Category Archives: FDA Advice

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 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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FDA launches new consumer outreach website

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An FDA Consumer Update

You may know that the Food and Drug Administration (FDA) is responsible for protecting your health by ensuring that the food you eat is safe, and that the drugs and medical products you and your family use are safe and effective.

But did you also know that FDA needs your help?

“It’s true,” says Richard Klein, director of FDA’s Patient Liaison Program within the Office of Health and Constituent Affairs. “We invite consumers to get involved in the process of helping FDA make the decisions that affect their lives.”

And thanks to FDA’s Patient Network initiative, it’s easy.

According to Klein, FDA has a long history of working with patients and patient advocates representing specific groups, beginning with the AIDS crisis of the 1980s.

Since then, FDA has reached out to advocacy groups, such as the National Council of Rare Health Disorders and other disease-specific groups, to ask for their input on proposed regulations and guidance documents.

More recently, in July 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) which calls for the agency to increase patient participation in the regulation of medical products.

According to project manager James Valentine, M.H.S., the Patient Network helps to bring the unique perspective of patients, family members, caregivers and patient advocates to the decision-making processes of the FDA.

There are a number of ways to become involved, including becoming a patient representative on a committee that advises FDA on key issues.

Valentine explains that the three-phase program began in 2011 with the launch of the twice-monthly newsletterPatient Network News.

A recent issue includes information on a product that has been linked to potentially serious eye infections; an upcoming public meeting on breast cancer; a story on active ingredients in children’s medicines; and information on pet health.

“It’s a good way to find out just what FDA is up to—and in ways that are relevant to you, the individual,” Valentine says.

The annual Patient Network meeting, the second of which will take place this summer, is the second phase. “We’re gearing up for it now,” Klein notes.

By popular demand from patient organizations, Klein says, the meeting will focus on “demystifying the FDA, by providing a basic primer about medical product regulation.”

“We need to demonstrate that from both FDA’s and industry perspectives medical product development isn’t a simple 1-2-3 recipe,” he adds.

Phase 3 is the FDA Patient Network website, to launch the week of April 22, 2013. The website is an interactive tool for educating patients, patient advocates and consumers on how their medications and medical devices go from idea to the shelf.

FDA launched the site to engage patients and consumers as partners, and encourage them to share ideas and concerns about the medical product development process.

“When it comes to FDA’s regulatory process, we feel very strongly patients should have a say,” notes Klein. “The new website provides an excellent place to start.”

According to Klein, consumers have complained that they find it difficult to locate the information they need on the agency’s website, and when they do, it is targeted for industry use.

“This website provides a concentrated, one-stop forum from which we can reach patients and vice versa,” Valentine says. The website connects patients, caregivers, and advocacy groups to the agency through e-mail, webinars, live chats, open meetings and announcements of opportunities for patients to comment on FDA regulations.

There are sections on what FDA does, FDA advisory committees, FDA initiatives, and frequently asked questions. The website also helps patients, caregivers, and advocacy groups find information on:

  • getting involved in the regulatory process;
  • finding relevant clinical trials;
  • finding additional treatment options;
  • getting information about diseases; and
  • getting information about their medications, including whether they have been issued a warning label or recalled from the market, whether there are other, off-label uses of the drug, or if anyone has had an adverse reaction to their medication.

“We’ve worked hard to make it easily navigable and user friendly,” Valentine says.

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

April 23, 2013

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FDA wants your opinion on dairy-product labels

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A Consumer Update from US Food and Drug Administration

If you’re a lover of chocolate milk, but want to watch your weight, you might reach for the carton labeled “reduced calorie.”  But dairy manufacturers would rather that the carton simply say “chocolate milk.”

Why? According to a petition submitted to  US Food and Drug Administration (FDA), one reason is that industry groups believe labels such as “reduced calorie” or “no added sugar” are a turn-off to kids who might otherwise reach for flavored milk with non-nutritive (artificial) sweeteners at the school cafeteria or from the grocery store cooler.

The petition from the International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) was published for public comment in the Federal Register and has generated much interest—and confusion. It remains open for comment until May 21, 2013.

Chocolate Milk

According to Mary Poos, Ph.D., deputy director of FDA’s Office of Nutrition, Labeling and Dietary Supplements, FDA has received more than 30,000 comments on the issue to date.

