Category Archives: FDA Advice

Mixing medications and supplements can be dangerous – FDA

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A Consumer Update from the FDA

supplementsWhen you take prescription or over-the-counter (OTC) medications, do you take also a vitamin, mineral, or other dietary supplements? Have you considered whether there is any danger in mixing medications and dietary supplements?

There could be, says Robert Mozersky, a medical officer at the Food and Drug Administration (FDA). “Some dietary supplements may increase the effect of your medication, and other dietary supplements may decrease it,” he says.

“Natural does not always mean safe.”

Certain dietary supplements can change absorption, metabolism, or excretion of a medication and therefore affect its potency.

“You may be getting either too much or too little of a medication you need,” Mozersky warns.

Consequently, combining dietary supplements and medications could have dangerous and even life-threatening effects. For example, drugs for HIV/AIDS, heart disease, depression, treatments for organ transplants, and birth control pills are less effective when taken with St. John’s Wort, an herbal supplement. Depending on the medication involved, the results can be serious. Continue reading

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Inks found in certain tattoo kits cause infections – FDA

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tatoo inkConsumer Update from the US Food and Drug Administration

Tempted to get a tattoo? Today, people from all walks of life have tattoos, which might lead you to believe that tattoos are completely safe.

But beware—there may be associated health risks.

Recently, the Food and Drug Administration (FDA) became aware of a problem after testing inks in home use tattoo kits marketed by White and Blue Lion, Inc. FDA has confirmed bacterial contamination in unopened bottles of the company’s inks.

White and Blue Lion, Inc. recalled contaminated products on July 11, 2014, but FDA is still concerned that tattoo artists may be using contaminated inks from other distributors.

According to Linda Katz, M.D., M.P.H., director of FDA’s Office of Cosmetics and Colors, using these inks for tattoos could cause infection.

“FDA has confirmed one case of skin infection involving a consumer that used this company’s tattoo products,” Katz says, “and we are aware of other reports linked to tattoo products with similar packaging.”

Risks Can Be Severe

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‘Gluten-Free’ now means what it says

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Bread and grainsA Consumer Update from the FDA

In August of last year, the Food and Drug Administration (FDA) issued a final rule that defined what characteristics a food has to have to bear a label that proclaims it “gluten-free.”

The rule also holds foods labeled “without gluten,” “free of gluten,” and “no gluten” to the same standard.

Manufacturers had one year to bring their labels into compliance. As of August 5, 2014, any food product bearing a gluten-free claim labeled on or after this date must meet the rule’s requirements.

Without a standardized definition of “gluten-free,” these consumers could never really be sure.

This rule was welcomed by advocates for people with celiac disease, who face potentially life-threatening illnesses if they eat the gluten found in breads, cakes, cereals, pastas and many other foods.

Andrea Levario, executive director of the American Celiac Disease Alliance, notes that there is no cure for celiac disease and the only way to manage the disease is dietary—not eating gluten.

Without a standardized definition of “gluten-free,” these consumers could never really be sure if their body would tolerate a food with that label, she adds. Continue reading

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New hepatitis C treatments – FDA Consumer Update

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fda-logo-thumbnailFrom the US Food and Drug Administration

At the approval of several new drugs for hepatitis C is  welcome news for baby boomers—who make up three of four adults with the hepatitis C virus—and millions of other Americans, many of whom don’t yet know they are infected and carriers, says the US Food and Drug Administration in this Consumer Update.

Hepatitis C can be cured, and today’s drug therapies are very effective and easier for patients to take, says Jeffrey S. Murray, M.D., the deputy director of the Division of Antiviral Products in FDA’s Center for Drug Evaluation and Research. Murray is an internist who specializes in infectious diseases.

A Preventable and Curable Disease

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Medications for allergies – an FDA Consumer Update

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bee on flowerConsumer Update from the FDA

You’re sneezing, your eyes are itchy and you feel miserable. Seasonal allergies aren’t just a nuisance, they are real diseases that can interfere with work, school or recreation, and can range from mild to severe.

May is National Asthma and Allergy Awareness Month, and many allergy treatment options are approved by the Food and Drug Administration (FDA). For the first time, these include three sublingual (under the tongue) prescription products to treat hay fever (also called “allergic rhinitis”)—with or without eye inflammation (called “conjunctivitis”)—caused by certain grass pollens and short ragweed pollen.

The new products—GrastekOralair and Ragwitek—can be taken at home, but the first dose must be taken in a health care provider’s office.

