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FDA Requires Label Declaration of Cochineal Extract and Carmine on All Foods and Cosmetics
January 5, 2009By Ricardo Carvajal –
FDA has issued a final rule that requires declaration of the color additives cochineal extract and carmine in the ingredient statement on the label of all food and cosmetic products that contain those additives. FDA has made no changes to the proposed rule that it published in January 2006. The final rule is effective on January 5, 2011, but FDA states that it “will not object to voluntary compliance immediately upon publication of the final rule.”
The final rule requires the declaration of the color additives in all foods (including butter, cheese, and ice cream) and all cosmetics (including professional-use-only products and gifts or free samples). The agency plans to initiate separate rulemaking to implement the FDC Act’s requirement for declaration of inactive ingredients in drugs (that requirement has already been implemented for OTC drugs). Although some comments asked FDA to require label declaration of the fact that cochineal extract and carmine are insect (or animal) derived, FDA demurred on the ground that such information is not material within the meaning of section 201(n) of the FDC Act (i.e., it is a fact that is not material with respect to consequences which may result from the use of the product as labeled or customarily used).
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- We Have an LDT Proposed Rule! September 29, 2023
- Fool Me Once, Shame on You. Fool Me Twice and It’s a Federal Felony—Always? September 29, 2023
- Clinical Trial Diversity: Understanding the Effects of the New Federal Guidelines on Your Clinical Trials September 29, 2023
- FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA September 28, 2023
- Hyman, Phelps & McNamara, P.C. Names Jeff Grizzel Chief Marketing Officer September 26, 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
- 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