Category Archives: Alternative Medicine

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

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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.

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Can a dietary supplement treat a concussion? No

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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

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

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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.

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Fake diabetes treatments flood marketplace – FDA warns

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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

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

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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.

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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 warns customers to avoid stimulant found in popular supplements

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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.

 
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Vilifying food – How fad diets are affecting our children’s health

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Seattle Children's LogoFrom Seattle Children’s blog On the Pulse

Fad diets have taken the U.S. by storm: PaleoMediterranean, the “Fast Diet” – even Gwyneth Paltrow has a new cookbook.  Just as quickly as one diet is “out,” another diet emerges to take its place. With so many options, celebrity endorsements and websites full of misinformation, how can parents know which diets are safe – especially for kids?

Celia Framson, MPH, RD, CD, and Mary Jones Verbovski, MS, RD, CD, clinical pediatric dietitians at Seattle Children’s Hospital encourage parents to keep kids in mind when evaluating a potential diet.

“The alarming prevalence of these diets and trends has created an entirely new entity in the family dynamic,” says Jones Verbovski. “The subject of food and diet can really affect the parent-child relationship. Many parents are constant dieters. Sometimes we overlook how a diet may be affecting a child.”

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For parents who diet

Parents who adopt certain diets or dietary lifestyles should be aware of the implications on kids. Children are easily influenced by external factors – school, peers, family and celebrities. Also, they are not the ones buying the food that sits in the pantry. A parent’s dietary choice usually falls onto the child.

Children are impressionable and may adopt a diet simply because they want to copy their parents or fit in with their friends. Recently, a 7-year-old girl’s “diyet list” garnered media attention and raised controversy among both dietitians and parents. The girl reportedly learned about dieting from a friend.

Framson and Jones Verbovski say it’s important to develop a positive relationship with food and set a good example for your child.  If your child announces they want to incorporate certain foods or restrict certain foods, make sure you understand what is motivating the change and help them understand they need a wide variety of foods. Have they decided to cut out meat, sweets or carbohydrates because you have?

Many of the most popular diets in the U.S. have a tendency to vilify foods. Framson says that trend isn’t healthy for kids who need a balanced diet for their growing bodies and minds. We have taught children and teens to look at foods as being either “good” or “bad,” she says, instead of promoting a healthy balanced diet, and taking a holistic approach to nutrition.

Framson and Jones Verbovski encourage parents to be aware of how they speak about foods and diets. Saying a cupcake is “bad” or that sweets will make you fat, can give the impression that a child should feel ashamed if they eat them.

Teaching children to feel shame in association with certain foods can lead to unhealthy habits.

According to the Academy of Nutrition and Dietetics’ newly updated position paper, families should focus on moderation, portion size and exercise for balancing food and beverage intakes.

Rather than labeling cupcakes as “bad” and apples as “good,” focus instead on feeling your best, stopping when you’re full and eating a balanced diet. Teaching children to feel shame in association with certain foods can lead to unhealthy habits, say Framson and Jones Verbovski, like binge eating or restrictive eating disorders. It’s easy for a child to go from “this food is bad” to “I am bad” for wanting to eat that food, says Framson.

It’s important to talk to children about nutrition and healthy eating choices. Typically, children only learn the most basic principles of nutrition at school.

Many times these lessons are misconstrued and children take away that they need to cut out sugar all together from their diet, a lesson that Jones Verbovski says isn’t necessarily the right approach.  “Parents should give their children options,” she says. “In our house sugar is okay in moderation.”

Vegetarian and vegan kids

Don’t be surprised if kids around six or seven years old decide to go vegetarian, says the American Academy of Pediatrics. When children first learn where food comes from it’s perfectly normal to have mixed emotions.

The controversial children’s book “Vegan is Love” has ignited a recent debate among parents – is veganism healthy for kids? The book depicts animals crowded behind bars and discusses animal testing. It wasn’t so much the content that stirred the heated debate, however, it was the uncertainty behind the nutritional safety of the vegan diet.

