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FDA Holds the Line on Green Tea Qualified Health Claims
September 17, 2008FDA has denied a petition for administrative reconsideration of its June 2005 decision on qualified health claims for green tea and certain cancers. In that decision, FDA stated its intent to consider the exercise of enforcement discretion for two weakly worded qualified health claims for the relationship between consumption of green tea and a reduced risk of breast cancer and prostate cancer, but denied qualified health claims for the relationship between consumption of green tea and a reduced risk of various other cancers.
Under 21 C.F.R. § 10.33(e), a request for reconsideration must demonstrate that FDA did not consider or adequately consider relevant information or views contained in the administrative record, among other things. According to FDA, the request for reconsideration failed to meet this test. FDA’s denial further asserts that, even if the request for reconsideration were granted under 21 C.F.R. § 10.33(d) as being in the public interest and in the interest of justice, FDA would reach the same decision as it reached in 2005. FDA’s denial notes that the agency may revisit its decision as warranted by the emergence of new scientific evidence or changes in consumption patterns.
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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