FDA Declares Homeopathic Drugs Illegal

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Facts about the Homeopathic Treatment

The statistics of using medications shows that about 5 million U.S. adults and 1 million U.S. children use homeopathy every year. Food and Drug Administration (FDA) follows its campaign of this natural health modality.

In the guidance document in December 2017, FDA gave the best shot to homeopathic remedies, or as they put it in it “drug products labeled as homeopathic. According to the FDA, all of these products are labeled as “new drugs” and are part of FDA enforcement action at any time.

In the guidance, the FDA states:

– Any homeopathic drug that has not been generally recognized as safe and effective (GRAS/E) is considered a new drug;

– New medicaments cannot be marketed unless it goes through the FDA’s approval process;

– FDA has not determined a GRAS/E homeopathic drugs

– No, any producer afford to take homeopathic drugs through the approval process if they haven’t gone through FDA approval

According to FDA, the risk for the patients include:

– Products with reported safety concerns

– Products that contain or claim to contain unsafety ingredients

– Products for routes of administration other than topical and oral

– Products for vulnerable populations

– Products for the prevention or treatment of serious and/or life-threatening conditions and diseases

– Products that do not meet standards of quality, strength or purity according to the law

FTC Targeted Homeopathy in 2016

Besides the FDA, in November 2016, the FTC claimed that homeopathic remedies are effective, but their makers must provide a proof. If the proof is not provided, the remedies must state there is “no scientific evidence that the product works.”

Because of the longtime safety history of homeopathic medicines, the FTC would consider proposing new regulations now. It is clear that this governmental agency is ignoring important scientific evidence, and one must wonder if they are protecting Big Pharma from competition instead of protecting the consumer.

Does Homeopathy Work?

The homeopathy was founded by German physician Dr. Samuel Hahnemann, based on the idea that health conditions can be healed by treating a person with smaller but stronger doses of a substance that would produce similar symptoms to their health condition if given in larger doses.

Homeopathic remedies are made from plants, minerals or other substances and are commonly administered in pellet form. They are used by dissolving them under the tongue. A number of stimulating studies suggest homeopathy as effective and safe for a variety of ailments, including flu. In another study, nearly twice as many patients who were given Oscillococcinum recovered from the flu within 48 hours, like those given a placebo.

According to research homeopathy’s promising role can be seen in the following conditions:

In patients with allergies, homeopathy showed improvements in nasal airflow compared with a placebo group.

– With homeopathic treatment, is seen an improvement in nasal inspiratory peak flow, similar to that found with topical steroids

– Homeopathic treatment significantly reduced the severity and duration of chemotherapy

– Homeopathic medicine effectively treats acute childhood diarrhea with the decreased duration of diarrhea and the number of stools per day

– The positive effects of homeopathy is seen in the children with the attention deficit hyperactivity disorder (ADHD)

– The people with fibromyalgia are treated by homeopathy, which lessened tender point pain and improved quality of life

FDA Continues Protect Big Pharma by Cracking Down on Natural Substances

The FDA’s new push to regulate homeopathic products based on the plant kratom. People have used leaves from the kratom tree for pain relief for hundreds of years, and according to scientists they contain compounds that target the brain similarly to opioids. It is for sure that the plant may be safer than opioids for pain relief.

In November 2017, the FDA issued a public health advisory regarding risks associated with kratom use. They suggested that its usage could “expand the opioid epidemic.”

Concerning to the right to choose what form of “medicine” to put in your body Dr. Lee Hieb, an orthopedic surgeon didn’t advertise any particular over-the-counter remedy, but disagree with the decision given to the FDA to limit what the people can take into their bodies, and at the same time virtually force them to be given what they prescribe.

Dr. Lee thinks that this issue should be of responsibility of commerce and truth in advertising. He actually favors the freedom to research and decides for himself what supplements to take, even if my supplements ultimately do him no good.

The FDA’s new draft guidance on homeopathic drugs attempts to discredit such remedies’ proven healing powers from the beginning.

 

Sources:

– 1 National Center for Complementary and Integrative Health, Homeopathy

– 2, 4 U.S. FDA December 18, 2017

– 3, 7 U.S. FDA Draft Guidance December 2017

– 5, 6 Alliance for Natural Health USA January 11, 2018

– 8, 9 Venable December 22, 2017

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