FDA Provides Flexibility to States in Enforcing FSMA Produce Safety Rule for Small Farms
FDA is providing flexibility for when states may begin conducting routine inspections of small farms, other than sprouts operations, under the Food Safety Modernization Act (FSMA) Produce Safety Rule.
Routine inspections of small farms, other than sprouts operations, subject to the Produce Safety Rule, will generally begin in Spring 2020; however, the FDA is clarifying that states receiving competition A/B funding as part of the State Produce Implementation Cooperative Agreement Program (CAP) may begin routine inspections as early as January 1, 2020. This clarification is being made after several requests from states to have greater flexibility to align routine inspections with the winter growing season where applicable.
USMCA Deal Reached
The replacement to NAFTA is expected to be ratified by all three countries next year. More information here.
Latest FDA Import Alerts
Import alerts have been updated for Cheese, seafood, produce, dried pepper and more.
National Organic Standards Board Meeting Scheduled
The National Organic Standards Board (NOSB) makes recommendations to the USDA about whether substances should be allowed or prohibited in organic production and/or handling, assists in the development of standards for organic production, and advises the Secretary on other aspects of the implementation of the OFPA. The NOSB is holding a public meeting to discuss and vote on proposed recommendations to the USDA, to receive updates from the USDA National Organic Program (NOP) on issues pertaining to organic agriculture, and to receive comments from the organic community. The meeting will be held April 29-May 1, 2020, from 8:30 a.m. to approximately 6:00 p.m. Eastern Time. The meeting and webinars are open to the public. No registration is required except to sign up for oral comments. All meeting documents and instructions for participating will be available on the AMS website at https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-crystal-city-va. Please check the website periodically for updates. Meeting topics will encompass a wide range of issues, including substances petitioned for addition to or removal from the National List of Allowed and Prohibited Substances (National List), substances on the National List that are under sunset review, and guidance on organic policies.
FDA Update on Tailor Cut Salmonella Outbreak
FDA and the Pennsylvania Department of Health (DOH) are investigating an outbreak of illnesses caused by Salmonella Javiana in Pennsylvania. Epidemiologic and traceback evidence indicate that fruit mix with cantaloupe, honeydew, pineapple, and grapes from Tailor Cut Produce of North Brunswick, New Jersey, are a potential source of this outbreak. FDA recommends that food service and institutional food operators should not sell or serve the fruit mix with cantaloupe, honeydew, pineapple, and grapes prepared by Tailor Cut Produce. More information here.
Commercial Customs Operations Advisory Committee (COAC) Recommends CBP Utilize a Global Business Identifier so Firms can view Unauthorized Use of Their Business for Importations
Firms would be able to access data on entries in which their global business identifier was used, which will help them combat unauthorized use of their business in importing transactions. More information here.
FSIS Extends Comment Period on Country of Origin Labeling Petition by Cattlemen
FSIS is extending the comment period for a petition submitted by the United States Cattlemen’s Association on “Made in U.S.A” and “Product of U.S.A” labeling claims. The petition requests that FSIS update its FSIS Food Standards and Labeling Policy Book to limit the use of these labeling claims to products from cattle that were born, raised, and harvested in the United States. The petition is available on the FSIS website at https://www.fsis.usda.gov/wps/wcm/connect/42bc4cbb-f776-4c30-a992-2b48d43ee263/19-05-usca-102319.pdf?MOD=AJPERES. The comment period will now close on January 30, 2020.
FSIS Transitions to Using WGS Data from Salmonella Isolates to Determine Serotype
FSIS is announcing a modernization of laboratory methods to determine serotype of Salmonella isolates. For all Salmonella positive samples collected after January 1, 2020, whole genome sequencing (WGS) data will be used to determine Salmonella serotype.
Smucker Recalls Cat Food
Severe symptoms in cat’s possible. More information here.
FDA Updates Interstate Certified Shellfish Shippers List
The latest list is available here.
FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2018 for Use in Food-Producing Animals
The report showed that domestic sales and distribution of medically important antimicrobials for use in food-producing animals increased nine percent between 2017 and 2018. Despite this increase, 2018 is the second-lowest year on record and the overall trend continues to indicate that ongoing efforts to support antimicrobial stewardship are having an impact: sales in 2018 are down 21 percent since 2009, the first year of reporting, and down 38 percent since 2015, the peak year of sales and distribution.
FDA Recall Alert on Basic Reset and Biogenyx Supplements
FDA is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, Tennessee. In September, a federal court entered a consent decree of permanent injunction between the United States and the two companies and their owner, Fred R. Kaufman III. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree. More information here.
FDA Update on Blackberry Hep A Outbreak
CDC reports increasing case count and additional grocery store; FDA traceback continues. More information here.
Consumer Group Files Petition with FSIS on National Residue Program
The Center for Food Safety is petitioning FSIS to change the National Residue Program to (1) test for residues of all drugs approved/used in food animals; (2) establish clear definitions and parameters for minimum levels of applicability (MLA); ( 3) improve annual reporting mechanisms; (4) ensure that staff utilize the best available technology and methods that allow for the lowest limits of detection (LOD) for each compound among other things. See the petition here.
Latest FDA Warning Letters
The latest FDA warning letters are:
Posted Date |
Company Name |
Issuing Office |
Subject |
12/11/2019 |
Alkermes, Inc. |
Center for Drug Evaluation and Research | CDER |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
12/10/2019 |
OHM Pharma, Inc. |
Office of Pharmaceutical Quality |
CGMP/Finished Pharmaceuticals/Adulterated |
12/10/2019 |
Hill’s Pet Nutrition Inc. |
Office of Human and Animal Foods Division II West |
Interstate Commerce/Food/Adulterated |
12/10/2019 |
Prolifix Nutrition, LLC |
Office of Human and Animal Foods Division IV West |
CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |
12/10/2019 |
Friendly’s Manufacturing and Retail LLC |
Office of Human and Animal Food Operations East – Division 1 |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
12/10/2019 |
ECIG Online Ltd d/b/a Vvapour |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
12/10/2019 |
KingPin Cigarettes, Inc. d/b/a Blackhat Vapor Company |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
12/10/2019 |
Teligent Pharma, Inc. |
Division of Pharmaceutical Quality Operations I |
CGMP/Finished Pharmaceuticals/Adulterated |
12/10/2019 |
Valley Proteins, Inc. |
Division of Human and Animal Food Operations East II (HAFE2) |
New Animal Drug/Adulterated |
12/10/2019 |
Vapes by Enushi |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
12/10/2019 |
VitaCig Canada |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
12/10/2019 |
TJ’s E-Cigarettes Limited |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
12/10/2019 |
Ralfy’s Emporium |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
12/10/2019 |
Vape 180 LLC |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
12/06/2019 |
Liveyon Labs Inc |
Office of Biological Products Operations – Division 2 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Please contact Erik Lieberman at elieberman@usfoodimports.com or (202) 765-1800 if you have questions or would like additional information. |