Caffeine Information Revealed

Numbness & Caffeine Withdrawal

You might not think of caffeine as a narcotic. However, a research paper published in "Neuropsychopharmacology: 5th Generation of Progress" states that caffeine is arguably one of the most "robust forms of drug self-administration known to man." Like other stimulant drugs, caffeine can cause addiction as well as a number of side effects. As with other narcotics, you also may experience certain withdrawal symptoms, including numbness, when you stop using caffeine.

Caffeine's Effects on Your Body

Caffeine is a naturally occurring drug produced in the leaves and seeds of certain plants, including tea leaves, cocoa beans and coffee beans. Most people use caffeine for a quick pick-me-up due to its stimulating effects on the nervous system. Caffeine can cause an increase in alertness, elevate your mood and give you a temporary energy burst. As with other narcotics, your body can quickly become addicted to these seemingly pleasant effects. However, when your body becomes accustomed to caffeine, you require more and more in order to achieve the desired outcome. While caffeine's effects vary based on your age, weight and height, even small amounts of caffeine can interfere with your sleep, cause digestive upset, increase your heart rate and result in unwanted mood symptoms such as nervousness or irritability.

Caffeine Withdrawal Symptoms

Caffeine can be addictive even if you use it in low doses. The caffeine found in an average cup of coffee, around 75 to 250 milligrams, can cause dependence if used regularly. Authors of the book "Substance Abuse: A Comprehensive Textbook" note that high doses of caffeine -- between 750 and 1,000 milligrams -- administered on a daily basis can produce complete tolerance. That is, you experience no symptoms from caffeine use because your body has learned to tolerate it. However, once you stop using caffeine, your body can go into withdrawal, especially if you are used to very high, regular doses. Caffeine withdrawal can cause irritability, depression, anxiety, headaches, nausea, fatigue, lethargy, heavy feelings in your legs and arms, vomiting, stiffness in your joints, problems concentrating and numbness in your extremities and on your skin.

Numbness and Caffeine Withdrawal

Numbness is not a common symptom of caffeine withdrawal. Although it has not been well-documented in clinical trials, symptoms of numbness, tingling and paresthesia, a condition characterized by tingling, burning and numbness of the skin, can occur in some people during caffeine withdrawal, according to a clinical review published in 2004 in the journal, "Psychopharmacology."

Treatment

Symptoms of caffeine withdrawal generally disappear after a few days but can last up to nine days. Headache and bodily aches and pains generally can be treated effectively using over-the-counter medications such as ibuprofen, aspirin and acetaminophen. Although it's uncommon, numbness can be a sign of a more serious underlying disorder. If your symptoms persist, do not attempt to self-diagnose your condition. Consult your doctor to discuss your symptoms and obtain treatment advice.

IS CAFFEINE A NARCOTIC DRUG?

No, its a stimulate. It gives you energy for a little while and then makes you really tired. Narcotic drugs make you somewhat sleepy, dizzy.

NARCOTIC ANALGESIC/ASPIRIN/CAFFEINE - ORAL

USES: This combination medication is used to treat moderate pain, fever, and swelling. The narcotic pain reliever (opiate-type) acts on certain centers in the brain to give you pain relief. Aspirin helps to decrease the pain, fever, and swelling. Caffeine helps increase the effects of aspirin on pain.

HOW TO USE: Take this medication by mouth as directed by your doctor. Take with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this medication. If you have nausea, you may take this medication with food. Consult your doctor or pharmacist about other ways to decrease nausea (e.g., antihistamines, lying down for 1-2 hours with as little head movement as possible).The dosage is based on your medical condition and response to therapy. If you are extremely drowsy after using this medication, consult your doctor or pharmacist promptly. Your dosage may need to be lowered. Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as runny nose, watery eyes, restlessness) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.Inform your doctor if your pain persists or worsens.

