FDA Update on Caffinated Alcoholic Beverages

In response to pressure from law makers and published peer-reviewed literature, on November 17, 2010, FDA issued Warning Letters to four companies known to produce caffienated malt alcoholic beverages.  FDA stated that it found no support for the claim that the addition of caffeinie to alcoholic beverages is 'generally recognized as safe' and that the combinations of caffeine and alcohol in the cited products may actually pose a public health concern.  The Warning Letters required the four named manufacturers to respond to FDA within 15 days to inform it of the specific steps that the companies intended to  take to remedy the violation or to provide evidence and supporting information to support its contention that the products are not unsafe.  Although that may seem like a short amount of time to respond, the companies were on notice of FDA's concern as early as this time last year.

FDA reports that within the last week, significant progress has been made.  All four manufacturers have reported that they have either ceased manufacturing, marketing and/or shipping the offending beverages or are having all product pulled from store shelves by December 13. 

While the available fact sheets certainly indicate that bans and limitations on caffeinated alcoholic beverages may make sense and while FDA is certainly acting within the power granted to it by regulating these drinks, one has to wonder how far FDA plans on taking this issue.  More than a few alcohol manufacturers promote the mixture of their alcoholic beverages with caffeinated drinks; there's nothing new or exciting about the combination of those two ingredients.  FDA certainly has the ability to regulate advertisement of food and other beverages - the quetion is whether it will use that power to adversely impact major players in the alcohol game, or whether it will limit itself to wrist slapping a few minor producers to quiet public discontent. 

Graphic Images On Cigarette Packages? Help FDA Select Them

 You, the public, are being asked to help select the images, and/or you may post comments on the FDA’s proposal, from now until January 11, 2011. On November 10, 2010, the FDA posted on the Internet a set of 36 graphic color images showing the dangers of smoking grouped in nine categories, which are to be placed on the packages with appropriate text warnings. The public is being asked to help select from the 36 images a set of nine of them, one from each of nine categories.

Congress enacted the Family Smoking Prevention and Tobacco Control Act in 2009, requiring pointed health warnings with color graphics on all cigarette packages and advertisement after September 12, 2012.  Representing each of the nine categories, the text warnings, each to be coupled with a related image or photo, are:

v     WARNING: Cigarettes are addictive

v     WARNING: Tobacco smoke can harm your children

v     WARNING: Cigarettes cause fatal lung disease

v     WARNING: Cigarettes cause cancer

v     WARNING: Cigarettes cause strokes and heart disease

v     WARNING: Smoking during pregnancy can harm your baby

v     WARNING: Smoking can kill you

v     WARNING: Tobacco smoke causes fatal lung disease in nonsmokers

v     WARNING: Quitting smoking now greatly reduces serious risks to your health

Each of these congressionally mandated warnings will accompany a related color image, together to cover 50% of the both the front and back panels of each package, and to cover at least 20% of each advertisement. The various warnings will rotate on each package and advertisement periodically.

Some of the scenes depicted are:

o       smoke being exhaled from a tracheotomy opening of the smoker;

o       a baby and mother, with second-hand smoke from the mother engulfing the baby’s face;

o       side-by-side photographs of a healthy lung and a diseased lung;

o       an illustration of a cigarette package with an arrow pointing to a gravestone; and

o       second-hand smoke wafting from a smoker toward a non-smoker’s face during conversation.

When the public comment period ends on January 11, 2011, the FDA will use the comments and scientific research and results to pare the list of 36 images to nine. Secretary Kathleen Sebelius of U.S. Department of Health and Human Services says that she is hopeful that the tragic images will stop young people from picking up their first cigarette and also give smokers the incentive to quit. “Every day,” Secretary Sebelius says, “almost 4,000 youths try a cigarette for the first time, and 1,000 youths become regular, daily smokers.” Over 2,600 adults also try smoking for the first time every year.

The Centers for Disease Control and Prevention says tobacco use is the single biggest cause of preventable death in the United States, killing more than 443,000 users and victims of second-hand smoke every year, and causing serious illness in 8.6 million Americans. Most of smokers dying began smoking when they were under the age of eighteen.

The proposed rules were published in Federal Register, Vol. 75, No. 218, Friday, November 12, 2010.

To see the graphic color images with their text warnings, go to:


To submit comments on the warning labels and the proposed rule, through Tuesday, January 11, 2011:

a) go to:   www.regulations.gov and insert docket number FDA-2010-N-0568-0001 into the “Search” box. (The proposed regs should be at the top of the list of Titles, and follow the prompts, clicking on the docket number in the fourth column to view the regs; to comment on the proposed regs and the color images, click on “Submit a Comment” in the right-hand column.)

b) send a fax*, with your comments, to:   301-827-6870

c) for paper submissions*, or disk* or CD-ROM* submissions, send by mail, or courier or hand delivery to :

            Division of Dockets Management (HFA-305)

            Food and Drug Administration

            5630 Fishers Lane, Room 1061

            Rockville, MD 20852


*NOTE: All comments should be identified by Docket ID No. FDA-2010-N-0568, and only one copy is necessary.

For the FDA’s notice, click here or go to this link


More information below:

As provided in the “Background” section of the proposed regulations, in 1964 the U.S. Surgeon General of the Public Health Service issued the landmark report titled “Smoking and Health,” which concluded that cigarette smoking is a health hazard of sufficient importance in the U.S. to warrant appropriate remedial action. Shortly thereafter, Congress passed the Federal Cigarette Labeling and Advertising Act of 1965, which required a printed warning to appear on cigarette packaging. Although the current text warnings on packages have been in use for twenty-five years, there is considerable evidence that the current warnings are given little consideration by viewers, and the warnings are said to have become “invisible” and fail to convey relevant information in an effective way. 

The FDA says that there is evidence of a strong worldwide consensus that effective tobacco health warnings should be large and should include a graphic image component. The World Health Organization’s (WHO) Framework Convention on Tobacco Control (FTCT) has called for such a program of graphic images, and over 30 nations or jurisdictions have implemented such a program, including Canada, India, Mexico and the United Kingdom, with efforts pending in several others. (As of August 2010, there are 168 signatories to the Convention, including the United States, although the U.S. has not ratified this Treaty.)

Results from the 2009 National Health Interview Survey (NHIS) indicate that approximately 46.6 million U.S. adults are cigarette smokers (20.6% of the adult population). During the period of 1998 to 2009, adult smokersdeclined from 24.1% to 20.6%, although from 2005 to 2009 rates showed virtually no change.


Social Media - Still No Guidance, but FDA Is Getting Interested

The bad news?  Despite claims made earlier this year that it was on track to issue guidance regarding the use of the internet and social media by the industry, the FDA has remained mum.  At this point, release of guidelines before the end of the year is doubtful, but we remain hopeful for the beginning of next year.  Even then, due to the scope of the issues being addressed by FDA, we do not expect the first round of guidance to be very instructive. 

The good news?  If you've been paying close attention, it looks like someone at FDA is starting to understand the importance of social media and other online marketing and communication tools.  In the last year, FDA has moved into Facebook, Flickr, and even Twitter to communicate to the public regarding everything from salmonella outbreaks caused by peanuts to salmonella outbreaks caused by eggs.  FDA's Twitter feed is particularly active, with over 1,200 notifications of drug, device, biologic and food recalls since the account has been opened. 

Most, if not all, companies involved in the manufacturing and production of regulated devices and drugs should be paying close attention to social media issues and start preparing for the guidance that FDA will likely issue in the next three to six months.  For those who want to get started early, there is at least one conference being held in Washington D.C. this January.