Tag Archives: Ann Marie Gaitan

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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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On May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research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FDA issues Draft Guidance on 3D Printing of Medical Devices

On May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM)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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07 Jun

FDA Declares “Evaporated Cane Juice” is Misleading

The Food and Drug Administration (FDA) recently issued a final guidance declaring use of the term “evaporated cane juice” (ECJ) on food labeling to be misleading. “Evaporated cane juice” is a term commonly used on food labels to identify the presence of sweeteners derived from the fluid extract of sugar cane.  However, FDA’s most recent

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10 May

FDA Allows Use of “Healthy” Claims on Food Label

The U.S. Food and Drug Administration (FDA) issued a constituent update today explaining its decision to allow KIND, LLC to use “healthy” claims on food labels and labelling, while also vowing to reevaluate regulations regarding nutrient content claims and the labeling of food as “healthy.” Nutrient content claims are those that expressly or implicitly characterizes

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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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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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