A psychoactive drug, psychopharmaceutical, or psychotropic is a chemical substance that crosses the blood–brain barrier and acts primarily upon the central nervous system where it affects brain function, resulting in alterations in perception, mood, consciousness, cognition, and behavior. These substances may be used recreationally, to purposefully alter one's consciousness, as entheogens, for ritual, spiritual, and/or shamanic purposes, as a tool for studying or augmenting the mind, or therapeutically as medication.

Because psychoactive substances bring about subjective changes in consciousness and mood that the user may find pleasant (e.g. euphoria) or advantageous (e.g. increased alertness), many psychoactive substances are abused, that is, used excessively, despite health risks or negative consequences. With sustained use of some substances, psychological and physical dependence ("addiction") may develop, making the cycle of abuse even more difficult to interrupt. Drug rehabilitation aims to break this cycle of dependency, through a combination of psychotherapy, support groups and even other psychoactive substances. However, the reverse is also true in some cases, that is certain experiences on drugs may be so unfriendly and uncomforting that the user may never want to try the substance again. This is especially true of the deliriants (e.g. Jimson weed) and powerful dissociatives (e.g. Salvia divinorum). Most purely psychedelic drugs are considered to be non-addictive (LSD, psilocybin, mescaline etc.); "psychedelic amphetamines" or empathogen-entactogens (such as MDA, MDMA etc.) may produce an additional stimulant and/or euphoriant effect, and thus have an addiction potential.

In part because of this potential for abuse and dependency, the ethics of drug use are the subject of debate. Many governments worldwide place restrictions on drug production and sales in an attempt to decrease drug abuse. Ethical concerns have also been raised about over-use of these drugs clinically, and about their marketing by manufacturers.

Psychoactive substances are used by humans for a number of different purposes to achieve a specific end. These uses vary widely between cultures. Some substances may have controlled or illegal uses while others may have shamanic purposes, and still others are used medicinally. Other examples would be social drinking or sleep aids. Caffeine is the world's most widely consumed psychoactive substance, but unlike many others, it is legal and unregulated in nearly all jurisdictions. In North America, 90% of adults consume caffeine daily^.

Psychoactive drugs are divided into three groups according to their pharmacological effects:

• Stimulants ("uppers"). This category comprises substances that wake one up, stimulate the mind, and may even cause euphoria, but do not affect perception.

Examples: coffee, tea, tobacco, coca, amphetamine, phenethylamine, cocoa, guarana, matér, ephedra and khat.

• Depressants ("downers"), including sedatives, hypnotics, and narcotics. This category includes all of the calmative, sleep-inducing, anxiety-reducing, anesthetizing substances, which sometimes induce perceptual changes, such as dream images, and also often evoke feelings of euphoria.

Examples: opioids, barbiturates, benzodiazepines and alcohol.

• Hallucinogens, including psychedelics, dissociatives and deliriants. This category encompasses all those substances that produce distinct alterations in perception, sensation of space and time, and emotional states.

Examples: psilocybin, LSD, Salvia divinorum and nitrous oxide.

Marijuana is an example of a psychoactive drug that combines properties of each of these groups.

CAFFEINE BEVERAGES-TO DRINK OR NOT

by Ibrahim B. Syed, Ph. D.  President  Islamic Research Foundation International, Inc.  7102 W. Shefford Lane  Louisville, KY 40242-6462, U.S.A.  E-mail: IRFI@INAME.COM  Website:  http://WWW.IRFI.ORG

Islam is a universal religion. Islam is submission to the Will of God.  This implies doing right, being an example to others to do right, and having the power to see that the right prevails.  One should set an example to others to eschew wrong and have the power to see that wrong and injustice are defeated. 

 Islam disciplines the human being so that a Muslim can do good and ward off evil.  Islam brings out the best in a human being, exalts him/her to the highest position on earth.  Therefore by following the word and spirit of Islam one can strive to become a perfect human being.  This statement is supported by the fact that our Prophet Muhammad (PBUH) was the most perfect human being ever lived on earth (See Dr. Ahmad Deedat's Video Tapes). 

