The FDA and Their Attempts Against Homeopathy – A Call To Action

The FDA is changing things, as they say, because they have seen a, “Large uptick in products labeled as homeopathic.” They go into detail in their Compliance Policy Guidance Manual saying, “The homeopathic drug market has grown to become a multimillion dollar industry in the United States, with a significant increase shown in the importation and domestic marketing of homeopathic drug products.”

On December 18th, 2017, the FDA made an official announcement, in what they call Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry, a draft document. They claimed to be creating new risk based enforcement priorities to help “protect” people from homeopathy, even though the FDA had already previously approved homeopathy as medical support, causing cure. In a press announcement, they reported, “FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients.”

The FDA Nonbinding Recommendations begins with background information on the topic saying, “In 1938, when the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted, the bill’s senatorial sponsor, Dr. Royal Copeland, himself a homeopathic practitioner, added a provision to the law recognizing the Homeopathic Pharmacopoeia of the United States (HPUS) alongside its counterparts, the U.S. Pharmacopeia and the National Formulary.3. Recent years have seen an increase in the sale of products labeled as homeopathic. In the past, these products were mostly prepared by homeopathic physicians for individual patients. Today they are frequently mass manufactured and widely marketed as over-the-counter (OTC) products.”

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Their solution, they created a document, which they say, “This document provides guidance on the regulation of OTC and prescription homeopathic drugs and delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S. Agency compliance personnel should particularly consider whether a homeopathic drug is being offered for use (or promoted) significantly beyond recognized or customary practice of homeopathy.”

Homeopathy was formulated in the 1700s by Samuel Hahnemann. It is the true definition of a traditional practice. 

“It seems to me as though the FDA wants to create confusion in the marketplace so that then homeopathic pharmacies and manufacturers, they’re commissioned to make mistakes. So then the FDA can say, look you guys are making all theses mistakes, let us regulate this for you – and that is how we lose our freedom with homeopathy,” says Paola Brown, the President of Americans For Homeopathy Choice. Poala is a firm believer in homeopathy both because her grandmother used it and credits it with the only thing that resolved her health issues after doctors provided options that didn’t resolve her Interstitial Sinusitis, an autoimmune disease where the bladder bleeds internally. “There are nano molecular levels of homeopathy in that homeopathic preparation. That is what is simulating the healing. We see that homeopathy is nontoxic, by definition. It stimulates that period of action.”

We’ve already see the FDA take action by removing Hyland’s Teething Tablets and Hyland’s Nighttime Tablets from the store shelves in April of 2017. Due to investigations and FDA concerns, Hyland’s had stopped making and shipping these products in October of 2016, the previous year. Standard Homeopathic Company  made the recall which happened due to the FDA’s conclusion, “That the medicines have been found to contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products’ labels.”

Belladonna is a deadly nightshade, which, when used in homeopathic remedies higher than a 15x, doesn’t contain a single atom of the deadly nightshade, however, is reported to contain the powerful energy of the product. Belladonna is most often used for situations which are red, hot, restless, cold or flu, earaches, high fevers, congestive headaches, sleepy conditions where the person can not sleep and throbbing pains, as well as others. In situations where belladonna is used, the person is generally better when standing or sitting tall. Motion, noise and light make them feel worse. 

Regarding belladonna, the FDA said, “FDA believes that belladonna represents a serious health hazard to children and that the effects of belladonna are unpredictable. The Agency has stated to the Company, ‘There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it’.”

“The FDA believes….” apparently holds a lot of power. Stepping stones are used for a reason.

Medical Doctor Maesimund Panos, and Jane Heimlich wrote the book Homeopathic Medicine At Home, published in 1980. They say, “The power of the infinitesimal dose is not clearly understood, but neither is the action of aspirin and many other drugs. The process of potentization makes it impossible to use substances such as certain metals, charcoal, and sand, which are inert in their natural state, as medicines. A potentized remedy does not contain sufficient matter to act directly on the tissues, which means that homeopathic medicine is nontoxic and cannot cause side effects.”(p 12).

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The belladonna in the teething tablets from Hyland’s were a 3x potency.

More importantly, they go on to say, “In over 150 years of (commercial) use (thousands of years of traditional use), no homoeopathic remedy has ever been recalled.”(p 13). That is until pressure was put on the production of teething tablets, which had been successfully used for years. 

When a public retail business online was asked about what the current FDA position, they said, “It’s a worry.” (Business name withheld due to obvious reasons).

When a private retailer who supplies practitioners with product was asked about the issue, they said, “Due to the Hyland’s issue with the teething tablets, FDA will monitor closely what they consider ‘higher risk’ homeopathic remedies. Mostly this is going to affect, if at all, few remedies that are sold directly to consumers on retail outlets. Manufacturing standards are high mainly due to HPUS, so manufacturers that comply with HPUS and FDA guidelines and regulations, should not have any issues. On the contrary, manufacturers that do not comply with current regulations will be in serious problems.” (Business name withheld due to obvious reasons).

The classification of homeopathic remedies are what the FDA considers OTC pharmaceuticals (over the counter) since they have previously reviewed by the FDA, suitable remedies. The word remedy is only used by the FDA when a product remedies symptoms. It is not a term used lightly. OTC pharmaceuticals are required to follow many FDA and HPUS regulations. 

The December 2017 draft document from the FDA is a draft, not for implementation. It says, “Homeopathic drugs are subject to the same regulatory requirements as other drugs. The FDA has not reviewed any drug products labeled as homeopathic under the OTC Drug Review, because the Agency categorized these products as a separate category and deferred consideration of them. There are no drug products labeled as homeopathic that are approved by FDA.”

