FDA Finalizes Rule Related to Gluten-Free Labeling for Foods Containing Fermented, Hydrolyzed Ingredients
The final rule to establishes compliance requirements for fermented and hydrolyzed foods, or foods that contain fermented or hydrolyzed ingredients, that bear the “gluten-free” claim. The final rule, titled “Gluten-Free Labeling of Fermented or Hydrolyzed Foods,” covers foods such as yogurt, sauerkraut, pickles, cheese, green olives, FDA-regulated beers and wines, and hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings.
Because gluten proteins in hydrolyzed and fermented foods are no longer intact and, currently, cannot be adequately detected and quantified through testing, the final rule states that FDA will determine compliance based on records kept by the manufacturer to show that their foods are gluten-free before fermentation or hydrolysis. It also includes a discussion of compliance for distilled foods such as vinegar. The rule does not change the definition of “gluten-free” established by FDA in 2013. More information here.
FSIS Discontinues Sampling and Testing for Chicken Necks, Hearts, Gizzards, and Livers
More details here.
FDA Update on Red Onion Salmonella Outbreak
The latest information is here.
FSIS Updates Establishment Directory
The newest directory may be found here.
USDA Announces More Eligible Commodities for CFAP
USDA has announced that the following commodities are now eligible for the Coronavirus Food Assistance Program-a program that provides direct payments to farmers who have lost income due to declines in commodity values as a consequence of the COVID-19 pandemic:
- Specialty Crops – aloe leaves, bananas, batatas, bok choy, carambola (star fruit), cherimoya, chervil (french parsley), citron, curry leaves, daikon, dates, dill, donqua (winter melon), dragon fruit (red pitaya), endive, escarole, filberts, frisee, horseradish, kohlrabi, kumquats, leeks, mamey sapote, maple sap (for maple syrup), mesculin mix, microgreens, nectarines, parsley, persimmons, plantains, pomegranates, pummelos, pumpkins, rutabagas, shallots, tangelos, turnips/celeriac, turmeric, upland/winter cress, water cress, yautia/malanga, and yuca/cassava.
- Non-Specialty Crops and Livestock – liquid eggs, frozen eggs and all sheep. Only lambs and yearlings (sheep less than two years old) were previously eligible.
- Aquaculture – catfish, crawfish, largemouth bass and carp sold live as foodfish, hybrid striped bass, red drum, salmon, sturgeon, tilapia, trout, ornamental/tropical fish, and recreational sportfish.
- Nursery Crops and Flowers – nursery crops and cut flowers.
FSIS Enhances PHIS Export Module
Details here.
FSIS and Vermont Sign Cooperative Interstate Shipping Agreement
The agreement will allow certain state-inspected meat and poultry processors in Vermont to ship their products across state lines.
FSIS Updates List of Foreign Establishments Eligible to Export to the U.S.
Latest FDA Import Alerts
The latest FDA import alerts are available here and include produce, soft cheeses from France, undeclared colors and pesticides among other things.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
08/12/2020 |
AkivaMed Inc. |
Center for Devices and Radiological Health |
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
08/12/2020 |
Holistic Health International, LLC |
Center for Devices and Radiological Health |
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
08/12/2020 |
CoreMedica Laboratories, Inc. |
Center for Devices and Radiological Health |
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
08/12/2020 |
Fair Price Labs, Inc. |
Center for Devices and Radiological Health |
Adulterated and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
08/12/2020 |
Oxford Medical Instruments USA, Inc. |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
08/11/2020 |
Copoliva Inc. |
Division of West Coast Imports |
Foreign Supplier Verification Program (FSVP) |
08/11/2020 |
Sugiyo USA Inc. |
Division of Human and Animal Food Operations West VI |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
08/11/2020 |
TAKA USA, INC. dba Cosmetic Innovations |
Division of Pharmaceutical Quality Operations II |
CGMP/Finished Pharmaceuticals/Adulterated |
08/11/2020 |
Davis Ventures, Inc dba The Green Herb and New Genesis Health |
Division of Human and Animal Food Operations West IV |
CGMP/Dietary Supplement/Adulterated/Misbranded |
08/11/2020 |
Soluciones Cosmeticas, SA de CV |
Center for Drug Evaluation and Research | CDER |
CGMP/Adulterated/Unapproved/Misbranded |
08/10/2020 |
H-Lab Life |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Please contact Erik Lieberman at elieberman@usfoodimports.com or 202.765.1800 if you have questions or would like additional information. |