About Allergies

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FDA warns consumers to stop using GenStrip Blood Glucose Test Strips.

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GenStrips

From the FDA

The US Food and Drug Administration is advising people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels.

GenStrip Blood Glucose Test Strips, sold by Shasta Technologies LLC, are “third-party” blood glucose monitoring test strips. Shasta’s GenStrips are advertised for use with the LifeScan OneTouch family of glucose meters (e.g. Ultra, Ultra 2 and Ultra Mini). Continue reading

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Treating head lice — every parent’s nightmare

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Two lice viewed under an electron microscope. Note the claws used to grasp onto individual hairs. Credit: CDC

Lice viewed under an electron microscope, their claws grasping onto individual hairs. – CDC

Consumer Update from the FDA

Head lice. Every parent’s nightmare.

A year-round problem, the number of cases seems to peak when the kids go back to school in the fall and again in January, says Patricia Brown, M.D., a dermatologist at the Food and Drug Administration (FDA).

An estimated 6 to 12 million cases of head lice infestation occur each year in the United States in children 3 to 11 years of age, according to the Centers for Disease Control and Prevention.

Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have lice.

Contrary to myth, head lice are not caused by poor hygiene, Brown says. They are spread mainly by direct head-to-head contact with a person who already has head lice. You cannot get head lice from your pets; lice feed only on humans. Continue reading

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Watch out for websites claiming to be Canadian pharmacies, FDA warns

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Consumer Update from the US Food and Drug Administration

pills capsules in orbit FDADon’t order medicines from web sites that claim to be Canadian pharmacies.

Most are not legitimate pharmacies, and the drugs they supply are illegal and potentially dangerous.

Claiming to be a Canadian pharmacy is one of the hallmarks of Internet sites that sell illegal prescription drugs which, in many cases, are not made in Canada at all, but in a number of other countries. Continue reading

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Use certain laxatives with caution, FDA warns

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Alert IconThe US Food and Drug Administration warns that laxatives containing sodium phosphate are potentially hazardous if not taken as directed. People with certain health conditions or taking certain medications are at particularly high risk. The FDA has issued the warning after there have been dozens of reports of serious side effects, including 13 deaths, associated with the use of sodium phosphate laxatives. Continue reading

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Nipple aspirator

Nipple aspirate test is no substitute for mammogram – FDA

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Consumer Update from the US Food and Drug Administration

ucm378297Many women admit that getting a mammogram is no fun, and may wish there was an easier, more comfortable way to screen for breast cancer in its earliest and most treatable stages.

Some companies today are promoting a test in which a breast pump is used to collect fluid from a woman’s nipple to screen for abnormal and potentially cancerous cells. This test—called a nipple aspirate—is being marketed as the latest and greatest tool in early breast cancer screening, one that is easier, more comfortable and less painful than the mammogram.

However, there is no clinical evidence to support these claims, says David L. Lerner, M.D., a medical officer at the Food and Drug Administration (FDA) and a specialist in breast imaging.

“FDA’s concern is that the nipple aspirate test is being touted as a stand-alone tool to screen for and diagnose breast cancer as an alternative to mammography,” Lerner explains. “Our fear is that women will forgo a mammogram and have this test instead.” This could result in serious health consequences if breast cancer goes undetected, he notes.

FDA is unaware of any valid scientific data to show that nipple aspirate tests, when used on their own, are an effective screening tool for any medical condition, including the detection of breast cancer or other breast disease, Lerner says. Researchers are still studying whether these tests may one day be used, in conjunction with other medical devices, to screen for disease.

In February 2013 FDA issued a warning letter to Atossa Genetics, Inc. that, among other things, informed the company that their test was misbranded in that its labeling was false or misleading. The agency asked the firm to take prompt action to correct the violations addressed in the warning letter. In October 2013, Atossa initiated a voluntary recall to remove the ForeCYTE Breast Health Test from the market.

Unsubstantiated Claims

In addition to stating that the test can help women 18 years and older determine their risk level for breast cancer, Atossa claimed that its test was “literally a Pap smear for breast cancer.” According to FDA medical officer Michael Cummings, M.D., who reviews obstetrical and gynecological devices for the agency, this claim is unsubstantiated.

“The cervical Pap smear has a known clinical benefit supported by extensive clinical studies over many years,” Cummings says. “Its scientific ability to screen for cervical cancer is unquestioned.” The nipple aspiration test has no such evidence supporting it, he attests.

