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FDA: All Homeopathic Drugs Illegal (NB - Misleading Title)


Health & Wellness  (tags: Homeopathic Pharmacopoeia of the United , HPUS, FDA, New Drug Approval process )

Evelyn
- 486 days ago - anh-usa.org
Prior to release of FDAâEUR(TM)s guidance document homeopathic drugs didn't need to go through New Drug Approval process, they underwent a different kind of pre-market approval. Homeopathic drugs required a monograph Homeopathic Pharmacopoeia of the US (HPUS)



   

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Evelyn B (63)
Monday January 22, 2018, 4:01 am
FDA: All Homeopathic Drugs Illegal
By anh-usa on January 11, 2018 War On Natural Medicine

But not all will be pulled from the market, yet. Action Alert!

The policy comes in the form of a guidance document, which lays out the FDA’s current position on the regulation of homeopathic drugs.

In the guidance, the FDA says:

Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug;
FDA has not determined that any homeopathic drugs are GRAS/E;
A new drug cannot be marketed unless it goes through the FDA’s approval process;
No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process.

That’s right: in one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally. The guidance explains that the agency will apply a risk-based regulatory approach that will prioritize enforcement actions against:

products with reported safety concerns;
products that contain or claim to contain ingredients associated with potentially significant safety concerns, e.g., belladonna or strychnine;
products for routes of administration other than oral and topical, e.g., injectable and ophthalmic products;
products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions, e.g., cancer, heart disease and opioid addition;
products for vulnerable populations, e.g., children; and
products that are deemed adulterated under FDC Act § 501, e.g., do not meet standards of quality, strength or purity as required under the law.

The FDA also says that it recognizes that many homeopathic drugs fall outside of these categories and does not intend to take action against such products at this time, but the writing is on the wall. If it wants to, the FDA could go after any homeopathic drug currently on the market.

Is this level of regulatory scrutiny necessary? No. Although prior to the release of FDA’s guidance document homeopathic drugs did not need to go through the New Drug Approval process, they underwent a different kind of pre-market approval. Homeopathic drugs traditionally required a monograph from the Homeopathic Pharmacopoeia of the United States (HPUS), which involves clinical verification of the efficacy of the substance.

FDA’s process started two years ago, when the agency held a public hearing to evaluate its enforcement policies for homeopathic products. We suspected the agency was planning to tighten its grip on homeopathy, which, after all, competes with the pharmaceutical drugs that fund the FDA.

We cannot let the FDA eliminate consumer access to homeopathy.


Action Alert! Write to the FDA and tell them that previous rules were sufficient to regulate homeopathic products, and this new proposal threatens the future of homeopathy. Please send your message immediately.
 

Evelyn B (63)
Monday January 22, 2018, 4:05 am
A slightly different version:
Food And Drug Administration Plans Crackdown On Risky Homeopathic Remedies

December 18, 20172:26 PM ET
Heard on All Things Considered
Rob Stein

Updated at 4:17 p.m. ET to include comment from homeopathic pharmacists.

The Food and Drug Administration said it plans to crack down on the sale of some homeopathic products.

The agency unveiled a new, risk-based approach to regulating homeopathic treatments Monday that aims to protect the public from dangerous products.

"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," FDA Commissioner Scott Gottlieb said in a statement announcing the new policy.

"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," Gottlieb says.

Homeopathy is an ancient practice based on the idea that small traces of substances that cause diseases can actually be used to treat illness. But critics have long charged that there is no scientific evidence to support homeopathy and that some homeopathic products could be dangerous.

Critics have been especially concerned about products being contaminated with dangerous substances, or sold for serious conditions for which other, proven treatments work.

The FDA has issued warnings about specific products in the past, and the Federal Trade Commission has required better labeling of homeopathic products.

But over the past decade, the homeopathic drug market has grown "exponentially," according to the FDA, becoming a nearly $3 billion industry in the United States.

The FDA has seen a "corresponding increase in safety concerns, including serious adverse events" resulting from homeopathic products, the FDA says.

In response to the growth and continuing concerns, the FDA convened a public hearing to revisit a 1988 decision not to regulate homeopathic products like standard medical treatments.

Under the new policy, the FDA will more carefully scrutinize these products, especially those sold to treat infants and children, those containing ingredients with significant safety concerns, such as belladonna, and those sold for serious conditions such as opioid addiction, heart disease and cancer.

"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," Gottlieb says.

Mark Land, president of the American Association of Homeopathic Pharmacists, said in an email that the group "shares the FDA's commitment to protecting public health," and noted the action "would not materially affect the vast majority of homeopathic drug products available in the United States."

"As always, AAHP is committed to ensuring that consumers have access to natural, safe, homeopathic medicines in the United States and throughout the world," Land said.

