Food, Dietary Supplement & Cosmetics Regulatory Update, Issue 6

Food, Dietary Supplement & Cosmetics Regulatory Update, Issue 6

Read the Food, Dietary Supplement & Cosmetics Update, Issue 6 newsletter.

Top News

FDA to Hold Public Meeting and Extends Comment Period on Proposed Rules on Nutrition and Supplement Facts Labels
FDA will hold a public meeting in late June on the proposed food labeling rules to revise Nutrition and Supplement Facts labels and the Serving Sizes of Foods. The purpose of the meeting is for FDA to inform the public of the proposed rules and the rulemaking process, field questions about the proposed rules, and provide a chance for stakeholders to give oral presentations. The meeting will be held on June 26 from 8:30 a.m. to 5:00 p.m. in Washington, D.C. Attendees are encouraged to register online to attend in person or via live webcast. FDA recently extended the comment period for the proposed rules. Comments are now due August 1.

USDA and CDC Sign MOU on Foodborne Pathogens in Meat, Poultry, Eggs
USDA's Food Safety Inspection Service ("FSIS") and the Centers for Disease Control and Prevention's Agency for Toxic Substances and Disease Registry recently signed a Memorandum of Understanding ("MOU") providing for a comprehensive and multidisciplinary approach to addressing foodborne health hazards associated with meat, poultry, and processed egg products. The MOU outlines mutual roles and responsibilities for the training of personnel and the planning of interagency assessment of FSIS-regulated establishments as part of foodborne illness investigations and health hazard evaluations. The MOU does not modify any existing interagency collaborative work, which includes illness cluster and outbreak investigations.

USDA to Begin Testing Ground Beef for Salmonella this Summer
On May 16, USDA's Acting Under Secretary for Food Safety Brian Ronholm posted on USDA's blog that the Food Safety Inspection Service will begin testing ground beef for Salmonella, alongside its E. coli testing program. He described the plan as "super-sizing" the agency's pathogen testing program. FSIS will collect data about the prevalence of Salmonella in ground beef toward the goal of new standards for ground beef processors to strengthen Salmonella controls. Positive samples will be tested for multidrug resistance and specific serotypes in order to assess ground beef's contribution to human illness.

FDA Approves New Sugar Substitute Advantame
On May 20, FDA approved a new artificial sweetener called Advantame. The water-soluble white powder is the sixth artificial sweetener to obtain approval from FDA. Like other artificial sweeteners, Advantame does not contain calories or raise blood sugar levels.

Other News
Interagency Webinar on Foodborne Illness
FDA Holds Webinar on Temporary Tattoo Safety
NY Officials Using Yelp to Uncover Food Poisoning Cases
U.S. Faces Higher Food Price Inflation 2014, Led By Meats –USDA
Pew Asks If Food Is Too Cheap for Our Own Good
USDA Delays Whole Grains Rule for School Pastas

Regulatory Updates

FDA Extends Comment Period on Sanitary Transportation Proposed Rule
In the May 23 Federal Register, FDA announced that it will extend the comment period on the sanitary transportation proposed rule by 60 days. The proposed rule would require certain shippers, receivers, and carriers that transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. It would establish criteria for sanitary transportation practices, such as properly refrigerating food, adequately cleaning vehicles between loads, and properly protecting food during transportation. Comments due July 30.

FDA Extends Comment Period on Nutrition and Supplement Facts Labels
In the May 27 Federal Register, FDA announced that it will extend the comment period for its proposed revisions to the Nutrition and Supplement Facts labels. The proposed rule will update the Nutrition Facts label for packaged foods to reflect the most recent public health and scientific information, including information about the link between diet and chronic diseases such as obesity and heart disease. The proposed label would also update out-of-date serving size requirements to better align with how much people really eat, and it features a fresh design to highlight key parts of the label such as calories and serving sizes. Comments due August 1.

FDA Issues Final Rule on Food Additive Advantame
In the May 21 Federal Register, FDA issued a final rule amending the food additive regulations to provide for the safe use of advantame as a non-nutritive sweetener and flavor enhancer in foods generally, except meat and poultry. Comments due June 21.

USDA Seeks Nominations to Advisory Committee on Meat and Poultry Inspection
USDA is seeking applications and nominations for membership to the National Advisory Committee on Meat and Poultry Inspection. Membership is encouraged for individuals with knowledge of and interest in meat, poultry, and egg product safety and other FSIS responsibilities. Persons from industry; state and federal government; public health, scientific, and academic communities; and consumers and consumer organizations, as well as all other interested persons, are invited to submit nominations. Nominations due June 16.

FDA Amends Animal Drug Rule Reflecting Change of Sponsor: 172 NADAs, 14 ANADAs
In the May 20 Federal Register, FDA announced that it is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications and 14 approved abbreviated new animal drug applications. Effective May 20.

FDA Periodic Reassessment
Defining Small Numbers of Animals for Minor Use Designation (no deadline for comments) 

FDA announces the opportunity to comment on the following proposed information collections
Animal Drug User Fees and Fee Waivers and Reductions (comments due June 16)
Safety Communication Readership Survey (comments due June 16)

USDA announces the opportunity to comment on the following proposed information collections
Export Certification, Accreditation of Non-Government Facilities (comments due June 16)
Importation of Fresh Baby Kiwi from Chile Under a Systems Approach (comments due June 16)
Qualitative Feedback on FSIS Service Delivery (comments due June 16)
Importation of French Beans and Runner Beans from Kenya (comments due June 18)
''Clear Title''—Protection for Purchasers of Farm Products (comments due June 20)

Other USDA announcements
SNAP-Ed Connection Recipe Submission and Review Form (comments due July 14)
Livestock Slaughter Survey (comments due July 15)
Notice of Intent to Grant Exclusive License "Nash" chickpea variety (comments due June 16)


Public Meeting in preparation for the International Cooperation on Cosmetics Regulation Meeting (ICCR-8), June 4 in College Park, MD.

Meeting of the Codex Alimentarius Commission, June 18 in Geneva, Switzerland.

USDA Secretary's Advisory Committee on Animal Health, June 18–19 in Washington, DC.

Public Meeting on Proposed Rules on Nutrition and Supplement Facts Labels, June 26 in Washington, DC.

General Conference Committee of the National Poultry Improvement Plan ("NPIP") and the NPIP's 42nd Biennial Conference, July 10–12 in Charlotte, NC. 

2015 Dietary Guidelines Advisory Committee, July 17–18 via webcast. 

International Association for Food Protection Annual Meeting, August 3–6 in Indianapolis, IN.

Enforcement Updates

A variety of meat products were the subject of recent recalls by USDA. Chicken products were recalled for misbranding and undeclared allergens, while a large quantity of ground beef was recalled due to possible E. coli contamination. Pork and poultry products were also recalled for lack of inspection.

FDA recently announced a number of recalls for undeclared food allergens. Cheese spread and prepared noodle salad were recalled for undeclared soy, while soymilk and snack bars were recalled for undeclared nuts. Prepared pancakes were also recalled for undeclared milk. A few recalls for bacterial contamination in a variety of products were also announced over the last two weeks. Walnuts and dips were recalled for Listeria monocytogenes contamination, and cottage cheese was recalled for potential spoilage.

For a complete list of product recalls, click here for FDA-regulated products, and here for USDA-regulated products.

Warning Letters
FDA posted letters issued to three seafood processing facilities indicating they failed to comply with various HACCP and CGMP regulations. FDA also continues to post letters to dairies for illegal drug residues. A food manufacturing facility was cited for CGMP violations for unsanitary conditions, specifically water leaking from the ceiling. FDA also posted a letter noting violations of CGMP regulations by a dietary supplement facility. That letter also pointed out that the labels and websites for two of the dietary supplement products included claims that rendered those products unapproved new drugs.

It should be replaced with: "Click here for FDA's Warning Letters Home page (scroll down for listing of recently posted Warning Letters).