Food Industry Regulatory Update August 16, 2024

In This Week’s Edition:

  • FDA Sodium Reduction Guidance
  • FSIS Launches Avian Influenza Dairy Cow Testing Program
  • FDA Issues Warning Letter to Manufacturer of Apple Cinnamon Fruit Puree Products Containing Elevated Levels of Lead and Chromium
  • Update on Outbreak Investigation of Salmonella: Cucumbers
  • Federal Trade Commission Announces Final Rule Banning Fake Reviews and Testimonials
  • Skip the Antibacterial Soap; Use Plain Soap and Water
  • FDA CORE Outbreak Investigation Status Update
  • FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
  • FDA Import Alerts
  • FDA Warning Letters

FDA Sodium Reduction Guidance

FDA issued draft guidance for the second phase of it’s work to reduce sodium across the food supply through voluntary industry efforts. Prior to 2021, consumer intake was approximately 3,400 milligrams per day on average, far higher than the limit recommended by the Dietary Guidelines for Americans of 2,300 milligrams per day for those 14 years and older. If finalized, the new set of voluntary targets would support reducing average individual sodium intake to about 2,750 milligrams per day. 

FSIS Launches Avian Influenza Dairy Cow Testing Program

FSIS has issued a notice which provides information and instructions to Public Health Veterinarians, Supervisory Consumer Safety Inspectors, and Consumer Safety Inspectors regarding the testing of dairy cows for H5N1 Influenza A under the National Residue Program. The testing will begin on September 16.

Federal Trade Commission Announces Final Rule Banning Fake Reviews and Testimonials

The Federal Trade Commission announced a final rule that will combat fake reviews and testimonials by prohibiting their sale or purchase and allow the agency to seek civil penalties against knowing violators.

FDA Issues Warning Letter to Manufacturer of Apple Cinnamon Fruit Puree Products Containing Elevated Levels of Lead and Chromium

FDA issued a Warning Letter to AUSTROFOOD S.A.S., the manufacturer of the apple cinnamon fruit puree pouches that were recalled last year and that were found to contain elevated levels of lead and chromium. The letter is part of the agency’s ongoing efforts to enhance the safety of cinnamon, ground spices, and other foods, particularly those consumed by babies and young children.  

Outbreak Investigation of Salmonella: Cucumbers

The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Salmonella Africana and Salmonella Braenderup infections with 449 illnesses in 31 states and the District of Columbia. While originally reported as two separate outbreaks, CDC and FDA combined these two outbreak investigations as they shared several similarities, including when and where illnesses occurred, the demographics of ill people, and the foods they reported eating before they became sick. Laboratory, epidemiological, and traceback data have determined that cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, and Thomas Produce Company, of Boca Raton, Florida, are likely sources of illnesses in this outbreak; however, these growers do not account for all the illnesses in this outbreak.

FDA: Skip the Antibacterial Soap; Use Plain Soap and Water

FDA says there isn’t evidence to show that over-the-counter antibacterial soaps are better at preventing illness than washing with plain soap and water. In fact, some data suggest that antibacterial ingredients could do more harm than good over the long-term.

“Following simple handwashing practices is one of the most effective ways to prevent the spread of many types of infection and illness at home, at school and elsewhere,” says Theresa M. Michele, M.D., of the FDA. “We can’t advise this enough. It’s simple, and it works.”

Harmonized System Update

Harmonized System Update (HSU) 2412 was created on August 13, 2024, and contains 1000 harmonized tariff records and 4,158 ABI records.

HSU 2412 includes several updates to PGA HTS flag indicator for AMS and adjustments required by the verification of the 2024 Harmonized Tariff Schedule.

National Advisory Committee on Meat and Poultry Inspection

FSIS is announcing a virtual meeting of the National Advisory Committee on Meat and Poultry Inspection. The purpose of the Committee is to advise the Secretary of Agriculture on State and Federal meat and poultry inspection programs, food safety, and other matters that fall within the scope of the Federal Meat Inspection Act and the Poultry Products Inspection Act. The committee will convene virtually on September 16 and 17, 2024. The Committee will review and advise FSIS on whether the Agency should change its definitions for establishment sizes to better assess and describe current business operations. The Committee will also offer input on ways technology could enhance FSIS’ inspection activities.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

  • For the outbreak of Cyclospora cayetanensis illnesses (ref #1245) linked to a not yet identified product, the case count has increased from 2 to 21.
  • For the outbreak of Salmonella Newport (ref #1248) linked to a not yet identified product, the case count has increased from 2 to 3. FDA has initiated traceback.
  • For the outbreaks of Cyclospora cayetanensis (ref #1237 and ref #1239), these outbreaks are being combined into the Cyclospora cayetanensis outbreak (ref #1237) based on traceback information from FDA’s investigation and epidemiology provided by the Centers for Disease Control and Prevention (CDC). For the outbreak of Cyclospora cayetanensis (ref #1237), the case count has been adjusted from 26 to 44; this includes 16 cases from the combined Cyclospora cayetanensis (ref #1239) outbreak plus additional illnesses.
  • For the outbreak of Salmonella Typhimurium (ref #1234) linked to a not yet identified product, the case count has increased from 88 to 89.
  • For the investigation of illnesses (ref #1233) linked to Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies, the advisory has been updated to include additional illnesses and laboratory results of product samples. 
  • For the outbreak of Salmonella Africana and Salmonella Braenderup illnesses (ref #1227), FDA has updated the advisory to include additional investigational findings.

CORE Investigation Table

FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.

FDA Import Alerts

The latest FDA import alerts include food products that appear to be misbranded, foods due to heavy metal contamination, and more.

FDA Warning Letters

AUSTROFOOD S.A.S. 
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 
LS Promotions Inc.
CGMP/Finished Pharmaceuticals/Adulterated 
Konrad Rejdak, M.D., Ph.D.
Bioresearch Monitoring Program/IRB
Txsyn Int. LLC
CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 
Nowrez & Ismail Shukri Company
CGMP/Finished Pharmaceuticals/Adulterated 
BullyKamp Products LLC
Unapproved New Animal Drug Products 
Top Dog Pet Store LLC dba The Bulldog Cartel
Unapproved New Animal Drug Products 
Baylab USA, LLC
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device 
Central Admixture Pharmacy Services, Inc.
Compounding Pharmacy/Adulterated Drug Products 
Globus Medical, Inc.
CGMP/QSR/Drug/Medical Devices/Adulterated 
Dream Vapor LLC
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded