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FDA 648 articles

FDA Issues Warning Letter for Sales of E-Cigarettes to Minors

e-cigarette vaping - photo by the-best-electronic-cigarette-review dot com

The U.S. Food and Drug Administration (FDA) issued the first warning letters last week to 55 tobacco retailers for selling e-cigarettes, e-liquids and cigars, which are newly regulated, to minors. The new regulations enforced last month make it illegal to sell e-cigarettes, cigars, and hookah tobacco to anyone younger than 18, either in person or online. The restrictions also include the requirement to check the photo ID of anyone younger than 27. When the FDA moved forward with compliance checks, targeting major national retail chains, they found that even after the new regulations were enacted, minors were still able to purchase the tobacco products, ... Read More

FDA accepts new drug application for treatment of aggressive melanoma mutation

melanoma

The U.S. Food and Drug Administration (FDA) is reviewing a potential new drug to treat melanoma. The agency expects to make a decision on the New Drug Application (NDA) by June 30, 2017. Array BioPharma’s drug binimetinib is for the treatment of NRAS-mutant melanoma. Studies show that NRAS mutations arise in 15 to 25 percent of all melanomas. These mutated tumors are known to be even more aggressive than the fast-growing BRAF-mutated melanoma tumors and this type of melanoma has the worst prognosis in metastatic patients, according to Cancer Commons. Melanoma itself is the most aggressive form of skin cancer, ... Read More

Vegetable recall announced by Country Fresh due to possible presence of Listeria monocytogenes

vegetable

Nearly 30,000 cases of various fresh-cut vegetables are now under recall by Country Fresh LLC due to potential Listeria contamination. According to the U.S. Food and Drug Administration (FDA), Listeria monocytogenes are responsible for causing serious and sometimes fatal infections in both young children and frail or elderly adults, especially those with weakened immune systems. The recalled vegetable products were shipped to retailers in the following states with the Country Fresh and store brand labels: Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee and Virginia. Each recalled vegetable product should have “BEST IF USED BY” dates ranging from ... Read More

Sales of E-cigarettes Expected to Increase Seventeenfold in the Next Fifteen Years

e-cigarette vaping - photo by the-best-electronic-cigarette-review dot com

With flavoring descriptions such as “an exotic fusion of pineapple and coconut with champagne infused blueberries” and “creamy milk chocolate and rich peanut butter flavors,” who can resist the draw of e-cigarettes? E-cigarette manufacturers have picked up on the increase of sales when there are a wide variety of flavors – more than 7,000 total so far – but public health experts are concerned with the addictive nature of nicotine in the vaping liquids, which opens the door to harmful chemicals sucked into the lungs. Many believe that e-cigarettes serve as a gateway to smoking tobacco, particularly for minors. E-cigarettes are far from “safe,” as ... Read More

Vaping Lowers a Person’s Chance of Successfully Quitting Cigarettes, Doctor Says

e-cigarette vaping - photo by the-best-electronic-cigarette-review dot com

Many people believe that smoking e-cigarettes, or vaping, is less toxic than using regular cigarettes, and that they’ll help with quitting regular cigarettes. However, there is little data and evidence to back those beliefs. Dr. Stanton Glantz, a professor of medicine at the University of California, San Francisco, says that a person is not doing himself a favor by using e-cigarettes as a method of smoking cessation from regular cigarettes. Glantz has analyzed a number of studies that focused on the use of e-cigarettes to quit regular cigarettes. He found that vaping actually lowers a person’s chance of successfully quitting regular cigarettes by 28 percent. ... Read More

BEK Catering ordered to shut down seafood production due to multiple HACCP violations

Red snapper in cooler

Following multiple inspections by the U.S. Food and Drug Administration (FDA), BEK Catering LLC and the United States have entered into a consent decree of permanent injunction, banning the company from receiving, processing, manufacturing, preparing, packing, holding or distributing food until it comes into compliance with FDA requirements. BEK Catering, a seafood business based in Daphne, Ala., operating under the name “Floppers Foods,” has been under scrutiny by the FDA after investigations between September 2011 and April 2015 uncovered repeated deviations from Hazard Analysis and Critical Control Point (HACCP) requirements. The seafood HACCP regulations were created with the intention of ... Read More

Texas Woman Diagnosed with Severe Lung Disease After Years of Occupational Diacetyl Exposure

Coffee Beans

Julysabel Cerda is only 35 years old and had worked at a coffee roasting plant in Texas since 2007. Part of her everyday routine was climbing the ladder to the mezzanine at the top of a grinder where coffee beans were processed. She would stir the beans, inhaling aromas that are suspected of destroying her lungs. Only a year after working there, she began to notice being increasingly winded after climbing the same ladder every day. She was fit, healthy and active otherwise. She suspected something must be wrong. A cough persisted, her throat constantly felt dry, and she couldn’t figure out why ... Read More

General Mills flour recall prompts FDA and CDC to remind consumers raw flour can carry contaminates

cookie dough - FDA image

It seems just about everyone is aware of the dangers associated with consuming raw cookie dough, but what had seemed to be a foodborne illness caused by raw egg has now been linked to possibly E. coli tainted flour. According to new findings by the Centers for Disease Control (CDC) and the U.S. Food and Drug Administration (FDA), an E. coli outbreak responsible for sickening as many as 38 people across 20 states may be connected to flour manufactured by General Mills. The bacteria comes from an uncommon strain of Shiga toxin-producing E. coli known as 0212. Affected batches of the flour ... Read More

Former FDA commissioners explain difficulty in regulating dietary supplements

supplement - Jack3d

Ensuring the safety of dietary supplements sold in the United States has been a constant uphill battle for the Food and Drug Administration (FDA) given the agency’s limited resources and inability to act outside Congress, a panel of six former FDA commissioners said in a historic meeting in Aspen, Colo. The rapidly expanding industry of dietary supplements not only includes vitamin and mineral formulations, but it has grown to include those derived from herbs, glands, amino acids, and enzymes that are sold individually in any amount or in combinations, sold in tablets, capsules, gel caps, powders or liquids. In some cases, ... Read More

High Levels of Diacetyl Found in the Air at a Small Coffee Roasting Plant

Coffee Beans

When diacetyl and 2,3 pentanedione (a diacetyl substitute) was tested for in the air at a small coffee roasting plant, the levels were shockingly high, according to a study published last year by Toxicology Reports, an online journal. According to the study, green unroasted coffee beans contain little to no diacetyl or 2,3-pentanedione. It’s the roasting process that plumes the toxicity into the air, and if a facility doesn’t have proper ventilation, the concentrations could prove to be health-damaging. A second study published by Toxicology Reports by some of the same authors simulated a coffee-shop setting where the exposure to both the barista and ... Read More