Tag Archives: RECALL

OIG Report Finds FDA Recall Process is Slow

As our readership is well aware, the Food Safety Modernization Act (FSMA) equips the FDA with mandatory recall authority to remove a potentially dangerous food product from the marketplace when a company does not voluntarily cease distribution and initiate a recall. But the Agency has very rarely used this authority. In practice, the FDA most often works with … Continue Reading

Complimentary Webinar TODAY: Recall Refresher

Complimentary Webinar TODAY:  Refresher on Food Recalls and Recall Protection Don’t miss out!  Join Keller and Heckman partners, Art Garrett and Leslie Krasny, for a complimentary refresher webinar on recalls and what you can do now to protect your company.  The webinar is today, July 21, at 12 – 1 pm Pacific (3 – 4 … Continue Reading

Recalls Revisited

HHS OIG issues early alert criticizing FDA’s food recall procedures. Under the FDA Food Safety Modernization Act (FSMA), FDA now has mandatory recall authority over conventional foods.  However, FDA has only threatened the use of this authority twice.  In reality, firms continue to work voluntarily with FDA to recall risky foods under the Agency’s recall … Continue Reading

Tomato Toss

Federal judge tosses final claim in tomato farm’s lawsuit against FDA. (subscription to Law360 required) In June 2008, FDA mistakenly linked a multistate Salmonella outbreak to tomatoes and warned consumers about the potential dangers associated with the consumption of raw red tomatoes in New Mexico and Texas.  Federal and state officials struggled to track the actual … Continue Reading

Tattoo Troubles

FDA issues warning about bacterial contamination in tattoo inks. FDA has the authority to regulate the safety of cosmetics in the United States.  Tattoo inks meet the statutory definition of a “cosmetic,” which means:  “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part … Continue Reading

Doubling Up

U.S. food recalls have nearly doubled over the past decade. Food recalls occur with relative frequency in the United States, with the reasons for such recalls ranging from labeling issues to food safety concerns, such as potential contamination with pathogens like Salmonella, Listeria, or E. coli.  FDA posts up-to-date information regarding food recalls on its website. A recent … Continue Reading

Blue Bell Blues

FDA issues public update regarding listeriosis outbreak linked to ice cream products. FDA has many tools in its arsenal to prevent and respond to food contamination issues; these include the Agency’s inspection power and various enforcement authorities (e.g., warning letters, mandatory recall orders in class I situations, administrative detention, seizure, suspension of facility registration).  In … Continue Reading

(Re)call and Answer

FDA publishes draft guidance on mandatory food recalls. Among other things, the FDA Food Safety Modernization Act (FSMA) granted the Agency the authority to order a responsible party to recall food if there is a reasonable probability that the food is adulterated or misbranded and that use of or exposure to the food will cause … Continue Reading