This post first appeared on HCPLive.com/Psychiatry.

The Food and Drug Administration has sent a letter to 30 companies warning that it hasn’t approved beverages containing both caffeine and alcohol, and that it intends to begin removing such products from store shelves in 30 days if the companies can’t explain why such products are safe and legal.

The letter cited research showing that the combo drinks increase the risk of motor vehicle accidents and sexual assaults.

In one such study, Mary Claire O’Brien of Wake Forest University found that nearly one quarter of all college students claimed to have consumed such beverages in the last month alone.

O’Brien found that students who consumed alcohol-laced energy drinks were 70% more likely to be taken advantage of sexually (6.4% vs. 3.7%) and more than twice as likely (3.7% vs. 1.7%) to have taken sexual advantage of someone than students who drank alcohol alone.

O’Brien reported similarly appalling statistics for riding with a driver that had been drinking (38.9% vs. 22.5%), being hurt or injured (12.3% vs. 5.9%), and requiring medical treatment (2.6% vs. 1.2%). 
 
Last year, state authorities persuaded Anheuser-Busch and MillerCoors to remove their combo drinks, known as Bud Extra, Tilt, and Sparks from the market.

But at least 30 smaller companies still market the drinks, which contain roughly the same dose of caffeine as a large cup of Joe and nearly 10% alcohol. The provocatively-named beverages include Max Vibe, Moon Shot and Slingshot Party Gel.

In its press release on the matter, the FDA cited regulations that deem as unsafe all substances added to food or alcoholic beverages unless their “particular use has been approved by the FDA, or (they are) ‘Generally Recognized As Safe.’”

In a press conference explaining the FDA’s move, Joshua Sharfstein, the agency’s principal deputy commissioner explained that the “FDA is not aware of the basis on which these manufacturers have concluded that caffeine added to alcoholic beverages is, quote, ‘Generally Recognized As Safe.’” (more…)

The FDA has been on a seek and destroy mission against Web sites that distribute products it has not approved for use in the fight against H1N1.

Since May in fact, the agency has warned at least 75 Web sites to stop selling more than 135 products with fraudulent claims of efficacy against H1N1.

The FDA’s latest move in this regard has been to issue a joint warning letter, along with the FTC, to a Web site that markets fraudulent supplements claiming to help prevent spread of the virus.

The letter advises the Web site owners to cease and desist within 48 hours or else face the heavy hand of the law, which could include an injunction by the FTC and seizure of products, an injunction or criminal prosecution by the FDA.

To date, the FDA has identified all sorts of bogus H1N1 products, including:
- A shampoo claiming to protect against H1N1,
- A dietary supplement claiming to protect infants and children from H1N1,
- A supplement claiming to cure H1N1 in 4-8 hours,
- A spray claiming to leave a layer of ionic silver on one’s hands that kills the virus
- Several tests claiming to detect the virus, and
- An electronic instrument costing thousands of dollars claiming to use “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1.

“Products that are offered for sale with claims to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully evaluated,” said FDA Commissioner Margaret Hamburg. Such products can “make matters worse by providing consumers with a false sense of protection,” she added.

The FDA has approved 2 anti-viral drugs for treatment and prophylaxis of the 2009 H1N1: Tamiflu and Relenza.  It has also issued Emergency Use Authorizations that extend their approved labeling to additional, specific authorized uses as the pandemic spreads.

The Food and Drug Administration is mad as hell about illegal products marketed over the Internet claiming to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 (Swine) flu virus.

And it’s not going to take it anymore.

The FDA has warned consumers to stay away from Swine flu products that it has not approved, cleared, or authorized, and beginning in May, it warned more than 50 offending Web site operators to cut it out (see full list here).

Approximately 66% of them did so.

That wasn’t good enough for FDA Commissioner Margaret Hamburg. In a press release last week she said “we are committed to pursuing those who attempt to take advantage of a public health emergency by promoting and marketing unapproved, or unauthorized products. We will (continue) our efforts to protect consumers from these fraudulent, potentially dangerous products.”

The bogus products targeted by the FDA include:
- A shampoo claiming to protect against H1N1,
- A dietary supplement claiming to protect infants and children from H1N1,
- A supplement claiming to cure H1N1 in 4-8 hours,
- A spray claiming to leave a layer of ionic silver on one’s hands that killes the virus
- Several tests claiming to detect the virus, and
- An electronic instrument costing thousands of dollars claiming to use “photobiotic energy” and “deeply penetrating mega-frequency life-force energy waves” to strengthen the immune system and prevent symptoms associated with H1N1.

The scammers were discovered during Internet sweeps undertaken by the several FDA departments and other agencies.

The FDA has threatened to take civil or criminal enforcement action against vendors that fail to comply with the marching orders.