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Food, Dietary Supplement & Cosmetics Regulatory Update, Issue 4

Food, Dietary Supplement & Cosmetics Regulatory Update, Issue 4

In this issue:

Top Stories

  • Sebelius Steps Down, Obama Nominates Burwell for HHS Top Post
  • NRDC Presses FDA on GRAS Oversight
  • New House Bill Would Preempt State GMO Labeling Laws
  • FDA Enforces Against Liquid "Supplement" Maker for Selling a Conventional Food Beverage with Unapproved Food Additive
  • FDA Issues Draft Guidance on Honey
  • Other News
    • FDA Asked to Drop Food & Cosmetics From IND Guidance
    • FDA Guidance Clarifies Intent of Bioterrorism Law Affecting Dietary Supplements
    • USDA Intends to Finalize Proposed Rule to Increase Poultry Inspection Line Speeds
    • FSA Announces New Round of Tests to Check Beef for Horse Meat
    • Cargill Expects Flour Merger with ConAgra to be Finalized in Six to Eight Weeks
    • Increase in Obesity Class-Action Lawsuits
    • FDA's New Probe into Evaporated Cane Juice Lawsuits Should Stop Tidal Wave of Lawsuits, Attorney Says
    • Beer Brewers Protest Proposed Animal Feed Rule
    • FDA Warns Makers of Craze for Using Unapproved Drugs in Dietary Supplements

Regulatory Updates

  • FDA Issues Draft Guidance for Proper Labeling of Honey and Honey Products
  • FDA Amends Food Additive Rule on Ionizing Radiation for Crustaceans
  • FDA Responds to Public Comments on HACCP for NRTE Comminuted Poultry Products
  • FDA Amends Color Additive Regulations to Expand Safe Uses of Spirulina Extract
  • FDA Issues Final Rule on NADAs and ANADAs
  • FDA Withdraws Approval of 19 NADAs for Medicated Articles and Feeds
  • USDA's APHIS Consolidates Permit Procedures for Transporting Plants
  • USDA's Commodity Credit Corporation Issues Final Rule on Emergency Assistance
  • USDA's APHIS Clears Certain Importation Restrictions on Unshu Oranges from Japan
  • USDA's APHIS Allows Importation of Jamaican Mangoes
  • FDA Releases Guide on Hypoglycin A in Ackee Products
  • USDA announced the opportunity to comment on the following proposed information collections:
    • Disaster Assistance—General (comments due May 9)
    • National Animal Health Monitoring System; Bison 2014 Study (comments due May 15)
    • Federal Crop Insurance Corp. Standard Reinsurance Agreement (comments due June 6)
    • Extension for Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (comments due June 6)
    • Current Good Manufacturing Practice Regulations for Medicated Feeds (comments due June 6)
    • Transfer of Farm Records Between Counties (comments due June 9)
    • Customer Satisfaction Surveys (comments due June 16)
    • Recordkeeping and Records Access Requirements for Food Facilities (comments due June 16)
    • Livestock, Poultry, and Seed Program (comments due June 17)
    • Farm Service Agency Volunteer Program (comments due June 20)
    • Meat Slaughter Industry Survey (comments due May 21)
    • Tenure, Ownership, and Transition of Agricultural Land survey (comments due June 20)
  • FDA announced the opportunity to comment on the following proposed information collections:
    • Cosmetic Labeling Regulations (comments due June 16)
    • Submission of Petitions: Food Additive, Color Additive (Including Labeling), and GRAS Affirmation (comments due June 16)
  • USDA Issued the following Notices of Funds Availability and Invites Applications:
    • Foreign Market Development Cooperator Program
    • Technical Assistance for Specialty Crops Program
    • Quality Samples Program
    • Market Access Program

Other USDA Announcements:

  • Federal Crop Insurance Corporation Proposes to Amend the Common Crop Insurance Regulations, Pear Crop Provisions (comments due May 12)
  • Grain Inspection Service Survey and Application for Designation (comments due May 15)
  • Overdue Domestic Date Handler Assessments (comments due June 6)
  • FSIS Best Practices Guidance for Controlling Listeria monocytogenes (Lm) in Retail Delicatessens (comments due June 20)
  • FSIS Compliance Guidelines for Allergens and Ingredients of Public Health Concern: Identification, Prevention and Control, and Declaration Through Labeling (comments due June 20)
  • Notice of Appointment of Members to the National Agricultural Research, Extension, Education, and Economics Advisory Board
  • Expansion of Areas in the Philippines Considered Free of Mango Seed Weevil and Mango Pulp Weevil and Establishment of a Lower Irradiation Dose as a Treatment for Mango Pulp Weevil
  • Kiwifruit Grown in California—Continuance Referendum

Upcoming Meetings, Workshops, and Conferences

The National Organic Standards Board will hold its annual meeting on April 29–May 2 in San Antonio, TX. Written comments and signup for oral public comments due April 8.

The Agricultural Air Quality Task Force will meet to continue discussions on critical air quality issues in relation to agriculture on April 30 and May 1 in Boise, ID. Special emphasis will be placed on obtaining a greater understanding about the relationship between agricultural production and air quality. The meeting is open to the public, and a draft agenda is included in this notice.

The Plant Variety Protection Board will hold an open teleconference meeting on May 13.

The National Agricultural Research, Extension, Education, and Economics Advisory Board will meet May 5–7 in Wooster, OH.

The International Association for Food Protection will host its Annual Meeting on August 3–6 in Indianapolis, IN. The attendees will receive information on current and emerging food safety issues, the latest science, innovative solutions to new and recurring problems, and the opportunity to network with thousands of other food safety professionals.

The General Conference Committee of the National Poultry Improvement Plan ("NPIP") and the NPIP's 42nd Biennial Conference will be held on July 10–12 in Charlotte, NC. Topics for discussion at the upcoming meeting include a Salmonella update from the industry and CDC and approval of rapid testing devices as well as APHIS budget and cooperative agreements updates.

Enforcement Updates

  • Recent Product Recalls
  • Recent Warning Letters
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