FDA requests comments on adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Federal Register
Comments due May 22, 2012

FDA extends enforcement deadline on phytosterol health claims until publication of a final rule
Federal Register (PDF)

Interim Final Rule: Amendment to Record Availability Requirements.
Federal Register
Comments due May 23, 2012

PAST ITEMS:

Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues
Comments due Dec. 2, 2011

Docket No. FDA-2011-N-0529
Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Request for Comments.  Pages  45818-45820 [FR Doc. 2011-19333  Federal Register (PDF)
Comments due October 17, 2011

Docket No. FDA-20110-N-0528
Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012. 
Federal Register (PDF)
Comments due October 31, 2011

Docket No. FDA-2011-N-0529
Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Request for Comments.
Pages 45818-45820 [FR Doc. 2011-19333]
Federal Register (PDF)

Docket No. FDA-20110-N-0528
Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012.
Pages 45820-45825 [FR Doc. 2011-19331]
Federal Register (PDF)

Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues —the NDI Draft Guidance is available on FDA's website.

Federal Register Notice on Postmarketing Adverse Event Reporting—revised draft guidance. (The revised draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic)

FDA Proposed Collection of information: FDA Recall Regulations

FDA request for comments on the procedure by which companies submit new dietary ingredient premarket notifications to FDA (due 8/2/2011):

FDA requests comments (due 8/2/2011) regarding the guidance document entitled ‘‘Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act’’ available on FDA's website.
Click here for the Federal Register notice.

FTC revision of guidance on disclosures in online advertising.

Preventive Controls for Registered Human Food and Animal Food/Feed Facilities (comments due 8/22/2011)
Click here for the Federal Register notice.