Category Archives: Alternative Medicine

California’s tough new law overcomes distrust of vaccines

Share

Boy gets shot vaccine injectionBy April Dembosky, KQED

On Tuesday, Gov. Jerry Brown of California signed into law a requirement that nearly all children be vaccinated in order to attend school.

With the stroke of a pen, California went from being a state with relatively lax vaccination rules to one of the most strict in the country — joining Mississippi and West Virginia as states where even exemptions for religious beliefs are not allowed.

As the bill worked its way through the legislative process, it faced strong, consistent, vocal opposition from some parents, including a small group of protesters who stood vigil outside the Capitol in Sacramento for days before it was clear Brown would sign the bill.

The protesters are passionate, inflamed mainly by discredited beliefs that vaccines are linked to autism. But opposition to vaccines is far from new. Continue reading

Share

Cancer quackery fuels concern among doctors, FDA

Share

Photo Credit:  Bo Jungmayer / Fred Hutch News Service

Be wary of possible side effects, drug interactions when using alternative health supplements, physicians caution

By By Bill Briggs
Fred Hutch News Service

One potentially fake cancer drug sold online can actually cause malignancies. One enema machine, purported to treat ovarian cancer under the FDA banner, was never cleared for sale in the U.S., federal health officials assert.

Those products and more were targeted last week in a global crackdown on more than 1,000 websites that sell possibly dangerous and bogus medicines and medical devices. The bust, conducted by the U.S. Food and Drug Administration and Interpol, coincides with the surge of unproven cancer “cures” hawked by Internet sellers, the FDA warns.

For curious consumers, the FDA posts a running list of “fake cancer cures” that currently spans 187 oils, drinks, plants and animals parts sold by web merchants from North Carolina to Oregon.

Cancer-treatment fraud is “particularly heartless,” FDA officials say, because it preys on the desperation of patients who are tempted “to jump at anything that appears to offer a chance for a cure.” At Fred Hutchinson Cancer Research Center, some doctors are equally leery when patients ask to add claimed “natural” remedies to their treatment regimens.

“We’re quite clear: No over-the-counter herbal treatments – the things people get that are supposed to help their immune system, [or] whatever scams that people come across,” said Dr. George Georges, a hematopoietic cell transplant doctor at Fred Hutch. Continue reading

Share

U.S. FDA warns five companies over BMPEA stimulant in supplements | Reuters

Share

fda-logo-thumbnailThe U.S. Food and Drug Administration warned five companies on Thursday to stop selling dietary supplements containing an unapproved stimulant known as beta-methylphenylethylamine, or BMPEA.

BMPEA is an amphetamine-like substance that has been shown to raise blood pressure and heart rate in animals and is classified as a doping agent by the World Anti-Doping Agency.

Source: U.S. FDA warns five companies over BMPEA stimulant in supplements | Reuters

Share

States ask U.S. Congress to launch inquiry of herbal supplements | Reuters

Share

Ginkgo bilobaA group of 14 state attorneys general on Thursday asked the U.S. Congress to investigate the herbal supplements industry after a New York probe of the products turned up ingredients that were not listed on labels and raised safety concerns.

via States ask U.S. Congress to launch inquiry of herbal supplements | Reuters.

Share

FDA warns consumers of the dangers of using homeopathic products to treat asthma

Share

FDA warns consumers about the potential health risks of over-the-counter asthma products labeled as homeopathic

From the Food and Drug Administration

Illustration of the lungs in blueThe U.S. Food and Drug Administration is warning consumers not to rely on asthma products  labeled as homeopathic that are sold over-the-counter (OTC). These products have not been evaluated by the FDA for safety and effectiveness.

Asthma is a serious, chronic lung condition. If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing, and could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization.

Although there is no cure for asthma, there are many prescription asthma treatments approved by FDA as safe and effective, as well as some products that are marketed OTC in accordance with an FDA monograph.  Continue reading

Share

Beware of products promising miracle weight loss – FDA

Share

A Consumer Update from the US Food and Drug AdministrationScale

“This year, I’m going to lose some weight.”

If you find yourself making this common New Year’s resolution, know this: many so-called “miracle” weight loss supplements and foods (including teas and coffees) don’t live up to their claims.

Worse, they can cause serious harm, say FDA regulators.

The agency has found hundreds of products that are marketed as dietary supplements but actually contain hidden active ingredients (components that make a medicine effective against a specific illness) contained in prescription drugs, unsafe ingredients that were in drugs that have been removed from the market, or compounds that have not been adequately studied in humans.

