What’s Going On With the FDA & Homeopathic Eye Drops?
PART 1
What is a homeopathic medication?
The central principle behind homeopathy is that the more times an active ingredient is diluted in a liquid, the more powerful the resulting liquid. Homeopathic ingredients are believed to work on a ‘vibrational’ or ‘energetic’ level.
Homeopathic ingredient strengths are given in units of X or C. A higher number indicates greater dilution, corresponding to greater activity. A good explanation of homeopathic medicine can be found here.
Because homeopathic drugs start from raw materials (plant, animal and mineral) which are ground and then diluted, there is no guarantee as to the consistency of any one ingredient from batch to batch. The active ingredients in a typical homeopathic eye drop refer to plants (such as Euphrasia, or eyebright) or metals (such as mercurius sublimatus, or mercury) as opposed to individual ‘chemical’ ingredients.
Many homeopathic eye drops are marketed as preservative free. Preservative free products are susceptible to bacterial contamination during use if packaged in standard multi-dose bottles. A homeopathic eye drop label may state “discard after 30 days,” but this does not prevent significant contamination from occurring during this time. Consumers are often reluctant to throw out a ‘mostly full’ bottle of eye drops after 30 days.
Some homeopathic eye drops may have a silver-containing ingredient listed as a preservative. Silver in any form is not a modern eye drop preservative. Silver’s principal ophthalmic use was as a preventive treatment for eye infection in newborns (as silver nitrate), but this use was stopped many years ago due to toxicity and lack of effect.
Silver that contacts the surface of the eye can cause argyrosis, which is a permanent dark discoloration of the conjunctiva. This generally requires contact with a significant concentration of silver over a long period. Since colloidal silver and silver nitrate eye drops fell out of use, argyrosis is mostly a historical curiosity (although it can also occur with environmental exposure to silver).
PART 2
The FDA’s history with homeopathic eye drops
In 1988, the FDA said Yes to marketing homeopathic eye drops.
In 2019, they revoked the Yes.
In 2022, as previously announced, they started to enforce the revocation.
In 2023, they started taking significant action against the manufacturers and distributors who had ignored them all this time.
And you might be thinking, how is a Warning Letter “significant action”?
It’s not like the FDA is the IRS, right? Can it throw you in jail?
The FDA is bound by law to follow certain administrative processes when dealing with manufacturers and distributors of prescription and OTC drugs. One critical process is the Warning Letter. Warning Letters usually go out after months of pissy back and forth correspondence, and possibly an FDA manufacturing facility inspection.
Warning Letters (which are always publicly viewable, unlike Untitled Letters and Form 483 inspection reports) contain words and phrases like “seizure,” “injunction” and “detention without examination.”
Between September 11 and September 12, 2023 the FDA published six Warning Letters to makers of homeopathic eye drops, with a total of 34 products between them.
The Warning Letters have several consistent themes.
PART 3A
Theme: Unproven drug product claims
First, all the products made unproven drug product claims. A few examples of the numerous and creative drug product claims are reversing cataracts; decreasing floaters; and increasing production of the aqueous and mucin layers of tears.
What kind of drug product claim does not require proof? The OTC Ophthalmic Monograph stipulates in detail OTC eye drop claims that do not require proof through clinical trials. Without realizing it, you have been reading Monograph language every time you read an OTC dry eye drop box. If you think about it, you’ll realize that OTC eye drops typically describe relief of a symptom such as dryness or irritation, not treatment of a disease or condition.
The FDA is particularly touchy about OTC eye drop therapeutic claims regarding potentially blinding diseases. It deeply frowns upon unproven claims that relate to changing the structure or function of any part of the eye – for example, increasing aqueous production or mucin secretion. Reducing inflammation is definitely a drug product claim.
PART 3B
Theme: Frankenstein eye drops
Here at the Foundation, we have coined the term Frankenstein eye drop to mean a preservative free eye drop packaged in a bottle (any bottle) that does not have a multi-dose preservative free dropper.
Following the EzriCare tragedy earlier in 2023, the FDA recognized that “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”
Translated, this means that if you swallow a contaminated product, stomach acid and other components of your digestive tract have an opportunity to kill bacteria or otherwise deal with impurities. If you rub a contaminated or impure ointment on your skin, you are likely to notice irritation or infection, make the connection to the ointment quickly, and get swift treatment. If nothing else works, doctors can always cut out a goodly chunk of your rotting skin and graft it later. Not so the cornea. The surface of the eye is especially vulnerable and difficult to repair.
