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Food, Dietary Supplement & Cosmetics Regulatory Update, Issue 2

Food, Dietary Supplement & Cosmetics Regulatory Update, Issue 2

In this issue:

Top Stories

  • FDA Extends Comment Period for Proposed Rule on Intentional Adulteration and Accompanying Risk Analysis
  • FDA Seeks Input on Information to be Submitted to FDA's Reportable Food Registry and Used to Notify Consumers in Grocery Stores
  • Cosmetics Content on FDA.gov Reorganized
  • HHS and FDA Sued Over Food Additives Rule
  • Federal Court Finds that California's Sherman Law Authorizes Criminal Penalties on Consumers Who Possess Misbranded Foods
  • California Beef Recall Highlights Lack of Restaurant Oversight

Other News

  • FDA To Hold April 4, 2014 Public Meeting on Environmental Impact Statement for FSMA Produce Safety Rule
  • FDA Likely to Stand Firm on Proposed "Added Sugar" Labeling Requirements
  • FDA Announces New Reporting Tool for Livestock Animal Food Problems
  • FDA Clarifies Sweetmyx GRAS determination
  • Government Scientists' Study Suggests BPA Is Safe as Currently Used
  • Study Questions Link Between Fat and Heart Disease

Regulatory Updates

  • FDA Extends Comment Period and Announces Public Meeting for FSMA Produce Rule EIS
  • FDA Extends Comment Period on Proposed Rule on Intentional Adulteration and Accompanying Risk Assessment
  • FDA Announces New Food Additive Petition for Chromium Propionate for Chicken Feed
  • FDA Rejects Objections to Vitamin D2 Regulation
  • FDA Issues Direct Final Rule on New Animal Drug Application Confidentiality
  • FDA Withdraws NADA and ANANDAs at Sponsors' Requests
  • FDA Amends Animal Drug Regulations to Reflect Change in Sponsor for 110 Approved NADAs
  • FDA Amends Regulations for Food Additives in Swine Feed—Benzoic Acid
  • USDA Will Renew National Organic Standards Board Charter
  • USDA Proposes Rule to Revise Pistachio Aflatoxin Sampling Regulations
  • USDA Determines BASF's Genetically Engineered Soybean No Longer a Regulated Article
  • USDA Extends Dairy Forward Pricing Program
  • USDA Adds Arkansas as Primary Peanut Producer
  • USDA Issues Final Rule to Allow Importation of Fruit from Malaysia
  • USDA Announces Decreased Assessment Rate for Olives Grown in California
  • USDA's AMS Issued Referendum Orders for the Following:
    Texas Onion Growers
    California Walnut Growers
    Spearmint Oil (comments due March 31)
    Florida Citrus Growers
  • FDA announced the opportunity to comment on the following proposed information collections:
    Importer's Entry Notice (comments due April 14).
    Extension and revision of a currently approved collection on "Laboratory Approval Programs" (comments due May 19).
  • FDA announced that OMB has approved the following proposed information collections:
    Premarket Notification for a New Dietary Ingredient.
    Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.
    Designation of New Animal Drugs for Minor Use or Minor Species—Final Rule.
    Eye Tracking Experimental Studies To Explore Consumer Use of Food Labeling Information and Consumer Response to Online Surveys.
  • USDA announced the opportunity to comment on the following proposed information collections:
    Special Nutrition Program Operations Study—Year 3 (comments due April 17).
    Extension of Approval of Information Collection on South American Cactus Moth Quarantine and Regulations (comments due May 12).
    Extension for AMS's Child Nutrition Labeling Program collection (comments due May 12).
    AMS Web-Based Supply Chain Management Commodity Offer Form (comments due May 13).
    AMS Dairy Request for Applicant Form required for AMS Dairy Grading Branch to set up accounts to allow applicants to do business with AMS Dairy Grading Branch (comments due May 13).
    National Organic Program; Organic Certification Cost-Share Programs (comments due May 16).
    Emergency approval for a new information collection under the Farmers' Market and Local Food Promotion Program (comments due May 19).
  • USDA announced that OMB has approved its proposed information collection for Procedures for the Safe Processing and Importing of Fish and Fishery Products.

Upcoming Meetings, Workshops, and Conferences

  • USDA's Farm Service Agency will host a 2014 Farm Bill Implementation Listening Session. March 27 in Washington, D.C. Written comments due April 2.
  • FDA will hold a public EIS-scoping meeting for the FSMA Produce Rule. April 4 in College Park, MD.
  • The annual Food Safety Summit will host four certification programs in HACCP, Seafood HACCP, Food Fraud, and ServSafe in addition to a variety of speakers and exhibitors. April 7–10 in Baltimore, MD.
  • 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.

Enforcement Updates

  • Recent Product Recalls
  • Recent FDA food product recalls continue a trend of Listeria contamination in processed dairy products. Listeria also prompted the recall of peanut butter, cheese, salsa, and spread from one manufacturer. Another bacterial contamination, Salmonella, was found in some plant products. Undeclared allergens in a variety of food products were also the cause of several recalls.

Recent Warning Letters

Warning letters issued for food in March concerned violations of the Seafood HACCP for failing to affirmatively verify that the imported fish had been processed under conditions equivalent to those required of domestic processors. FDA also cited one manufacturer for violations of the Juice HACCP regulations and two dairies for antibiotic drug residues and inadequate animal holding conditions.


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