Tag Archives: FDA

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FDA issues draft guidance on device changes that warrant new premarket review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

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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.

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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

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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.

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