In addition, Lerner explains that if a Pap smear shows abnormal cells of the cervix, there are follow-up procedures that can be done to try to identify the location of those cells, after which a biopsy of the area is possible. With a breast nipple aspirate, if there are abnormal cells, the test does not target where those cells are coming from, so a biopsy may not be possible. Moreover, while the risk of abnormal cervical cells progressing to cancer is known, the risk of abnormal breast cells progressing to cancer is not.

Lerner says the test may produce results that are falsely positive or falsely negative. “False positives are possible because cells can be damaged in the aspiration process and look abnormal,” he notes. “We are even more concerned about false negatives,” he adds. Companies acknowledge that over 90% of their fluid samples may contain either very scant cells or no cells at all. Yet the companies call such results “diagnostically useful” and even conclude that a patient is healthy based on a cell-free sample, he says. “The test may be missing cancers and giving women dangerous false assurance,” Lerner says.

Mammography Still the Best

The mammogram can be uncomfortable for the woman being screened because it compresses the breast to flatten out the breast tissue and increase the clarity of the X-ray image. Still, FDA is not alone in believing that mammography is the most effective method for screening for breast cancer. Other organizations agree, including the American Cancer Society, the American College of Radiology (the professional society of physicians who specialize in medical imaging) and the National Cancer Institute, a division of the National Institutes of Health.

The National Cancer Institute states that screening mammography can help reduce the number of deaths from breast cancer among women ages 40 to 70. The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and that it should not be used as a breast cancer screening technique.

FDA recommends that women who have received a nipple aspirate test as a form of breast cancer screening should also have a mammogram according to screening guidelines or as recommended by their doctor, and should talk to their health care professional about whether additional tests are needed.

“The bottom line is that women should not rely solely on these nipple aspirate tests for the screening or diagnosis of breast cancer, “Lerner says. “Mammography is still the gold standard.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Dec. 12, 2013

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FDA moves to reduce use of long-acting opioid pain drugs

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The US Food and Drug Administration has changed the labeling on long-acting opioids, such as OxyContin, in an effort to limit the use of these drugs to patients with severe refractory pain. Here’s is the Consumer Update from the FDA released today.

FDA Consumer Update

FDA logojpgConsumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.

In addition to requiring new labeling on these prescription medications, the Food and Drug Administration (FDA) is also requiring manufacturers to study certain known serious risks when these drugs are used long-term.

“The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications. They also are meant to reduce problems associated with their use,” says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA’s Center for Drug Evaluation and Research.

“Altogether, the actions we’re now announcing are part of FDA’s efforts to make opioids as safe as possible for those who need them,” Throckmorton adds.

He noted that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.

How Labeling Will Change

Opioids work by changing the way the brain perceives pain. They are available by prescription as pills, liquids, and skin patches.

Extended-release and long-acting (ER/LA) forms pose a greater safety concern because—as their names suggest—they produce their effects for a longer period, and many contain higher doses compared with immediate release or opioid/non-opioid combination products.

They include, to name a few, long acting versions of opioids such as morphine, oxycodone, and fentanyl.

Currently, labeling on these ER/LA opioids indicate they are for “the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.”

However, the updated indication for when to prescribe and take these medicines will, when finalized, emphasize that other, less potentially addictive, treatment options should be considered first.

FDA is requiring labeling that says the drugs are “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

The “limitations of use” portion of the new labeling retains language indicating that the drugs are not intended for use as an “as-needed” pain reliever.

Furthermore, the new labeling adds: “Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

This new labeling language emphasizes that patients in pain should be assessed not only by their rating on a pain intensity scale, but also based on a more thoughtful determination that their pain—however it may be defined—is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.

This framework better enables prescribers to make decisions based on a patient’s individual needs, given the serious risks associated with ER/LA opioids, against a backdrop of alternatives such as immediate release (IR) opioids and non-opioid pain relievers.

It allows prescribers to make an assessment of pain relative to a patient’s ability to perform daily activities or enjoy a reasonable quality of life.

FDA-approved labeling of these pain relievers already describes the effects on newborns of exposure to these drugs while in the mother’s womb and warns against use by women during pregnancy and labor and while nursing.

The new labeling, however, will provide more detail and will elevate the risk of neonatal opioid withdrawal syndrome (NOWS) to the most prominent position in labeling—a boxed warning. Symptoms of NOWS may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.

Postmarket Studies

Recognizing the need for more scientific data about the benefits and risks of ER/LA opioids when used over long periods, FDA also decided to require drug companies to conduct longer term studies and trials of ER/LA opioid pain relievers on the market.

