Schumer: Fed Approval of Powdered Alcohol is Imminent & Could Hit Shelves by Fall

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Senator calls on the FDA to immediately investigate & prohibit sale of the substance.

Washingon, DC - May 5, 2014 - U.S. Senator Charles E. Schumer today called on the Food and Drug Administration (FDA) to step in and immediately halt Palcohol - a new and obviously dangerous powdered alcoholic product - from getting federal approval and hitting store shelves this fall. Palcohol is easily concealable, can be mixed with water and sprinkled onto food, and can even be snorted. The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates the alcohol industry as it relates to taxation and labeling, and recently approved Palcohol’s labels only to quickly rescind those approvals the same day. However, TTB and Palcohol have noted that the temporary repeal of those approvals is only due to a technical, and easily addressed, issue with the amount of powdered alcohol in each package. Palcohol plans to soon resubmit the labels for approval, which could be the last step before the product is produced and marketed to the general public this year. 
 
Schumer is therefore asking the FDA to swiftly step in to stop these approvals, given that the agency shares authority with, and can supersede the TTB in regulating alcohol products when there are significant health concerns, like in the case of Four Loko. Schumer said that the FDA should look into the obvious health concerns surrounding Palcohol so that the product does not ever reach store shelves and create a mind-boggling array of serious consequences and tragedy. Schumer was joined by Josh Lafazan, a member of the Syosset Board of Education and a representative of the Long Island Council on Alcoholism & Drug Dependence.
 
“With powdered alcohol on its way to store shelves by this fall, we’re sitting on a powder keg. Clearly our food and drug safety experts must step in before this mind-boggling product, surely to become the Kool-Aid of teen binge drinking, sees the light of day,” said Schumer. “Palcohol can be easily concealed and brought into concerts, school dances and sporting events, it can be sprinkled on food and can even be snorted. Given that the federal TTB can only judge and approve new alcohol products based on labeling and taxation, it’s clear the FDA must utilize their authority to intervene when alcohol products create significant health risks – as they did with Four Loko – and stop this potentially deadly product in its tracks.”  
 
Palcohol is made by company Lipsmark LLC, and is freeze dried alcohol produced in a powder form. According to their website, the company plans to release six types of Palcohol packets including vodka, Puerto Rican rum, cosmopolitan, mojito, powderita (margarita) and lemon drop.  The vodka and rum pouches can be combined with water or another liquid to instantly create an alcoholic beverage. The company also suggests adding Palcohol to food like guacamole, salads and sauce.
 
The company’s original website brazenly suggested different ways in which Palcohol could be used. The company suggested illegally bringing Palcohol to stadium events to avoid overpriced drinks. The company also suggested combining Palcohol with foods after they are cooked; some suggestions included: vodka on eggs and rum on a sandwich. The company explained that Palcohol could be snorted to get drunk “almost instantly.” This version of the website has since been taken down.
 
Palcohol was originally approved by TTB, which was then rescinded on April 21st due to a discrepancy in the “fill level” for each packet, or the amount of powder in each pouch.  Lipsmark agreed to surrender the label, but has noted that “This doesn’t mean that Palcohol isn’t approved. It just means that these labels aren’t approved. We will re-submit labels.” Schumer said that while the resubmission date is unknown, the company still notes their expectation that the product will be available for sale this fall. 
 
Schumer noted his grave concern that the TTB does not have the legal authority to disapprove Palcohol’s labels based on health risk, and therefore called on the FDA to intervene. Schumer explained that a 1976 district court ruling determined the roles and overlap between TTB and the FDA when it comes to regulating alcoholic beverages. Following that decision, the TTB and FDA came to a memorandum of understanding that gave TTB primary regulatory control over alcohol, but gave FDA the ability to raise concerns and investigate unsafe products. For example, the FDA stopped companies from selling Four Loko even after the TTB approved the product. Schumer is asking the agency to prevent the product from ever hitting the shelves, to avoid hospitalizations and death that are likely to follow, particularly when the product’s dangers are largely unknown in the first few months of availability.
 
Schumer also got involved with Four Loko and urged the FDA and FTC to ban the drink based on serious risks to consumer health and safety. In 2010, after agreeing to investigate, the FDA ruled that caffeine was an unsafe food additive to alcoholic beverages, effectively making products like Four Loko prohibited for sale in the United States.
 
A copy of Schumer’s letter appears below:
 
Dear Commissioner Hamburg:
Thank you for your ongoing work to protect consumers and the health of all Americans. An important part of this work is combating underage drinking. This is a duty that should be prioritized and taken very seriously both in Congress and throughout the relevant agencies within federal government. I am writing today to urge you to take action on Palcohol – a new, dangerous substance that is currently under review by the Department of Treasury’s Alcohol and Tobacco Tax and Trade Bureau – by working together to assess the potential public health concerns that arise by combining this dangerous product with food and beverages. It is vital that consumers are aware of the risks associated with Palcohol and that the Food and Drug Administration (FDA) step in immediately, before this product hits shelves this fall.
 
Palcohol is a powdered version of alcohol that can be consumed in several ways: it can be added to any beverage to make an instant cocktail, added to food, or snorted for the same effect of getting drunk. Alcohol in this chemical form should be considered highly hazardous especially because there are no substantive studies or research on the effects of ingesting powdered alcohol.  Because so little is known about its potency, consumers are more likely to ingest inappropriate levels of alcohol that can lead to a myriad of serious health concerns and even death. According to experts at the University of Colorado, Palcohol has a high risk of abuse but also has high potential to appeal to children and teens. A 2011 study in the Journal of Studies on Alcohol and Drugs showed that the number of hospitalizations of young adults ages 18-24 due to alcohol overdoses has been steadily increasing for over a decade, costing hospitals and patients hundreds of millions of dollars in hospital fees. We have witnessed tragic incidents of abuse that resulted from the consumption of new alcoholic products, such as Four Loko, that were not properly assessed for safety before they were put on the market.
 
Given that it is packaged in small, single serving packs, Palcohol is easy to conceal and carry into venues that prohibit alcohol. It could be brought into concerts, school dances, and sporting events and its use in these places can bring harm to not only those eating, drinking or abusing the substance, but to those around them. It is imperative that your agency works with all stakeholders as soon as possible to ensure that Palcohol does not have the same devastating effect on our youth.
 
I am eager to work with the FDA to better inform consumers and ensure that the health of Americans are not put at risk by any substance with a high likelihood of abuse. Given that the federal Alcohol and Tobacco Tax and Trade Bureau can only judge and approve new alcohol products based on labeling and taxation, the FDA must utilize their authority to intervene when alcohol products create significant health risks. The FDA has a great deal of responsibility to protect the health of the public by assuring the safety of our food and beverage products. I ask that the FDA do its part and inform consumers of the safety of this and similar products for consumption.
 
Sincerely,
Charles E Schumer
United States Senator
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