misleading because of the high levels of saturated fat in the products.
The Original Chocolate Bars contain 3.5 grams of saturated fat per labeled serving (one bar weighing 22 grams), or approximately 6.4 grams per reference amount customarily consumed (40 grams) .1 The Blueberry & Almond Chocolate Bars contain 3 grams of saturated fat per labeled serving (one bar weighing 22 grams), or approximately 5.5 grams per reference amount (40 grams). Thus, each of these products contains more than 20% of the Daily Value (DV) for saturated fat (20 grams) per reference amount. A food that contains 20% or more of the DV of a nutrient per reference amount is high in that nutrient (see 21 CFR 101 .54(b)(1), defining "high"). Further, the labels of the Original Chocolate Bars and Blueberry & Almond Chocolate Bars recommend consuming two servings a day (i.e., two bars). Following this recommendation would result in consuming approximately one-third of the DV for saturated fat from these candy bars alone.
The relationship between saturated fat intake and risk of coronary heart disease is well established (DHHS and USDA, Dietary Guidelines for Americans, 2005, 6th Edition, Washington, D.C., U.S. Government Printing Office, January 2005). Because of their high levels of saturated fat, your Original Chocolate Bars and Blueberry & Almond Chocolate Bars do not promote a healthy heart when consumed daily as recommended on the product label, even though the products also contain ingredients, such as plant sterol esters, that have been shown to lower LDL cholesterol when consumed as part of a low fat, low cholesterol diet. As a matter of fact, the regulation authorizing a health claim for plant stero/stanol esters and reduced risk of heart disease includes the requirement that the food bearing the claim be low in saturated fat (1 g or less of saturated fat per reference amount and not more than 15% of calories from saturated fatty acids) [21 CFR 101.83(c)(2)(iii)(B)].
Moreover, your Original Chocolate Bars and Blueberry & Almond Chocolate Bars are promoted for uses that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. The labels of these products bear the claims
"Formulated to Help Reduce Bad Cholesterol"
"Cocoa Via™ Chocolate Bars contain natural plant extracts that have been proven to reduce bad cholesterol (LDL) by up to 8%*."
These claims promote your Original Chocolate Bars and Blueberry & Almond Chocolate Bars to prevent, mitigate, and treat hypercholesterolemia, a disease. Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs under section 201(g)(1)(B) of the Act. Because these products are not generally recognized as safe and effective when used as labeled, they are also new drugs as defined in section 201(p) of the Act [21 U.S.C. 321(p)]. Under section 505(a) of the Act [21 U.S.C. 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA).
The above violations are not meant 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 the laws and regulations enforced by FDA.
Please notify this office in writing, within 15 days of receipt of this letter, of the specific steps you have taken or plan to take to correct the noted violations. You should direct your written reply to Jennifer Thomas, 5100 Paint Branch Parkway (HFS-607), College Park,
Joseph R. Baca
Office of Compliance
Center for Food Safety and Applied Nutrition
1 The reference amount customarily consumed (reference amount) is a standard serving size established by FDA based on data from national food consumption surveys on the amount of food customarily consumed per eating occasion (meal or snack) (see 21 CFR 101 .12). The serving size that appears on the food label (labeled serving) must be based on the reference amount but is not necessarily the same as the reference amount (see 21 CFR 101.9(b).