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FDA to crack down on “potentially harmful, unproven homeopathic drugs”

FDA to crack down on “potentially harmful, unproven homeopathic drugs”

Most homeopathic drugs will be left alone

https://www.fda.gov/AboutFDA/CentersOffices/ucm557569.htm

Earlier this week, the FDA announced a coming crackdown on “potentially harmful, unproven homeopathic drugs”.

Homeopathic drugs are holistic and said to stimulate the body’s power to heal itself by focusing on the entire picture of health and not only the ailment needing treatment. Some swear by homeopathy, even if there’s little science to back it up.

Unlike agency crackdowns of administrations past, the FDA’s recent announcement aims to protect consumers from snake oil salesman promising untested relief from serious medical issues.

“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,” said FDA Commissioner Scott Gottlieb, M.D. “Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. 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.”

Unlike other drug manufacturers, products labeled ‘homeopathic’ “have been manufactured and distributed without FDA approval under the agency’s enforcement policies since 1988,” according to the FDA.

Most homeopathic products will be left alone — those claiming to help with routine health issues like the common cold, acne, allergies, those types of ailments. But products targeting vulnerable populations will be subject to FDA scrutiny:

The FDA’s proposed approach prioritizes enforcement and regulatory actions involving unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients. Under this approach, many homeopathic products will likely fall outside the risk-based categories described in the new draft guidance and will remain available to consumers. The FDA intends to focus its enforcement authorities on the following kinds of products:

  • products with reported safety concerns;
  • products that contain or claim to contain ingredients associated with potentially significant safety concerns;
  • products for routes of administration other than oral and topical;
  • products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
  • products for vulnerable populations; and
  • products that do not meet standards of quality, strength or purity as required under the law.

Examples of products that may be subject to the enforcement priorities in the draft guidance are infant and children’s products labeled to contain ingredients associated with potentially significant safety concerns, such as belladonna and nux vomica; and products marketed for serious conditions, such as cancer and heart disease.

Homeopathy was a small, niche market for more than 100 years, but in the last decade, the homeopathic drug market has exploded to a nearly $3 billion industry.

“During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks,” says the FDA.

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Comments

DINORightMarie | December 23, 2017 at 3:40 pm

This is the Democrat’s wet dream! They have been gunning to regulate vitamins, homeopathics, etc. since at least the 1970’s, but have been successfully fended off…..apparently till now.

This is more over-reach, an extension of ObamaCare medical-market control.

Bad. Very bad.

    healthguyfsu in reply to DINORightMarie. | December 23, 2017 at 4:14 pm

    Disagree…this stuff is long overdue for oversight since the FDA punted on it.

    If someone is taking an SSRI and takes St. John’s Wort they can easily get serotonin syndrome. Yohimbe bark was on the market for years before the dangers of it came out. Ephedra and caffeine…welcome to increased risk of tachyrhythmia and impending heart attack or stroke.

    It’s simple, if you want to advance alternative medicine, do so properly through the research tools we have available today and application of the scientific method.
    Identify the ingredients in these remedies that produce the benefits (or combo of ingredients if necessary), screen them for potential side effects, and perform careful trials in both humans and model organisms. Anecdotal evidence and an endorsement from a Caribbean med school doctor trying to grab money before the lawsuits come down is neither ethical nor prudent.

    It’s about time …

    This is the Democrat’s wet dream! They have been gunning to regulate vitamins, homeopathics…

    Maybe a statist’s dream, but not necessarily only Democrats. Every single person I know who uses homeopathic remedies is a diehard liberal and reliable Democrat vote, and likely to see this crackdown as an Republican assault on public health.

    Vitamins and supplements are a whole other matter. Users run across the political spectrum. And the little matter that both prescribed medications and non-prescribed supplements can have different effects on different people.

    Take a common one- iron. I routinely advise all my friends and relatives who are male or post-menopausal to avoid any multivitamin that includes iron. Iron is good for you- and very very bad for you if there’s too much in you. (Look up hemochromotosis.) I also advise everyone I know to give blood as frequently as possible within Red Cross guidelines for the specific purpose of lowering the body’s iron load since flour, bread, and all sorts of commonly consumed items are iron fortified. There is almost no childhood anemia in the U.S. because of this. I attribute the rising rates of diabetes and other high iron related diseases in the older population to this. Science hasn’t gotten around to agreeing with me yet. But my primary doctor does after I explained it to him. I know exactly one male, a few years younger than me, taking iron supplements by doctor’s orders. He has trouble absorbing dietary iron. The average male doesn’t.

