FDA Notification (AKA a pending recall) : Caffeinated Alcoholic Beverages

Caffeinated alcoholic beverages to me are something of an oxymoron. Like “jumbo shrimp”. “Seriously joking”. “Taped live”. And “working vacation”.

After today, though, I feel confident in predicting a sudden rush of caffeinated alcoholic beverage purchases. That’s because the FDA today “notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.”

In other words, you’re in range now. Smile when you see the flash.

The logic for the FDA’s targeting of caffeinated alcoholic beverages is explained in the press release…

“Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS).  FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS.  For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.”

Soooo…. flavored alcoholic beverages might also be targeted under this interpretation, right? Or anything not specifically OKed by the FDA?

The press release also spells out that the FDA isn’t going to be messing around with the preliminaries this time out.

“The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned.  FDA’s letter informed each company that if FDA determines that the use of caffeine in the firm’s alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.”

And who got a copy of the FDA’s nastygram?

Charge Beverages Corporation
Products: Liquid Charge, Liquid Core, High Gravity Core

United Brands Company, Inc
Products: Joose, Max Vibe, Max Fury, Max Live, 3Sum

Phusion Projects LLC
Products: Four, Four Loko, Four Maxed

Point Blank Beverages Co.
Products: Torque

Hard Wired Brewing Company, LLC
Products: Hard Wired

Mix Master Beverage Co
Products: 24/7

Catalyst Beverage Company
Products: Catalyst

New Century Brewing Company
Products: Moonshot

Melanie Brewing Co
Products: Evil Eye

Thomas Creek Brewery, LLC
Products: Mobius Lager

Diageo North America, Inc
Products: Smirnoff Raw Tea Malt Beverage

Constellation Brands
Products: Wide Eye

The P.I.N.K. Spirits Company/Prohibition Beverage Inc
Products: P.I.N.K. Vodka, P.I.N.K. Tequila, P.I.N.K. Rum, P.I.N.K. Gin, P.I.N.K. White Whiskey, P.I.N.K. Sake

Delicious Brands Inc.
Products: Lotus Vodka

Sovereign Brands
Products: 3AM Vodka

Moet Hennessey/Millennium Import LLC
Products: Belevedere IX

Shotpak Vodka
Products: Gravity Vodka

Wingard USA (Importer)
Products: V2 Vodka with Caffeine, Everglo Vodka

LeVecke Corporation
Products: Vicious Vodka with Caffeine

Rocktail Drinks/Liquid Manufacturing LLC
Products: Slingshot Party Gel

Cold Spring Brewing Company/Atomic Brands
Products: A:M Carpe Noctern

808 Spirits Co.
Products: 808 Mango Beat

Gaamm Imports Inc.
Products: Booya Espresso Silver Tequila with Caffeine

Ithaca Beer Co.
Products: Ithaca Eleven Malt Beverage with Coffee

Gluek Brewing Company
Products: Gruv Malt Beverage with Guarana

MHW, Ltd and Niche Import Company
Products: Agwa De Bolivia

Rizer Spirits Inc
Products: XZO Vodka with Caffeine, Taurine, and Guarana


Buy ’em now if you want ’em.

Here’s the link to the FDA notification here.

Recall : Some Liposyn and Propofol products may contain itty bitty pieces of stainless steel

Little shards of stainless steel aren’t too good for your bloodstream the last time I checked.

This voluntary recall from Hospira is for “85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80… The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall.”

The reason for this recall is that… “some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process.”

In the list of things this particulate matter might do to you is “…potentially act as emboli and impede blood flow.  Particulates may also cause mechanical damage to the body and may escalate damage through the Systemic Inflammatory Response Syndrome (SIRS).  Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.”

You know. The usual side effects.

Fortunately nobody has been hurt by this, and Hospira is asking that “anyone with an existing inventory should quarantine the product immediately and call Stericycle at 1-866-654-0725 to arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187 between 8 a.m. and 5 p.m. CST, Monday through Friday.”

Here’s the link to the official FDA recall.

Recall : CLASS 1 : Edwards Lifesciences’ CardioVations EndoClamp Aortic Catheter

When you make a product that’s designed to clamp down on the aorta and drip solution to stop the heart during cardiopulmonary bypass procedures, you really should have that product go through some ruthlessly insane levels of quality control. Then test the product again, retest it, and then test it some more.

Well, today’s FDA recall is for a product that does just that. The official CLASS 1 recall is for “Edwards Lifesciences CardioVations EndoClamp Aortic Catheter ” and is specifically targeting “CardioVations EndoClamp Aortic Catheter, Model Numbers EC1001 and EC65”.

