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FDA Consent Decree Calls for Retention of Food Labeling Expert
February 8, 2013By Ricardo Carvajal –
FDA announced a somewhat unusual consent decree for permanent injunction in which a manufacturer of fruit and juice products agreed to retain a labeling expert (among other experts) to ensure compliance with applicable FDA regulations. In part, the government alleged that the juice products were misbranded because they were labeled as “natural” and “100% natural” even though they contained “chemical additives such as sodium benzoate, and artificial colorants Yellow #5 and Red #40.” The product labels were further alleged to bear impermissible nutrient content claims. The government also alleged that the products were adulterated due to failure to comply with cGMP and HACCP requirements. These were alleged to be repeat violations.
Under the terms of the consent decree, the manufacturer and its president (Defendants) are permanently enjoined from marketing food “unless and until… Defendants retain, at Defendants’ expense, an independent person or persons (the “Labeling Expert”)… who by reason of background, experience, education, and training is qualified to review Defendants’ labeling and ensure that all such labels are in compliance with the applicable FDA regulations.” The Labeling Expert must review all of the labels and submit a written report to the Defendants and FDA. The Defendants must also retain sanitation and HACCP experts.
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- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024
- OMB Completes its Review of the Final LDT Rule—A Final Rule Coming Anytime Now April 25, 2024
- Senators to DEA: Consider Treaty Obligations In Marijuana Rescheduling April 23, 2024
- “Heigh-ho” Taiho! The PTO Says LYTGOBI Patent is Ineligible for PTE Because of Untimely Application . . . And a Corrected NDA Approval Letter is No Saving Grace April 22, 2024
- Clear that Cabinet Tour ‘24 April 18, 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
- 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
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- 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