“If a child wishes to be vegetarian or vegan, parents need to look deeper and make sure that is an appropriate choice that works with the family’s food values,” Framson says. “Parents also need to watch for red flags and ensure their child or teen is consuming enough nutrients and calories.”

If families choose to adopt a vegan or vegetarian diet, parents need to be mindful of the dietary implications. Young children need many specific nutrients for their growing minds and bodies. Parents need to incorporate variety into a child’s diet, making sure they get enough vitamin B12, protein, iron, calcium and omega-3 fatty acids.

Tips for dieting parents

Framson and Jones Verbovski suggest parents incorporate diets that fit into their family dynamic and culture. Think about your schedule and lifestyle – cooking is time consuming, organic foods can cost more and there may not be an abundance of fresh fruits or vegetables in your neighborhood. “Your lifestyle needs to fit your food and your food needs to fit your lifestyle,” says Jones Verbovski.

Also, set realistic expectations and don’t focus on losing x amount of weight. “Children shouldn’t be trying to lose significant amounts of weight,” says Jones Verbovski. Parents should allow children to choose what they eat, within reason. For example, offer 2 different veggies at dinnertime, rather “you have to eat this” Incorporate a variety of foods into a child’s diet and give them the responsibility of picking which works best for them. Allow them to engage in choosing what’s on the menu sometimes. “Focus on feeling good about yourself and your lifestyle,” says Framson. Remember, being healthy isn’t about a number on the scale. Fad diets come and go; eating a well balanced diet and feeling healthy can last a lifetime.

Remember to look at the bigger picture. Some days are better than others when it comes to eating well. Look at each week instead of each day, says Framson and Jones Verbovski You should spend some time and energy planning meals and snacks so you make choices you feel good about, but not so much time and energy that it increases stress. Life, after all, is a balance.

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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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Beware of fraudulent flu products, FDA warns

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FlagFDA Consumer Update

As the flu continues to make people sick—and even cause deaths—scammers are alive and well, promoting their fraudulent products to the unsuspecting public.

These scammers sell their products with claims to prevent, treat or cure the flu, even though they have not been tested and the Food and Drug Administration (FDA) has not approved them.

FDA warns consumers to steer clear of fraudulent flu products, which can be found online and in retail stores and may include products marketed as dietary supplements or conventional foods, drugs, nasal sprays and devices.

“As any health threat emerges, fraudulent products appear almost overnight,” says Gary Coody, R.Ph., FDA’s national health fraud coordinator. “Right now, so-called ‘alternatives’ to the flu vaccine are big with scammers.”

“These unproven products give consumers a false sense of security,” says Mary Malarkey, director of FDA’s Office of Compliance and Biologics Quality. “There is no need to buy a product that claims to be an alternative to the vaccine. Flu vaccine is still available and it’s not too late to get vaccinated.”

The best way to prevent the flu is by getting vaccinated every year, and the Centers for Disease Control and Prevention (CDC) recommends the vaccine for adults and children over six months of age. To find a list of clinics, supermarkets, pharmacies and other vaccine providers in your neighborhood, visit www.flu.gov, click on “Flu Vaccine Finder” and enter your zip code.

If you get the flu, two FDA-approved antiviral drugs—Tamiflu (oseltamivir) and Relenza (zanamivir)—are treatment options recommended by CDC. These prescription drugs can help fight the virus in your body and shorten the time you’re sick. They can also be used to help prevent the flu.

Flu Fraud Red Flags!

  • These flu claims on an unapproved product indicate that it may be fraudulent:
  • reduces severity and length of flu
  • boosts your immunity naturally without a flu shotsafe and effective alternative to flu vaccine
  • prevents catching the flu
  • effective treatment for flu
  • faster recovery from flu
  • supports your body’s natural immune defenses to fight off flu

Types of Fraudulent Flu Products

There are no legally marketed over-the-counter (OTC) drugs to prevent or cure the flu. However, there are legal OTC products to reduce fever and to relieve muscle aches, congestion, and other symptoms typically associated with the flu.