The problem? According to the recall notice, “The balloon catheters may spontaneously rupture during surgery.”

Oh yeah. That’s FUBAR. Big time.

The recall was started by the company on September 24th, but the FDA just issued the public notice today.

The CLASS 1 bit on FDA releases is “the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

If you have CardioVations EndoClamp Aortic Catheter Model Numbers EC1001 and/or EC65, you can “contact the company’s Customer Service Organization at 1-800-424-3278, Monday through Friday, 6:00 a.m. – 4:30 p.m., Pacific Time.”

Here’s the link to the official FDA recall.

Recall (warning) : FDA coming down on flavoerd cigarette sellers

This didn’t take long. The FDA is now pursuing online sites that are still selling flavored cigarettes. The FDA is specifically enforcing the “cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites.”

Flavored cigarettes were banned around the 22nd of September, so it’s been a good month and some change for these companies to get their products in order. Right now, pretty much any cigarettes with flavor in them are illegal. Flavored cigars may or may not be included, depending on who’s interpreting the law at the moment.

What really gets me is the justification for this ban. Lawrence R. Deyton, M.S.P.H, M.D., director of FDA’s Center for Tobacco Products said in the release that the… “FDA takes the enforcement of this flavored cigarette ban seriously. These actions should send a clear message to those who continue to break the law that FDA will take necessary actions to protect our children from initiating tobacco use.”

So…. if this is for the kids, how about a real simple solution. ID everyone buying tobacco. Wouldn’t that solve the whole problem? Leave the flavored cigs to the few adults who like them, and just bust the people selling them to children. Doesn’t that work for regular tobacco? And alcohol?

Anyhow, I ranted about this already when it first popped up. I’ll push the horse back into the closet now.

Oh, and if you look at the link that shows the sites that got the warning from the FDA about selling the flavored cigarettes? When I checked, most of them were 404… completely gone.

Here’s the link to the official FDA warning / recall.

Recall : Jelly Belly’s cylinder-style 49 Flavors jelly beans

Jelly Belly announced today that they are voluntarily recalling the… “7.5-ounce cylinder-style packages of 49 Flavors Jelly Belly jelly beans because the package is incorrectly labeled. The mislabeled packages failed to list peanut butter and peanut flour in the ingredient statement.”

Wait… they use peanuts and peanut butter to make jellybeans? Seriously?

The recall says… “The Jelly Belly 49 Flavors cylinder packages were… packaged in a clear 7.5-ounce acetate cylinder with white label on the bottom of the package with lot codes 090925, 090928, 090929 or 091001. UPC code 071567989398”

Here’s the link to the official FDA recall.

Recall (Warning) : FDA says “Stiff Nights” will probably kill you

OK, right up front, who the hell uses something called “Stiff Nights”? If someone is actually desperate enough to fork over good money for a jar of something called “Stiff Nights”, I can pretty much guarantee they’re not too concerned about their own immediate health and well being.

Having said all that now, the FDA recently issued a warning that “Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal.”

The gist of it is that… “the FDA determined that the product contains sulfoaildenafil. This is a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure.”

Here’s the link to the official FDA warning page. And another link to the Stiff Nights website.

Recall : PetSmart recalling two Dentley’s Beef Hoof products

If you recently bought a Dentley’s Beef Hoof snack for your dog from PetSmart, you might want to take a look at the trea’s UPC code because some of them might have been contaminated with salmonella.

The FDA release says “PetSmart… is voluntarily recalling two Dentley’s Beef Hoof products for potential salmonella contamination… The recalled products include only the following types of Dentley’s Beef Hooves purchased between Oct. 2, 2009 and Nov. 3, 2009: Dentley’s Bulk Cattle Hoof UPC# 73725703323 [and] Dentley’s 10 Pack Beef Hooves UPC# 73725736055”

Here’s the link to the official FDA recall.

Recall : Morningstar Foods assorted cream products for undeclared soy

Morningstar Foods announced that it is voluntarily recalling several of its’ products because they may contain soy protein.

From the notice… “This recall includes only the products listed. Each product is sold in a cardboard gable-top carton. Consumers can find the expiration date and the plant code on the top of the gable top package. The UPC code will either be located on the back or the side panel of the gable top carton. No other Great Value, Kroger or Wholesome Farm products are involved in this recall.

