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U.S. Department of Health and Human Services

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Enforcement Actions

The Hershey Company 2/14/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD 20740
 

WARNING LETTER

FEB 14 2012
 

VIA OVERNIGHT MAIL
Return Receipt Requested

John P. Bilbrey, CEO and President
The Hershey Company
925 Reese Ave
Hershey, Pennsylvania 17033-2271
 

Dear Mr. Bilbrey:

The Food and Drug Administration (FDA) has reviewed the labels for your Hershey's® Syrup+Calcium and Hershey's® Syrup Sugar Free with Vitamin & Mineral Fortification. Based on our review, we have concluded that these products are 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). These products are misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product labels bear nutrient content claims but do not meet the requirements to make the claims. You can find copies of the Act and FDA regulations through links in FDA's home page at http://www.fda.gov.

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 regulation authorizing the use of such a claim. Characterizing the level of a nutrient in food labeling 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.

The label of your Hershey's® Syrup+Calcium product bears the term "plus" as part of its name and further describes the product as having added vitamins and minerals. The principal display panel states, "Includes 5 Essential Vitamins and Minerals!"; the information panel states "SPECIALLY FORTIFIED WITH VITAMINS AND MINERALS"; and the ingredient list includes the following added vitamins and minerals: tricalcium phosphate (declared at 10% of the Daily Value (DV) for calcium), vitamin E acetate (declared at 10% of the DV for vitamin E), biotin (declared at 10% of the DV for biotin), zinc sulfate (declared at 10% of the DV for zinc), and calcium pantothenate (declared at 10% of the DV for pantothenic acid).

Similarly, the label of your Hershey's® Syrup Sugar Free with Vitamin & Mineral Fortification product bears the term "fortification" as part of its name. The ingredient list includes the following added vitamins and minerals: zinc sulfate (declared at 10% of the DV for zinc), vitamin E acetate (declared at 10% of the DV for vitamin E), niacinamide (declared at 10% of the DV for niacin), and biotin (declared at 10% of the DV for biotin).

Your Hershey's® Syrup+Calcium and Hershey's® Syrup Sugar Free with Vitamin & Mineral Fortification products are misbranded within the meaning of section 403(r)(1)(A) of the Act because they bear the nutrient content claims "+Calcium," "FORTIFIED WITH VITAMINS AND MINERALS," and "Vitamin & Mineral Fortification" but do not comply with the regulations governing the use of these claims. FDA has defined the terms "plus" and "fortified" in 21 CFR 101.54(e). These terms may be used on the label or in the labeling of foods to describe the level of nutrients (such as vitamins and minerals) in the food, provided that (1) the food contains at least 10 percent more of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) for the nutrient per reference amount customarily consumed than an appropriate reference food, (2) where the claim is based on nutrients that are added to the food, that the fortification is in accordance with the policy on fortification of foods in 21 CFR 104.20, and (3) the claim bears the required information for relative claims as described in 21 CFR 101.130)(2) and 101.54(e)(1)(iii).

Specifically, your Hershey's® Syrup+Calcium and Hershey's® Syrup Sugar Free with Vitamin & Mineral Fortification products fail to 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 FDA does not consider it appropriate to fortify sugars or snack foods such as candies and carbonated beverages. Because your products are syrups, consisting primarily of high fructose com syrup, com syrup, water, cocoa, and sugar for your Hershey's® Syrup+Calcium product and consisting primarily of water, cocoa processed with alkali, erythritol, and glycerin for your Hershey's® Syrup Sugar Free with Vitamin & Mineral Fortification product, fortification of your products with calcium, vitamin E, biotin, zinc, and pantothenic acid does not comply with the policy on fortification of foods in 21 CFR 104.20(a). Therefore, the "plus" and "fortification" claims on your product labels may not be made.

In addition, your Hershey's® Syrup Genuine product is not an appropriate reference food, as required by 21 CFR 101.54(e)(1)(i). The ingredient statement for your Hershey's® Syrup Genuine product does not include any of the added ingredients declared on your Hershey's® Syrup+Calcium and Hershey's® Syrup Sugar Free with Vitamin & Mineral Fortification products. This does not permit a comparison of the RDI for the added vitamins and minerals to be made between your fortified products and the reference food product. Even if your Hershey's® Syrup Genuine product were an appropriate reference food, the labels of your Hershey's® Syrup+Calcium and Hershey's® Syrup Sugar Free with Vitamin & Mineral Fortification products do not state the identity of the reference food and the percentage (or fraction) of the amount of the nutrient in the reference food by which the nutrient in the labeled food differs, as required by 21 CFR 101.130)(2).

This letter is not intended to be an all-inclusive list of violations in your products or their labeling. It is your responsibility to ensure that all of your products comply with the Act and its implementing regulations.

You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action without further notice. Such action may include, but is not limited to, seizure and injunction.

Please respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations. You should include in your response documentation such as revised labels or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for the delay and state when you will correct any remaining violations.

Please send your written response to Lara Snyder, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance, Division of Enforcement, Labeling and Dietary Supplement Compliance Team (HFS-608), College Park, Maryland 20740-3835. If you have any questions, you may contact Ms. Snyder at 240-402-1626.
 

Sincerely,
/S/

Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition