Category Archives: Uncategorized

FDA Offers Guidance for Mandatory Food Recalls

The U.S. Food and Drug Administration (FDA) recently issued guidance to the “industry” and FDA staff as to mandatory food recalls and providing integral information on how to handle and/or implement such food recalls when necessary. This guidance expands upon the FDA’s mandatory food recall authority that was first enacted under Section 423 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which was added by Section 206 of the FDA Food Safety Modernization Act of 2011 (FSMA).  The FDA’s mandatory food recall authority…

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Keep Your Hands Inside the Hayride: E. Coli Outbreak in Utah linked to Fall Festivities

Utah public health officials are investigating a marked increase in E. coli infections this fall that seem to correspond with visits to petting zoos, corn mazes, and hayrides. Although the exact source has not been identified, several of the 20 cases of E. coli infections were reported following visits to these popular autumnal attractions. Since October 1st, twenty cases of Siga toxin-producing E. coli have been reported in the Central and Southwestern regions of Utah. The infected individuals range in age from 10 months to…

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Seven Deadly(?) Substances: FDA Removes Seven Food Additives from Approved List Due to Cancer Risk

The FDA has revised its food additive regulations to block the use of seven synthetic flavoring substances in food products that may increase cancer risk in humans. Evidence submitted to the FDA by the Breast Cancer Fund, the Center for Environmental Health, the Center for Food Safety, and others, demonstrated that six of the synthetic substances caused cancer in lab animals under study conditions. The seventh flavor, styrene,  is being removed from the food additive list because it is no longer widely used by the…

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Claims Regarding Post-FDA Approval Problems Not Preempted

While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims.  In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body.  The product was removed from the market in 2010, a warning letter was…

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FDA To Require New Warnings on Drugs Containing Acetaminophen of Serious Skin Reactions

The Food and Drug Administration is going to require warning labels be added to prescription drugs containing acetaminophen based on the drug’s association with rare skin reactions known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN) and acute generalized exanthematous pustulosis (AGEP).  The FDA will also be asking manufacturers of over the counter drug products containing acetaminophen to warn about serious skin reactions. The FDA’s action was based on a review of the FDA Adverse Event Reporting System database and the existing medical literature.  The…

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