“When the product contains a drug or other ingredient which is not listed as an ingredient we become especially concerned about the safety of the product,” says James P. Smith, M.D., an acting deputy director in FDA’s Office of Drug Evaluation.

Tainted products

Continue reading

Share

Mixing medications and supplements can be dangerous – FDA

Share

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

Share

Wealthy L.A. Schools’ Vaccination Rates Are as Low as South Sudan’s – The Atlantic

Share
Photomicrograph of the bacteria that causes whooping cough

Pertussis, the whooping cough bacteria — CDC photo

The Hollywood Reporter has a great investigation for which it sought the vaccination records of elementary schools all over Los Angeles County. They found that vaccination rates in elite neighborhoods like Santa Monica and Beverly Hills have tanked, and the incidence of whooping cough there has skyrocketed.

via Wealthy L.A. Schools’ Vaccination Rates Are as Low as South Sudan’s – The Atlantic.

Share

Can a dietary supplement treat a concussion? No

Share

Illustration of the skull and brainA Consumer Update from the US Food and Drug Administration

Exploiting the public’s rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).

The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease.

The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes.

These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.

One common claim: Using a particular dietary supplement promotes faster healing times after a concussion or other TBI.

Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA’s National Health Fraud Coordinator.

“We’re very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready,” says Coody. “Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs.”

A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional.

The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.

A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion.

Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.

“As amazing as the marketing claims here are, the science doesn’t support the use of any dietary supplements for the prevention of concussions or the reduction of post-concussion symptoms that would enable one to return to playing a sport faster,” says Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs.

The Claims

One of the first alarms raised about dietary supplements being promoted to treat TBI came from the U.S. Department of Defense.

“We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue,” says Jason Humbert, a senior regulatory manager with FDA’s Office of Regulatory Affairs. “That sparked our surveillance.”

FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.

Typically, products promising relief from TBIs tout the benefits of ingredients such as turmeric and high levels of omega-3 fatty acids derived from fish oil. Turmeric is an Indian spice in the ginger family.

For Omega-3, FDA has recommended a maximum daily level of 3 grams per day from all sources due to possible problems with increased risk of bleeding, increases in cholesterol and problems with controlling blood sugar levels.

In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have “the world’s first supplement formulated specifically to assist concussion recovery,” saying “it has the dynamic ability to minimize long-term effects and decrease recovery time.”

A National Football League player testified to its “proven results in my own recovery” from a concussion, and an unnamed “licensed trainer” said he had incorporated it into his “concussion management protocol.”

Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, the violations could result in legal action taken without further notice, such as seizure or injunction.

Both companies changed their websites and labeling.

In December 2013, FDA issued a warning letter to Star Scientific, Inc., for marketing its product Anatabloc with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.

“As we continue to work on this problem, we can’t guarantee you won’t see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them,” says Coody. “If someone tells you otherwise, walk away.”

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

Dec. 31, 2013

Share
Acupuncture Thumb

Health law boosts status of alternative medicine — at least on paper

Share

Acupuncture ThumbBy Ankita Rao
KHN Staff Writer

Jane Guiltinan said the husbands are usually the stubborn ones.

When her regular patients, often married women, bring their spouses to the Bastyr Center for Natural Health to try her approach to care, the men are often skeptical of the treatment plan — a mix of herbal remedies, lifestyle changes and sometimes, conventional medicine.

After 31 years of practice, Guiltinan, a naturopathic physician, said it is not uncommon for health providers without the usual nurse or doctor background to confront patients’ doubts. “I think it’s a matter of education and cultural change,” she said.

As for the husbands — they often come around, Guiltinan said, but only after they see that her treatments solve their problems.

Complementary and alternative medicine — a term that encompasses meditation, acupuncture, chiropractic care and homeopathic treatment, among other things — has become increasingly popular.

About four in 10 adults (and one in nine children) in the U.S. are using some form of alternative medicine, according to the National Institutes of Health.

And with the implementation of the Affordable Care Act, the field could make even more headway in the mainstream health care system. That is, unless the fine print — in state legislation and insurance plans — falls short because of unclear language and insufficient oversight.

One clause of the health law in particular — Section 2706 — is widely discussed in the alternative medicine community because it requires that insurance companies “shall not discriminate” against any health provider with a state-recognized license.

That means a licensed chiropractor treating a patient for back pain, for instance, must be reimbursed the same as medical doctors.

