The FDA’s New Witch-Hunt

Now they're all-but-banning these trusted medicines

By Janet Levatin, M.D.
Special to Vibrant Life

Do you like freedom of choice when deciding what types of medicines to use for your minor, self-limited illnesses? Those everyday ailments we all experience from time to time?

I know I do.

I want to be able to choose herbs, homeopathic medicines, nutritional supplements, or conventional pharmaceuticals (aka allopathic medicine) … depending on the circumstances.

I have used homeopathy regularly for myself, my family, and my patients for decades.

As a holistic pediatrician and parent, I rely on having unfettered, legal access to the full range of properly-manufactured homeopathic medicines.

A simple over-the-counter solution for minor eye problems

For at least a decade, I’ve relied on homeopathic eye drops for minor eye complaints, including conjunctivitis, commonly called pinkeye.

I’ve also used and recommended them for:

✔️ Allergy-related eye symptoms
✔️ Dry eyes
✔️ Eye strain due to overexposure to computers and other screens.
✔️ Styes

Homeopathic eye drops from six different companies have been sold in the U.S. for decades.

These drops have a stellar safety record.

In fact, there has never been a complaint filed against them for causing side effects.

Similasan, the brand I love using the most, has been sold in the U.S. for 40 years.

Similasan eye remedies were widely available at health food stores and pharmacies like Walgreens and CVS … until recently.

Enter the FDA

At various times in 2023, the Food and Drug Administration recalled dozens of over-the-counter eyedrops, both homeopathic and conventional.

These recalls were for a variety of reasons, including suspected contamination and potential risk of infection.

The FDA has also previously cited companies making homeopathic medicines as in violation of current good manufacturing practices (CGMP).

Some eye drops were recalled.

Other companies were issued warnings.

Homeopathic eyedrops were subjected to both recalls and import alerts that prevented them from being imported into the U.S.

While some homeopathic manufacturers had purported CGMP violations, others with no CGMP violations were also put on an import ban.

It’s important to understand that a CGMP violation does not necessarily mean there is a problem with a product’s quality, safety, or purity.

Certain infractions, such as documents being filed incorrectly or the fact that every bottle of the product was not hand-inspected individually, fall under CGMP violations.

Recalls lead to improved products back on the market

The manufacturers of most of the recalled non-homeopathic eyedrops corrected their CGMP violations, improved the quality of their products, and got them back on the market.

The companies selling homeopathic eyedrops also corrected their violations. However, none of the homeopathic products have been allowed back.

Most people don’t realize that the FDA has not permitted homeopathic eyedrops to return to the American market.

Instead, this government regulatory agency has made a confusing and arbitrary decision to classify all homeopathic medicines as “unapproved new drugs” that are being illegally marketed.

What in the heck is going on?

The legal status of homeopathic medicine

Homeopathy, developed by a German physician over 200 years ago, is a system of alternative medicine.

Homeopathy works by using specially prepared, diluted medicines that assist the body to heal and balance itself.

Hundreds of millions of people around the world have used it safely and effectively for over 200 years.

In fact, the Ontario College of Homeopathic Medicine estimates that today about 500,000,000 people use homeopathy regularly… not a trivial number!

The United States Congress assured that homeopathic medicines would be available to our country’s citizens when they passed the Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, as detailed by the nonprofit organization, Homeopathy Choice.

This legislation recognized homeopathic medicines as a distinct category of medicines—different than conventional pharmaceuticals—due to their safety and the fact that they are usually made from natural sources that can’t be patented. Think plants and minerals.

Most homeopathic medicines are classified as over-the-counter (OTC), which means they are usually affordable and consumers can use them without a prescription.

The 1938 law acknowledged that production of homeopathic medicines should be regulated differently than production of conventional drugs.

While conventional drugs are regulated by standards set forth in the United States Pharmacopoeia (USP) and the National Formulary (NF), Congress recognized the Homoeopathic Pharmacopoeia of the United States (HPUS), founded in 1897, as the appropriate regulatory body to set and maintain official standards for the development and production of homeopathic medicines.

The 1938 law has been amended a few times over the years. However, homeopathy has always retained its special legal status as a distinct category of medicine with its own regulatory body.

Thus, homeopathy has been readily available to anyone who wants to use it.

But that has recently changed.

In the past few years, the FDA decided to arbitrarily target and change the status of homeopathic medicines.

In 2022, the FDA issued a guidance document in which they stated that going forward, they would consider homeopathic medicines as “new drugs” since they have not gone through the same steps to come to market that conventional drugs have.

This categorization applies to almost all homeopathic medicines, even those that have been used safely and effectively since 1938.

This FDA guidance is not a law.

But if it were actually fully enforced, it would mean that all homeopathic medicines would be treated as “unapproved new drugs” that are being illegally marketed.

Here is a quote from the guidance:

“Absent a determination that a homeopathic drug product is not a ‘new drug’ under section 201(p), all homeopathic drug products are subject to the premarket approval requirements in section 505 of the FD&C Act or section 351 of the PHS Act.”

Premarket approval requirements for a new drug are a lengthy and burdensome process.

It can cost hundreds of millions of dollars to bring a single new drug to market.

If homeopathic manufacturers are required to adhere to these guidelines and get each of their products approved as a new drug, it will effectively put an end to the availability of homeopathic medicines in the United States.

What about eyedrops?

So far the FDA has not uniformly enforced their new guidelines when it comes to all homeopathic products.

They have, however, implemented an import alert, which is the equivalent to a ban, on all homeopathic eyedrops.

A few years ago, they did this with homeopathic injectable products, which are still unavailable in the U.S.

Unless the import alert is lifted, homeopathic eyedrops will have no legal pathway to return to the market.

This is to the detriment of consumers.

Many are suffering, and will continue to suffer, because of losing access to the eyedrops.

One manufacturer of homeopathic eyedrops, a small company based in Colorado, called Natural Ophthalmics, had to close their entire business. Even though the company was based in Colorado, the eyedrops were manufactured in the Netherlands.

Others, such as Similasan, a company based in Switzerland, are struggling to stay afloat.

Many of us who benefit from homeopathy are wondering if the FDA will try to get rid of all homeopathic medicines.

What products will they ban next?

The FDA’s explicit mission is “to protect … the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices...”

In other words, the FDA’s job is to monitor the quality of our medicines. Their mission is not to override legislation that Congress has enacted.

As a medical doctor, I am disheartened to see that, instead of protecting the public, the FDA is doing its best to limit the availability of safe and effective medicines that many people rely on and use regularly.

About the author:

Janet Levatin, M.D., is a holistic pediatrician and the medical director of the Hyper Health Wellness Center in Medina, Ohio. She promotes freedom of choice in medical decision-making and advocates for the use of natural alternatives to promote health and wellness. She is currently working on a book called Helping Your Child Get Healthy and Stay Healthy with Dr. Janet’s Natural Alternatives.

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