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Candy + Calcium = Warning Letter
March 21, 2011By Riëtte van Laack –
On March 4, 2011, FDA issued a warning letter to Goetze’s Candy Co. Inc., because the addition of calcium to Goetze’s Caramel Cream Chocolate goes against FDA’s food fortification policy, 21 C.F.R. § 104.20. Goetze marketed its product with the (impermissible) nutrient content claim “fortified with calcium.”
Although this is not the first time FDA cited its fortification policy in a warning letter, it is the first time in recent memory that the targeted product is candy. Previous warning letters citing the fortification policy focused on carbonated beverages. Candy and carbonated beverages are the snack foods specifically mentioned in FDA’s fortification policy. Thus, this warning letter does not provide insight into what other types of fortified snack foods might violate FDA’s fortification policy.
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- Clear that Cabinet Tour ‘24 April 18, 2024
- The Fourth Circuit Upholds CMS’ Definition of “Line-Extension Drug” and “New Formulation” April 17, 2024
- Does the Drug Shortage White Paper Fall Short? April 9, 2024
- OPQ’s 2023 Annual Report: an Upbeat Review of CDER’s Quality Efforts April 8, 2024
- FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah) April 3, 2024
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
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- Pharma IQ
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- Orphan Drugs
- OTC Drugs and Cosmetics
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- Uncategorized