     One should have the knowledge to distinguish between what is good and what is bad or evil.  Anything that produces harm, injury or death is bad, by definition.  Also anything that deviates or distracts a Muslim from performing his Islamic obligations or duties is also bad or harmful. Halal means lawful, permissible.  The acts of Halal are made by Allah (SWT) and revealed to man through Al-Qur'an. If one examines Halal in detail one sees that Halal is designed for the benefit and welfare of mankind.  It is designed to be for the "good" of mankind. Therefore Halal can be construed as good and could be synonymous with "good".  Similarly Haram could be interpreted to mean bad or evil.  Whenever the word Halal is mentioned we invariably understand that it is applied to meat and other foods. 

Let there arise out of you

A band of people inviting to all

That is good, enjoining what is right

And forbidding what is wrong:

They are the ones to attain felicity.

—      Al- Qur'an, 3: 104

Commenting on this verse Allama Yusuf Ali says " the root idea is attainment of desires, happiness, in this world and the next; success; freedom from anxiety, care or disturbed state of mind;.....   The ideal Muslims community is happy, untroubled by conflicts or doubts, sure of itself, strong, united, and prosperous: because it invites to all that is good; enjoins the right; and forbids the wrong. " 

    Al Qur'an is guidance for all of mankind and for all times, present and future. The concept of Halal to the personal habits of Muslims is extended based on the arguments given initially and on the following verses taken from the Noble Qur'an: 

Enjoin ye righteousness upon mankind.

                   …… Surah, Baqara, 2: 44               

Eat and drink of that which Allah hath provided, and do not act corruptly, making mischief in the earth.

…………… Surah, Baqara, 2: 60 

Those who believe and do good works: such are rightful owners of the Garden (Jannah).  Surah Baqara, 2: 82

O mankind! Eat of that which is lawful and wholesome in the earth, and follow not the footsteps of the devil. Lo! he is an open enemy for you.  ……..Surah, Baqara 2: 168

O ye who believe! Eat of the good things wherewith We have provided you.... .  2: 172 

The righteous man is he who wardeth off (evil).  Surah, Baqara, 2: 189.  

The best provision is to ward off evil.  ..   Surah, Baqara, 2: 197  

Allah loveth those who have a care for cleanness… Surah Baqara, 2: 222. 

O Ye who believe! Strong drink (intoxicants) and games of chance (gambling) and idols and divining arrows (superstition) are only an infamy of Satan's handiwork.  Leave it aside in order that ye may succeed (prosper).       …Surah, Al-Ma'ida, 5: 90 

Satan seeks only to cast among you enmity and hatred by means of strong drink (intoxicants) and games of chance (gambling) and to turn you from remembrance of Allah and from (His) worship.  Will ye then not abstain?

                                                            ………Surah, Al-Ma'ida,. 5: 91 

...   So be mindful of your duty (to Allah) and do good works, and again: be mindful of your duty, and believe; and once again: be mindful of your duty, and do right. Allah loveth those who do good………Surah, Al-Ma'ida…5: 93

Caffeine, theophylline and theobromine, three closely related alkaloids, occur in plants, which are widely distributed throughout the world.  From ancient times, water extracts of these plants have served as beverages for man.  These alkaloids possess important pharmacologic properties and are therapeutic agents.  Coffee-extracted from the seeds of Coffea Arabica and related species- contains caffeine.  For making tea, the leaves of Thea sinesis are used.  They contain caffeine and theophylline. The seeds of Theobroma cacao are used to make cocoa, which contains caffeine and theobromine.  Mate, a popular national drink of many South American countries, contains caffeine.  Even the so-called "soft drinks", particularly the cola-flavored drinks popular in the U.S. and many other countries, also contain caffeine.  These drinks are made using extracts of kola nuts, which, like the guru nuts chewed by the natives of Sudan, contain about two percent caffeine.

