Editorial – The FDA Protecting the Public

Written by Alan V. Schmukler

Nov 2019 Editorial – The FDA Protecting the Public

Since 1988, The U.S. Food and Drug Administration (FDA) has regulated homeopathy based on Compliance Policy Guide (CPG) § 400.400.  This policy basically oversaw good manufacturing practices. Recently the FDA introduced a new set of rules (Draft Guidance), which was essentially a tool for suppressing homeopathy. It allowed public comment on the rule which resulted in thousands of comments supporting homeopathy and disparaging the new rule. The FDA then withdrew that Draft Guidance and substituted it for another one equally draconian.

This new Draft Guidance would crack down on:

  1. Products that contain ingredients “associated with potentially significant safety concerns.”
  2. “Products for vulnerable populations (e.g., children, the elderly, pregnant women ).”
  3. “Products intended to be used for the prevention or treatment of serious… diseases.”

4.“Products with reports of injury…”

To give you an idea what this looks like in practice, here’s an excerpt from a letter the FDA recently sent to a long-established homeopathic pharmacy, telling them what violations they’ve committed:

“Your homeopathic drug products are indicated for treating conditions in infants and children, and they are manufactured from ingredients such as Nux vomica, Belladonna, Aconitum napellus, and Gelsemium sempervirents that pose potentially toxic effects. For example, Nux vomica contains strychnine. Strychnine is a highly toxic, well-studied poison that is used as a rodenticide.”

Forbidding remedies for infants and children misses the whole point. Homeopathic remedies are often used for children precisely because they are safe, and their use helps avoid toxic prescription drugs. The same goes for pregnant women and the elderly. Also, citing the ingredients homeopathic remedies are derived from, ignores the fact that anything toxic is removed during the potentization process. If the FDA can prevent the sale of remedies derived from toxic substances, that would include most all homeopathic remedies.

The FDA wants to forbid remedies “intended to be used for the treatment of serious or life-threatening diseases.” Imagine that a patient has an antibiotic resistant infection and is dying, but a homeopathic doctor won’t be allowed to prescribe Pyrogenum, Lachesis, Arsenicum, Anthracinum, Crotalus or any other, indicated, life-saving remedy.

The FDA guidelines would also stop homeopaths from using remedies to prevent disease, another area where homeopathy has repeatedly proven its effectiveness. In Cuba in 2007, 2.3 million people were inoculated with the homeopathic nosode of the disease Leptospirosis. This resulted in a large reduction in the incidence of Leptospirosis and control of the epidemic. In India, homeopathy has successfully been used for hundreds of thousands of people to prevent cholera, the H1N1 influenza, chickenpox, Japanese encephalitis, dengue fever and chikungunya.  The FDA would forbid that in the U.S., favoring high cost, often ineffective or dangerous pharmaceuticals.

The FDA would also ban remedies when someone reported an injury, even if it were never verified as being due to a remedy.

The FDA also warned a manufacturer of homeopathic remedies for pets that their products were:

… intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under… the Federal Food, Drug and Cosmetic Act….  Further, these products are unapproved new animal drugs and marketing them violates the FD&C Act.”

To summarize, the new Draft Guidance would make virtually all remedies vulnerable to being banned, and prohibit their use for the young, the old, the seriously ill, and even your dog or cat. There you have it, the FDA protecting the public from safe, effective, affordable healthcare.

You can submit constructive comments to the FDA regarding the new Draft Guidance by going to:   https://homeopathychoice.org/fdacomment/


November 2019 –  In this issue:


– The FDA Protecting the Public –  Alan V. Schmukler

–– Feedback Letters from October 2019 – Hpathy.com


Dr. Álvaro Sierra Máyer is interviewed by Katja Schütt.  Dr. Máyer is founder, of the Community, University and Hospital “REMAD”, Hidalgo, Mexico, where the Integral Homeopathy Course is offered.


–– Vignette on Cancer, “Oh, they were so nice, everybody loved them!” – Allyson McQuinn

–– Distorted media How the Media Subverts Alternative Medicine – Gill Graham

–– The Soul of Remedies -Anhalonium – Dr. Rajan Sankaran

–– Remarkable Short Stories – Cases to Remember Part III – Dr. Subrata K. Banerjea

––  The Benefits of Alternative and Complementary Therapies in Veterinary Medicine – Gill Graham

–– A Systemic and Ecological Basis for Homeopathy – Dr. Kenneth Silvestri

––  DYS CO Bowel Nosode – Dr. Gaurang Gaikwad

––  A Homeopathic View of Dysmenorrhoea by Cross Repertorizaton –  Drs. Rajeev Saxena, Sonal Sinha, Pooja Jain, Seema Gupta

–– QUESTIONS PATIENTS ASK – 25  –    Elaine Lewis

–– TIPS & SECRETS – Alan V. Schmukler


–– B-Cell Lymphoma in a Man of 25  – Aadi Chimthanawala

––Pancreatitis in a Man of 63 – Dr. A.P. Sivakumaran

–– GERD in a Man of 40 – Dr. Ranjini Venkatanathan

–– Pseudofoster Kennedy Syndrome -Dr. Vasudha Jij

–– Atopic Dermatitis/Allergic Bronchitis – Dr. Vivek R. Ghadage

––  Anxiety and Insomnia in a Woman of 38 – Fiona Chaff

––  Ulcerated Toe in a Man of 60 – Dr. Parinita Srivastava

––  Acute Dacryocystitis in a Woman of 49 – Dr. Sandeep Sathye

–– Ureterolithiasis in a Man of 52 – Drs. Gaur Shruti / Sharma Bhawani Shankar

–– Ileocolitis in a Woman of 38 Dr. Sarita Dev Bhatia

–– Venous Ulcers – Saritha Agarwal

–– Corns in a Woman of 19 – Dr. Jitesh Sharma

–– Asthma in a boy of 7 – Dr. Ami Bhayani


Organ Diseases of Women; Notably, Enlargements and Displacements of the Uterus and Sterility, Considered as Curable by Medicines by Dr. J. Compton Burnett is reviewed by Dr. Walter M. James, MD.


–– ASK THE HOLISTIC VET – November 2019 – Dr. Deva Khalsa


–– CROSSWORD November 2019 – Alan V. Schmukler


–– Cartoon    –  Double Talk  –  Alan V. Schmukler


––  Maria’s Nightmare – Elaine Lewis

––   Revisiting: Would You Be Sad If I Hung Myself? –  Elaine Lewis, Shana Lewis


–– THE PLANT DOCTOR – October 2019 – Radko Tichavsky

About the author

Alan V. Schmukler

Alan V. Schmukler is a homeopath, Chief Editor of Homeopathy for Everyone and author of ”Homeopathy An A to Z Home Handbook”, (also in French, German, Greek, Polish and Portuguese). He is Hpathy’s resident cartoonist and also produces Hpathy’s Tips & Secrets column and homeopathy Crossword puzzles each month. Alan is a recipient of the National Center for Homeopathy Martha Oelman Community Service Award. Visit Alan at his website: Here.


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