The companies must evaluate long-term use, with the goal of assessing a variety of known serious risks, including misuse, abuse, addiction, overdose, and death, as well as the risks of developing increasing sensitivity to pain.

Education to Reduce Risk

Following implementation of the safety labeling changes, certain educational materials for patients and health care professionals will be modified to reflect the new labeling for the ER/LA opioid pain relievers.

As part of the new labeling changes, opioid manufacturers also must revise a paper handout patients receive with their prescription.

The ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) will also be updated after the labeling changes are finalized.

The ER/LA Opioid Analgesics REMS requires manufacturers to make available continuing education courses for health care professionals who prescribe these drugs.

The courses, from accredited sources, teach about risks and safe prescribing and safe use practices of these medications.

“By improving information about the risks of ER/LA opioid pain relievers and by clarifying the populations for whom the benefits outweigh the risks, we aim to improve the safe and appropriate use of these products,” says Throckmorton.

He adds: “This is not the first or last initiative, and we will continue supporting broader efforts to solve the serious public health problems associated with the misuse and abuse of opioids.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Sept 10, 2013

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What is gluten-free?

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An FDA Consumer Update

White Bread by Ricardo PerinaPeople with celiac disease can now have confidence in the meaning of a “gluten-free” label on foods.

The Food and Drug Administration (FDA) has issued a final rule that defines what characteristics a food has to have to bear a label that proclaims it “gluten- free.” The rule also holds foods labeled “without gluten,” “free of gluten,” and “no gluten” to the same standard.

This rule has been eagerly awaited by advocates for people with celiac disease, who face potentially life-threatening illnesses if they eat the gluten found in breads, cakes, cereals, pastas and many other foods.

As one of the criteria for using the claim “gluten-free,” FDA is setting a gluten limit of less than 20 ppm (parts per million) in foods that carry this label.

This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten.

This level is consistent with those set by other countries and international bodies that set food safety standards.

“This standard ‘gluten-free’ definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled ‘gluten-free’ meet a clear standard established and enforced by FDA,” says Michael R. Taylor, J.D., deputy FDA commissioner for foods and veterinary medicine.

Andrea Levario, executive director of the American Celiac Disease Alliance, notes that there is no cure for celiac disease and the only way to manage the disease is dietary—not eating gluten. Without a legal definition of “gluten-free,” these consumers could never really be sure if their body would tolerate a food with that label, she adds.

“This is a tool that has been desperately needed,” Levario says. “It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them.”

“Without proper food labeling regulation, celiac patients cannot know what the words ‘gluten free’ mean when they see them on a food label,” says Allessio Fasano, M.D., director of the Center for Celiac Research at MassGeneral Hospital for Children, visiting professor of pediatrics at Harvard Medical School and member of the American Celiac Disease Alliance.

What Is Gluten?

Gluten means the proteins that occur naturally in wheat, rye, barley, and crossbreeds of these grains.

As many as 3 million people in the United States have celiac disease. It occurs when the body’s natural defense system reacts to gluten by attacking the lining of the small intestine.

Without a healthy intestinal lining, the body cannot absorb the nutrients it needs. Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia (a lower than normal number of red blood cells) and osteoporosis, a disease in which bones become fragile and more likely to break. Other serious health problems may include diabetes, autoimmune thyroid disease and intestinal cancers.

Before the rule there were no federal standards or definitions for the food industry to use in labeling products “gluten-free.” An estimated 5 percent of foods currently labeled “gluten-free” contain 20 ppm or more of gluten.

How Does FDA Define ‘Gluten-Free’?

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food “gluten-free” if the food does not contain any of the following:

  1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
  2. an ingredient derived from these grains and that has not been processed to remove gluten
  3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten

Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” if they inherently don’t have any gluten.

The regulation will be published Aug. 5, 2013 in the Federal Register, and manufacturers have one year from the publication date to bring their labels into compliance.

Taylor says he believes many foods labeled “gluten free” may be able to meet the new federal definition already. However, he adds, “We encourage the food industry to come into compliance with the rule as soon as possible.”

Under the new rule, a food label that bears the claim “gluten-free,” as well as the claims “free of gluten,” “without gluten,” and “no gluten,” but fails to meet the requirements of the rule would be considered misbranded and subject to regulatory action by FDA.

