Food Safety Rules: On Wednesday, June 26, a federal court in California ruled that FDA must issue final regulations under the Food Safety Modernization Act by November 31, 2013. FDA failed to meet the original deadlines set by Congress, and consumer groups asked the court to require FDA to issue the new rules by August. The case raises separation of powers issues about whether a federal court can impose binding rulemaking deadlines in the absence of Congressional action. The caption is Center for Food Safety v. Hamburg, 4:12 -cv -04529, (N.D. Cal. Aug. 29, 2012) (Judge Phyllis J. Hamilton).
Pomegranate Seeds: On Saturday, June 29, FDA announced plans to detain certain pomegranate seed imports from Turkey. FDA and the Centers for Disease Control determined that the Turkish pomegranate seeds may have contained Hepatitis A, which may have contributed to 127 cases of Hepatitis A that were associated with Townsend Farms Organic Antioxidant Blend, sold by Costco. Read FDA’s press release here.
Fruit Juice Recalls:
- Jus Made, Inc. recalled lots of Roo’s Juice Tropical Flavor Juice because they have “the potential to contain polysaccharide-based bacterial biofilm, mold, and red water mites.”
- Minute Maid, Inc. recalled various lots of orange juice, apple juice, cranberry juice, strawberry juice and mixed berry juice “because there is the potential that some of the bottles could exhibit spoilage or damage to the lip of the bottle.”
Compounding pharmacy mold case: On Friday, June 21, FDA sued a New Jersey compounding pharmacy, Med Prep Consulting, for producing intravenous medicines that contain mold and for which the manufacturer had not obtained appropriate approvals. Six days later, on Thursday, June 27, Med Prep signed a consent decree with FDA under which Med Prep agreed to hire an outside consultant to inspect its facilities and to establish and follow Good Manufacturing Practices. The caption is United States v. Med Prep Consulting, 3:13-cv-03856, (June 21, 2013, D. N.J.) (Judge Peter Sheridan).
Internet Pharmacies: On June 27, FDA announced that is had shut down 1,677 online pharmacies for selling counterfeit medicine, substandard medicine, and medicines that have not been approved by FDA. FDA arrested 58 people and seized $41 million of goods. The most recent Warning Letter to one of these online pharmacies is available here.