Category Archives: Ann Marie Gaitan

26 Apr

FDA Increases Enforcement Efforts Against Cosmetic Companies

Since 2015, an increasing number of cosmetic companies have come under the harsh scrutiny of the US Food and Drug Administration (FDA) for reasons ranging from “misbranding” due to drug like claims to “adulteration” by contamination.  The FDA’s increased focus on cosmetic companies and cosmetic products is seen in the recent uptick in warning letters,

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03 Mar

FDA to Exercise Enforcement Discretion with First Responders Not Meeting DSCSA Product Tracing Requirements

On February 29, 2016, the FDA published a guidance entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act—Compliance Policy.” The guidance is effective immediately (starting on Tuesday, March 1) and states that the Agency will not take action against first responders failing to obtain product tracing information, as required under

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30 Apr

FDA Warning Letters demand “immediately cease distribution” of dietary supplements with BMPEA

On April 23, 2015 the U.S. Food and Drug Administration (FDA) issued warning letters to several dietary supplement companies distributing dietary supplements containing beta-methylphenethylamine (BMPEA), an ingredient widely used in weight loss,  energy, and exercise endurance supplements. Studies show that BMPEA can cause an accelerated and irregular heartbeat. These warning letters come over one year

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23 Apr

USDA to expand fresh produce imports from Peru allowing importation of papayas, oversized mangoes, peppers and citrus

Today, the U.S. Department of Agriculture (USDA) Animal Plant Health Inspection Services (APHIS) announced  the potential expansion of fresh produce imports from Peru including papayas, oversized mangoes, peppers, and citrus, stating in its press release: [t]he U.S. Department of Agriculture (USDA)and the Peruvian Ministry of Agriculture (MOA) met in Washington, D.C., to recognize recent market

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07 Apr

Pesticide Companies Selling Antimicrobial Pesticide with Unapproved Claims to Pay Civil Penalties to EPA

Integrated Environmental Technologies (IET), a South Carolina based pesticide registrant, and Seriously Clean, Ltd., of Nixa, Mo., a firm that served as an authorized distributor of IET’s product under a different brand name, have agreed to pay civil penalties of $87,344 and $91,829, respectively, to the Environmental Protection Agency (EPA) to settle alleged violations of

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06 Apr

U.S. government sues food manufacturer after Listeria outbreak

On April 3, 2015, the U.S. government filed suit against Wholesome Soy Products of Chicago, to stop the company from distributing food products after an outbreak of Listeria was linked to the company’s mung bean and soybean sprouts, associated with several illnesses last summer. That same day, Wholesome Soy Products Inc. accepted a consent degree outlining conditions it

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21 Jan

FTC target deceptive advertisers of weight-loss products

On January 7, 2014, the Federal Trade Commission (FTC) announced a law enforcement initiative to stop deceptive advertising claims to relating to weight- loss products, from food additives and skin cream to dietary supplements. Recognizing that Americans spend billions of dollars every year on supplements, foods and devices in hopes of improving their health and

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26 Sep

FDA to begin regulating mobile medical applications

The FDA has issued Mobile Medical Applications Final Guidance regarding the monitoring of Smartphone software applications with medical applications as a “medical device” under the Federal Food, Drug, and Cosmetic Act (FD&C Act).  Consistent with FDA’s existing regulatory approach that considers functionality rather than platform, the FDA intends to exercise its jurisdiction over those mobile

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