VRVK Nutraceuticals, LLC, DBA DR. VENESSA’S FORMULAS of Orlando, Florida, is voluntarily recalling 3998 bottles of ULTIMATE ANTIOXIDANT TABLETS DIETARY SUPPLEMENT, 120 count bottles, with Kelp Atlantic Powder that may contain crustacean shellfish, an undeclared allergen. This product also contains Hesperidin Complex 40%, Pancreatin Powder and Pepsin, three ingredients that contain undeclared milk.
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Category Archives: Food Safety News
FDA approves Repatha to treat certain patients with high cholesterol
The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.
Bimbo Bakeries Voluntary Regional Recall of Certain Limited Breads Produced Under the Sara Lee, Great Value, Kroger, Bimbo, Nature’s Harvest and L’Oven Fresh Brands
Bimbo Bakeries USA has initiated a voluntary regional recall of certain bread products under the Sara Lee®, Kroger®, Bimbo®, Nature’s Harvest®, Great Value and L’Oven Fresh® brands due to the possible presence of fragments of glass caused by a broken light bulb at one of its bakeries.
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FDA takes action against three tobacco manufacturers for making “additive-free” and/or “natural” claims on cigarette labeling
Today the U.S. Food and Drug Administration issued warning letters to three tobacco manufacturers — ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd. — who describe their cigarettes on product labeling as “additive-free” and/or “natural.” The warning letters are for violations of section 911 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA extends use of Promacta in young children with rare blood disorder
The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen.
FDA approves first treatment for sexual desire disorder
The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
Federal judge approves consent decree with Iowa drug and dietary supplement maker, Iowa Select Herbs
Today, U.S. District Judge Edward J. McManus for the U.S. District Court for the Northern District of Iowa entered a consent decree of permanent injunction against Iowa Select Herbs LLC, a manufacturer and distributor of drugs and dietary supplements, and its two co-owners, Gordon L. Freeman and Lois A. Dotterweich. The complaint, filed by the U.S. Department of Justice, sought a permanent injunction against the company and its owners for unlawfully manufacturing and distributing unapproved new drugs, misbranded drugs, adulterated dietary supplements and misbranded dietary supplements.
Federal judge enters permanent injunction against Wisconsin dietary supplement manufacturers
Three dietary supplement companies, under the same ownership and located in Wautoma, Wisconsin, will not be allowed to manufacture or sell dietary supplement products until FDA has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015.
FDA acts to stop Sacramento tofu and sprout manufacturer from selling adulterated food
On August 3, 2015, U.S. Magistrate Judge Carolyn K. Delaney in the U.S. District Court for the Eastern District of California entered a consent decree against Henh Wong Fresh Produce, a tofu and sprout manufacturer and distributor, and its owner, current manager, and former manager after the U.S. Food and Drug Administration documented multiple violations of federal food safety laws and regulations. The U.S. Department of Justice sought the consent decree on behalf of the FDA.
FDA approves non-surgical temporary balloon device to treat obesity
The U.S. Food and Drug Administration today approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.