November 24, 2010
Contact the appropriate regional affiliate to learn how to join the one that serves your state. For more information, visit www.npainfo.org.
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
The FDA’s action follows a scientific review by the agency—it 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. The FDA also performed its own independent laboratory analysis of these products.
“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 bill cleared a key procedural hurdle when, on November 17, the Senate voted 74-25 to limit debate (60 votes are necessary to invoke debate-limiting cloture), setting the stage for a final vote. The Senate debated the bill through November 18, but was unable to bring the bill to a vote before breaking November 19 for the Thanksgiving holiday. The Senate is expected to continue debate and to hold additional votes when it returns November 29.
If passed, the bill could overhaul the nation’s food-safety system and grant new powers to the Food and Drug Administration. A delay may threaten the legislation.
IGH Solutions’ new Nattera Milkweed™ gift card is made from 30 percent post-consumer recycled content sourced from recycled milk jugs, and merchants are able to print both a barcode as well as apply a magnetic stripe to these cards.
“We found that consumers want to do the right thing for the environment, but they are confused about many of the claims made by various environmentally friendly cards,” said Martha Weaver, product manager for IGH Solutions. “Turning milk jugs into recycled plastic and then into new cards is something a consumer can understand—they can see the immediate results from their effort to recycle.”
The IGH Nattera™ line of earth-friendly products includes a broad range of stored value cards of various constructions that offer a combination of a visual appeal and performance, providing an extensive selection of green card alternatives, the company said.
For more information, visit www.ighsolutions.com.
In addition, Dentali observed, “Taking into account the actual forms of valerian in the tested products, a re-analysis of ConsumerLab’s data indicates that six—not four—of the tested products contain levels of valerenic acids claimed, expected from the EP standard for dried and cut valerian root, or likely to be found in fresh root.”
AHPA noted that CL relies on valerenic acids as the sole indicator of valerian quality, implying that the level of valerenic acids is the only factor that can be used to determine whether a valerian product has any benefit.
“While valerenic acids are useful markers for identifying a valerian ingredient, there is no scientific consensus that these are the sole or even primary constituents that contribute to valerian's therapeutic value,” noted Dentali. “It is at best an oversimplification to try to ‘test in the quality’ of a valerian product simply by measuring valerenic acids, and this narrow approach has in at least one case ignored a product’s proven efficacy.”
AHPA also disputes CL’s use of California standards regarding lead levels. “ConsumerLab has again chosen an arbitrary reference to determine whether products meet its self-assigned quality standards,” said Michael McGuffin, AHPA’s president. “While AHPA has been active in providing information to assist companies to comply with the California law, the lead levels in these products do not represent adulteration under federal law.”
For more information, visit www.ahpa.org.
“GOED is pleased that AKBM—one of the leading krill-oil manufacturers—has joined our organization,” said GOED Executive Director Adam Ismail. “We appreciate that AKBM will work inside GOED to contribute to the responsible growth and development of krill products with defined and transparent criteria and specifications that help enable consumer trust. Krill oil is a growing and important source of EPA and DHA for consumers worldwide, so proactive quality initiatives driven by companies like AKBM and other krill manufacturers will be important.”
GOED is made up of 90 businesses that comply with the organization’s monograph standard, and adhere to a code of ethics in their marketing practices. These members include Martek Biosciences, Ocean Nutrition Canada, EPAX and Nordic Naturals, among others.
For more information, visit www.goedomega3.com.