Interestingly the FDA has long classified intranasal administration of homeopathic medications as riskier, probably because significant absorption of ingredients into the bloodstream can occur via the nose (see “snorting cocaine”).
Anyway, the FDA is exercised over the fact that most homeopathic eye drop manufacturers, selling to “I want natural products” consumers, do not befoul their energetic liquids with anything so evil as a preservative.
The FDA has specifically called out the use of silver-containing ingredients as preservatives for being a) potentially harmful, and b) unproven as effective in killing bacteria or fungi.
PART 3C
Theme: Are those rat droppings?
This brings us to FDA inspections. The Warning Letters that reference manufacturer inspections had many bad things to say, in very dry language.
I do not want to translate too much of the technical jargon, except to explain two critical concepts: aseptic processing and the media fill.
Aseptic processing refers to the fact that the entire eye drop manufacturing process must ensure that all the ingredients and packaging components (bottles/caps/lids) start sterile, and that no manufacturing step introduces contamination. A general principle of aseptic processing is that the more often a human is involved in the process, the more likely it is that contamination will occur.
To prove that your facility has its aseptic act together, the FDA requires that a liquid called media, which bacteria and fungi love to live in, be run through every step in the manufacturing process. The media is then evaluated for evidence of bacterial and fungal growth. A media fill must happen three times successfully – with no growth – before the “fill line” (the term for all the equipment, start to finish, and all the processes, start to finish including those that require humans) is certified as ready to manufacture the actual eye drop.
Manufacturers can beat, cheat and ignore the media fill process by skipping steps during the media fill that normally take place during eye drop manufacture; by repeating the media fill without figuring out why the first run failed, and getting lucky on a clean run; or by having no idea what a media fill is and never doing one (not making this up).
If Global Pharma Healthcare Pvt Ltd had been doing media fills properly and not shredding bad news, it might have realized that it had a Pseudomonas contamination problem. This is the purpose of media fills.
For the curious and tech minded, see the Global Pharma Form 483 (unfortunately heavily redacted).
Back to the homeopathics…preservatives are the last line of defense against contamination during manufacture. Multi-dose preservative free bottles don’t protect you if the liquid in the bottle is already contaminated.
If you’re going to manufacture a preservative free eye drop, you need to have impeccable form in your aseptic processing. You need to prove it through properly conducted and meticulously documented media fills.
I was startled to read that a Swiss homeopathic eye drop manufacturing facility was cheating on media fills by skipping steps, as well as failing to check every bottle for particulate gunge. Their reason for skipping the gunge check: took too long. If there were ever a product prone to particulate gunge it would be a liquid containing ground up plants.
PART 4
What this means for you
Some of you reading this blog may have been using homeopathic eye drops for years without any complications.
If you are a believer in the “energy” concept of homeopathy, you must also believe that every crop of eyebright will yield the same amount of energy regardless of growing conditions. You also need to have faith that there isn’t any actual mercury in that bottle, only mercury energy.
Or, you may be using a homeopathic eye drop as a non-irritating glorified saline.
I’m not going to argue with your individual experience either way. I’m here to let readers know that manufacturers of homeopathic eye drop cannot scientifically control their ingredients, because their ‘ingredients’ are plants and minerals that are ground up and diluted and these are not controllable raw materials. This concern is equally true for people who want energy vibrations in their eye drops, and people who don’t even know what homeopathy means.
Before 2023, who would have agreed that OTC eye drops could blind you or kill you? No one. When the Foundation posted its Frankenstein eye drop video on biologiceyedrops.org in May 2022, it got a big yawn.
Now, there is a greater understanding that an OTC eye drop can blind and / or kill you. Yet many thousands of people used EzriCare artificial tears and only 28 of them ended up with vision loss or dead. Why don’t we call that a good stat? Because the number is supposed to be ZERO.
If you wouldn’t use EzriCare eye drops today, why would you use a preservative free homeopathic eye drop in a standard bottle tomorrow? It takes just one bad batch and the contaminated bottle ends up in your hand, and thus in your eyes.
This concern is equally valid for homeopathy believers and for the “it’s just saline” consumer. Germs are germs and extremely dilute flower extracts won’t kill them.
Maybe the Swiss manufacturer should add this to their label Warnings section: Check for sediment before using.
Sandra Brown MD
Medical Advisor, The Dry Eye Foundation