In addition, nods to alternative medicine are threaded through other parts of the law in sections on wellness, prevention and research.

“It’s time that our health care system takes an integrative approach … whether conventional or alternative,” said Sen. Tom Harkin, D-Iowa, who authored the anti-discrimination provision, in an e-mail. “Patients want good outcomes with good value, and complementary and alternative therapies can provide both.”

Guiltinan

Guiltinan

The federal government has, in recent years, tapped providers like Guiltinan, who is also the dean at the Bastyr University College of Naturopathic Medicine, to help advise the federal government and implement legislation that could affect the way they are paid and their disciplines are incorporated into the health care continuum.

In 2012, Guiltinan, based in Kenmore, Wash., was appointed to the advisory council of the National Center for Complementary and Alternative Medicine, part of the National Institutes of Health.

Proving that alternative medicine has real, measurable benefits has been key to increasing its role in the system, said John Weeks, editor of the Integrator Blog, an online publication for the alternative medicine community.

The Patient-Centered Outcomes Research Institute, created by the health law, is funding studies on alternative medicine treatments to determine their effectiveness.

Weeks said both lawmakers and the general public will soon have access to that research, including the amount of money saved by integrating other forms of medicine into the current health system.

But the challenges of introducing alternative care don’t stop with science.

Because under the health care law each state defines its essential benefits plan — what is covered by insurance — somewhat differently, the language concerning alternative medicine has to be very specific in terms of who gets paid and for what kinds of treatment, said Deborah Senn, the former insurance commissioner in Washington and an advocate for alternative medicine coverage.

She pointed out that California excluded coverage for chiropractic care in its essential benefits plan, requiring patients to pay out of pocket for their treatment. Senn thinks the move was most likely an oversight and an unfavorable one for the profession. Four other states — Colorado, Hawaii, Oregon and Utah — ruled the same way in the past year.

“That’s just an outright violation of the law,” she said, referring to the ACA clause.

Colorado and Oregon are in the process of changing that ruling to allow chiropractic care to be covered, according to researchers at Academic Consortium for Complementary and Alternative Health Care.

Some states, like Washington, are ahead of the rest of the country in embracing alternative practitioners. The Bastyr University system, where Guiltinan works, treats 35,000 patients a year with naturopathic medicine. Sixty percent of the patients billed insurance companies for coverage.

Guiltinan said a change in the system is not only a boon for alternative medicine doctors, but helps families of all income levels access care normally limited to out-of-pocket payment.

That’s why some alternative medicine aficionados like Rohit Kumar are hoping the law will increase the ability of his family — and the larger community — to obtain this kind of care.

Kumar, a 26-year-old business owner in Los Angeles, said his parents and brothers have always used herbs and certain foods when they get sick, and regularly see a local naturopath and herbalist. He’s only used antibiotics once, he says, when he caught dengue fever on a trip to India.

While the Kumar family pays for any treatments they need with cash — the only payment both alternative providers accept — they also pay for a high-deductible health plan every month to cover emergencies, like when his brother recently broke his arm falling off a bike.

Paying for a conventional health care plan and maintaining their philosophy of wellness is not cheap.

“We pay a ridiculous amount of money every month,” Kumar said of the high-deductible insurance. “And none of it goes toward any type of medicine we believe in.”

Even so, he said the family will continue to practice a lifestyle that values wellness achieved without a prescription — a philosophy that Guiltinan also adopted in her practice.

As a young medical technician in a San Francisco hospital she decided that the traditional medical system was geared more toward managing diseases and symptoms rather than prevention. Naturopathic medicine, on the other hand, seemed to fit her idea of how a doctor could address the root cause of illness.

“The body has an innate ability for healing, but we get in its way,” Guiltinan said. “Health is more than the absence of disease.”

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

Share
health scams quack

Fake diabetes treatments flood marketplace – FDA warns

Share

health scams quackFrom the FDA

As the number of people diagnosed with diabetes continues to grow, illegally sold products promising to prevent, treat, and even cure diabetes are flooding the marketplace.

The Food and Drug Administration (FDA) is advising consumers not to use such products. They may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as over-the-counter (OTC) products when they should be marketed as prescription products.

They carry an additional risk if they cause consumers to delay or discontinue effective treatments for diabetes. Without proper disease management, people with diabetes are at a greater risk for developing serious health complications.

“People with chronic or incurable diseases may feel desperate and become easy prey. Bogus products for diabetes are particularly troubling because there are effective options available to help manage this serious disease rather than exposing patients to unproven and risky products,” said Gary Coody, R.Ph., national health fraud coordinator for FDA.

