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FDA’s Letter to P&G over VICKS DayQuil and NyQuil Plus Vitamin C is Back (for now?)
November 2, 2009By Ricardo Carvajal –
FDA has again posted a warning letter to Procter and Gamble stating that the company’s VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C are unapproved new drugs and are misbranded. The letter states that, when “drug and dietary ingredients are combined into a single dosage form, the combination becomes a drug under section 201(g)” of the FDCA. As noted in the letter to P&G, FDA previously staked out that position in warning letters in October 2008 to Bayer for its products combining aspirin with either phytosterols or calcium, and in 2001 to Omni Nutraceuticals for its products combining acetaminophen with either glucosamine sulfate or glucosamine sulfate and chondroitin sulfate, and to B.F. Ascher its product combining acetaminophen and melatonin.
FDA first posted a warning letter to P&G over VICKS on October 14, but then removed the posting, citing an administrative error. The fact that this latest posting is accompanied by a press release emphasizes that this time it’s for real.
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- Proposed Changes to Short-Form Version of Safe Harbor Proposition 65 Warning January 20, 2021
- AMG v. FTC: A Moot Court-Worthy Conflict at the Supreme Court January 15, 2021
- Orange Book Modernization Act: Congress Largely Codifies FDA’s Existing Orange Book Practices, But Also Brings PTAB Decisions Into the Fold January 14, 2021
- OTC Monograph Drug User Fees FY2021 (Temporarily?) Off the Table January 11, 2021
- When Will the Emergency End? January 11, 2021
- 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