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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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- FDA’s Revised Draft Guidance on Biological Product Promotion Provides Additional Recommendations/Clarifications April 26, 2024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