In This Week’s Edition:
- Lead Levels in Applesauce Investigation
- Federal Court Enters Consent Decree for Balance of Nature to Stop Making and Selling Supplements Over Claims, CGMP
- USDA Announces Key Staff Appointments
- APHIS Proposing to Expand Exemptions for Moving GMOs
- U.S. Canadian Border Inspection Agency Opposes Petition to Remove The 50 Mile Geographical Radius For FSIS Port of Entry Inspection
- APHIS to Allow Importation of Fresh Beef From Paraguay
- USDA Announces Grants Intended to Expand Access to Healthy Foods
- Certain Paper Shopping Bags From China and India; Anti-Dumping, Countervailable Subsidies
- GIPSA Posting and Posting of Stockyards
- NY AG Suing PepsiCo Over Plastic Pollution
- FTC Warns Trade Associations and Influencers About Inadequate Disclosure in Social Media Posts Promoting Consumption of Aspartame or Sugar
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
Lead Levels in Applesauce Investigation
FDA, along with CDC and state and local partners, is investigating reports of elevated blood lead levels in individuals with reported exposure to Apple Cinnamon Fruit Puree pouches manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands.
As of November 16, 2023, there have been 34 reports of illness potentially linked to recalled product submitted to FDA. FDA is continuing to evaluate incoming adverse reports of illnesses.
Federal Court Enters Consent Decree for Balance of Nature to Stop Making and Selling Supplements Over Claims, CGMP
FDA announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court to stop producing and selling their products until they come into compliance by ceasing to make prohibited drug claims in their marketing and complying with CGMP requirements.
USDA Announces Key Staff Appointments
USDA announced the names of individuals who will hold senior staff positions in Washington, D.C.
- Eric Womack has been named Deputy General Counsel in the Office of General Counsel
- Brian Sowyrda was named Director of External Affairs in the Office of Congressional Relations
- Elaine Trevino has been appointed Associate Administrator in the Foreign Agricultural Service (FAS)
APHIS Proposing to Expand Exemptions for Moving GMOs
USDA is advising the public that they are proposing to add five new types of genetic modifications a plant can contain and be exempt from the regulations for the movement of organisms modified or produced through genetic engineering because such modifications could otherwise be achieved through conventional breeding methods.
U.S. Canadian Border Inspection Agency Opposes Petition to Remove The 50 Mile Geographical Radius For FSIS Port of Entry Inspection
The USCBIA comment on Petition 23-06 to remove the 50-mile geographical radius for FSIS port of entry inspection asks that the 50-mile radius rule be kept in place because it contends it is one of the most important safeguards is the port of entry meat inspection. Read the full comment here.
APHIS to Allow Importation of Fresh Beef From Paraguay
APHIS is amending the regulations governing the importation of certain animals, meat, and other animal products by allowing, under certain conditions, the importation of fresh (chilled or frozen) beef from Paraguay. Based on the evidence from a risk analysis, APHIS has determined that fresh beef can safely be imported from Paraguay, provided certain conditions are met.
USDA Announces Grants Intended to Expand Access to Healthy Foods
USDA announced an investment of more than $52 million to improve dietary health and access to fresh fruits and vegetables for eligible families.
DOC Issues Preliminary Ruling that Subsidies Being Provided to Paper Bag Makers in India and China
The U.S. Department of Commerce preliminarily determines that countervailable subsidies are being provided to producers and exporters of certain paper shopping bags (paper bags) from China and India.
GIPSA Posting of Stockyards
USDA is taking action to post stockyards under the Packers and Stockyards Act (P&S Act). Specifically, they are proposing that 15 stockyards now operating subject to the P&S Act be posted. USDA is also posting 10 stockyards that were identified previously as operating subject to the P&S Act.
NY AG Suing PepsiCo Over Plastic Pollution
New York Attorney General Letitia James filed a lawsuit against PepsiCo Inc. for harming the public and the environment with its single-use plastic packaging. The lawsuit alleges that PepsiCo substantially causes public harm in Buffalo, has failed to warn consumers about the potential health and environmental risks of its single-use plastic packaging, and misleads consumers and the public about its efforts to combat plastic pollution.
FTC Warns Trade Associations and Influencers About Inadequate Disclosure in Social Media Posts Promoting Consumption of Aspartame or Sugar
Federal Trade Commission staff have sent warning letters to two trade associations and 12 registered dieticians and other online health influencers warning them about the lack of adequate disclosures that they were compensated by industry in their Instagram and TikTok posts promoting the safety of the artificial sweetener aspartame or the consumption of sugar-containing products.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
• A new outbreak of Listeria monocytogenes (ref #989) linked to a not yet identified product has been added to the table. FDA has initiated sample collection and analysis. FDA’s investigation is ongoing.
• A new outbreak of E. coli O103 (ref #1192) linked to a not yet identified product has been added to the table. FDA has initiated a traceback investigation. FDA’s investigation is ongoing.
• For the investigation of illnesses (ref #1198) linked to apple cinnamon fruit puree pouches, the FDA has updated the advisory to include expanded recall information from the firm and additional reports of illness.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include foods for pesticides, products that appear to be adulterated for economic gain, and more.
FDA Warning Letters
Global Pharma Healthcare Private Limited |
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
Amazon.com, Inc. |
Unapproved New Drugs/Misbranded |
Ming Fai Industrial Co LTD |
CGMP/QSR/Medical Devices/Adulterated |
American Distribution and Manufacturing Co., LLC |
Foreign Supplier Verification Program (FSVP) |
Natural Relief Inc. |
Unapproved New Drugs/Misbranded |
Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi |
CGMP/Finished Pharmaceuticals/Adulterated |
Wello Inc. |
CGMP/QSR/Medical Devices/Misbranded |