June 19, 2019

Federal Register

Food and Drug Administration

Notices

Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds

Filed on: 06/19/2019 at 8:45 am Scheduled Pub. Date: 06/20/2019

FR Document: 2019-13122 PDF 5 Pages (34.6 KB) Permalink

Animal and Plant Health Inspection Service

Proposed Rules

Swine Health Protection Act; Amendments to Garbage Feeding Regulations

Filed on: 06/19/2019 at 8:45 am Scheduled Pub. Date: 06/20/2019

FR Document: 2019-13154 PDF 7 Pages (186 KB) Permalink

Environmental Protection Agency

Rules

Tolerance Exemptions:

Melamine formaldehyde polycondensate resin

Filed on: 06/19/2019 at 8:45 am Scheduled Pub. Date: 06/20/2019

FR Document: 2019-12994 PDF 12 Pages (242 KB) Permalink

FDA

Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products

Statement on new guidance for the declaration of added sugars on food labels for single-ingredient sugars and syrups and certain cranberry products

Recalls

Date	Brand	Product Description	Reason/Problem	Company
06/17/2019	Mai sushi my way	Spicy shrimp tempura crunch roll, Spicy shrimp tempura roll	Undeclared eggs	Mai Cuisine Inc.

Warning Letters

Posted Date	Letter Issue Date	Company	Issuing Office	Subject
06/18/2019	06/06/2019	PRL Inc	Division of Human and Animal Food Operations East V	CGMP/Dietary Supplement/Adulterated/Misbranded
06/18/2019	06/07/2019	Earthworks Health	Office of Human and Animal Food- West Division II	Unapproved New Drugs/Misbranded

AMS

USDA Partners with U.S. Farmers and Ranchers Alliance to Promote U.S. Agriculture

AMS Issues Complaint against Clinton Livestock Auction LLC, Sandra Berry and Jack Blake Berry

AMS Reaches a Consent Decision and Civil Penalty with Cargill Meat Solutions Corporation

AMS Issues Complaint against Michael J. Rogers

FNS

USDA Applauds Recent Settlement Regarding SNAP Quality Control Misconduct

@FrankYiannasFDA

• · Smarter Food Safety = People-led + FSMA-based + Technology-enabled. Thanks @QAMagazine for your interest in this new era. It will require all of us - public & private sectors - working together. https://t.co/mFrgcbb2i2
• · Today, #FDA is providing guidance for the declaration of added #sugars for single-ingredients sugars & syrup & certain cranberry products as part of the process of updating the Nutrition Facts Label. Background & my full statement are here > https://go.usa.gov/xy33z

@FDAMedia

• · 1/5 FDA issued final guidance to provide labeling clarification for the Added Sugars declaration on single-ingredient sugars, syrups & certain cranberry products: https://go.usa.gov/xyqSm
• · 2/5 For single-ingredient sugars and syrups, the Nutrition Facts label will now only provide a percent Daily Value for Added Sugars.
• · 3/5 Manufacturers may add a “†” symbol on packages & containers of single-ingredient sugars & syrups immediately following the percent Daily Value declaration for Added Sugars.
• · 4/5 This symbol leads consumers to info about the gram amount of Added Sugars, as well as info about how that amount of sugar contributes to the percent Daily Value.
• · 5/5 For certain cranberry products, where sugar is added and does not exceed the level in a comparable fruit product, the label may indicate that sugar has been added because cranberries are naturally tart. To learn more, check out our new video!

@US_FDA

• · Sugar is added to a lot of foods & it can be hard not to eat too much of it. It’s important to get less than 10% of your total daily calories from added sugars. Changes to the Nutrition Facts label will let you know how much added sugar you’re eating.

@FDAfood

• · Today the #FDA has released final “Guidance for Industry: Declaration of Added #Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars & Syrups, & Certain Cranberry Products.” https://go.usa.gov/xy33g
• · This guidance for #food manufacturers clarifies labeling requirements for added sugars on the Nutrition Facts Label.
• · If you're at #FutureFoodTech in NYC, don't miss Dennis Keefe from the US #FDA speaking on the panel discussion ‘Solving A Food System Under Stress: How Can Biotech Produce the Next-Gen Products We Need?’ on Wednesday June 19 at #futurefoodtech.
• · Safety #Alert Norovirus https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/winco-foods-llc-recalls-frozen-red-raspberries-because-possible-health-risk

@FDAanimalhealth

There’s a lot of talk on the internet about CBD for treating dogs who react to loud noises. You should be aware that FDA has NOT evaluated these products and can’t say whether they are safe or effective, how they are manufactured, or whether they contain CBD. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis

June 20, 2019

Federal Register

Food and Drug Administration

Rules

Guidance:

Determining the Number of Employees for Purposes of the Small Business Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food)

Filed on: 06/20/2019 at 8:45 am Scheduled Pub. Date: 06/21/2019

FR Document: 2019-13223 PDF 6 Pages (179 KB) Permalink

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Substances Generally Recognized as Safe: Notification Procedure

Filed on: 06/20/2019 at 8:45 am Scheduled Pub. Date: 06/21/2019

FR Document: 2019-13220 PDF 3 Pages (83.4 KB) Permalink

Threshold of Regulation for Substances Used in Food-Contact Articles

Filed on: 06/20/2019 at 8:45 am Scheduled Pub. Date: 06/21/2019

FR Document: 2019-13117 PDF 8 Pages (109 KB) Permalink

Food and Nutrition Service

Rules

Supplemental Nutrition Assistance Program:

Student Eligibility, Convicted Felons, Lottery and Gambling, and State Verification Provisions of the Agricultural Act; Correction

Filed on: 06/20/2019 at 8:45 am Scheduled Pub. Date: 06/21/2019

FR Document: 2019-12910 PDF 7 Pages (173 KB) Permalink

FDA

FDA Announces New Qualified Health Claims for EPA and DHA Omega-3 Consumption and the Risk of Hypertension and Coronary Heart Disease

Recalls

Date	Brand	Product Description	Reason/Problem	Company
06/18/2019	Signature Select	Avocado Chunks	Listeria monocytogenes	Nature’s Touch Frozen Foods West Inc.

USDA

USDA World Agricultural Outlook Board Chair Dr. Seth Meyer to Depart

FSIS

Notices

Number	Title	Date Issued	Expiration Date
19-19	Label Verification of Imported Raw Beef Products Labeled “For Cooking Only” or “For Full Lethality Treatment”	Jun 19, 2019	Jul 01, 2020

@FDAMedia

• · 1/3 FDA is allowing for the use of a qualified health claim that EPA & DHA #Omega-3 may reduce the risk of hypertension, a risk factor for heart disease. While there is some evidence suggesting this, the evidence is inconclusive and inconsistent: https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-new-qualified-health-claims-epa-and-dha-omega-3-consumption-and-risk-hypertension-and
• · 2/3 To prevent consumer deception, a qualified health claim for EPA & DHA #Omega-3 must be accompanied by a disclaimer that accurately describes the level of scientific evidence supporting this claim.
• · 3/3 FDA does not recommend eating more than 3 grams per day of EPA & DHA #Omega-3 fatty acids. 3.6 grams per day is the minimum amount associated with a reduced risk of hypertension.

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