“Based on these comments, we’re seeing a fair amount of confusion about what the labeling change would actually mean,” Poos says.

FDA wants to hear from consumers on this issue, but also wants to ensure that they understand the exact nature of the proposed change, she adds.

What the Change Would Mean

The petition from IDFA and NMPF calls for FDA to change the “standard of identity” for milk. A standard of identity is the federal requirement that determines what ingredients some food products must (or may) contain to be marketed under certain names.

Currently, if a manufacturer wants to include an ingredient that is not among those in the product’s standard of identity, the name of the food on the package’s main display panel must be modified with a nutrient content claim (such as “reduced calorie”) to show how it has been changed.

For example, under existing regulations, the replacement of a nutritive sweetener (such as sugar) with a non-nutritive sweetener (such as sucralose, acesulfame potassium, or aspartame) in flavored milk would reduce the milk’s calorie count.

Because of the replacement, words such as “reduced calorie” must be prominently displayed on the package.  The specific name of the sweetener used must still be included in the list of ingredients.

The two groups asked FDA to amend the standard of identity for flavored milk and 17 other dairy products (including nonfat dry milk, heavy cream, eggnog, half-and-half and sour cream) so that non-nutritive sweeteners are among the standard ingredients. The products would then not require any additional description on the label.

“If we granted the petition, a carton of chocolate milk made with non-nutritive sweeteners would simply say ‘chocolate milk,’ the same as a carton made with nutritive sweeteners, such as sugar,” notes Felicia Billingslea, director of FDA’s Food Labeling and Standards staff. “You would need to read the ingredient list, which is typically on the back or the side of the product, in order to tell the difference between the two.”

People commenting in response to the Federal Register notice appear to be under the impression that the non-nutritive sweeteners will not be listed anywhere on the product—which is not the case. They would still be named in the ingredients list on the package.

Why Do Dairy Groups Want the Change?

In their petition, the dairy groups give the following reasons for requesting the change in FDA’s regulations:

  • Studies show school-age children are more likely to consume flavored milk than regular milk.
  • Flavored milk labels that bear nutrient content claims such as “reduced calorie” are unattractive to children.
  • The proposed amendments would promote more healthful eating practices and reduce childhood obesity.
  • Updating the standard of identity for milk in this way would promote honesty and fair dealing by creating consistency in the names of flavored milk products.

What Does FDA Want From Consumers?

The FDA recognizes the importance of this decision and is interested in hearing from the public and industry on the petition, says Billingslea. In particular, comments are welcome on issues such as:

  • Will the proposed change in FDA’s milk labeling regulations provide sufficient information for consumers to understand what is in the milk they’re buying?
  • The petition states that flavored milk labels with descriptions such as “reduced calorie” are unattractive to children. Are children’s purchasing habits affected by flavored milk labels that currently bear these descriptions?
  • Will the proposed change in FDA’s milk labeling regulations create an increased burden for consumers who want to know whether a product contains a nutritive or non-nutritive sweetener?

You can submit your comments at www.regulations.gov. You can search for a rule by its docket number, in this case Docket No. FDA-2009-P-0147.

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

April 15, 2013

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FDA approves migraine patch

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This new FDA-approved treatment for migraines includes a computer chip and delivers a prescription drug through a patch that can be wrapped around a patient's upper arm or thigh. (Product photo courtesy of NuPathe)

This new FDA-approved treatment for migraines includes a computer chip and delivers a prescription drug through a patch that can be wrapped around a patient’s upper arm or thigh. (Product photo courtesy of NuPathe)

FDA Consumer Update

If you’re one of the more than 30 million Americans who suffer from migraines, you know that calling them “just another headache” is like calling a hurricane “just another storm.”

Fortunately, says neurologist Eric Bastings, M.D., deputy director of the Division of Neurology at the Food and Drug Administration (FDA), there are practical measures you can take to prevent painful migraines and FDA-approved medications to either stave off their onset or relieve their pain.

There are two basic kinds of medications for migraine: abortive medications (also called acute medications) that treat migraines after they begin, and preventive medications that help keep migraines from developing in the first place.

