W

ASHINGTON — U.S. health officials plan to crack down on a growing number of unproven alternative remedies, focusing on products containing dangerous ingredients that have occasionally been linked to serious injury and death.

The Food and Drug Administration on Monday issued a new proposal for regulating homeopathic medicines that have long been on the fringe of mainstream medicine. The agency plans to target products that pose the biggest safety risks, including those marketed for children or for serious diseases.

But under the government’s framework, the vast majority of low-risk products would remain on the market.

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Long regarded by scientists as a form of modern-day snake oil, homeopathic products are treated as drugs under law, but not supported by modern science. Most remedies contain heavily diluted drugs, vitamins, and minerals. Popular homeopathic brands include Zicam Allergy Relief and Cold-Eeze.

“We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm,” FDA Commissioner Dr. Scott Gottlieb said in a statement.

Homeopathic products are similar to dietary supplements, in that the FDA does not review their safety or effectiveness before they are sold. But unlike supplements, homeopathic medicines can state that they are intended for specific medical symptoms and conditions, similar to drugs.

A handful of products in recent years have been subject to major safety problems, usually involving potentially toxic ingredients.

Last year, the FDA warned consumers about the risks of teething tablets marketed by Hyland’s Homeopathic after they were tied to seizures and deaths in infants and children. FDA testing later confirmed the products contained high levels of belladonna, also called nightshade, a poisonous herb that has long been used at low dosages in homeopathic medicine. The products were recalled in April.

In 2009, the FDA ordered Zicam to stop marketing three products that contained zinc gluconate after more than 100 users reported losing their sense of smell.

The FDA said its proposal also targets products that claim to treat serious diseases like cancer, or are administered via unconventional routes such as ear drops. The agency will take comments on its proposal for 90 days before beginning to finalize the plan.

Consumer advocates said the FDA plan makes sense for products that are mostly harmless, but can be dangerous if manufacturers stray from traditional ingredients, dosing and manufacturing.

“I think the rules do a good job of going after the things that are most problematic,” said Dr. Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center.

The FDA hasn’t updated its regulations for homeopathic medicine since 1988, when it essentially exempted the industry from basic production standards that are mandatory for traditional drugs, like listing ingredients on product labels.

Since then the once-niche market has grown into a $3 billion industry, according to FDA figures.

Hundreds of homeopathic remedies today are sold alongside over-the-counter drugs like Tylenol and aspirin at pharmacies across the U.S. The National Institutes of Health has said there’s little evidence that homeopathic medicine is effective for treating any specific condition.

— Matthew Perrone

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  • “The agency will take comments on its proposal for 90 days before beginning to finalize the plan” where can I go comment so the FDA will hear what I have to say?

  • Hi
    I have used homeopathic medicines for shoulder arthritis, dyspepsia, although I am allopathic doctor.I found wonderful relief symptomatically since past 7 years n more.
    What FDA has discovered,I fully respect that if indeed cancers,children are likely to suffer,yes those products may be asked for re evaluation from hahneimann labs in Germany and if they confirm futility, maybe withdrwn as per FDA policy
    Thanks

  • Diagnosed with Crohn’s in May 2008. Pursued normal treatment till 2013 containing steroids. Right eye Cataract was operated. Left eye was developing cataract. I switched to homeopathy in 2013. Within 15 days was off steroids and am in remission since without debilitating symptoms able to eat what I want including lactose which I couldn’t tolerate earlier. All you need is a good homeopathic doctor. Denigrating homeopathic regimen betrays ignorance to me. May be motivated by pharmaceutical industrial mafia. My experience shows this should be seriously and sincerely studied. Had it been a hoax how could it sustain this long and still be followed in the modern world.

  • All this from the same people who say that Cannabis has no medical value…?
    Why do I have such a hard time believing these people?

  • Kara, we are very much on the same page.

    The Achilles heel of medicine is state licensing. Almost all the major players owe their livelihoods to one master: the government that controls their educations, gives them a licenses to practice (or to operate in the case of hospitals and insurers), and provides physicians with a near-monopoly over the prescribing of drugs. The client doesn’t even typically pay his/her bills, and so has zero consumer power, zero autonomy. Welcome to the Medical Industrial Complex.

    Have you ever heard of a physician whose license was yanked for overprescribing antibiotics? The independent physicians who dare help people in pain risk even imprisonment.

  • Nicolas,

    Exactly right again! Couldn’t agree with you more. The fact that the medical profession has thrown millions of people in pain under the bus in favor of unsubstantiated “science” or rather cherry picked data and well, let’s call it what it is … pseudoscience is remarkedly self serving. I guess it’s just in keeping with their modus operandi. Huh?

    I do understand self preservation. BUT, when a person chooses a profession where their code of honor/ethics includes first and foremost doing no harm, I’d like to believe that no matter what it takes to adhere to their code they darn well ought to do it. And if that means the possibility of losing their license than so be it! All through history people have lost a lot more to stand up for a lot less. Leaving people to exist in a constant state of torture is supposed to be against our social belief system. And yet physicians have ubiquitously abandoned their patients in exchange for hiding like spineless puppets in the safe harbor of denial.

    • Sorry, I meant to reply to you here. If you haven’t read him, I highly recommend two books by Thomas Szasz I think will interest you. The first is Ceremonial Chemistry, and the second is Our Right To Drugs. Szasz spent five decades warning about the “therapeutic state,” and here we are, completely at its mercy. STAT is one of its PR agencies.

  • No data regarding morbidity and mortality are provided. How risky are “high-risk” homeopathic “remedies” compared to medical errors in hospitals, estimated to kill 250,000 to over 400,000 a year.

    • Exactly right!

      Why isn’t there a Hospital Error “epidemic”!? They talk about an opioid “epidemic” that results in fewer deaths than Tylenol, slips and falls and many, many other things! Crazy!

    • Kara, I’m afraid the reason is old-fashioned self-interest. Physicians have a great deal to lose by admitting their their profession is a leading killer. The same is true for nurses. STAT protects the medical cartel ferociously.

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