But unapproved drugs—which sometimes are also marketed as dietary supplements, conventional foods (such as herbal teas) or devices (such as air filters and light therapies)—are fraudulent if they make flu prevention, treatment or cure claims, says Coody, “because they haven’t been evaluated for these uses.”

On Jan. 25, 2013, FDA and the Federal Trade Commission jointly sent a warning letter to the company that markets “GermBullet,” a nasal inhaler that makes flu prevention and treatment claims. The firm is required to remove the language in its labeling and advertising that violates federal law.

“If the company continues to sell the product without removing the deceptive and illegal language, the firm may be subject to enforcement action, which could include seizure of the products or other legal sanctions,” says FDA Regulatory Counsel Brad Pace, J.D., of FDA’s Health Fraud and Consumer Outreach Branch.

Fraudulent Online Pharmacies

Online pharmacies present an opportunity for Internet scammers to take advantage of unsuspecting consumers. Legitimate online pharmacies do exist, but so do many websites that look like professional and legitimate pharmacies but are actually fraudulent and illegal.

These websites may be selling unapproved antiviral drugs. “Beware of websites that sell generic Tamiflu or Relenza,” says FDA pharmacist Connie Jung, R.Ph., Ph.D., of FDA’s Office of Drug Security, Integrity and Recalls. “Currently there are no FDA-approved generics available for these drugs on the U.S. market.”

“With unapproved products, you really don’t know what you’re getting and can’t be sure of the quality,” adds Jung. “The products could be counterfeit, contaminated, or have the wrong active ingredient or no active ingredient. You could experience a bad reaction, or not receive the drug you need to get better.”

Jung also warns consumers not to be tempted by an online seller that offers much lower prices than typically charged for prescription drugs by your local pharmacy. “Deep discounts on price are a good indicator of a fraudulent, illegal online pharmacy. You should avoid these online sellers because you might get products that are harmful to your health.”

FDA encourages consumers to buy prescription drugs only through an online pharmacy that requires a valid prescription from a doctor or other authorized health care provider and is licensed by the state board of pharmacy (or equivalent state agency) where the patient is located.

Health fraud is pervasive and it’s not always easy to spot a fraudulent product, says Coody. “If you’re tempted to buy an unproven or little known treatment, especially if it’s sold on the Internet, check with your health care provider first.”

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

Feb. 1, 2013

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No evidence that black cohosh relieves menopause symptoms

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By Glenda Fauntleroy, Contributing Writer
Health Behavior News Service

Although many women coping with hot flashes and other distressing symptoms of menopause have turned to black cohosh supplements as a treatment alternative, a new review by the Cochrane Library finds no evidence that the herb is effective.

“I was a little surprised of the outcome of the review given the large number of perimenopausal women that use the herb across the globe for the management of menopausal symptoms, as well as the many manufacturers and therapists that promote the herb for this purpose,” said lead reviewer Matthew Leach, Ph.D., a research fellow in the School of Nursing & Midwifery at the University of South Australia.

Leach and his co-reviewer evaluated 16 studies involving 2,027 menopausal women. Study participants used an average daily oral preparation of 40 mg of black cohosh for an average of 23 weeks.

Treatments for randomly assigned comparison groups included using placeboes, hormone therapy, red clover, or antidepressants.

The reviewers found there was insufficient evidence to support the effectiveness of black cohosh for menopausal symptoms. There was no significant difference between it and the placebo groups in changing hot flash frequency. Compared to black cohosh, hormone therapy significantly reduced hot flash frequency.

“I have many women patients who have tried black cohosh,” said Brent A. Bauer, M.D., director of the Complementary and Integrative Medicine Program at the Mayo Clinic in Minnesota.

“I would say the response seems to roughly fall into three camps: those that get a pretty noticeable improvement in symptoms and continue to use it long term, those that get some improvement but not enough to get enthusiastic about it, and those that try it and perceive no benefit at all.”