“Failure to follow well-established treatment plans can lead to, among other things, amputations, kidney disease, blindness and death,” Coody said.

Warning Letters Issued

Recently, FDA launched an initiative to counter these illegally sold products aimed at consumers who have diabetes. In addition to evaluating numerous consumer complaints, FDA surveyed the marketplace for illegally sold products promising to treat diabetes and its complications.

In July 2013, FDA issued letters warning 15 companies about selling products for diabetes in violation of federal law. These products are sold as dietary supplements; alternative medicines, such as ayurvedics; prescription drugs and over-the-counter drugs, including homeopathic products.

Examples of claims observed on these illegally marketed products include:

  • “Lower your blood sugar naturally.”
  • “Lowers A1C levels significantly.”
  • “You’ll lower your chances of having eye disease, kidney disease, nerve damage and heart disease!”
  • “It can replace medicine in the treatment of diabetes.”
  • “For Relief of Diabetic Foot Pain.”

Some of the companies also promote unapproved products for other serious diseases, including cancer, sexually transmitted diseases, and macular degeneration.

FDA tested products marketed as “all natural” treatments for diabetes and discovered some of them contained one or more active ingredients found in prescription drugs to treat type 2 diabetes.

Undeclared ingredients can cause serious harm. If consumers and their health care professionals are unaware of the actual ingredients in the products they are taking, these products may interact in dangerous ways with other medications.

One possible complication: Patients may end up taking a larger combined dose of the diabetic drugs than they intended, and that may cause a significant unsafe drop in blood sugar levels, a condition known as hypoglycemia.

FDA also looked at sales of prescription drugs from fraudulent online pharmacies. Signs that indicate an online pharmacy is legitimate include: requiring that patients have a valid prescription; providing a physical address in the U.S.; being licensed by a state pharmacy board; and having a state-licensed pharmacist to answer questions.

Some fraudulent online pharmacies illegally sell drugs that are not approved in the United States, or sell prescription drug products without meeting necessary requirements.

One website that is subject to a warning letter shipped a prescription diabetes drug without requiring a prescription, and even included an unsolicited free sample of a prescription drug for erectile dysfunction.

Moreover, the prescription diabetes drug was dispensed without the medication guide and other precautions required by FDA to ensure the drug is used safely and appropriately.

Although some of these websites may offer for sale what appear to be FDA-approved prescription drugs, FDA cannot confirm that the manufacture or the handling of these drugs follows U.S. regulations or that the drugs are safe and effective for their intended uses. Also, there is a risk the drugs may be counterfeit, contaminated, expired or otherwise unsafe.

A Far-Reaching Problem

There are 26 million people in the U.S. who have diabetes, including about 7 million who are undiagnosed, according to the Centers for Disease Control and Prevention.

Millions more have pre-diabetes, meaning they have higher than normal blood sugar levels and can reduce their risks of developing diabetes through healthy lifestyle changes, including diet and exercise.

“Products that promise an easy fix might be alluring, but consumers are gambling with their health. In general, diabetes is a chronic disease, but it is manageable and people can lower their risk for developing complications by following treatments prescribed by health care professionals, carefully monitoring blood sugar levels, and sticking to an appropriate diet and exercise program,” said Coody.

Health care professionals and consumers are encouraged to report any adverse events related to products intented to treat or cure diabetes to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

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

July 23, 2013

For More Information

Share

Third naturopath charged for participating in Hempfest marijuana prescription “mill”

Share

Cannabis_leaf_marijuana_potThe Washington State Board of Naturopathy and the Department of Health has charged naturopathic physician Jeffrey T. Moore, with “providing sub-standard care in authorizing medical marijuana to patients.”

According to the charges, Moore examined and treated 100 patients seeking medical marijuana authorization at the Seattle “Hempfest” event in 2011, the Department of Health said in a statement released Wednesday:

“The allegations include inadequate review of patient medical histories; inadequate documentation of the examinations and diagnoses; and failure to establish ongoing patient care relationships. The charges say in some cases the patients’ conditions did not meet medical marijuana authorization requirements.

“Moore, who has 20 days to respond to the statement of charges, granted authorizations to 99 of the 100 patients he saw at the event. Health officials say this “assembly-line” practice amounts to an “authorization mill” and doesn’t meet patient care standards.”

Two other naturopathic physicians have been disciplined for similar practices at the 2011 Hempfest, Carolyn Lee Bearss, who saw 106 patients and gave all but one a medical marijuana authorization, according to the Department of Health, and Dimitrios Magiasis, “who saw 110 people and gave all but one a medical marijuana authorization based on exams that averaged less than 15 minutes.”

The documents detailing the charges can be seen online by clicking “Look up a health care provider” on the Department of Health website; copies can be requested by calling 360-236-4700.

That’s also the number to call to file complaints against health care providers in Washington.

Share
Caffeine thumbnail

FDA to investigate caffeine-laced products

Share

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

Share

FDA warns customers to avoid stimulant found in popular supplements

Share

DMAAThe US Food and Drug Administration is warning consumers to avoid products containing the stimulant dimethylamylamine (DMAA), an ingredient found in many supplements that claim promote weight loss and performance enhancement.

The compound “can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest,” the FDA warns, and has been

FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal.

Here is the FDA Consumer Update on DMAA and a Q&A on DMAA in Dietary Supplements

Stimulant potentially dangerous to health, FDA warns

FDA Consumer Update

The Food and Drug Administration (FDA) is using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.

The ingredient, DMAA, is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine.

As of April 11, 2013, FDA had received 86 reports of illnesses and death associated with supplements containing DMAA. The majority are voluntary reports from consumers and healthcare practitioners.

The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.

FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal.

Such warnings offer the quickest way at FDA’s disposal to halt the further distribution of dietary supplements containing DMAA in the marketplace.

In fact, all but one of the companies sent a Warning Letter have agreed to stop using DMAA as an ingredient in their dietary supplements.

The one company that has yet to agree to such action, USPLabs, has responded to FDA’s warning by submitting published studies that purport to challenge FDA’s conclusions.

However, after reviewing the studies provided by USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.

FDA is finalizing a formal response to the firm to reflect its findings, according to Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Program.

FDA’s authority over dietary supplements is very different from its authority over drugs and other medical products. FDA is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don’t voluntarily comply.

As FDA continues the process needed to get DMAA off the market, the agency is urging consumers to check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The alternatives are listed at FDA’s DMAA web page.

The Challenge

FDA’s response to the use of DMAA illustrates the challenges that the agency faces in addressing incidents involving potentially dangerous dietary supplements. The effort is increasingly important as the use of dietary supplements increases worldwide. A 2011 study found that more than half of U.S. adults used a dietary supplement between 2003 and 2006, compared to 40% between 1988 and 1994.

In recent years, FDA has alerted consumers to hundreds of tainted products marketed as dietary supplements. Consumers should be aware that dietary supplements are subject to different oversight than drugs and other medical products.

“Consumers may mistakenly look at a capsule and think that FDA has signed off on that product as safe and effective prior to that product appearing on the market, as we do with drugs and other medical products,” says Fabricant. “In contrast, with dietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe.”

FDA’s role in overseeing dietary supplements is laid out in a 1994 law and subsequent amendments. FDA’s enforcement capabilities range from issuing warning letters seeking voluntary cooperation—the quickest way to get a product off the market—to bringing criminal charges.

In recent years, FDA enforcement actions involving dietary supplements have included banning products, executing injunctions, working with U.S. marshals to seize products, and issuing safety alerts and consent decrees—which are agreements approved and enforced by a federal court.

In many cases, FDA has acted when dietary supplements were found to contain ingredients approved for use in prescription drugs. DMAA was approved in 1948 for use as a nasal decongestant, but the approval was withdrawn in 1983.

The products cited in the warning letter to USPLabs are Oxy Elite Pro and Jack3D. These products claim, among other things, to be fat-burning and performance-enhancing supplements, respectively. While action in that case in pending,

FDA is following up to ensure that other companies which promised to cease using DMAA as an ingredient in their dietary supplements are actually doing so.

FDA is also looking to see if there are other dietary supplement products containing DMAA in the marketplace, and will continue to act to ensure that such products, when identified, are no longer distributed and available for sale to consumers.

Consumers are urged to report any problems associated with supplement use to the company or the agency, and to always consult with their health care professional before using a supplement.

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

April 11, 2013

 

Q & A on DMAA in Dietary Supplements

DMAA in Dietary SupplementsDMAA, also known as 1,3-dimethylamylamine, methylhexanamine or geranium extract, is an ingredient found illegally in some dietary supplements and often touted as a “natural” stimulant. DMAA, especially in combination with other ingredients such as caffeine, can be a health risk to consumers. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack. Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market. FDA has issued warning letters to companies notifying them products with DMAA need to be taken off the market or reformulated to remove this substance. Most companies warned are no longer distributing products with DMAA. While FDA is working to get these products off the market, consumers should not buy or use any dietary supplement product containing DMAA.

