Showing posts with label mandated recall. Show all posts
Showing posts with label mandated recall. Show all posts

Friday, April 6, 2018

FDA Uses Ability to Mandate Recall for First Time, This for Contaminated Kratom

FDA issued its first mandatory recall of contaminated 'food' product (although this product is a dietary supplement which are considered food) when the agency issued one for powdered kratom product contaminated with Salmonella.  The ability to mandate a recall was granted to FDA under the FSMA regulation.  Kratom has been involved in a wide spread Salmonella outbreak.

According to the news report, "The agency asked Triangle on Friday to voluntarily recall the kratom items. When the company did not comply with the request, the FDA the next day ordered the firm to cease distribution. The company could have requested a hearing, the agency said, but it did not respond within the required time frame. The agency then issued the mandatory recall order."

Once the weapon is pulled out of the holster for the first time, it become a lot easier the second time around.

Washington Post
https://www.washingtonpost.com/news/to-your-health/wp/2018/04/03/in-a-first-fda-orders-recall-of-a-contaminated-food-kratom-with-salmonella/?utm_term=.214cd8fb6fe4
In a first, FDA orders recall of a ‘contaminated food’ — kratom with salmonella
by Laurie McGinley by Laurie McGinley Email the author
To Your HealthApril 3, 2018