In January 2013, FDA approved an acute medication that uses a widely-prescribed drug for treating migraines (sumatriptan, name brand Imitrex), but delivers the drug through a new mechanism — a transdermal system in the form of a patch that can be wrapped around a patient’s upper arm or thigh. (Transdermal drug delivery is absorption through the skin.)

“Although consumers are familiar with using a patch for, say, smoking cessation, this is the first patch FDA has approved to treat migraines,” says Bastings.

How the Patch Works

Named Zecuity, the battery-powered patch is manufactured by the pharmaceutical company NuPathe. About 8 inches long and 4 inches wide, it wraps around the arm or thigh much like an ace bandage.

According to Bastings, it uses an electrical current to move the drug through the skin over the course of 4 hours. A small battery and computer chip regulate the charge to make sure the patient gets the right dosage.

The patch provides an alternative to pills, nasal sprays and injections. “Many migraine sufferers experience debilitating pain — sometimes so acute that they can’t swallow a pill,” says Bastings.

He adds that some people don’t like the unpleasant taste the nasal spray can leave behind, and others are uncomfortable with injecting themselves.

That said, the patch does have some drawbacks, notes Bastings. For one thing, it’s large enough that it can show when worn under short-sleeved shirts or shorts, and requires some privacy (and at times, the need to undress) to put it on.

“For many people, popping a pill is a lot more immediate and simple,” Bastings says.

And the patch is not without side effects: about 25 percent of subjects in the clinical study complained of a painful sensation at the patch application site. Others didn’t like the reddening that most patients developed after using the patch.

What Causes a Migraine?

According to the National Institutes of Health (NIH), about 12 percent of the U.S. population experience migraines. Migraines affect both children and adults, but affect adult women three times more often than men.

Bastings explains that migraines are neurovascular headaches. They are characterized by throbbing and pulsating pain caused by the a temporary widening of blood vessels in the brain, triggered by abnormal activation of nerve pathways involved in the transmission of pain signals.

Characteristics of a migraine frequently include:

  • Pain that has a pulsating or throbbing quality
  • Moderate to intense pain that affects daily activities
  • Nausea or vomiting
  • Sensitivity to light or sounds
  • Aura, visual disturbances that signal the beginning, such as dots, flashing lights or blind spots

Bastings also says that a number of studies show that migraines are underdiagnosed by patient and physician, alike. “Many people don’t recognize the symptoms as belonging to migraine,” he says. Or they don’t think of sharing information about the occasional headache with their physician, even if it is severe.

FDA-Approved Drugs

FDA has approved a number of drugs for treating acute migraine, including the triptans (such as Imitrex), which bind to serotonin receptors in the brain nerve fibers and blood vessels. (Serotonin acts as a neurotransmitter, a type of chemical that helps relay signals from one area of the brain to another.) There are also non-prescription drugs available “over the counter,” such as ibuprofen, aspirin and acetaminophen.

“These abortive medications work most effectively if taken early in the attack,” Bastings notes.

Many people who experience frequent or severe migraines may use preventive medications, including beta-blockers, a type of blood pressure drug, such as metoprolol. Certain antiepileptic drugs are also prescribed, such as topiramate and divalproex sodium.

In October 2010, FDA also approved Botulinum toxin (known as Botox) for use in treating patients who suffer chronic migraines at least 15 days a month.

Another way to prevent migraines is to learn your personal “triggers” for the headache, Bastings says. Common ones include:

  • Hormonal changes in women, with migraines frequently occurring around the menstrual cycle;
  • Certain foods and beverages, such as alcoholic and caffeinated drinks, chocolate and aged cheeses;
  • Stress; and
  • Changes in waking and sleeping patterns.

“It certainly can help to know your triggers and avoid them when possible,” Bastings says. “Of course if a major trigger is stress, few of us can entirely avoid that in our lives.”

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

March 21, 2013

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Know the active ingredients in your child’s meds – FDA

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Read the Drug Facts Label: Active ingredients, which make a medicine effective against the illness it is treating, are listed first on the product's Drug Facts label.

Read the Drug Facts Label: Active ingredients, which make a medicine effective against the illness it is treating, are listed first on the product’s Drug Facts label.

FDA Consumer Update

Ah-choo!

If your child is sneezing up a storm, it must be allergy season once more.