For more information:


Questions & Answers

What is DMAA?

DMAA (1,3-dimethylamylamine) is an amphetamine derivative that has been widely used in sports supplements sold in the United States. Also known as methylhexanamine or geranium extract, DMAA is often touted as a “natural” stimulant, with many claimed functional uses including a body-building aid, an athletic performance enhancer, and a weight-loss aid. Although DMAA at one time was approved as a drug for nasal decongestion, no medical use of DMAA is recognized today. FDA is not aware of any reliable science indicating that DMAA exists naturally in plants.

DMAA-containing dietary supplements are illegal and their marketing violates the law. Based on the scientific information reviewed by FDA, DMAA is not a dietary ingredient.

Is it safe to consume DMAA?

No, FDA does not have any information to demonstrate that consuming DMAA is safe. FDA is very concerned about DMAA and we advise consumers not to purchase or use any dietary supplement containing DMAA. This substance narrows blood vessels and arteries, which can elevate blood pressure, and may lead to cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack, as well as seizures and other neurological and psychological conditions. FDA has received 86 reports of adverse events involving products containing DMAA. These events include psychiatric disorders, heart problems, nervous system disorders, and death.

How does FDA regulate ingredients in dietary supplements like DMAA?

The law requires companies to notify FDA when they intend to market a dietary supplement containing a New Dietary Ingredient (NDI) in the United States, if the NDI has not been used in the food supply in the same chemical form.  An NDI is a dietary ingredient that was not marketed in a dietary supplement prior to October 15, 1994. Unlike drugs, dietary supplements do not have pre-market approval for safety or effectiveness. If a safety issue arises post-market, FDA can investigate and take steps to remove products that may be unsafe from the market. However, in order for FDA to ban a compound in a dietary supplement, FDA is required under the statute to undertake a series of lengthy scientific and legal steps. In the interim, FDA can take direct action by issuing warning letters to industry to obtain removal of ingredients in dietary supplements and protect the public from potentially harmful products. FDA can also take a seizure action to remove products from the market or obtain an injunction against a company to prevent it from manufacturing and distributing illegal products.

What is FDA doing to remove DMAA-containing dietary supplements from the market?

FDA sent warning letters to a total of 11 companies advising them that DMAA-containing products marketed as dietary supplements are illegal and must be taken off the market or reformulated to remove DMAA. These 11 companies account for most of the DMAA products sold in the United States. This action was taken to protect consumers and get these products off the shelves as quickly as possible. To date, all but one of the companies warned by FDA have agreed to stop marketing products with DMAA. FDA is in communication with the one remaining company to bring the issue to closure. FDA is also sending its investigators to the companies that agreed to reformulate or remove DMAA to verify that they have taken the appropriate action. Six companies have been visited so far. Five of the companies were in compliance and the sixth company, which was not in compliance, agreed to recall their product after discussions with FDA.

Why hasn’t the FDA banned this ingredient, especially after the U.S. military took it off their shelves?

The U.S. military initiated a temporary hold on the sale of DMAA-containing products in military exchanges. The law requires FDA to follow certain lengthy steps before the agency can ban dietary supplements containing DMAA. FDA has been working to remove dietary supplements containing DMAA from the marketplace and we will continue to look at all regulatory and legal options to bring companies into compliance and protect consumers.

How do consumers know if a dietary supplement contains DMAA?Consumers should look for DMAA listed on the product label. It may also be listed as:

  • 1,3-DMAA
  • 1,3-Dimethylamylamine
  • 1,3-Dimethylpentylamine
  • 2-Amino-4-methylhexane
  • 2-Hexanamine
  • 4-Methyl-2-hexanamine
  • 4-Methyl-2-hexylamine
  • 4-methyl- (9CI)
  • Dimethylamylamine
  • Geranamine
  • Methylhexanamine
  • Methylhexanenamine

Some products also will list Pelargonium graveolens extract or Geranium extract, which may indicate that the product contains DMAA.

What should consumers do if they believe they’ve been harmed by consuming DMAA?

Consumers can report incidents directly to FDA. See Dietary Supplements – Report an Adverse Event.

Consumers can also report these adverse events to the company whose name and contact information is on the product label.

In addition, consumers should contact their health care practitioner if they have suffered or are still being affected by an adverse event.

 
Share