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.

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Evidence does not back-up spinal manipulation for acute lower back pain

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By Joan Vos MacDonald, Contributing Writer
Health Behavior News Service

Manipulating or “adjusting” the spine is a popular way to treat occasional or acute lower back pain and is covered by many health insurance plans, but a recent review by The Cochrane Library finds no evidence to suggest it is more effective than other therapy options.

According to the National Institutes of Health, lower back pain affects eight out of 10 people, and is commonly caused by injury or overuse.

Spinal manipulation (SMT), a technique used by chiropractors, osteopaths, naturopaths and some medical doctors, is used to improve the range of motion of the joints in the spine.

“SMT is a worldwide, extensively practiced intervention; however, its effectiveness for acute lower back pain is not without dispute,” said lead reviewer Sidney Rubinstein, senior researcher at the VU University Medical Center in Amsterdam.

Key Points:

  • Acute lower back pain, defined as pain lasting six weeks or less, resolves on its own in most cases.
  • Spinal manipulation, often used by chiropractors and osteopaths, is no more effective than exercise, NSAIDs or other physical therapy to treat acute lower back pain.

The reviewers studied the results from 20 randomized controlled trials representing 2,674 participants with lower back pain of less than six weeks duration.

Reviewers concluded that SMT neither reduced pain nor sped recovery faster than treatment options such as exercise, the use of NSAID pain medications or physiotherapy.

Surprisingly, the review also found no evidence to suggest that SMT was more effective than therapies known to be ineffective.

“This last finding would suggest more research is needed,” said Dr. Rubinstein. If SMT is just as effective as accepted interventions, it should be better than ineffective therapies, such as using ultrasound or heat therapy.

“Such reviews may be confusing because they are not comparing apples to apples,” said Mitchell Freedman, D.O., director of Physical Medicine and Rehabilitation at the Rothman Institute at Thomas Jefferson University Hospital in Philadelphia. “For a start, there are different kinds of manipulation, some more aggressive and some limited to stretching. Also, while spinal manipulation is not useful in all circumstances, it can be in some. You do need to look across a whole spectrum.”

Another complicating factor is the nature of acute lower back pain. Defined as lasting six weeks or less, it tends to go away on its own in almost 90 percent of all cases.“Studies do promote the use of manipulation in subacute to chronic pain which is different from acute pain,” said Freedman.

Health Behavior News Service is part of the Center for Advancing Health

The Health Behavior News Service disseminates news stories on the latest findings from peer-reviewed research journals. HBNS covers both new studies and systematic reviews of studies on (1) the effects of behavior on health, (2) health disparities data and (3) patient engagement research. The goal of HBNS stories is to present the facts for readers to understand and use for themselves to make informed choices about health and health care.

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King County naturopaths charged in medical marijuana cases

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From the Washington State Department of Health:

OLYMPIA – Two naturopathic physicians face state charges of providing sub-standard care in conducting patient examinations to authorize medical marijuana.

The Board of Naturopathy and the state Department of Health have issued charges against King County naturopathic physicians Carolyn Lee Bearss (NATU.NT.60134517) and Dimitrios Jimmy Magiasis (NATU.NT.60199408) in separate legal actions.

The statements of charges say Bearss and Magiasis examined and treated more than 200 patients seeking medical marijuana authorization at the 2011 “Hempfest” event in Seattle.

The charges say the examinations were below the standard of care. Allegations include inadequate review of patient medical histories; inadequate documentation of the examinations and diagnoses; and failure to establish an ongoing patient care relationship.

The allegations say that in some cases the patients’ conditions did not meet state requirements for a medical marijuana authorization.

Bearss and Magiasis each have 20 days to respond to the statement of charges, which are available online by clicking, “Look up a health care provider” on the Department of Health home page (doh.wa.gov) or by calling 360-236-4700.