During a briefing for reporters about the proposed new policy, FDA officials stressed that the agency had no intention of requiring most homeopathic products that are on the market to undergo formal FDA review, however, or to remove most homeopathic products. So people who believe such products help them will still have access to many of them, the officials said.

The proposed policy will be open for public comment for 90 days. The agency will review the comments before making the policy final.

The agency's move was praised by long-term critics of the industry.

"I think that it's about time that these snake oil salesmen were held accountable for what they're selling," says Paul Offit, a pediatrician at the Children's Hospital of Philadelphia. "The consumer will clearly benefit."
 

Sheryl G (359)
Monday January 22, 2018, 4:10 am
It is a mess over here. People with no health insurance can't afford medications and resort to these type of things as well as some people by choice prefer them.

Also the Trump Administration just passed some bill that allows those of religious beliefs to not treat patients in certain medical procedures if it goes against their religious beliefs.

That is opening up a whole door of non treatment of women seeking safe abortions and even obtaining birth control. Transgender patients will be turned away and even those who are known to be gay. Also in the past, there were people who used religion to turn away people of a different skin tone than theirs, or a Christian may refuse to treat a Muslim and opens the door for vice versa.

Bottom line.......Instead of the USA making it more easy or affordable for more people to obtain health care it is pushing forward with making it a lot harder.
 

Nita L (127)
Monday January 22, 2018, 4:11 am
Signed and shared.
Thank you Evelyn.
 

Evelyn B (63)
Monday January 22, 2018, 4:19 am
I think I'd rephrase that last line ...

"The big pharmaceutical companies will clearly benefit."

Because, while I recognise that homeopathic medicine doesn't have the same tightly controlled (in principle ... at least) scientific testing that allopathic medicine goes through, it has clearly shown its value ... around the world.

And NPR's use of "ancient practice" seems to me to be pushing the idea of "old wives' tales" - rather derisory.

It dates from the 18th century - almost 19th century (1796)

BUT - what is perhaps needed is good guidelines on dosage, because there are people who think - homeopathic is safe, so one is taking no risk ... - and that's not wise.

I just wish they'd pay a little more attention to what Monsanto & Bayers & similar companies put out
And more attention to what goes in to new vaccines ...

It's like they want to stamp out little patches of flames in the lawn, while the main house is burning down ...

And as the article says - the door is being opened to "reject" any homeopathic remedies that threaten Big Pharma ...
 

Animae C (508)
Monday January 22, 2018, 4:27 am
INSANITY
Homeopathic remedies are NOT drugs!!!

BIG pharma rules!!!!
 

Animae C (508)
Monday January 22, 2018, 4:27 am

http://www.anh-usa.org/action-alert-protect-homeopathy/

Petition signed & shared.
 

Evelyn B (63)
Monday January 22, 2018, 5:16 am
I wish I could sign, but don't have a US address ... & they ask for details here
 

Darren Woolsey (218)
Monday January 22, 2018, 11:54 am
Hyperlinked AniMae's petition
Protect Homeopathy!
 

Darren Woolsey (218)
Monday January 22, 2018, 11:55 am
Shared the articles AND petition over social media to raise and spread awareness AND encourage signers.
 

Colleen L (3)
Monday January 22, 2018, 1:09 pm
Petition signed. Thanks Evelyn
 

Peggy B (43)
Tuesday January 23, 2018, 9:14 am
TYFS
 

Evelyn B (63)
Tuesday January 23, 2018, 10:55 am
Nita has posted
Action Alert: Protect Homeopathy-Please Sign


Please - note it, even if you've already signed ...
 

Sue H (7)
Tuesday January 23, 2018, 11:49 am
Noted and petition so signed. The FDA allows big pharma drugs on the market that end up killing people. They have no right to pretend this action isn't brought about by big pharma wanting more $$.
 

Kathy B (106)
Tuesday January 23, 2018, 12:13 pm
I would challenge the FDA to a contest, they take a bottle of one of their approved drugs, I'll take a like quantity of homeopathic s the one that gets sick/dies first loses the contest :)
 

Bonnie Lynn M (1)
Tuesday January 23, 2018, 5:18 pm
Petition signed. Thank you
 

Past Member (0)
Wednesday January 24, 2018, 12:29 am
signed, ty
 

Doris F (18)
Wednesday January 24, 2018, 7:25 am
tyfs
 

Richard A (2)
Wednesday January 24, 2018, 9:28 am
Big Pharma strikes again.
When will We The People come to NOT accept that OUR representatives are in the pocket of Big Business?
Thank you for bringing this forward.
 

Eric Lees (6)
Wednesday January 24, 2018, 9:52 am
Abolish the Unconstitutional FDA along with many other agencies.

Give us the facts and let we the people decide what is or is not medicine. And end the war on natural drugs.
 

S J (124)
Wednesday January 24, 2018, 4:01 pm
meowww Evelyn
 
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