“Filthy, Putrid or Decomposed” What’s Going On with Homeopathic Eye drops?
Why I Wrote This Blog Post
FDA Warning Letters to homeopathic eye drop distributors:
FDA Warning Letters to homeopathic eye drop manufacturers:
FDA Letters to drug stores selling private label homeopathic eye drops:
*This excludes Ivizia, which is distributed in the US by Similasan but is not manufactured or marketed by this company. I bet Ivizia is regretting its choice of US marital partner.
Part 1: What is a homeopathic eye drop?
Homeopathic eye drops derive their active ingredients from ‘natural’ raw materials such as plants and minerals. These materials are ground, mixed and diluted in a liquid. Rather than individual chemical names, the Active Ingredients information typically lists plants (such as Euphrasia, or eyebright) or metals (such as mercurius sublimatus, or mercury).
The central principle behind homeopathy is that the ingredients work on a ‘vibrational’ or ‘energetic’ level. Another central principle is that the more times an ingredient is diluted in a liquid, the more powerful the resulting liquid.
Homeopathic ingredient strengths are given in units of X or C, and the higher the number the more dilute the ingredient (indicating greater energetic activity according to homeopathic principles). A good explanation of homeopathic ingredient dilution can be found here.
Many homeopathic eye drops state that they are preserved with silver. 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 benefit. The absence of an effective preservative means that nothing kills bacteria, fungus or mold that is introduced during the manufacturing process.
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.
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 both prescription and OTC drugs. One critical step is the Warning Letter. Warning Letters usually are sent after months of pissy back and forth correspondence between the drug distributor and / or manufacturer and the FDA, depending on who’s in the firing line.
The Warning Letter represents the culmination of months of arduous work by beleaguered FDA officials, some of whom had to dumpster-dive in countries with climates that make coastal Louisiana in August seem cool and dry.
Between September 11, 2023 and February 27, 2024 the FDA published seven Warning Letters to distributors or manufacturers of homeopathic eye drops.
These Warning Letters have several consistent themes. Read on.
Part 3, Theme 1: Unproven drug product claims
Homeopathic eye drop distributors are fond of making unproven drug product claims such as reversing cataracts and decreasing floaters. There is no evidence that any eye drop can do these things.
The allowed claims (benefits or effects) that a distributor can make about an OTC eye drop are stipulated in detail in an FDA document called the OTC Ophthalmic Monograph. You read Monograph language every time you read an OTC eye drop box. Allowed OTC eye drop claims 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 problems such as internal eye inflammation, cataracts, glaucoma, and retinal diseases. If a consumer attempts to treat a serious condition with an OTC homeopathic eye drop which is illegally marketed for that problem – such as cataracts – this could delay seeking proper care and potentially lead to a worse outcome.
The Warning Letters to distributors linked above extensively list the unallowed drug product claims for individual eye drop products, as well as taking shots at the contract manufacturers.
Part 3, Theme 2: 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 post a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”
If you swallow a contaminated homeopathic product, stomach acid and other components of your digestive tract have an opportunity to kill bacteria or otherwise deal with impurities. Your gut is a natural defense.
The eye is not the gut. The surface of the eye is vulnerable to infection, and the cornea is difficult or impossible to repair.
The FDA is understandably exercised over the fact that most homeopathic eye drop manufacturers, in keeping with their target “I want natural products” consumers, do not befoul their energetic liquids with anything so evil as a preservative.
The FDA has specifically rejected the use of silver-containing ingredients as preservatives. Silver compounds in eye drops are potentially harmful to the ocular surface. But more importantly, there is no evidence that silver – in the concentrations used in homeopathic eye drops – effectively kills bacteria, fungus, and mold.
PART 3, Theme 3: Are those rat droppings?
Many homeopathic eye drops don’t contain “chemical” preservatives, because the “natural” consumer doesn’t want them. But effective modern preservatives are the last line of defense against contamination during manufacture. The riskiest eye drop a consumer can use is a non-preserved product made in an improperly designed and badly operated factory, in a country with little ability to regulate drug manufacturers.
This brings us to FDA factory inspections. The Warning Letters to distributors that reference manufacturer inspections had many frightening things to say. The Warning Letters addressed to the manufacturers themselves were the inspiration for this blog post’s title: filthy, putrid or decomposed.
To appreciate the key issues in the Warning Letters, you need to understand two critical drug manufacturing concepts: aseptic processing, and the media fill.
Aseptic processing
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.
Media fill
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 checked 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.
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.
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
Repeating the media fill without figuring out why the first run failed, and getting lucky on a clean run
Or, having no idea what a media fill is and never doing one.
They can also delete and fake the testing data.
Some of my favorite outtakes from the Warning Letter to Amman Pharmaceutical Industries, maker of homeopathic drug products, include (but are not limited to):
“Your laboratory records lacked complete and trustworthy data”
“Laboratory records were unreliable including discrepant and missing data”
“You lacked reliable and authentic data”
And the prizewinner:
“Your analytical chemists were able to manipulate (test equipment) parameters to erroneously obtain results meeting the established specifications”
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.
You may be using a homeopathic eye drop as a non-irritating glorified saline.
Or you may be fully committed to the “energy” concept of homeopathy. You must also believe that every crop of eyebright will yield the same amount of vibrational energy. And fingers crossed that there isn’t any actual mercury in that bottle, only mercury energy.
I’m not going to argue with your individual experience either way.
The question is, are you willing to use a homeopathic eye drop that could blind or kill you?
Of the major homeopathic eye drop brands on the US market,
Similasan got a Warning Letter about its factory conditions and cheating on media fills and subsequently was pulled from bricks-and-mortar pharmacy shelves;
TRP is labelled as being manufactured in Jordan, the location of Amman Pharmaceutical – probably not a coincidence; TRP eye drops are no longer available except in nooks and crannies of e-commerce;
Natural Ophthalmics is officially out of business, because they couldn’t afford to prove that their eye drops reversed cataracts, stimulated tear production, or desensitized the eye to allergies;
Sunnie Natural isn’t registered with the FDA, which means the company is breaking the biggest rule of all. I expect Sunnie Natural’s turn will come.
Part 5: Filthy, Putrid or Decomposed
You might be wondering where the title of this blog post came from.
I love reading the United States Code. I recognize that this makes me strange. There is a lot to admire in the older parts of it, like the Federal Food Drug & Cosmetic Act.
21 USC Section 351 says (in part) -
A drug shall be deemed adulterated if it consists in whole or in part of any filthy, putrid or decomposed substance.
In 8 compact sentences, the Code then lays out the philosophical underpinnings of safe drug manufacturing, packaging, and storage.
I think that American consumers should be angry, let’s make that furious, that foreign drug manufacturing facilities have been flouting so many sensible laws and rules, for so long. If it weren’t for stomach acid, we would have been dying like flies.
The FDA has been doing an impossible job with ridiculously few resources, while suffering constant political kicking, for a long time.
It’s time for us – this includes Congress – to thank the FDA, rather than shit on it whenever it says that our favorite worthless dangerous OTC crap is worthless and dangerous.