DISCOVERY OF COFFEE

The earliest history of these beverages is not known except for many conjectural statements and mythical stories.  Legend credits the discovery of coffee to Kaldi, an Arab goatherd.  This appears fairly reliable as the word "coffee" comes from the Arabic word "gahwa", and until the end of the 17^th century, the world's limited supply of coffee was obtained almost entirely from Yemen in Southern Arabia.  The story goes that in about 850 CE the shepherd observed night-long friskiness and frolic in goats who had fed on berries of the evergreen coffee plant.  Puzzled by the queer antics of his flock, he picked the berries so that he might make a beverage from them.  This drink made him experience a sense of exhilaration and thereby proclaim his discovery to the world. The stimulating effect of coffee made it popular.  This drink proved to be very helpful for enduring long religious services of the Muslims, particularly in the month of Ramadan.  The orthodox priests pronounced it intoxicating and were against the use of this devotional antisoporific.  But despite the threat of severe penalties, coffee drinking spread rapidly among Arabs and their neighbors.  Today that in the US alone, over a billion kilograms are consumed annually. An adult American consumes an average of 8 kilograms of coffee or about 800 cups each year of the brown, non-nutritious liquid.  It is estimated that more than half the world's coffee beans are brewed in America.  The stimulatory effects of caffeine and the aroma of coffee are the two main reasons for the popularity of coffee.  The taste and general desirability of a heated beverage are two minor reasons.  Although toxic effects have been reported, no deaths have been reported from the drinking of coffee and the practice continues to increase in popularity.

The alkaloids are xanthine derivatives or methyl xanthines.  Caffeine is 1,3,7-trimethylxanthine.  Xanthine itself is dioxypurine and is related to uric acid in structure.  The fact that these alkaloids bear similar structural formulae may not be obvious to the practicing pharmacist.

Caffeine was first extracted from plants in 1820 by the German scientist, Friedlieb Runge, as a white odorless, crystalline powder.

BENEFICIAL EFFECTS

The most important ingredient in coffee-and the one primarily responsible for its continuing  popularity-is caffeine, a drug that powerfully stimulates the central nervous system and gives that familiar coffee "lift."  Caffeine clears away mental cobwebs, relieves drowsiness, masks fatigue and creates for many a general sense of well-being.

Caffeine in small doses helps produce a clearer train of thought, a keener appreciation of sensory stimuli and a swifter reaction time.  Its "pick-me-up" properties largely account for the popularity of cola drinks, 600 ml of which have roughly the same amount of caffeine as a 174 ml cup of brewed coffee.

Since children are more sensitive to the stimulant effects of caffeine than adults, doctors discourage youngsters from drinking colas and cocoa (depending on the source of the chocolate, cocoa can have as much as half the caffeine as a cup of coffee).  In addition to stimulating the brain, caffeine stimulates the kidneys to produce more urine.

Caffeine's virtues have prompted many drug manufacturers to include it in medications designed to relieve pain, premenstrual tension and cold symptoms (where it counters the drowsiness produced by antihistamines).  Caffeine is also the active ingredient in over-the-counter (OTC) drugs to help people stay awake.  In fact, the dose of caffeine in a single stimulant tablet is no greater than that in a cup of brewed coffee, but the unaware consumer may pay a lot more for caffeine in the drug than in the drink.

Caffeine, which constricts cerebral blood vessels, is used to treat migraine-type headaches and to counter the effects of drugs that depress the central nervous system.  It is being studied as a treatment for hyperactivity in children (in whom it has a calming effect) and to stimulate breathing in premature babies who tend to stop breathing during sleep.

UNTOWARD EFFECTS

At the same time, however, caffeine may have untoward effects.  It can interfere with fine muscular coordination and possibly accuracy of timing.  Large doses of caffeine-the result, say, of drinking several cups atone time or 10 or more cups a day- can cause irregular or rapid heart beats; insomnia, upset stomach; increased breathing rates, blood pressure and body temperature; nervousness and irritability.

