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FDA Extends Compliance Period for Change in Enforcement Discretion Policy Concerning Phytosterol Health Claims
February 20, 2011By Riëtte van Laack –
As previously reported, on Dec. 8, 2010, FDA published a proposal to amend the interim final rule ("IFR") governing health claims concerning the risk of cardiovascular heart disease and consumption of phytosterols (see 21 C.F.R. § 101.83). FDA stated that, as of February 22, 2011, it intended to discontinue its policy of enforcement discretion that had been in effect since 2003 concerning certain health claims that go beyond the IFR. Based on comments and petitions by industry contending that more than 75 days were needed to relabel and reformulate products (see our prior post here), FDA decided to extend the 2003 enforcement discretion policy until February 21, 2012. FDA’s decision does not constitute a response to the petitions it received in response to the proposed rule.
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- DEA To Host Supply Chain Conference March 31, 2023
- 2023 IS the Year for OTC Naloxone! March 30, 2023
- What is Special about September 24, 2023 for the UDI System? March 28, 2023
- The “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps” – Availability of HPM’s Presentation Deck and Recording of the Presentation March 28, 2023
- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 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
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- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
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- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
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- FDA News
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- Import/Export
- In Vitro Diagnostic Devices
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- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized