FDA WARNING_LETTER - Hershey Malaysia Sdn Bhd (The Hershey Company - Johor Plant)

The FDA issued a Warning Letter to The Hershey Company regarding misbranded labels for "Hershey's Syrup+Calcium" and "Hershey's Syrup Sugar Free with Vitamin & Mineral Fortification." The products are deemed misbranded under section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act because they bear unauthorized nutrient content claims.

Specifically, the terms "plus" and "fortification" are used, implying added vitamins and minerals (calcium, vitamin E, biotin, zinc, pantothenic acid, niacin). However, these products, being syrups primarily composed of sugars or sugar substitutes, violate 21 CFR 104.20(a), which states that it is inappropriate to fortify sugars or snack foods.

Furthermore, "Hershey's Syrup Genuine" is not an appropriate reference food for comparison as required by 21 CFR 101.54(e)(1)(i), lacking the added ingredients. Even if it were, the labels fail to state the identity of the reference food and the percentage difference in nutrient content, as required by 21 CFR 101.13(j)(2).

The Hershey Company must take prompt action to correct these violations and prevent recurrence. A written response outlining specific corrective actions, including revised labels, is required within 15 working days to avoid further regulatory action such as seizure or injunction.