Caffeine "addicts" have sometimes been mistakenly diagnosed as suffering from an anxiety attack and treated incorrectly with tranquilizers instead of eliminating the cause of their difficulty.

Sometimes caffeine has paradoxical effects. In some people it may cause a headache; in others it may relieve one.  In some it raises the amount of sugar in the blood; in others in lowers it (and may consequently stimulate hunger pangs or, rarely, a hypoglycemic reaction - a dizzy, weak, nauseated headachy, irritable feeling). 

The effects of caffeine show up within 30 to 60 minutes of its ingestion and last several hours.  Half the amount consumed is gone from the body within three and half hours.

The source of caffeine does not seem to make much difference in how rapidly it is absorbed into the blood, how high a level is reached and how long it stays around. Many people believe that while coffee in the evening will keep them awake, tea won't.

A cup of tea does have less caffeine than coffee-between half and three-quarters the amount.  But one careful study showed that on an empty stomach the caffeine in tea is absorbed as readily as that in coffee, and when the same doses of caffeine are given as tea or coffee, the same levels of caffeine are reached in the blood.  Instant coffee has less caffeine than brewed coffee, but more than tea.

Caffeine and even decaffeinated coffee stimulates the release of acid in the stomach, and therefore, coffee in any form is ill-advised for ulcer patients.  Patients with high blood pressure or fever may also be told to avoid caffeine, since it raises both body temperature and blood pressure.

Although one major study indicated that coffee drinkers face an increased risk of heart attack, two subsequent studies that took other factors-including cigarette smoking-into account found no such relationship.

PREGNANCY

There have also been suggestions that excessive coffee intake during pregnancy may increase the risk of stillbirth, miscarriage or malformations in the child.  Although this relationship has by no means been proved, moderation in the use of  caffeine-containing substances during pregnancy would seem wise.

CANCER

An initial suggestion that coffee consumption may increase the risk of bladder cancer has not stood the test of further research.  However, a Japanese researcher using the U.N. statistics found correlation between estimated national  average consumption of coffee and age-adjusted death rate for prostate cancer in twenty countries. In laboratory studies, caffeine can cause cancer-like changes in cells at doses 20 to 40 times higher than the highest level ever measured in a habitual coffee drinker.

At lower doses, caffeine seems to inhibit the cancer-inducing effects of other chemicals, and thus may be protective.  However, British studies suggested that another substance in coffee, chlorogenic acid, may enhance the formation of cancer-causing nitrosamines in the stomach.

ASTHMA

A tea estate worker in Sri Lanka developed asthma in the presence of tea fluff.  "Coffee worker's lung" was found in a patient having circulating antibodies against coffee bean dust in the serum.  This patient had worked for more than 20 years in a coffee-roasting factory.

LETHAL DOSE

High doses of caffeine stimulates the spinal cord. This may lead to clonic convulsions and death in experimental animals.  However, in man the lethal dose of caffeine is estimated to be between three and 10 grams (gulping 30 to 100 cups of coffee rapidly at one time).  Six human deaths have been reported so far in the literature around the world.

WITHDRAWAL

Heavy coffee drinkers who decide to break their addiction to caffeine should beware of abrupt withdrawal.  Sudden withdrawal can cause headache, nausea and vomiting, mental depression, drowsiness and disinclination to work.  The symptoms, which begin 12 to 16 hours after the last dose of caffeine, can be relieved by caffeine.

The best way to withdraw from caffeine is slowly weaning yourself a cup or two at a time over a period of a week or more.

Because of the potential toxicity of caffeine and the widespread usage of its products, one should question the safety of prolonged and excessive drinking of caffeine beverages.

