FDA Enforcement and Recall Report Week of July 4

FDA Recalls – General Mills and Raw Cookie Dough

Each week the FDA reports on its enforcement activities as a guide to FDA compliance. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters. This week is both late and light due to the Independence Day holiday, but the FDA’s response to the General Mills recall raised eyebrows.

Holiday recall postings are typically light. This week was no exception. Only four new recall notices posted but the General Mills recall still filled the news. Two related to undeclared allergens, one related to E. Coli and another to an unapproved new drug. Although only four in number the General Mills recall of raw flour made a number of waves. It lead the FDA to issue an absitence-only consumer update on eating raw cookie dough. This is an unusaul move – not every recall, even the large multi-state outbreaks, results in this type of advice. A dietary supplment was recalled for containing Sibutramine. As you may remember a weight loss supplement was recalled last month for the same reason.

 FDA Warning Letters – GMPs

This week 12 Warning Letters posted. Of the 12, 11 are linked to GMP lapses. The GMP Warning to Chongqing Lummy is surprising because it alleges intentional  data manipulation including setting computer clocks back to make tests appear as if they had been conducted earlier. This type of conducts crops up from time to time. The FDA is in a particularly powerful position with this type of GMP warning letter because it can block all imports from the company. Popsalot received a warning letter for misbranding – it claimed gluten free when it wasn’t.

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Recalls Week of July 4

Warning Letters Week of July 4