Alcoholic Beverages Containing Caffeine

FDA to Evaluate Safety and Legality of Alcoholic Beverages Containing Caffeine

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible.” — Dr. Joshua Sharfstein, Principal Deputy Commissioner of Food and Drugs, FD

What are caffeinated alcoholic beverages?

Caffeinated alcoholic beverages are alcoholic beverages to which the manufacturer has intentionally added caffeine and/or other stimulants that are metabolized as caffeine (e.g., guarana). An increasing number of companies are producing these beverages, with young people as the apparent marketing target. The reported prevalence of combined caffeine and alcohol use among U.S. college students is high as 28%.

What are the potential health concerns with caffeinated alcoholic beverages?

• Studies have shown that people who drink caffeinated alcoholic beverages drink larger quantities of alcohol.
• Caffeine can mask the negative effects of alcohol intoxication, increasing the chance that users will engage in potentially risky behaviors, such as drinking and driving, because they don’t feel that they are intoxicated.
• Users of caffeinated alcoholic beverages are also more likely to experience alcohol-related consequences, such as being taken advantage of or taking advantage of someone else sexually.
• Consuming these beverages may also be associated with adverse effects on heart rhythm, most likely in individuals with pre-existing cardiovascular conditions.

Is caffeine approved by the FDA for use in alcoholic beverages?

A food additive is presumed by the FDA to be unsafe unless its particular use has been approved by federal regulation or is Generally Recognized As Safe (GRAS) under the conditions of its intended use. The FDA has approved caffeine as GRAS for use only in non-alcoholic cola- type beverages at concentrations of no greater 0.02 percent. The FDA has not approved caffeine for use at any level in alcoholic beverages.

What is the FDA doing about this?

On November 13, 2009, the FDA issued a mandate to nearly 30 manufacturers* of caffeinated alcoholic beverages to produce within 30 days their rationale and supporting data concluding that their use of caffeine in an alcoholic beverage is either GRAS or prior sanctioned.** To be GRAS, the burden is on the manufacturers to show that 1) the use of caffeine is safe for use in alcoholic beverages based on publicly available scientific evidence and 2) there is a consensus among qualified experts regarding the safety of caffeine for this use. In their letter to manufacturers of caffeinated alcoholic beverages, the FDA states that, “If FDA determines that the use of caffeine in your alcoholic beverage is not GRAS or subject to a prior sanction, FDA will take appropriate action to ensure that this product is removed from the marketplace.”

*In the past year, Anheuser-Busch and Miller agreed to discontinue their caffeinated alcoholic beverages and agreed to not produce any caffeinated alcoholic beverages in the future.

**A substance is considered prior-sanctioned if its specific use in food was authorized by the FDA or the Department of Agriculture prior to September 6, 1958.

SOURCES: Adapted by CESAR from the following documents available on the FDA website at http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm: “FDA to Look Into Safety of Caffeinated Alcoholic Beverages; Agency Sends Letters to Nearly 30 Manufacturers,” FDA Press Release, 11/13/09; FDA, Questions & Answers on Caffeine in Alcoholic Beverages, 2009; CAB Letter to FDA from Attorneys General, 9/25/09; CAB Letter to FDA from Scientists, 9/21/09.

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Clear Messages Reduce Teen Drug Use

Students With Parents Who Set and Enforce Clear Rules are Less Likely to Report Illicit Drug Use

Youths whose parents set clear rules for them are less likely to report using illicit drugs, according to data from the 2008-09 PRIDE Survey. Middle and high school students* whose parents set clear rules for them “a lot” or “often” were less likely to report using illicit drugs in the past year (12% and 21%, respectively) than students whose parents never set clear rules (49%). Similar results were found for having parents who punish them for breaking these rules (data not shown). Previous studies have found that youths living in households where parents kept track of their whereabouts and set curfews were less likely to report heavy drinking.

 

 

SOURCE: Adapted by CESAR from PRIDE, Questionnaire Report for Grades 6 to 12, 2008-09 National Summary – Grades 6 thru 12, 2009. Available online at http://www.pridesurveys.com/customercenter/us08ns.pdf.

Drugs and Kids: How Parents Can Keep Them Apart by Gary L. Somdahl

Minimising the Risk of Addiction to Codeine

New advice on over the counter analgesics containing codeine

The British Medicines and Healthcare products Regulatory Agency (MHRA) today announced new advice on over-the-counter (OTC) medicines containing codeine and dihydrocodeine (DHC) to minimise the risk of overuse and addiction.

The package of measures include clear and prominently positioned warnings on the label and patient information leaflet (PIL) about the risk of addiction, and the importance of not taking these medicines for longer than three days.

The revised guidance on the use of these products will focus on treating moderate pain not relieved by simple painkillers such as paracetamol and ibuprofen. There will also be updated controls on advertising to ensure the new warnings are clearly presented.