Many Americans are giving up coffee drinking as prices have soared 500% recently.

http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/UCM205286.pdf

November 13, 2009

Gaamm Imports, Inc. 10 Fairway Drive, Suite 122 Deerfield Beach, FL 33441  

 

Dear Company Official:

The Food and Drug Administration (FDA) is aware that your firm is marketing an alcoholic beverage that contains caffeine: Booya Espresso Silver Tequila with Caffeine. The addition of caffeine to this alcoholic beverage raises questions about the regulatory status of this product.

The Federal Food, Drug, and Cosmetic Act's (the Act) definition of food includes articles used for drink for man (Section 201(f)(1) of the Act [21 USC 321(f)(1)]). Therefore, your alcoholic beverages are subject to the Act's pre-market approval requirements for ingredients added to food.

An ingredient added to food is a food additive, unless it is generally recognized as safe or subject to a prior sanction, as discussed below. Food additives require pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition (Section 409(b) of the Act [21 U.S.C. 348(b)]). The agency issues food additive regulations specifying the conditions under which an additive has been demonstrated to be safe and, therefore, may be used lawfully (Section 409(c) of the Act [21 U.S.C. 409(c)]). There are no food additive regulations authorizing the use of caffeine in alcoholic beverages.

A substance is exempt from the definition of a food additive and thus, from pre-market approval, if, in pertinent part, it is generally recognized as safe (GRAS) by qualified experts under the conditions of intended use (Section 201(s) of the Act [21 U.S.C. 321(s)]). Accordingly, for a particular use of a substance to be GRAS, there must be both evidence of safety (the "technical element" of the GRAS standard) and a basis to conclude that this evidence is generally known and accepted by qualified experts. The technical element of the GRAS standard requires that the information about the substance establish that the intended use of the substance is safe, i.e., that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use. In addition, the data and information to establish the technical element must be generally available, and there must be a basis to conclude that there is a consensus among qualified experts about the safety of the substance for its intended use. GRAS is based on intended use such that a substance may be GRAS for one use but not GRAS for another use (21 CFR 170.30).

Uses of substances that are not GRAS or subject to a prior sanction are subject to the food additive pre-market approval requirements of the Act. An unapproved food additive is deemed "unsafe," and any food that contains an unapproved food additive is deemed adulterated (Sections 409(a), 402(a)(2)(C) of the Act [21 U.S.C. 348(a), 342(a)(2)(C)]). Adulterated foods cannot be legally imported or marketed in the United States. Additional information about the food additive requirements, prior sanction, and the GRAS exemption may be found on FDA's website at http://www.fda.gov/Food/FoodIngredientsPackaging/default.htm.

FDA has provided by regulation that caffeine up to a level of 0.02 percent is GRAS when used in cola-type beverages in accordance with good manufacturing practice (21 CFR 182.1180). However, this regulation does not confer GRAS status to the use of caffeine in your alcoholic beverages or at higher use levels.

FDA has not made a determination regarding the GRAS status of the use of caffeine in alcoholic beverages, but the agency is not aware of the basis upon which you have or may have concluded that your use of caffeine in an alcoholic beverage is GRAS. Nor are we aware of a basis for concluding that your use of caffeine in these beverages is prior sanctioned. We request that you provide us within 30 days with your rationale, and supporting data and information, for concluding that your use of caffeine in an alcoholic beverage is GRAS or prior sanctioned. The data and information that we are requesting should be sent to the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, HFS-200, 5100 Paint Branch Parkway, College Park, MD 20740.

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. It is your continuing responsibility to ensure that the foods you market are in compliance with all applicable legal and regulatory requirements.

Sincerely, Mitchell A. Cheeseman, Ph.D. Acting Director Office of Food Additive Safety Center for Food Safety and Applied Nutrition

cc: William H. Foster Assistant Administrator for Headquarters Operations Alcohol and Tobacco Tax and Trade Bureau

November 13, 2009

City Brewing 1106 3rd St. S La Crosse, WI 54601

Dear Company Official:

The Food and Drug Administration (FDA) is aware that your firm is marketing alcoholic beverages that contain caffeine: Hard Wired and 24/7. The addition of caffeine to these alcoholic beverages raises questions about the regulatory status of these products.