Anyone who believes a health care provider acted unprofessionally is encouraged to call that number to report the complaint.

The Board of Naturopathy regulates naturopathic physicians in Washington. The board establishes, monitors, and enforces qualifications for licensing, consistent standards of practice, continuing competency mechanisms and discipline. Rules, policies and procedures promote the delivery of quality health care to state residents.

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Mercury poisoning linked to skin products

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A Consumer Update from the U.S. Food and Drug Administration

Consumers should not to use skin creams, beauty and antiseptic soaps, or lotions that might contain mercury, U.S. Food and Drug Administration officials warn

The products are marketed as skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes and wrinkles, says Gary Coody, national health fraud coordinator in the Food and Drug Administration’s Office of Regulatory Affairs.

Adolescents also may use these products as acne treatments, adds Coody. Products with this toxic metal have been found in at least seven states.

Click on image for photos of more products

The products are manufactured abroad and sold illegally in the United States—often in shops in Latino, Asian, African or Middle Eastern neighborhoods and online.

Consumers may also have bought them in another country and brought them back to the U.S. for personal use.

“If you have a product that matches these descriptions (and others listed below), stop using it immediately,” says Coody.

Signs and Symptoms of Mercury Poisoning

  • irritability
  • shyness
  • tremors
  • changes in vision or hearing
  • memory problems
  • depression
  • numbness and tingling in hands, feet or around mouth

Source: Agency for Toxic Substances and Disease Registry

“Even though these products are promoted as cosmetics, they also may be unapproved new drugs under the law,” says Linda Katz, M.D., director of FDA’s Office of Cosmetics and Colors. FDA does not allow mercury in drugs or in cosmetics, except under very specific conditions, which these products do not meet.

“Sellers and distributors should not market these illegal products and may be subject to enforcement action, which could include seizure of the products and other legal sanctions,” says attorney Brad Pace, J.D., of the Heath Fraud and Consumer Outreach Branch within FDA’s Center for Drug Evaluation and Research.

Dangers of Mercury

“Exposure to mercury can have serious health consequences,” says Charles Lee, M.D., a senior medical advisor at FDA. “It can damage the kidneys and the nervous system, and interfere with the development of the brain in unborn children and very young children.”

You don’t have to use the product yourself to be affected, says FDA toxicologist Mike Bolger, Ph.D. “People—particularly children—can get mercury in their bodies from breathing in mercury vapors if a member of the household uses a skin cream containing mercury.” Infants and small children can ingest mercury if they touch their parents who have used these products, get cream on their hands and then put their hands and fingers into their mouth, which they are prone to do, adds Bolger.

How to Protect Yourself

  • Check the label of any skin lightening, anti-aging or other skin product you use. If you see the words “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury,” stop using the product immediately.
  • If there is no label or no ingredients are listed, do not use the product. Federal law requires that ingredients be listed on the label of any cosmetic or drug.
  • Don’t use products labeled in languages other than English unless English labeling is also provided.
  • If you suspect you have been using a product with mercury, stop using it immediately. Thoroughly wash your hands and any other parts of your body that have come in contact with the product. Contact your health care professional or a medical care clinic for advice.
  • If you have questions, call your health care professional or the Poison Center  at 1-800-222-1222; it is open 24 hours a day.
  • Before throwing out a product that may contain mercury, seal it in a plastic bag or leak-proof container. Check with your local environmental, health or solid waste agency for disposal instructions. Some communities have special collections or other options for disposing of household hazardous waste.

Tracking Skin Products Containing Mercury

Investigations in the past few years by FDA and state health officials have turned up more than 35 products that contain unacceptable levels of mercury.

FDA continues to add mercury-containing skin products to its import alerts, which authorize the agency’s field staff to refuse admission of shipments of these products.

But this is only a partial solution, says Coody. “Many of these products are coming into the country through channels we can’t easily track, such as international mail and personal baggage.

That’s why it’s so important for consumers and sellers to know about the dangers of possible mercury poisoning associated with the use of these skin products.”

