In This Week’s Edition:
- FDA Delays Amendment to Standard of Identity for Yogurt
- AMS Expands National List of Allowed and Prohibited Substances in Organics
- Update on FDA Investigation of Cronobacter Infections: Powdered Infant
- Formula
- FDA Effort on Improving Nutrition to Turn the Tide on Diet-Related Chronic
- Disease
- Use of the Term Healthy on Food Labeling
- 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 Delays Amendment to Standard of Identity for Yogurt
The U.S. Food and Drug Administration published a notice to clarify that the effectiveness of certain provisions of the yogurt standard of identity final rule have been stayed. The final rule, published on June 11, 2021, amended the standard of identity for yogurt and revoked the definitions and standards of identity for low fat yogurt and nonfat yogurt. Dairy standards of identity are subject to formal rulemaking procedures, which provide a 30-day period for any person adversely affected to file an objection and request for hearing. If objections are properly filed, then the provisions to which objections were made do not go into effect (i.e., are “stayed’). Because the FDA received objections to certain provisions of the final rule within this timeframe, the affected provisions are stayed pending final FDA action on the objections. Additional details can be found in the Federal Register notice.
AMS Expands National List of Allowed and Prohibited Substances in Organics
This final rule amends the National List of Allowed and Prohibited Substances section of the USDA organic regulations to implement recommendations submitted to the Secretary of Agriculture by the National Organic Standards Board. This rule allows the following substances for organic production: potassium hypochlorite to treat irrigation water used in organic crop production and fatty alcohols for sucker control in organic tobacco production. This rule also removes the listing for dairy cultures, as it is redundant with an existing listing.
Update FDA Investigation of Cronobacter Infections: Powdered Infant Formula
The FDA, along with CDC and state and local partners are investigating consumer complaints and/or reports of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility. All of the ill patients are reported to have consumed powdered infant formula produced from Abbott Nutrition’s Sturgis, MI facility. FDA is advising consumers not to use recalled Similac, Alimentum, or EleCare powdered infant formulas. Recalled products can be identified by the 7 to 9 digit code and expiration date on the bottom of the package. Products are included in the recall if they have all three items below:
- the first two digits of the code are 22 through 37 and
- the code on the container contains K8, SH, or Z2, and
- the expiration date is 4-1-2022 (APR 2022) or later.
FDA Effort on Improving Nutrition to Turn the Tide on Diet-Related Chronic Disease
March is National Nutrition Month, and the FDA is shining a highlighting on the importance of good nutrition and the impact it has on improving people’s lives and lowering the enormous costs of diet-related chronic diseases.
Use of the Term Healthy on Food Labeling
FDA is issuing a 30-day procedural notice on the preliminary quantitative consumer research it plans to conduct on voluntary symbols that could be used in the future to convey the nutrient content claim “healthy.” This notice summarizes and responds to the comments the FDA received on a 60-day procedural notice issued in May 2021. The FDA is conducting the consumer research on a potential symbol, which is intended to be a stylized representation of the nutrient content claim “healthy,” while at the same time developing a proposed rule that would update when manufacturers may use the “healthy” nutrient content claim on food packages. The agency intends to publish the proposed rule with the definition update soon. The update to the definition and study of a potential symbol for the “healthy” nutrient content claim are part of the FDA’s broader efforts to help reduce the burden of diet-related chronic diseases and advance health equity. FDA states updating labeling and making it more accessible helps empower consumers. In particular, claims and symbols can help consumers better understand nutrition information and identify foods that contribute to a healthy eating pattern. Manufacturers may also reformulate products to improve their nutritional value so they can use the claim.
For Additional Information: Procedural Notice on Consumer Research on “Healthy” Symbol (May 2021)
Use of the Term Healthy on Food Labeling
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the Salmonella Saintpaul outbreak, the case count has increased to 60.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include heavy metal contamination, unsafe food additives, FSVP, and more
FDA Warning Letters
Ohm Men Vape Shop LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Premier Trends LLC |
CGMP/Finished Pharmaceuticals/Adulterated |
Steam Puff Vapor LLC DBA Vapery 2 |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Marlin Steam Co |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
OC Raw Dog LLC |
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
Unimicro Medical Systems-Shenzhen Co., Ltd. |
CGMP/QSR/Medical Devices/Adulterated |
Apna Foods Imports Co. |
Foreign Supplier Verification Program (FSVP) |
GW FOOD USA Inc. |
Foreign Supplier Verification Program (FSVP) |
ECI Pharmaceuticals, LLC |
Failure to Register and List |