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Wednesday, June 08, 2011

DANGER BEHIND CAFFEINATED ALCOHOLIC BEVERAGES

The U.S. Food and Drug Administration warned four companies that the caffeine added to their malt alcoholic beverages is an “unsafe food additive” and said that further action, including seizure of their products, is possible under federal law. When alcoholic beverages are mixed with energy drinks, a popular practice among youth, the caffeine in these drinks can mask the depressant effects of alcohol. At the same time, caffeine has no effect on the metabolism of alcohol by the liver and thus does not reduce breath alcohol concentrations or reduce the risk of alcohol-attributable harms. Drinkers who consume alcohol mixed with energy drinks are 3 times more likely to binge drink (based on breath alcohol levels) than drinkers who do not report mixing alcohol with energy drinks.

FDA’s action follows a scientific review by the Agency.  FDA examined the published peer-reviewed literature on the co-consumption of caffeine and alcohol, consulted with experts in the fields of toxicology, neuropharmacology, emergency medicine, and epidemiology, and reviewed information provided by product manufacturers.  FDA also performed its own independent laboratory analysis of these products.

The four manufacturers and their products are:

  • Charge Beverages Corporation,
    which makes "Core High Gravity HG Green," "Core High Gravity HG Orange," and "Lemon Lime Core Spiked"*

    three drink cans: Green HG Core High Gravity , Orange HG Core High Gravity, Lemon Lime Core Spiked

  • New Century Brewing Company, LLC,
    which makes "Moonshot"*

    a bottle of Moonshot

  • Phusion Projects, LLC (doing business as Drink Four Brewing Company),
    which makes "Four Loko"*

    six drink cans of Four Loko in various colors

  • United Brands,
    which makes "Joose" and "Max"*

    fourteen drink cans in various colors showing Joose and Max products

The companies receiving Warning Letters and their products are:

• Charge Beverages Corp.: Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked
• New Century Brewing Co., LLC: Moonshot
• Phusion Projects, LLC (doing business as Drink Four Brewing Co.): Four Loko
• United Brands Company Inc.: Joose and Max

“FDA does not find support for the claim that the addition of caffeine to these  alcoholic beverages is ‘generally recognized as safe,’ which is the legal standard,” said Dr. Joshua M. Sharfstein, Principal Deputy Commissioner.  “To the contrary, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern.”

Experts have raised concerns that caffeine can mask some of the sensory cues individuals might normally rely on to determine their level of intoxication.  The FDA said peer-reviewed studies suggest that the consumption of beverages containing added caffeine and alcohol is associated with risky behaviors that may lead to hazardous and life-threatening situations.

The agency said the products named in the Warning Letters are being marketed in violation of the Federal Food, Drug, and Cosmetic Act (the FFDCA). Each Warning Letter requests that the recipient inform the FDA in writing within 15 days of the specific steps that will be taken to remedy the violation and prevent its recurrence. If a company does not believe its products are in violation of the FFDCA, it may present its reasoning and any supporting information as well. 

If the FDA believes that the violation continues to exist, the agency may pursue an enforcement action that could include seizure of the products or an injunction to prevent the firm from continuing to produce the product until the violation has been corrected.

FDA’s action today follows a November 2009 request to manufacturers to provide information on the safety of adding caffeine to their products.

FDA is aware that on November 16, Phusion Projects, LLC, the maker of Four Loko, announced its intention to remove caffeine and other stimulants from its drinks.  FDA views this announcement as a positive step. FDA has not yet heard officially from the company about this announcement, including how quickly it will remove present product from circulation and how quickly it will reformulate its product.  FDA intends to work with Phusion Projects, LLC and the other manufacturers to assure their products meet safety standards.

Source: http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm

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DONOT FEED DANGEROUS THICKENING PRODUCT SIMPLY THICK TO INFANTS

Do not feed the thickening product called SimplyThick to infants born before 37 weeks gestation because it may cause a life-threatening condition.This advice to parents, caregivers, and health care providers from the Food and Drug Administration (FDA) is based on reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and dies.

SIMPLY THICK SimplyThick is a brand of thickening agent—available to consumers and medical centers—to help manage swallowing difficulties. It is sold in packets of individual servings and in 64-ounce dispenser bottles. The product can be purchased from distributors and local pharmacies throughout the United States.Benson M. Silverman, M.D., director of FDA’s Infant Formula and Medical Foods Staff—himself a neonatologist—explains that the thickening agent is added to breast milk and infants’ formula to help the premature babies swallow their food and keep it down, without spitting up. The product is also used in older children and adults with swallowing problems caused by trauma to the throat, he notes.

 

The Problem

FDA first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. Silverman says he was alerted by two reports in FDA’s MedWatch Adverse Event Reporting system. He followed up with the physicians who filed those reports and subsequently with a network of other neonatologists.

Karl Klontz, M.D., a medical officer in FDA’s Center for Food Safety and Applied Nutrition, says the severity and scope of the problem soon became apparent. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick mixed with mothers’ breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.

At least four different medical centers around the U.S. have reported the illness in infants who became sick over the past six months.

This situation is unusual because NEC most often occurs in babies while they are in the hospital early in their premature course. But some of the ill babies that FDA is aware of got sick after they had been discharged from the hospital and sent home on a feeding regimen that included SimplyThick.

At this time it is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.

In the meantime, adds Klontz, parents should stop using the product even if their babies don’t appear to be sick. “Why take the risk?” he asks.

 

Symptoms to Watch for

  • bloated stomach
  • greenish-tinged vomiting
  • bloody stools

 

Advice for Parents and Caregivers

  • Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.
  • Contact your health care professional if your baby has any of the symptoms listed above or if you have other concerns related to using SimplyThick.
  • You or your health care professional may report side effects related to using SimplyThick to FDA's MedWatch Safety Information and Adverse Event Reporting Program by:
What FDA Is Doing

FDA is actively investigating the link between SimplyThick and the illnesses and deaths. FDA will provide updates as information is made available.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

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