In This Week’s Edition:
- FDA Responds to Petition Related to CBD and Dietary Supplements
- FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol
- FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Food Intended for Babies and Young Children
- FDA Issues Procedural Notice on Consumer Research on Front-of-Package Labeling
- FDA Announces Action Levels for Lead in Categories of Processed Baby Foods
- 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 Responds to Petition Related to CBD and Dietary Supplements
FDA denied the requests in three citizen petitions, from the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the Natural Products Association, that FDA issue a regulation that would allow cannabidiol (CBD) products to be marketed as dietary supplements. Such a regulation would be needed in order to provide a potential pathway for CBD products to be lawfully marketed as dietary supplements, because a provision in the law prohibits the marketing of certain drug ingredients as dietary supplements. The FDA’s responses explain that they do not intend to initiate such a rulemaking, because in light of the available scientific evidence, it is not apparent how CBD products could meet the applicable safety standard for dietary supplements.
FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol
Given the growing cannabidiol (CBD) products market, FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products. FDA is announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.
FDA to Hold Webinar on the Draft Guidance for Industry on Action Levels for Lead in Food Intended for Babies and Young Children
Join the FDA for a webinar on Thursday, March 2, 2023 at 1:00 pm (ET) to discuss the recent draft guidance on lead action levels for foods intended for children less than two years of age. The draft guidance, titled “Action Levels for Lead in Food Intended for Babies and Young Children: Draft Guidance for Industry,” issued in January informs industry on the proposed action levels for lead in a wide range of commercial foods targeted to this population. These draft action levels support the agency’s broader effort to reduce exposure to arsenic, lead, cadmium, and mercury from foods, and advance our goals in the Closer to Zero action plan.
FDA Issues Procedural Notice on Consumer Research on Front-of-Package Labeling
FDA has issued a 60-day procedural notice on its plans to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods.” As part of the Paperwork Reduction Act, federal agencies are required to publish notice in the Federal Register on each proposed information collection to give the public the opportunity to comment.
FDA Announces Action Levels for Lead in Categories of Processed Baby Foods
FDA is announcing draft guidance for industry on action levels for lead in processed foods that are intended for babies and children under two years of age, to help reduce potential health effects in this vulnerable population from dietary exposure to lead. The proposed action levels would result in significant reductions in exposures to lead from food while ensuring availability of nutritious foods. This action is part of Closer to Zero, which sets forth the FDA’s approach to continually reducing exposure to lead, arsenic, cadmium and mercury to the lowest levels possible in foods eaten by babies and young children.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- There are no updates to this week’s table.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- No new updates
FDA Import Alerts
The latest FDA import alerts include foods that are or contain unsafe additives, illegal/undeclared color additives, and more.
FDA Warning Letters
3rd Rock Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Zombieland LLC dba Mafia Street Vapor Company |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding |
Compounding Pharmacy/Adulterated Drug Products |
Lineage Vapors LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Larkin Community Hospital Institutional Review Board |
Bioresearch Monitoring Program/Institutional Review Board (IRB) |
Evimeria El Aztecano, Inc. |
Dietary Supplement/Misbranded |
Buzzagogo, LLC |
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
Leimax, Corp. |
Foreign Supplier Verification Program (FSVP) |
Fuentes Farms LLC |
Foreign Supplier Verification Program (FSVP) |
TL State Management, Inc. |
Foreign Supplier Verification Program (FSVP) |