And if your child is taking more than one medication at the same time, there could be dangerous health consequences if those medicines have the same active ingredient, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

A medicine is made of many components. Some are “inactive” and only help it to taste better or dissolve faster, while others are active.

An active ingredient in a medicine is the component that makes it pharmaceutically active—it makes the medicine effective against the illness or condition it is treating.

Active ingredients are listed first on a medicine’s Drug Facts label for over-the-counter (OTC) products. For prescription medicines, they are listed in a patient package insert or consumer information sheet provided by the pharmacist.

Many medicines have just one active ingredient. But combination medicines, such as those for allergy, cough, or fever and congestion, may have more than one.

Take antihistamines taken for allergies. “Too much antihistamine can cause sedation and—paradoxically—agitation. In rare cases, it can cause breathing problems, including decreased oxygen or increased carbon dioxide in the blood, Sachs says.

“We’re just starting allergy season,” says Sachs. “Many parents may be giving their children at least one product with an antihistamine in it.”

Over-the-counter (OTC) antihistamines (with brand name examples) include diphenhydramine (Benadryl), chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), fexofenadine (Allegra), loratadine (Claritin, Alavert), and cetirizine (Zyrtec).

But parents may also be treating their children for a separate ailment, such as a cough or cold. What they need to realize is that more than one combination medicine may be one too many.

“It’s important not to inadvertently give your child a double dose,” Sachs says.

Other Health Complications

The same goes for other active ingredients, often found in combination products for allergies but also used to treat other symptoms, such as fever, headache or nasal congestion:

  • Acetaminophen (in Tylenol and many other products), a pain reliever often used to treat fevers, mild pain or headache. Taking too much can cause liver damage.
  • Ibuprofen (for example, Advil or Motrin), another common medicine for relieving mild to moderate pain from headaches, sinus pressure, muscle aches and flu, as well as to reduce fever. Too much ibuprofen can cause nausea, vomiting, diarrhea, severe stomach pain, even kidney failure.
  • Decongestants such as pseudoephedrine or phenylephrine (found in brand name drugs such as Actifed and Sudafed) taken in large amounts can cause excessive drowsiness in children. They can also cause heart rhythm disturbances, especially if combined with products and foods containing caffeine. In the form of nasal sprays and nose drops, these products, as well as oxymetazoline (the active ingredients in products such as Afrin), can cause “rebound” congestion, in which the nose remains stuffy or gets even worse.

Any of the above symptoms may indicate a need for immediate medical attention. “The bottom line is that neither you, nor your children, should take multiple combination medicines at the same time without checking the active ingredients and consulting your health care professional first,” recommends Sachs.

Furthermore, two different active ingredients may serve the same purpose, Sachs says. For example, both acetaminophen and ibuprofen help reduce pain and fever. So there’s generally no need to give your child both medicines for the same symptoms.

Write It All Down

Whether you’re treating your child’s condition with OTC medicines from the drug store or ones prescribed by your doctor, it’s essential that you keep track of every medicine and the active ingredients each contains, Sachs says.

“It’s easy to forget which medicines you’re giving your child,” Sachs says. “And if you have more than one child, it can get even more complicated.” She recommends making it a habit to write down the name of any medicine you give your child, whether it’s OTC or prescription (download a daily medicine records template).

“It’s really a good idea to carry that list with you when you go to see your pediatrician or even when you go to the pharmacy,” she adds. You should also note whatever vitamins or supplements your child is taking, as these can interact unfavorably with certain medicines, too.

Most importantly, Sachs says parents should always read the Drug Facts label on OTC products, and the patient package insert or consumer information sheet that comes with prescription medicines, every time they’re considering a medication for their child, even if they think they already know the ingredients.

They should know that the ingredients can change without an obvious change in the packaging. And they should contact their health care professional with any questions.

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

March 12, 2013

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6 Tip-offs to rip-offs: Don’t fall for health fraud scams

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Miracle cureBogus product! Danger! Health fraud alert!

You’ll never see these warnings on health products, but that’s what you ought to be thinking when you see claims like “miracle cure,” “revolutionary scientific breakthrough,” or “alternative to drugs or surgery.”