In the document, the FDA is suggesting reexamination of its enforcement policies saying, “FDA has determined that it is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval, consistent with FDA’s risk-based regulatory approaches generally.”

Regarding the situation, the FDA says they take a risk-based approach saying, “The Agency historically has prioritized compliance actions involving unapproved new drug products that have potential safety risks, lack evidence of effectiveness, are health fraud products, present challenges to the new drug approval or OTC drug monograph systems under the OTC Drug Review, are violative of the FD&C Act in other ways, or that are reformulated to evade an FDA enforcement action.”

The FDA decides. They decide what is good for us, they decide what can be said in marketing a product, they decide if a product can be on the store shelves. They decide. 

At this point, the FDA has decided as “enforcement and regulatory priorities” the, “FDA intends to prioritize enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without the required FDA approval in the following categories: products with reported safety concerns, products that contain or purport 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, products deemed adulterated under section 501 of the FD&C Act.”

Some say, these points can be read to encompass any use of a homeopathic remedy. The situation is still new, and young. The attempt is clearly on the table. 

In historical situations, when business entities, or movements form together and make sure government agencies fully understand the movement, resolution is received and actions cease. These umbrella agencies exist in many business movements, such as the National Association of Realtors representing realtors as a whole, the American Medical Association representing medical doctors as a whole, the American Dental Association representing dentists as a whole, as well as many other organizations. A large governing group creates more control over people, not the original goal of our American settlers, yet they are a powerful voice and movement of money that works. This kind of situation is where we often see these movements work. 

Paola says, “Homeopathy is regulated by the FDA. Herbs are not FDA regulated. Supplements are not FDA regulated, but homeopathy is. There actually is a law under the Food, Drug and Cosmetic act that covers homeopathy, and there’s even the Homeopathic Pharmacopoeia of the United States that defines how the homeopathic remedies are homeopathic remedies. We want these remedies to be regulated and standardized so that when we buy homeopathic remedies from a pharmacy that’s FDA approved, which they all should be, that it’s a good standardized medicine.”

This means when a product says Arnica it just contains that potency of Arnica. 

Paola says, “Thirty years ago the FDA issues something called the Compliance Policy Guide section 400.400, CPG 400.400. This has been a wonderful document. It has ensured the standardization and enforcement of homeopathic manufacturing and marketing. It’s been mutually beneficial for both the FDA and the industry. It standardizes the remedies so that there have been virtually no safety concerns for homeopathy in 30 years. You think the conventional pharmaceutical industry has that track record? Absolutely not.”

The recent concerns over homeopathic remedies come from combined remedies, not single use remedies. 

The document 400.400 hadn’t been updated in 30 years so the FDA revisited it. Paola says, “In 2015, the FDA had this big hearing to update the document. They flew in amazing people from all over the country and even internationally. They brought in Peter Fisher, who is the Queen of England’s Homeopathic Doctor. They logged in 9,000 comments from consumers of homeopathy who expressed their love for homeopathy. They got all this feedback to edit and update this document. What did they do instead? Christmas 2017, they said we’re going to completely pull out and withdraw the CPG 400.400 and instead we’re going to replace it with these super unclear guidelines.”

She thinks this is where they are hoping to introduce confusion in the homeopathic marketplace, so they can step in for regulation. The draft documentation, linked above, is the FDA saying this is what they are doing. The FDA didn’t follow through on updated the 30-year-old document, instead they said, as stated above, “FDA has determined that it is in the best interest of public health to issue a new guidance that applies a risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval, consistent with FDA’s risk-based regulatory approaches generally.”

In the document, the FDA mentions death, however, no deaths have reportedly occured due to homeopathy. In addition, in the document, the FDA use the word potential 12 times and the word risk 17 times. They even say rat poison in used, even though no rat poison is in the homeopathic remedy. Scare tactics such as these are unfair and ridiculous. 

Paola recommends , a call to action, going the site homeopathychoice.org, as your call to action. They are currently trying to give their voice on homeopathy to the President of the United States of America. She says, “He’s the one who put Scott Gotleid as the head of the FDA and he’s in the position to check the FDA. We want to have a meeting with him, I have a (homeopathic) kit right with Melania’s Trump name on it, I want to gift it to her because I think every mom needs a homoepathy kit. We’re trying to bring this to his attention.”

*Nourishing Plot is written by Becky Plotner, ND, traditional naturopath, CGP, D.PSc. who sees clients in Rossville, Georgia. She works as a Certified GAPS Practitioner who sees clients in her office, Skype and phone. She has been published in Wise Traditions, spoken at two Weston A. Price Conferences, Certified GAPS Practitioner Trainings, has been on many radio shows, television shows and writes for Nourishing Plot. Since her son was delivered from the effects of autism (Asperger’s syndrome), ADHD, bipolar disorder/manic depression, hypoglycemia and dyslexia, through food, she continued her education specializing in Leaky Gut and parasitology through Duke University, finishing with distinction. She is a Chapter Leader for The Weston A. Price Foundation. becky.nourishingplot@hotmail.com

“GAPS™ and Gut and Psychology Syndrome™ are the trademark and copyright of Dr. Natasha Campbell-McBride. The right of Dr. Natasha Campbell-McBride to be identified as the author of this work has been asserted by her in accordance with the Copyright, Patent and Designs Act 1988.