To me, a “Dietary Supplement” is a glass of OJ with my eggs. Some bacon in my Whataburger. Things you actually consume with a meal as part of a meal to enhance said meal.

Having said that, I still fail to see how something called “RockHard Weekend” from RockHard Laboratories has anything to do whatsoever with “Dietary Supplement”. It’s either that or I’ve been doing something horribly wrong for breakfast, lunch and dinner this whole time.

The FDA announced that “RockHard Laboratories is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that voluntary lab analysis found… sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making RockHard Weekend an unapproved drug.”

In other words, just like the “stiff nights” recall, “RockHard Weekend” has some prescription-based ingredients that they tried to slip under the radar.

The FDA’s justification for the recall is the same one they used on the “stiff nights” recall. It might kill you! Maybe.

“The undeclared ingredient may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.”

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

This is a strange one. Mostly because of the veeeery carefully selected wording in the recall release.

Cardiac Science Corporation announced today that is “is initiating a voluntary field correction after it was determined certain automated external defibrillators (AEDs) may experience a rare product issue in which the AED may not be able to deliver therapy during a resuscitation attempt.”

Lots of adjectives back yonder. The release continues…

“Device failure may affect resuscitation of the patient, which could lead to serious adverse events or death. These AEDs have electronic components which may fail and the failure may not be detected by the device’s periodic self-tests. The affected models include the Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, and CardioVive 92531, 92532, and 92533 devices.”

Most of the remainder of the recall is pretty straightforward. That is until you get to the last paragraph. Put your waders on for this next part. It’s deep.

“This press release contains forward-looking statements. The word “believe,” “expect,” “intend,” “anticipate,” variations of such words, and similar expressions identify forward-looking statements, but their absence does not mean that the statement is not forward-looking. Forward looking statements in this press release include, but are not limited to, predictions of AED component failure rates, the availability of software updates to improve detection of the component issue, and the effectiveness of the planned software update. These are forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results and performance may vary significantly from those expressed or implied in such statements. Factors that could cause or contribute to such varying results and other risks are more fully described in the Annual Report on Form 10-K filed by Cardiac Science Corporation for the year ended December 31, 2008, as updated by subsequent quarterly reports on Form 10-Q. Cardiac Science Corporation undertakes no duty or obligation to update the information provided herein.”

Looks like the legal team got to slime this one before it got out the door. Sad.

Anyhow, here’s the link to the official recall NOT FORWARD LOOKING but MAYBE IT IS FORWARD LOOKING notice.

Steroids? In dietary supplements? And muscle building products? No! Say it isn’t so!

The FDA release says “IDS Sports announced today that it is conducting a voluntary nationwide recall of… Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR. The Food And Drug Administration (FDA) has notified IDS Sports that the recalled products contain the following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione.””

The items specifically recalled are…

You know, with steroids causing “shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death” as side effects, is all that really a good trade for 19 inch guns?

Lemme get back with you on that…

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

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?

Buy ’em now if you want ’em.

Here’s the link to the FDA notification here.