Health fraud scams have been around for hundreds of years. The snake oil salesmen of old have morphed into the deceptive, high-tech marketers of today. They prey on people’s desires for easy solutions to difficult health problems—from losing weight to curing serious diseases like cancer.

According to the Food and Drug Administration (FDA), a health product is fraudulent if it is deceptively promoted as being effective against a disease or health condition but has not been scientifically proven safe and effective for that purpose.

Scammers promote their products through newspapers, magazines, TV infomercials and cyberspace. You can find health fraud scams in retail stores and on countless websites, in popup ads and spam, and on social media sites like Facebook and Twitter.

Not Worth the Risk

Health fraud scams can do more than waste your money. They can cause serious injury or even death, says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Using unproven treatments can delay getting a potentially life-saving diagnosis and medication that actually works. Also, fraudulent products sometimes contain hidden drug ingredients that can be harmful when unknowingly taken by consumers.”

Coody says fraudulent products often make claims related to:

  • weight loss
  • sexual performance
  • memory loss
  • serious diseases such as cancer, diabetes, heart disease, arthritis and Alzheimer’s

A Pervasive Problem

Fraudulent products not only won’t work—they could cause serious injury. In the past few years, FDA laboratories have found more than 100 weight-loss products, illegally marketed as dietary supplements, that contained sibutramine, the active ingredient in the prescription weight-loss drug Meridia. In 2010, Meridia was withdrawn from the U.S. market after studies showed that it was associated with an increased risk of heart attack and stroke.

Fraudulent products marketed as drugs or dietary supplements are not the only health scams on the market. FDA found a fraudulent and expensive light therapy device with cure-all claims to treat fungal meningitis, Alzheimer’s, skin cancer, concussions and many other unrelated diseases. Generally, making health claims about a medical device without FDA clearance or approval of the device is illegal.

“Health fraud is a pervasive problem,” says Coody, “especially when scammers sell online. It’s difficult to track down the responsible parties. When we do find them and tell them their products are illegal, some will shut down their website. Unfortunately, however, these same products may reappear later on a different website, and sometimes may reappear with a different name.”

Tip-Offs

FDA offers some tip-offs to help you identify rip-offs.

  • One product does it all. Be suspicious of products that claim to cure a wide range of diseases. A New York firm claimed its products marketed as dietary supplements could treat or cure senile dementia, brain atrophy, atherosclerosis, kidney dysfunction, gangrene, depression, osteoarthritis, dysuria, and lung, cervical and prostate cancer. In October 2012, at FDA’s request, U.S. marshals seized these products.
  • Personal testimonials. Success stories, such as, “It cured my diabetes” or “My tumors are gone,” are easy to make up and are not a substitute for scientific evidence.
  • Quick fixes. Few diseases or conditions can be treated quickly, even with legitimate products. Beware of language such as, “Lose 30 pounds in 30 days” or “eliminates skin cancer in days.”
  • “All natural.” Some plants found in nature (such as poisonous mushrooms) can kill when consumed. Moreover, FDA has found numerous products promoted as “all natural” but that contain hidden and dangerously high doses of prescription drug ingredients or even untested active artificial ingredients.
  • “Miracle cure.” Alarms should go off when you see this claim or others like it such as, “new discovery,” “scientific breakthrough” or “secret ingredient.” If a real cure for a serious disease were discovered, it would be widely reported through the media and prescribed by health professionals—not buried in print ads, TV infomercials or on Internet sites.
  • Conspiracy theories. Claims like “The pharmaceutical industry and the government are working together to hide information about a miracle cure” are always untrue and unfounded. These statements are used to distract consumers from the obvious, common-sense questions about the so-called miracle cure.

Even with these tips, fraudulent health products are not always easy to spot. If you’re tempted to buy an unproven product or one with questionable claims, check with your doctor or other health care professional first.

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

March 4, 2013

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FDA Updates Safety Recommendations for Metal-on-Metal Hip Implants

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An FDA Consumer Update

The US Food and Drug Administration has updated its safety information and recommendations to patients and health care professionals based on the agency’s current assessment of metal-on-metal hip implants, including:

  • the benefits and risks
  • the evaluation of published literature
  • the results of an FDA advisory panel meeting held in June 2012

Risk:

Implant components slide against each other during walking or running, which releases tiny metal particles. These particles may damage bone or soft tissue surrounding the implant and joint. Soft tissue damage could lead to pain, implant loosening, device failure and the need for revision surgery.

Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause discomfort or illnesses.

Recommendations for People Considering a Metal-on-Metal Hip Implant

  • Be aware that every hip implant has benefits and risks.
  • Discuss your options for hip surgery with your orthopedic surgeon.

Recommendations for People With Metal-on-Metal Hip Implants

  • If you are not having any symptoms and your orthopedic surgeon believes your implant is functioning properly, continue to follow-up routinely with the surgeon every one to two years.
  • If you develop new or worsening problems, such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip) or a change in your ability to walk, contact your orthopedic surgeon right away.
  • If you experience changes in your general health, including new or worsening symptoms outside your hip, let your doctor or other health care professional know you have a metal-on-metal hip implant.

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5 things to know about breast implants

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A Consumer Update for the FDA

breast implantShould I get breast implants? Are there alternatives? Will they need to be replaced?

And if you decide to get implants, there are even more questions. Saline or silicone?  What style? How much monitoring is needed?

Researching breast implants can be overwhelming and confusing. The Food and Drug Administration (FDA) has online tools available to help women sort through the information and provides questions to consider before making the decision.

Know the Basics

FDA has approved implants for increasing breast size in women, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. Implants are also approved to correct or improve the result of a previous surgery.

A number of studies have reported that a majority of breast augmentation and reconstruction patients are satisfied with the results of their surgery.

FDA has approved two types of breast implants for sale in the U.S.: saline (salt water solution)-filled and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness and shape.

Know the Risks

Silicone implants sold in the U.S. are made with medical-grade silicone.  These implants undergo extensive testing to establish reasonable assurance of safety and effectiveness. Nonetheless, there are risks associated with all breast implants, including:

  • additional surgeries
  • capsular contracture—scar tissue that squeezes the implant
  • breast pain
  • rupture (tears or holes in the shell) with deflation of saline-filled implants
  • silent (without symptoms) rupture of silicone gel-filled implants

FDA experts suggest five things women should know about breast implants.

1. Breast implants are not lifetime devices.

The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery.  The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape.

“The life of these devices varies according to the individual,” says Gretchen Burns, a nurse consultant at FDA’s Center for Devices and Radiological Health (CDRH).  “All women with implants will face additional surgeries—no one can tell them when.” While a few women have kept their original implants for 20-30 years, “that is not the common experience.”

2. Research products.

Review the patient labeling. FDA advises that women look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. SSEDs have been produced for all approved saline and silicone gel-filled breast implants. These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device. Look at the frequency of serious complications found in the SSED. The most serious are “those that lead to further surgeries, such as ruptures or capsular contracture,” says Tajanay Ki, a biomedical engineer in CDRH.

FDA advises health care providers to give women the full labeling—all of the patient information from the manufacturer—for an implant. Ask your surgeon for the most recent version of the labeling. You should have at least 1-2 weeks to review the information before making a decision, but with some reconstruction or revision surgery cases, it may be advisable to perform surgery sooner.

3. Communicate with the surgeon.

Surgeons must evaluate the shape, size, surface texture and placement of the implant and the incision site for each woman. Ask the surgeon questions about his or her professional experience, the surgical procedure, and the ways the implant might affect an individual’s life.

Also, tell the surgeon about previous surgeries and your body’s response—for example, whether surgeries resulted in excessive scar tissue—and discuss your expectations. This helps the surgeon make operative decisions that achieve the desired appearance (i.e., incision location and size, implant size and placement).  Many women undergo reoperation to change implant size.  To achieve optimal results after the first procedure, careful planning and reasonable expectations are necessary.

4. Learn about long-term risks. 

Some women with breast implants have experienced connective tissue diseases, lactation difficulties or reproductive problems. However, current evidence does not support an association between breast implants and these conditions. FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. Women who have breast implants may have a very small but increased risk of developing ALCL in the fluid or scar tissue surrounding the implant. Like other lymphomas, ALCL is a cancer of the immune system and not of breast tissue.