* 32-ounce Great Value Half & Half: UPC  6 05388 187 16 1, item code 1871600, plant code 21-031, “use by” date of December 16, 2009
* 32-ounce Great Value 36% Heavy Whipping Cream: UPC  6 05388 187 18 5, item code 1871800, plant code 21-031, “use by” date of December 16, 2009
* 32-ounce Kroger brand 36% Heavy Whipping Cream:  UPC  0 11110 438 28 7, item code 4382900, plant code 21-031, “use by” date of December 16 and 17, 2009
* 64-ounce Wholesome Farms Chocolate Ice Cream Mix:  UPC  0 74865 57 983 4, item code  5798300, plant code 21-031, “use by” date of January 7, 2010 (if purchased in a multi-pack, the UPC code is 1 00 74865 57983 1)”

Here’s the link to the official FDA recall notice.

Recall : Some products from bodybuilding.com may have steroids

Another FDA recall notice today concerns bodybuilding.com. According to the FDA, “As part of its ongoing cooperation with the Food and Drug Administration… Bodybuilding.com… announced today that it is conducting a voluntary nationwide and international recall of all lots and expiration dates of 65 dietary supplement products… that were sold through the Company’s website.”

Apparently some of these ingredients in some of these supplements may have been spiced with steroids. “Specifically, the FDA has advised the Company of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.””

Why do I suddenly hear the voices of Hans and Franz?

Here’s the official recall list…

4Ever Fit D-Drol
Advanced Muscle Science Dienedrone
Advanced Muscle Science Liquidrone UTT
Anabolic Xtreme Hyperdrol X2
APS (aka Advanced Muscle Science) Mastavol
APS (aka Advanced Muscle Science) Revamp
APS (aka Advanced Muscle Science) Ultra Mass Stack
APS (aka Advanced Muscle Science) Ripped Stack
Better Body Sports Finadex
Black China Labs Straight Drol
Black China Labs Straight Phlexed
Body Conditioning Solutions TestraFLEX
Bjorklund Methyldrostanolone
BOSC Enterprises Epi-Tren
BOSC Enterprises Magna Drol
Chaparral Labs Epivol
Chaparral Labs Pheravol-V
Competitive Edge Labs M-Drol
Competitive Edge Labs P-Plex
Competitive Edge Labs X-tren
Diabolic Labs Epio-Plex
Diabolic Labs Finabolic 50
Diabolic Labs Revenge
Ergopharm 6-OXO
Ergopharm 6-OXO Extreme
EST (aka Engineered Sports Technology) MethAnstance
Extreme Labs Susto-Test Depot
Fizogen ON Cycle II Hardcore
G.E.T/ (Genetic Edge Technologies) SUS-500
G.E.T/ (Genetic Edge Technologies) Tren-250
Hardcore Formulations T-Roid
I Force Nutrition 1,4 AD Bold 200
I Force Dymethazine/Reversitol Combo Pack
I Force Reversitol
I Force Nutrition 17a PheraFLEX
I Force Nutrition Dymethazine
I Force Nutrition Methadrol
IDS (aka Innovative Delivery Systems) Bromodrol
IDS (aka Innovative Delivery Systems) Grow Tabs TR
IDS (aka Innovative Delivery Systems) Mass Tabs
IDS (aka Innovative Delivery Systems) Oxodrol Pro
IDS (aka Innovative Delivery Systems) Ripped Tabs TR
IDS (aka Innovative Delivery Systems) Rapid Release
Ripped Tabs
Kilo Sports Massdrol
Kilo Sports Phera-Mass
Kilo Sports Trenadrol
Monster Caps Monster Caps
Myogenix Spawn
Nutra Coastal D-Stianozol
Nutra Coastal H-Drol
Nutra Coastal MDIT
Nutra Coastal S-Drol
Nutra Coastal Trena
Performance Anabolics Methastadrol
Performance Anabolics Tri-Methyl X
Purus Labs E-pol Inslinsified
Purus Labs Nasty Mass
Rage RV2
Rage RV3
Rage RV4
Rage RV5
Redefine Nutrition Finaflex 550-XD
Redefine Nutrition Finaflex Ripped
Transform Supplements Forged Extreme Mass
Transform Supplements Forged Lean Mass

Here’s the link to the official FDA recall notice. And here’s a link to bodybuilding.com.

Recall : Pelican Bay’s Caramel Chocolate Truffle Hot Chocolate Mix

In another recall announcement, “Pelican Bay… is recalling all their Caramel Chocolate Truffle Hot Chocolate Mix because it may contain undeclared tree nuts…. Caramel Chocolate Truffle Hot Chocolate Mix is packaged in a cone shape poly bag with a hanging tag attached to the front of the package and SKU# 3204, UPC 94522 01015 on the back of the label.”

Tree nuts are pretty much everything *except* peanuts, coconuts, nutmeg and water chestnuts. Cashews, almonds, pecans and walnuts all count as tree nuts.

Here’s a link to the official FDA recall notice.