Those who need to know with certainty that a food is gluten-free are heralding the arrival of this definition. “This is a huge victory for people with celiac disease,” says Levario. “In fact, that’s the understatement of the year.”

Says Taylor, “FDA’s ‘gluten-free’ definition will help people make food choices with confidence.”

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

August 2, 2013

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FDA to investigate caffeine-laced products

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Caffeine CoffeeFrom the US Food and Drug Administration

The Food and Drug Administration (FDA) has announced that, in response to a trend in which caffeine is being added to a growing number of products, the agency will investigate the safety of caffeine in food products, particularly its effects on children and adolescents.

Michael R. Taylor, deputy commissioner for foods and veterinary medicine at FDA, answers questions about his concerns and possible FDA actions.

Q: The announcement comes just as Wrigley’s (a subsidiary of Mars) is promoting a new pack of gum with eight pieces, each containing as much caffeine as half a cup of coffee. Is the timing coincidental?

A: The gum is just one more unfortunate example of the trend to add caffeine to food. Our concern is about caffeine appearing in a range of new products, including ones that may be attractive and readily available to children and adolescents, without careful consideration of their cumulative impact.

One pack of this gum is like having four cups of coffee in your pocket. Caffeine is even being added to jelly beans, marshmallows, sunflower seeds and other snacks for its stimulant effect.

Meanwhile, “energy drinks” with caffeine are being aggressively marketed, including to young people. An instant oatmeal on the market boasts that one serving has as much caffeine as a cup of coffee, and then there are similar products, such as a so-called “wired” waffle and “wired” syrup with added caffeine.

The proliferation of these products in the marketplace is very disturbing to us.

Q. What is your first step in this process?

A. We have to address the fundamental question of the potential consequences of all these caffeinated products in the food supply to children and to some adults who may be at risk from excess caffeine consumption. We need to better understand caffeine consumption and use patterns and determine what is a safe level for total consumption of caffeine. Importantly, we need to address the types of products that are appropriate for the addition of caffeine, especially considering the potential for consumption by young children and adolescents.

We’ve already met with some companies to hear their rationale for adding caffeine to varied products and to express our concern. We’ve also reached out to the American Beverage Association, which represents the non-alcoholic beverage industry, and the Grocery Manufacturers Association, which represents food, beverage and consumer-products companies.

Q. What is currently considered a safe amount of daily caffeine?

A. For healthy adults FDA has cited 400 milligrams a day—that’s about four or five cups of coffee—as an amount not generally associated with dangerous, negative effects. FDA has not set a level for children, but the American Academy of Pediatrics discourages the consumption of caffeine and other stimulants by children and adolescents. We need to continue to look at what are acceptable levels.

We’re particularly concerned about children and adolescents and the responsibility FDA and the food industry have to protect public health and respect social norms that suggest we shouldn’t be marketing stimulants, such as caffeine, to our children.

Q. What currently are FDA requirements concerning caffeine being added to foods?

A. Manufacturers can add it to products if they decide it meets the relevant safety standards, and if they include it on the ingredient list. While various uses may meet federal food safety standards, the only time FDA explicitly approved adding caffeine was for colas in the 1950s. Existing rules never anticipated the current proliferation of caffeinated products.

Q. Is it possible that FDA would set age restrictions for purchase?

A. We have to be practical; enforcing age restrictions would be challenging. For me, the more fundamental questions are whether it is appropriate to use foods that may be inherently attractive and accessible to children as the vehicles to deliver the stimulant caffeine, and whether we should place limits on the amount of caffeine in certain products.

Q. Have you taken any actions on other caffeinated products?

A. In 2010, we brought about the withdrawal from the market of caffeinated alcoholic beverages, primarily malt beverages, in part because of studies indicating that combined ingestion of caffeine and alcohol may lead to hazardous and life-threatening situations. Caffeine can mask some of the sensory cues that people might normally rely on to determine their level of intoxication.

Q. Don’t new regulations take a lot of resources and time?

A. They do. But we believe that some in the food industry are on a dubious, potentially dangerous path. If necessary, and if the science indicates that it is warranted, we are prepared to go through the regulatory process to establish clear boundaries and conditions on caffeine use. We are also prepared to consider enforcement action against individual products as appropriate.

However, we hope this can be a turning point for all to prevent the irresponsible addition of caffeine to food and beverages. Together, we should be immediately looking at what voluntary restraint can be used by industry as FDA gets the right regulatory boundaries and conditions in place.

I’m hopeful that industry will step up.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

May 3, 2013

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