5. Monitoring is crucial. 

FDA recommends that women with breast implants:

  • promptly report any unusual signs or symptoms to their health care providers, and
  • report any serious side effects to MedWatch, FDA’s safety information and adverse event reporting program.

Furthermore, women with silicone implants should get MRI screenings to detect silent ruptures three years after their surgery and every two years after that.  Insurance may not cover these screenings.

Burns recommends that women with breast implants continue to perform self-examinations and get mammograms to look for early signs of cancer. “Just because you have implants doesn’t mean you can ignore other breast health recommendations,” she says.

FDA’s Online Resources

FDA has a breast implants web page (www.fda.gov/breastimplants) with resources that include:

  • Links to patient information and data for each product.
  • Information about risks and complications
  • Questions to ask health care professionals regarding breast implant surgery
  • Contact information for manufacturers of FDA-approved breast implants and related professional organizations

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

February 20, 2013

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FDA urges that oysters, clams, mussels, and some scallops products from Korea should be removed from the market

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The U.S. Food and Drug Administration (FDA) is urging food distributors, retailers, and food service operators to remove from sale or service all fresh, frozen, canned, and processed oysters, clams, mussels, and whole and roe-on scallops (molluscan shellfish) from Korea that have entered the United States.

This includes molluscan shellfish from Korea that entered the United States prior to May 1, 2012, when the FDA removed such products from the Interstate Certified Shellfish Shippers List (ICSSL), and that which may have inadvertently entered the country after that date.

These products and any products made with them may have been exposed to human fecal waste and are potentially contaminated with norovirus.

Molluscan shellfish contaminated with fecal waste and/or norovirus are considered adulterated under the Federal Food, Drug, and Cosmetic Act.

Following initial notifications last month, a number of food companies have begun to remove these products from their distribution chain. However, many others have yet to take action.

A comprehensive FDA evaluation determined that the Korean Shellfish Sanitation Program (KSSP) no longer meets the sanitation controls specified under the United States’ National Shellfish Sanitation Program.

The FDA’s evaluation found significant deficiencies with the KSSP including inadequate sanitary controls, ineffective management of land-based pollution sources and detection of norovirus in shellfish growing areas.

The deficiencies in the KSSP prompted the FDA to remove all Korean certified shippers of molluscan shellfish from the ICSSL on May 1, 2012.

Although Korean molluscan shellfish represent only a small fraction of the oysters, clams, mussels, and scallops sold in the United States, the removal of Korean shellfish shippers from the ICSSL is an important step in stopping the importation of molluscan shellfish harvested from polluted waters.

  • Consumers who have recently bought molluscan shellfish and are concerned that it may have come from Korea, should contact the store where it was purchased and ask about its origin.
  • Consumers can check the label on packaged seafood to see if it is from Korea. If it is not clear where the product is from, consumers can call the manufacturer to find out.
  • Consumers should dispose of molluscan shellfish from Korea and any products made with molluscan shellfish from Korea.

These actions only affect molluscan shellfish harvested from Korean waters. They do not affect the receipt of fresh and frozen molluscan shellfish by distributors, retailers, and food service operators from any of the other shellfish shippers listed in the ICSSL.

Further, these actions do not affect the importation of canned and other processed product made with molluscan shellfish harvested from non-Korean waters. The FDA is in ongoing discussions with Korean authorities to resolve the issue.

Although the heat treatment that canned products undergo should eliminate the risk of norovirus, the contents of the cans of molluscan shellfish from Korea are still considered not fit for human food because the products were harvested from waters subject to human fecal contamination.

For fresh, frozen, or products processed by methods other than canning, the products should also be considered food not for human consumption and may also carry a risk of norovirus.

Norovirus

Norovirus virus particles/CDC

Noroviruses cause gastroenteritis. Symptoms of illness associated with norovirus include nausea, vomiting, diarrhea, and stomach cramping.

Affected individuals often experience low-grade fever, chills, headache, muscle aches and a general sense of tiredness. Most people show symptoms 12 to 48 hours after exposure to the virus.

The illness typically lasts one to three days. Dehydration is the most common complication, especially in young children and older adults, which may require medical care.

While there have been norovirus illnesses in the United States from the consumption of Korean oysters as recently as 2011, there have been no U.S. illnesses from the consumption of Korean shellfish reported in 2012.

About the FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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