Tag Archives: FDA attorney

05 Dec

FDA issues over 400 Warning Letters to Tobacco Retailers

In light of the recently finalized Deeming Rule, the FDA has been conducting periodic compliance check inspections to determine tobacco retail establishment’s compliance with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and found several violations of the federal tobacco laws and regulations while conducting inspections. As a result, the FDA has

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01 Aug

One More Week to Go: FDA’s New Tobacco Rules Go Into Effect on August 8, 2016

Retailers, manufactures and retailer/manufacturers of tobacco products should take note that compliance with the U.S. Food and Drug Administration (FDA) new tobacco rules is rapidly approaching.  Certain provisions of the final rule become effective Monday, August 8, 2016.   On May 10, 2016, the FDA issued its final rule expanding the FDA’s definition of “tobacco

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22 Jun

New FDA Guidance Targets Electronic Health Records in Clinical Trials

On May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research organizations (CRO), and institutional review boards (IRB) on the use of electronic health record (EHR) data in FDA-regulated clinical

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22 Jun

FDA issues Draft Guidance on 3D Printing of Medical Devices

On May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM) devices (aka 3D printed medical devices), the category of manufacturing that includes 3-dimensional (3D) printing.  The FDA described this as a “leapfrog” guidance through

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05 May

FDA Authority Over E-cigarettes Expanded

The Food and Drug Administration (FDA) today announced long-awaited final rules expanding the FDA’s authority over e-cigarettes and other tobacco products.  The rule broadens the definition of tobacco products to include e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other products. Acting under its authority as established through the Tobacco Control Act of 2009, the FDA has

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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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21 Apr

FDA publishes draft guidance on foreign clinical data for medical devices in support of 510(k) premarket submissions

Today the FDA posted draft guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS). When finalized, this guidance will provide information on: FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices The special considerations that apply

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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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