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11 Jan

FDA to sample imports of orange juice and deny entry to shipments adulterated with carbendazim

The FDA announced today that it will begin sampling import shipments of orange juice and will deny entry to shipments that test positive for carbendazim. In a letter to industry, the FDA informed that it received information on December 28,2011, that low levels of carbendazim (in the low parts per billion range) was detected in currently marketed finished orange juice products, and orange juice concentrate. The FDA traced the issue back to the 2011 crop of oranges from Brazil, where the carbendazim is a legally used fungicide to combat black spot, a type of mold that grows on orange trees.

09 Jan

FDA warns that over the counter HCG products marketed for weight loss are illegal

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued Warning Letters in December 2011 to seven companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss. The letters warn the companies that they are violating federal law by selling unapproved new drugs, and by making

28 Jul

FDA issues draft guidance on device changes that warrant new premarket review

Manufacturers often make changes or modifications to a device after FDA clearance such as incorporating new technology or upgrading certain aspects of the device. Many changes do not require a 510(k) submission. But when the changes could significantly affect the product’s safety or effectiveness or constitute a major change to the intended use of the device, another 510(k) must be submitted.

15 Dec

FTC and States Settle Deceptive Advertising Case Against Dannon

Today, the Federal Trade Commission (FTC) and Attorney’s General (AG) from 39 states announced a settlement with The Dannon Company over deceptive advertising practices, based on marketing campaigns heralding the health benefits of its Activia brand yogurts and DanActive brand dairy drinks.

25 Oct

FDA announces voluntary recall of Halloween treats

Just six days before trick-or-treaters head out to collect candy, the Food and Drug Administration (FDA) announced the recall of two popular Halloween treats – Mega Pops lollipops and RAISINETS® Fun Size. Mega Pops brand lollipops – Colombina S.A. has issued a voluntarily recall of specific lots of Mega Pops in 14-ounce and 28-ounce cellophane

07 Oct

FDA & DOJ file an injunction to stop juice company’s processing & distribution

At the request of the U.S. Food and Drug Administration (FDA), the U.S. Department of Justice (DOJ) today filed a complaint for permanent injunction against Brooklyn-based juice company, Juices Incorporated (also known as Juices International and Juices Enterprises), to prevent it from processing and distributing juice products.

07 Oct

Online dietary supplement marketer receives joint Warning Letter from FTC & FDA

Telledant LLC, a Miami based online distributor of dietary supplements, was issued a joint Warning Letter on September 28, 2010 by the U.S. Federal Trade Commission (FTC) and Food and Drug Administration (FDA). In the Warning Letter, the FTC and FDA warn Telledant, LLC that its marketing and claims for a variety of products are in violation of federal laws and regulations.

03 Oct

FDA warns that Miracle Mineral Supplement turns to potent bleach

On October 1, 2010, The Food and Drug Administration (FDA) reported that a product marketed as Miracle Mineral Solution, Miracle Mineral Supplement, and MMS, “becomes a potent chemical that’s used as a bleach when mixed according to package directions.”

Category Archives: FDA