More than 23,000 Americans end up in emergency rooms each year after taking dietary supplements, an analysis shows. Most cases are linked to weight-loss products or energy-boosting supplements.
From the US Food and Drug Administration
Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You
Watch out for claims like these, which are often used to sell non-prescription health products. You can’t always trust what you read on the label or package—even if it is in a language you know. For more information about these products, visit:
If you buy imported products marketed as “dietary supplements” and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out: Health fraud scams abound. Continue reading
By Kristian Foden-Vencil
Oregon Public Broadcasting
When Portland resident Doris Keene raised her four children, she walked everywhere and stayed active. But when she turned 59, she says, everything fell apart.
“My leg started bothering me. First it was my knees.” She ignored the pain, and thinks now it was it the sciatic nerve acting up, all along. “I just tried to deal with it,” Keene says.
But eventually, she went to a doctor who prescribed Vicodin and muscle relaxants. In 2012, about one in four Oregonians received an opioid prescription – more than 900,000 people. The state currently leads the nation in nonmedical use of opioids. And about a third of the hospitalizations related to drug abuse in Oregon are because of opioids.
Keene says the drugs helped her, but only to a degree. Continue reading
Brooke Gladstone takes a deep dive into media misdirection on health and diet news, and puts together two Breaking News Consumer’s Handbooks to help you navigate the din.
First, an object lesson on bogus studies that make headlines with John Bohannon; how to read health news with Gary Schwitzer of HealthNewsReview.org; and Timothy Caulfield, author of Is Gwyneth Paltrow Wrong about Everything?, explains the science behind celebrity-endorsed diet trends and beauty treatments.
SONGS: Roary’s Waltz – John Zorn; Accentuate The Positive – Syd Dale
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
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.
“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
The 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.
A 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.
The vast majority of clinical trials involving fish oil have found no evidence that it lowers the risk of heart attack and stroke.
FDA warns consumers about the potential health risks of over-the-counter asthma products labeled as homeopathic
From the Food and Drug Administration
The 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
A Consumer Update from the US Food and Drug Administration
“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.
A Consumer Update from the FDA
When 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.”
“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
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.
A 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.
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
For More Information
Related Consumer Updates
By 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.”
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.