In This Week’s Edition:
- FDA Update on Enhancing the Safety of Imported Shrimp
- FDA and EPA Provide Consumer Advice About Eating Fish
- FNS To Include LGBTQI+ Individuals as Protected Class in Sex Discrimination Under SNAP
- AMS Proposed Rule on Preserving GIPSA Trust Benefits
- Withdrawal of Mycoprotein Food Additive Petition
- FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products
- FDA Update on Infant Formula Outbreak Investigation
- Statements by Secretary of Agriculture HHS Secretary on the White House Conference on Hunger, Nutrition, and Health
- Proposed Rule on Tobacco Product Standard for Characterizing Flavors in Cigars
- Proposed Rule on Tobacco Product Standard for Menthol in Cigarettes
- Listening Sessions; Public Meeting; Request for Comments on Proposed Tobacco Product Standards
- Notice of May 23, 2022, Meeting of the Board for International Food and Agricultural Development
- 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 Update on Enhancing the Safety of Imported Shrimp
The FDA recognizes the importance of establishing strong partnerships with all stakeholders along the farm to table continuum, including foreign governments. Looking at modern approaches to strengthen and leverage partnerships the FDA is exploring the use of a type of arrangement called a regulatory partnership. These arrangements aim to leverage commodity-specific oversight systems, along with data and information to strengthen food safety before and at the port of entry. To initially evaluate this approach, FDA’s objective is to partner with regulatory agencies in countries that export shrimp to the United States.
FDA and EPA Provide Consumer Advice About Eating Fish
FDA and EPA have released advice for consumers regarding eating fish. This advice can help those who might become or are pregnant or breastfeeding as well as parents and caregivers who are feeding children make informed choices when it comes to the types of fish that are nutritious and safe to eat.
FNS To Include LGBTQI+ Individuals as Protected Class in Sex Discrimination Under SNAP
USDA and Food and Nutrition Service (FNS) announced that it will interpret the prohibition on discrimination based on sex found in Title IX of the Education Amendments of 1972, and in the Food and Nutrition Act of 2008, as amended, Supplemental Nutrition Assistance Program, formerly the Food Stamp Program (7 USC § 2011 et seq.), to include discrimination based on sexual orientation and gender identity. Under the leadership of the Biden-Harris Administration, USDA and FNS are issuing this interpretation to help ensure its programs are open, accessible and help promote food and nutrition security, regardless of demographics.
AMS Proposed Rule on Preserving GIPSA Trust Benefits
AMS has proposed to revise the regulations providing instructions for livestock sellers and live poultry sellers or growers who desire to preserve their interest in statutory trusts under the Packers and Stockyards Act. The proposed revisions would add procedures and timeframes for a livestock seller to notify the livestock dealer and the Secretary of Agriculture that the seller has not received full payment for livestock purchased by the dealer and that the seller intends to preserve its trust interests.
Withdrawal of Mycoprotein Food Additive Petition
FDA announced the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 6A3930) proposing that the food additive regulations be amended to provide for the safe use of mycoprotein, derived from Fusarium graminearum (taxonomically reclassified as Fusarium venenatum), as a source of protein in certain foods.
FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products
FDA issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC. Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products.
FDA Update on Infant Formula Outbreak Investigation
Following the voluntary recall and hold of certain powdered infant formula products produced at the Abbott Nutrition facility in Sturgis, MI, Abbott has committed to completing enhanced testing of stored product batches prior to making release determinations. While the FDA recognizes that Abbott has conducted standard product testing, there were a limited number of samples tested. Additionally, although finished product testing does not eliminate the risk of contamination, the enhanced testing will provide for a greater chance to detect Cronobacter sakazakii, if present; however, this enhanced level of testing will take additional time.
Statements by Secretary of Agriculture HHS Secretary on the White House Conference on Hunger, Nutrition, and Health
The White House announced its effort to combat hunger and improve nutrition with its Conference on Hunger, Nutrition and Health. Read the statements released by Secretary of Agriculture Tom Vilsack and HHS Secretary Xavier Becerra here.
Proposed Rule on Tobacco Product Standard for Characterizing Flavors in Cigars
FDA is proposing a tobacco product standard that would prohibit characterizing flavors (other than tobacco) in all cigars and their components and parts. FDA states that characterizing flavors in cigars, such as strawberry, grape, cocoa, and fruit punch, increase appeal and make the cigars easier to use, particularly among youth and young adults.
Proposed Rule on Tobacco Product Standard for Menthol in Cigarettes
FDA is proposing a tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes. FDA states that menthol’s flavor and sensory effects increase appeal and make menthol cigarettes easier to use, particularly among youth and young adults.
Listening Sessions; Public Meeting; Request for Comments on Proposed Tobacco Product Standards
FDA is announcing listening sessions, public meetings and a request for comment on the proposed rules on tobacco product standard for menthol in cigarettes and characterizing flavors in cigars.
Notice of May 23, 2022 Meeting of the Board for International Food and Agricultural Development
Pursuant to the Federal Advisory Committee Act, notice was given of a public meeting of the Board for International Food and Agricultural Development, The Global Food Security Crisis: Exploring the Evidence Base and Lessons from the Past to Strengthen Agricultural, Nutrition, and Food Systems in the Face of Shocks. The meeting will be held on May 23, 2022 from 12:00 to 2:30 EDT online, with designated times for public comment from 1:30-1:50 p.m. EDT and from 2:15-2:20 p.m. EDT.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the investigation with a reference number 1064, the total adverse event reports have increased to 529 and sample collection and analysis has been initiated.
- For the Listeria monocytogenes outbreak in a not yet identified food (reference #1057), the case count has increased to 18 cases.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include undeclared sulifiting agents, foreign suppliers not in compliance with FSVP, and more.
FDA Warning Letters
Tiger Vapor, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Kingdom Harvest |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
Delta 8 Hemp |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
ATLRx, Inc. |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
BioMD Plus LLC |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
M Six Labs, Inc. |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
Lynda’s Legacy LLC d/b/a Chaney’s Tobacco Station |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Age Management Institute Santa Barbara |
Compounding Pharmacy/Adulterated Drug Products |
Global Imports Inc. |
Foreign Supplier Verification Program (FSVP) |
Bhan Kanom Thai Inc |
Foreign Supplier Verification Program (FSVP) |
The W.S. Badger Company, Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
Madras Groceries |
Foreign Supplier Verification Program (FSVP) |
MYA International, Inc. |
Unapproved New Drugs/Misbranded |
SCO Koladen LLC |
Foreign Supplier Verification Program (FSVP) |
Froggy’s Fog LLC |
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
C R Supplements, LLC |
Unapproved New Drugs/Misbranded |
Miami University Department of Chemistry and Biochemistry |
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
Don’t Run Out dba Public Goods |
Foreign Supplier Verification Program (FSVP) |
Cigsweb.com |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Crystal Canyon Vapes LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Rena’s Organic |
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
Best Fiji Kava, Inc. |
Foreign Supplier Verification Program (FSVP) |
Breathe Easy Vapes, LP dba Breathe Easy Vapes |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |