Laws and Regulations Committee Update – May 24 -25, 2021
May 24, 2021
FDA
May 21, 2021 – FDA Announces Seizure of Adulterated Dietary Supplements Containing Kratom
FSIS
Constituent Update – May 21, 2021
Recalls
Otten’s Seafood Inc. Recalls Siluriformes Fish Products Produced Without Benefit of Inspection
@DrWoodcockFDA
- Today, the FDA announced a seizure in Florida of more than more than 207,000 units of kratom dietary supplements and bulk dietary ingredients. The FDA continues to warn consumers not to use any products labeled as containing kratom. https://go.usa.gov/xHSd4
- There are currently no FDA-approved therapeutic uses for products containing kratom, and the FDA has identified significant safety concerns associated with its use.
- Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Kratom affects the same opioid brain receptors as morphine & appears to have properties that expose people who consume kratom to the risks of addiction, abuse and dependence.
- To protect the public health, the FDA will continue to take action against kratom-containing dietary supplements.
May 25, 2021
FDA
Warning Letters
| Posted Date | Issue Date | Company Name | Issuing Office | Subject |
| 05/25/2021 | 04/29/2021 | Africana Market LLC | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
| 05/25/2021 | 05/10/2021 | Great Lakes Gelatin Company | Office of Human and Animal Food Operations East-VI | New Drug/Misbranded |
FSIS
Be Sure to Invite Food Safety to Your Next Pig Roast
@FDA_ORA#DYK that #cicadas are related to shrimp & lobster? Don’t eat them if you’re allergic to seafood! LEARN MORE about FDA’s role in protecting people with #FoodAllergies: https://go.usa.gov/xHg69