In This Week’s Edition:
- FDA Proposes Definition of Term “Healthy” for Foods
- FDA Releases Overview of Activities to Enhance the Safety of Imported Produce
- APHIS Authorizes the Importation of Fresh Turmeric Rhizome From Samoa Into the U.S.
- APHIS Authorizes Importation of Fresh Sand Pears From the Republic of Korea Into the U.S.
- Listing of Color Additives Exempt From Certification; Calcium Carbonate
- FDA Releases Food Safety Prevention Strategies for Bulb Onions and Enoki, Wood Ear Mushrooms
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
FDA is proposing to update the definition for the implied nutrient content claim “healthy.” To meet the proposed definition, a food product would need to contain a certain amount of food from at least one of the food groups or subgroups (e.g., fruit, vegetables, grains, dairy and protein foods) recommended by the 2020-2025 Dietary Guidelines for Americans. The specific limits for added sugars, saturated fat and sodium would be based on a percentage of the Daily Value for these nutrients. DVs are reference amounts of nutrients to consume or not to exceed each day. The proposed criteria for how much food from a particular food group is required (called food group equivalents) and the specific limits for the three nutrients vary for individual food products, mixed products (which contain more than one food group), main dishes and meals, and are based on a Reference Amount Customarily Consumed, which is the basis for determining a serving size. Under the proposed definition, raw whole fruits and vegetables would automatically qualify for the “healthy” claim because of their nutrient profile and positive contribution to an overall healthy diet. More details are available here.
FDA Releases Overview of Activities Underway to Enhance the Safety of Imported Produce
FDA released an update on its activities to enhance the safety of imported produce. The document provides an overview of the work underway to advance the safety of produce imported into the United States. This overview follows the 2019 release of the Strategy for the Safety of Imported Food which described the agency’s comprehensive approach to enhancing the safety of food imported into the United States.
Notice of Decision To Authorize the Importation of Fresh Turmeric Rhizome From Samoa Into the U.S.
USDA is advising the public of their decision to authorize the importation into the U.S. of fresh turmeric rhizome from Samoa. Based on the findings of a pest risk analysis, which has been made available to the public for review and comment through a previous notice, USDA has determined that the application of designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh turmeric rhizome from Samoa.
Notice of Decision To Revise Import Requirements for the Importation of Fresh Sand Pears From the Republic of Korea Into the U.S.
USDA is notifying the public of their decision to revise requirements for the importation into the United States of sand pear fruit from the Republic of Korea. Based on the findings of a pest risk analysis, which was made available to the public for review and comment through a previous notice, USDA has determined that the application of designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh, non-precleared sand pear fruit from the Republic of Korea into all ports of the U.S. as an alternative to the preclearance program.
Listing of Color Additives Exempt From Certification; Calcium Carbonate
FDA is amending the color additive regulations to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules. FDA is taking this action in response to a color additive petition submitted by Colorcon, Inc..
FDA Releases Food Safety Prevention Strategies for Bulb Onions and Enoki, Wood Ear Mushrooms
FDA is taking further action to help prevent outbreaks of foodborne illnesses associated with certain foods through the development of food safety prevention strategies.
When a foodborne illness outbreak occurs, FDA, through its Coordinated Outbreak Response and Evaluation Network and federal, state, local, territorial, tribal, and international public health partners, as appropriate, work together to determine what food may have caused the outbreak and how it became contaminated. After the outbreak investigation ends, the information learned can be used to contribute to a food safety prevention strategy for that food.
While the agency is working with industry, state, international and other partners on the development of several food safety prevention strategies, the FDA is releasing the following first two strategies:
- Salmonellosis and listeriosis associated with imported enoki and wood ear mushrooms
- Salmonellosis associated with bulb onions
Additional prevention strategies for other foods will be released as they become available.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the Cyclospora outbreak in a not yet identified food (reference #1080), sample collection and analysis has been initiated and an on-site inspection has been initiated.
- For the Salmonella Mississippi outbreak in a not identified food (reference #1097), the investigation is closed, and the outbreak has ended.
- A new outbreak has been added to the table: Salmonella Litchfield (reference #1105) in a not yet identified food. Traceback has been initiated.
- For the Salmonella Typhimurium outbreak in a not yet identified food (reference #1095), the case count has increased from 84 cases to 86 cases.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include foods products due to mycotoxins, food products due to salmonella, cheese to microbiological contamination, and more.
FDA Warning Letters
La Crosse Smokes 4 Less 1 Inc. d/b/a SMOKES 4 LESS |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
American Legends Eliquid |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Bespoke Apothecary LLC |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Ecig Vapor Juice Store |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Med Pen Concepts, LLC |
CGMP/QSR/Medical Devices/Adulterated/Misbranded |
Vapeoholic LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Muscle Sports Products, LLC |
Unapproved New Drugs/Misbranded |
Zhejiang Tianyu Pharmaceutical Co., Ltd. |
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
System Kosmetik Produktionsgesellschaft fur kosmetische Gmbh |
CGMP/Finished Pharmaceuticals/Adulterated |
Mena Produce LLC |
Foreign Supplier Verification Program (FSVP) |
El Salvador Products Inc |
Foreign Supplier Verification Program (FSVP) |