Texas health officials say samples of face cream they tested contained mercury up to 131,000 times the allowable level. And a teenager in southern Texas who used a mercury-containing skin cream was recently hospitalized for mercury poisoning.

In Northern California, a 39-year old woman had more than 100 times the average amount of mercury in her urine and had symptoms of mercury poisoning, according to the California Department of Public Health.

For three years, the woman and her husband had been using an unlabeled mercury-containing face cream that was brought into the U.S. from Mexico by a relative.

Several other family members who did not use the cream, including a four-year-old child, also had elevated levels of mercury in their bodies.

Virginia, Maryland, and New York have also seen cases of elevated mercury levels in people exposed to skin products containing mercury.

In Minnesota, 11 of 27 imported skin products taken from store shelves contained mercury . Photos of some illegal mercury-containing products are shown here:

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

March 6, 2012

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Viewpoint: Exploring effective pain relief options

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By Bill Scott

After reading recent media reports such as The Seattle Times series, “Methadone and the politics of pain,” I’ve been saddened to learn of the overwhelming number of Washington residents living in chronic pain and/or addicted to painkillers. Also, the near universal frustration of both patients and providers for solutions is alarming.

I’m sure that all caring persons agree that no one should ever be left in agonizing pain, but is increasing dependence on painkillers the only answer?

For instance, why is this largely an American problem? With less than 5% of the world’s population, Americans consume 80% of painkillers sold. A recent comment on the Times website noted, “I just worked in Cuba. There (are) NO narcotics except for a couple of doses after major surgery. Tylenol is over the counter and ibuprofen by prescription. Somehow they manage and they have a lot less pain. Consider that paradox? They have no pain medicines and have less pain?”

According to recent news reports, I’ve been encouraged to hear that some patients are managing to get off painkillers, including Cynthia Toussaint. From an ABC NEWS report last June, she “was confined to her bed, writhing in pain from muscle spasms, unable to walk or to live a meaningful life.”

Yet, ten years later, after turning to a variety of integrative medicine treatments, she resumed her singing career. Toussaint noted, “There’s a whole range of under-appreciated non-traditional treatment options that are low-cost, effective and with no side effects.”

A recent article in The St. Petersburg Times explains how addiction to prescription painkillers nearly killed ex-NFL star Randy Grimes. Yet, at a point that Grimes describes as “a spiritual moment,” he began to regain control of his life, found renewed purpose and now works to help others to overcome the same addiction. Throughout my entire life, I’ve taken a spiritual approach to my own health and have experienced consistent, positive results.

It’s also encouraging to read reports on therapeutic approaches that focus on thought and the mind in reducing pain. Studies at Stanford, Duke and Wake Forrest Universities have proven many mind-body approaches to be effective in clinical trials.

One reason alternative therapies are not more commonly used by the public appears to be the lack of insurance coverage. According to The Seattle Times, Rep. Jim Moeller believes it is “unfortunate” that Medicaid covers narcotic painkillers but not alternative treatments.

However, there are signs this may be changing. From a recent press release, starting in July of 2012 the 13,000 employees of Maricopa County, Arizona will soon have the option of an integrative approach “that embodies the philosophy and practice of healing oriented medicine, addressing mind, body and spirit.”

Specialists who work with patients dealing with pain have told me they support expanding health coverage to include alternative therapies that are less obtrusive and generally more affordable.

On Dec. 16, the Obama administration surprised many by declaring that each state will now be allowed to have greater freedom in what their respective health exchanges will include.

This may be a unique opportunity to include alternative treatments, especially the treatments that already qualify as medical expense deductions for federal income tax purposes. Including alternative therapies in health insurance will make them more accessible to patients who may be struggling to find better ways to manage their pain.

This article first appeared on Blogcritics.

A retired architect, Bill Scott writes about spirituality and health for Blogcritics.org and also serves as the Christian Science Committee on Publication for Washington State.

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