The Federal Food, Drug, and Cosmetic Act's (the Act) definition of food includes articles used for drink for man (Section 201(f)(1) of the Act [21 USC 321(f)(1)]). Therefore, your alcoholic beverages are subject to the Act's pre-market approval requirements for ingredients added to food.

An ingredient added to food is a food additive, unless it is generally recognized as safe or subject to a prior sanction, as discussed below. Food additives require pre-market approval based on data demonstrating safety submitted to the agency in a food additive petition (Section 409(b) of the Act [21 U.S.C. 348(b)]). The agency issues food additive regulations specifying the conditions under which an additive has been demonstrated to be safe and, therefore, may be used lawfully (Section 409(c) of the Act [21 U.S.C. 409(c)]). There are no food additive regulations authorizing the use of caffeine in alcoholic beverages.

A substance is exempt from the definition of a food additive and thus, from pre-market approval, if, in pertinent part, it is generally recognized as safe (GRAS) by qualified experts under the conditions of intended use (Section 201(s) of the Act [21 U.S.C. 321(s)]). Accordingly, for a particular use of a substance to be GRAS, there must be both evidence of safety (the "technical element" of the GRAS standard) and a basis to conclude that this evidence is generally known and accepted by qualified experts. The technical element of the GRAS standard requires that the information about the substance establish that the intended use of the substance is safe, i.e., that there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under its intended conditions of use. In addition, the data and information to establish the technical element must be generally available, and there must be a basis to conclude that there is a consensus among qualified experts about the safety of the substance for its intended use. GRAS is based on intended use such that a substance may be GRAS for one use but not GRAS for another use (21 CFR 170.30).

Uses of substances that are not GRAS or subject to a prior sanction are subject to the food additive pre-market approval requirements of the Act. An unapproved food additive is deemed "unsafe," and any food that contains an unapproved food additive is deemed adulterated (Sections 409(a), 402(a)(2)(C) of the Act [21 U.S.C. 348(a), 342(a)(2)(C)]). Adulterated foods cannot be legally imported or marketed in the United States. Additional information about the food additive requirements, prior sanction, and the GRAS exemption may be found on FDA's website at http://www.fda.gov/Food/FoodIngredientsPackaging/default.htm.

FDA has provided by regulation that caffeine up to a level of 0.02 percent is GRAS when used in cola-type beverages in accordance with good manufacturing practice (21 CFR 182.1180). However, this regulation does not confer GRAS status to the use of caffeine in your alcoholic beverages or at higher use levels.

FDA has not made a determination regarding the GRAS status of the use of caffeine in alcoholic beverages, but the agency is not aware of the basis upon which you have or may have concluded that your use of caffeine in an alcoholic beverage is GRAS. Nor are we aware of a basis for concluding that your use of caffeine in these beverages is prior sanctioned. We request that you provide us within 30 days with your rationale, and supporting data and information, for concluding that your use of caffeine in an alcoholic beverage is GRAS or prior sanctioned. The data and information that we are requesting should be sent to the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, HFS-200, 5100 Paint Branch Parkway, College Park, MD 20740.

If FDA determines that the use of caffeine in your alcoholic beverages is not GRAS or subject to a prior sanction, FDA will take appropriate action to ensure that these products are removed from the marketplace. It is your continuing responsibility to ensure that the foods you market are in compliance with all applicable legal and regulatory requirements.

 

Sincerely, Mitchell A. Cheeseman, Ph.D. Acting Director Office of Food Additive Safety Center for Food Safety and Applied Nutrition  

cc: William H. Foster Assistant Administrator for Headquarters Operations Alcohol and Tobacco Tax and Trade Bureau

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