    Fiber supplements would likely be regulated under the FDA if they were given a chance. I was taking fiber supplements since it’s well known that various types of fiber aid in reducing cholesterol Zero effect on me. Then I looked up and actually read the studies on fiber- and discovered that the dosage I was taking- as label recommended on the most popular forms of psyllium (Metamucil and copycats) wasn’t near enough. By vastly increasing my fiber intake through supplements, including psyllium without added sugar, in the last 6 months my cholesterol finally dropped from 236 to 202. That’s significant, and without the side effects of statins, the approved medicinal therapy. There is a minor side effect of copious amounts of gas.

    What do I rely on for supplement information? Two sites most often. WEBMD.COM and EXAMINE.COM. There are a number of highly touted supplements I haven’t purchased after checking the effectiveness matrix on Examine or the side effects on Webmd.

Not promising. This has the usual Official Government-Issue Screwup printed all over it. It’s camouflaged in saccharine and mildly beneficent language, but it’s still governmentese, and probably thoroughly treacherous.

products that contain or claim to contain ingredients associated with potentially significant safety concerns;

Sounds harmless, right? Except when you remember California—

WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.

Not too many things don’t have this dire warning attached. Hey, Fruits and Nuts, right? No problem if you don’t live in California. But the next step is obvious; the FDA adopts California’s definitions, and then it has all the excuse it needs to regulate everything. A bureaucratic empire-builder’s dream.

I can think of a whole raft of things the FDA can aim its firepower at, all of them much further up the list than this.

Or, just for the hell of it, we can head back to a government of enumerated and limited powers. That Constitutional Article 1, Section 8 stuff. Some people not too long ago thought that was a good idea.

Oh, gosh, what great news! I am so glad that the feds are redoubling their efforts to idiot-proof the world! Where ever would we be without NannyState to make decisions for us?

They’ll take my Zicam from my cold, dead, nostrils.

Morning Sunshine | December 23, 2017 at 6:29 pm

sorry, while I might be convinced that alternative meds need some cleaning out, the FDA is not the body I trust to do it. They are a revolving door of drug and food industry personnel that green light what they are paid to do and stop that which has no funding. Actual research is ignored or not done because no one is paying for it to pass.

Seems a good place for it:

Did anybody hear about the homeopath who forgot to take his medication in the morning and died of an overdose?

(Because homeopathic drugs are just diluted and diluted… Oh, well. It was funny at one time.)

Herbal remedies are still drugs. And, drugs all have side effects. Most herbals, if taken in low doses, do produce positive results, for specific symptoms, and few negative side effects. The problem is people. Many people believe that with non-prescription drugs, more is better. However, they have no understanding of the potential for negative side effects and no knowledge of what dosage constitutes an overdose. People have inflicted significant, permanent liver damage on themselves with Tylenol [acetaminophen].

As herbal remedies become more aggressively marketed, the number of cases of negative side effects increases. Also, the problems of drug interaction increase. And, some study should be given to these problems.

All that being true, the nature and scope of the FDA’s intrusion into this areas has to be watched closely. There is a very real chance that this “regulation” may be used to eliminate competition to established drug manufacturers and practitioners of certain medical procedures. We’ll just have to watch what happens.

Thane_Eichenauer | December 24, 2017 at 3:34 am

It is past time to cut the FDA budget by 75%.

Homeopathic “remedies” by definition can’t be harmful, for the same reason they can’t be helpful: there’s nothing significant in them. They’re just pure water or alcohol.

    Except that doggedly attempting to treat a curable disease with a homeopathic remedy might delay the afflicted seeking tried and tested medical treatment. Everyone can make their own choices, but if the sufferer is unaware of effective medical treatments or the sufferer is a child, the ethics get very difficult.

Because I trust a government entity which approves drugs and treatments which later may prove to cause cancer, internal bleeding, fatal allergic reactions, etc and for which the ambulance chasers can now go after the pharmaceutical companies that make them. Cha ching!

“Herbal remedies are still drugs. And, drugs all have side effects.” BUT if they’re truly homeopathic then they’ve been diluted to the point where a retail-size bottle might not contain even one molecule of the remedy.

The supplements and homeopathic remedy business is a medicine show; nonetheless, Congress has chosen to give FDA scant if any authority to regulate it.

If FDA wants some sort of “safe and effective” requirement for these products, along with the authority to do something (anything) other than whine if these are not met, then it really needs enabling legislation. Without that, it will surely get its toes stubbed.

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