Large packs of effervescent codeine containing products will no longer be sold in the pharmacy but will be available on prescription, which further strengthens the voluntary action taken by manufacturers in 2005 on pack size reduction. All packs containing up to 32 tablets remain available for sale through a pharmacy.

MHRA Director of Vigilance and Risk Management of Medicines, Dr June Raine said that taken in the correct manner and for the right purposes, codeine and DHC are very effective and acceptably safe medicines.

“However, these products can be addictive and we are taking action to tackle this risk,” she said.

“The MHRA is ensuring that people have clear information on codeine containing medicines on what they are to be used for and how to minimise the risk of addiction.

“Anyone who has concerns should speak to their pharmacist or a doctor.”

All indications related to colds, flu, coughs and sore throats, and references to minor painful conditions will be removed. The remaining list of indications will be for the short term treatment of acute, moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone.

Patient Information Leaflets (PIL) and Labels
The PIL and Labels will state that the products are for short term use only (up to three days) for the treatment of moderate, acute pain, and that the products can cause addiction or overuse headache if used continuously for more than three days. In particular, the following warning will be positioned clearly and prominently on the front of the pack:

‘Can cause addiction. For three days use only’

The PIL will also carry information about the warning signs of addiction, ie if the medicine is needed for longer periods and in higher doses than recommended, and if stopping the medicine makes you feel unwell but you feel better when you start taking it again.

Advertising

The advertising and promotion code of practice for manufacturers and retailers will be updated to reflect the new indications and warnings, and to remove references to painkilling power and strength. Also, all advertisements will include the statement ‘Can cause addiction. For three days use only’.

Full story at British Medicines and Healthcare products Regulatory Agency

• See also;
• $4 Million Killer Kids
• Current Social Problems
• Double Trouble in Recovery for Alcoholics
• Ten percent of adults abuse drugs
• Types of Dysfunctional Families

Addict In The Family: Stories of Loss, Hope, and Recovery. by Beverly Conyers

Chicken Soup for the Soul: All in the Family: 101 Incredible Stories about our Funny, Quirky, Lovable & "Dysfunctional" Families by Jack Canfield

Raising a Peer Pressure-Proof Child

Teen Peer Pressure: Raising a Peer Pressure-Proof Child

Learn what kinds of peer pressure teens face, who’s most vulnerable, and how to help your son or daughter resist.

Remember when your teenager took her first steps as a toddler? You hovered behind her — back bent, arms spread — prepared to catch her should she fall. Much as you might like, you can’t shadow your adolescent as you did back then, being there to break her fall when she missteps.

But, say experts, there are steps you can take to support your adolescent in the face of teen peer pressure. Follow them and you’ll rest easier when your teen heads out of the house on a Friday night.

Teen Peer Pressure: What’s Being Pushed?

Here are some findings from recent surveys.

• Smoking. By the time adolescents are just 13, one in five has tried smoking.
• Alcohol use. Two-thirds of teens between the ages of 14 and 17 have tried alcohol. Of teen boys who have tried alcohol, 20% did so by the time they were 12. Episodic, or binge drinking, is also fairly common. Of the adolescents aged 12 to 17, one in four said they’d had five or more drinks consecutively within the past month. Almost a quarter of drinkers aged 16 to 21 admitted to driving after drinking.
• Drug use. Slightly more than 25% of adolescents aged 14 to 17 have used illegal drugs. One-third of young adult marijuana users aged 18 to 21 started using the drug by the time they turned 14.
• Sex. About one in every three kids aged 14 to 15 has had sexual intercourse. Of sexually active teens, almost 30% used no birth control during their last sexual encounter.

Other subjects in this article include;

• Identifying Vulnerable Teens
• Why Teens Fall Prey to Peer Pressure
• Making Your Child Resilient to Teen Peer Pressure

In spite of adolescents’ vulnerability and the strong influence of peers, parents can exert a positive influence on their adolescents’ decision-making processes, offering them ways to combat the effects of peer pressure. Experts explain how. Strategies include;

• Keep communication lines open
• Practice peer pressure scenarios
• Listen to your teen’s perspective
• Keep inviting your kids into your life
• Think beyond punitive responses

This article has some excellent proven strategies and can be found at; Raising Peer Pressure Proof Teens.

The Complete Idiot’s Guide to Surviving Peer Pressure for Teens by Sara Jane Sluke, Hilary Cherniss, Sara Jane Sluke Hilary Cherniss

Friends, Cliques, and Peer Pressure: Be True to Yourself (Teen Issues) by Christine Wickert Koubek

See also;

• A Problem Shared is a Problem Halved
• Adolescent Children of Alcoholics
• Adults give booze to kids
• Alcoholic Family Roles
• Is Your Teen Using Drugs or Drinking?