Tag Archives: FDA

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On May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research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FDA issues Draft Guidance on 3D Printing of Medical Devices

On May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM)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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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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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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16 Jan

Spa Owner Sentenced to Prison for Illegal Sylicone Injections

Elva Navarro, of Hidalgo,Texas,  has been sentenced to three years in federal prison to be immediately followed by one year of supervised release for violating the U.S. Food, Drug and Cosmetics Act by using an adulterated device. Court documents demonstrated that Navarro administered injections of liquid silicone into individuals who would frequent her facility – Bella

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