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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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- Separating the Hype from the Hyperbole Surrounding FDORA’s Alternatives to Animal Testing under the FD&C Act February 3, 2023
- Eleventh Circuit’s Decision is Not a Catalyst For Change February 1, 2023
- The Orphan Drug Act Almost Failed to Clear the Launch Pad Before Achieving so Much for Patients! January 31, 2023
- An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer January 30, 2023
- A (Not So) New Avenue to Challenge Misleading Rx Promotion – NAD January 25, 2023
- 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
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
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- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
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- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized