News Article

Laws and Regulations Committee Update 7/24 - 7/26, 2017

Posted on July 28, 2017

Blog: Association of Food & Drug Officials (AFDO)

July 24, 2017

Federal Register

Agriculture Department

Proposed Rule

Identifying Regulatory Reform Initiatives

FR Document: 2017-14920 Citation: 82 FR 32649 PDF Pages 32649-32650 (2 pages) Permalink

Ø USDA is requesting comments on “how we can provide better customer service and remove unintended barriers to participation in our programs in ways that least interfere with our customers and accomplish our mission.” USDA seeks ideas on regulations, guidance documents, or any other policy documents that are in need of reform, including ideas to modify, streamline, expand, or repeal those items. Comments are due July 17, 2018, but USDA will be reviewing the comments in four batches over the one year period, with deadlines for each batch being September 15, 2017; November 14, 2017; February 12, 2018; and July 17, 2018.

Food and Drug Administration

Rules

Civil Money Penalty Definitions; Technical Amendment

Filed on: 07/24/2017 at 08:45 am Scheduled Pub. Date: 07/25/2017

FR Document:2017-15532 PDF 4 Pages (161 KB) Permalink

Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period; Correction

Filed on: 07/24/2017 at 08:45 am Scheduled Pub. Date:07/25/2017

FR Document: 2017-15538 PDF 2 Pages (152 KB) Permalink

Ø This notice only corrects a typo in a RIN number in the original extension notice.

Statements of Organization, Functions, and Delegations of Authority

Filed on: 07/24/2017 at 08:45 am Scheduled Pub. Date: 07/25/2017

FR Document: 2017-15564 PDF 10 Pages (97.9 KB) Permalink

Ø This notice provides the new organizational structures for FDA’s Office of the Commissioner and Office of Operations.

FDA

FDA Investigates Multiple Salmonella Outbreak Strains Linked to Papayas

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
07/21/2017	Bhu Foods	Protein Bars	Listeria monocytogenes	Hudson Valley Foods, Inc.
07/21/2017	Oakdell, So Delicious, Bongard's, Signature Café	Coconut Beverage, Broccoli Cheddar Soup, Eggs, and Cheese Product	Potential spoilage bacteria	The Idaho Foodbank
07/21/2017	Super Panther 7K	Dietary Supplement	Unapproved new drug	Ultra Shop Supplement

FSIS

Jul 21, 2017 | PDF

Identifying Regulatory Reform Initiatives at USDA

Raw Pork Products Exploratory Sampling Program – Phase One Now Available

Food Safety Discovery Zone at California State Fair

USDA’s Spring 2017 Regulatory Agenda is Available

FSIS Schedules Industry Webinar for Roll-out of Egg Products Plant Food Safety Assessments

AMS

USDA Seeks Input in Developing a Proposed Bioengineered Food Disclosure Rule – AMS has extended the deadline for feedback on the 30 questions it posed on the bioengineered disclosure standard to August 25, 2017.

July 25, 2017

Federal Register

Food and Drug Administration

Proposed Rules

Food Additive Petition: Juice Products Association

Filed on: 07/25/2017 at 08:45 am Scheduled Pub. Date: 07/26/2017

FR Document: 2017-15535 PDF 2 Pages (8.01 KB) Permalink

Ø This petition proposes to amend the food additive regulations in 21 CFR 172.380 (Vitamin D3) by replacing the current RDI percentage values of calcium in fruit juices and fruit juice drinks with absolute values and to update the specifications for Vitamin D3 by incorporating by reference the most recent edition of the Food Chemicals Codex.

Food Additive Petitions:

Zinpro Corp.

Filed on: 07/25/2017 at 08:45 am Scheduled Pub. Date: 07/26/2017

FR Document: 2017-15533 PDF 2 Pages (84.4 KB) Permalink

Ø This petition proposes to amend 21 CFR 573 to provide for the safe use of zinc-l-selenomethionine as a nutritional source of selenium in complete feed for laying hens and for the safe use of silicon dioxide (21 CFR 573.940) as an anticaking agent for use with zinc-l-selenomethionine as a feed component.

FDA

FDA Completes Review of Qualified Health Claim Petition for Macadamia Nuts and the Risk of Coronary Heart Disease

Ø FDA intends to exercise enforcement discretion over the use of a qualified health claim characterizing the relationship between the consumption of macadamia nuts and reduced risk of coronary heart disease in response to a petition by Royal Hawaiian Macadamia Nut, Inc. The claim language is as follows: “Supportive but not conclusive research shows that eating 1.5 ounces per day of macadamia nuts, as part of a diet low in saturated fat and cholesterol and not resulting in increased intake of saturated fat or calories may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.”

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
06/29/2017	God Quest, Inc. d/b/a Creation Today	San Juan District Office	New Drug/Misbranded	Not Issued *
06/20/2017	Manns Fish Market	Kansas City District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *

FSIS
Stefano's Foods, Inc. Recalls Meat Products Due To Misbranding and Undeclared Allergen

AMS

USDA Enhances Livestock Mandatory Reporting for Cattle

July 26, 2017

FDA

Dietary supplement concerns? Tell the FTC and FDA

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
07/25/2017	Caribena	Yellow Maradol Papayas	Salmonella	Grande Produce
07/24/2017	LaBri's Body Health	Dietary Supplement	Unapproved new drug	EZ Weight Loss TX