8 products temporarily unavailable on Amazon and some other sites

In a nutshell - 

The following products are temporarily unavailable on Amazon and some other online retailers (yes, including Dry Eye Shop). The manufacturers are working to resolve marketing violations flagged by the FDA. The violations are not related to manufacturing quality. The products are not backordered nor are they subject to any recalls or shortages. 

Optase Brand
Optase MGD Advanced
Optase Dry Eye Intense (bottles and vials)
Optase Allegro
Optase Hylo Night ointment
Optase TTO Eyelid Cleansing Wipes
Optase TTO Eyelid Cleansing Gel
Optase Protect

Note: Optase Hylo Relief is still available everywhere.

Ivizia brand
Ivizia lubricant eye drops

Note: Ivizia Severe is still available everywhere.

What happened?

In July, FDA issued a Warning Letter to Scope Health for marketing violations with respect to 7 Optase brand products, and they issued a Warning Letter to Thea Pharmaceutical for marketing violations of 1 Ivizia brand product.

The primary marketing violations for which these companies were cited are:

1. making therapeutic claims that are not allowed for OTC drugs and
2. advertising ingredients that are listed as inactive.

Legally, these types of marketing violations are problematic because they automatically cause the products to be deemed unapproved prescription drugs - not because of what they contain, but because of how they are advertised. (In regulatory law, what makes a drug a drug is the words wrapped around the bottle, rather than the contents of said bottle.)

Ironically, both of these types of violations are actually common to the majority of OTC eye drop distributors in the USA - dominated by the big 3: Alcon (Systane brand), Bausch & Lomb (Biotrue and Blink brands) and Abbvie (Refresh brand).

Alcon blazed this trail long ago. Everyone and his lawyer followed in their wake till the practices became normalized. 

Today, approximately 75% of the brand name OTC products on the US market violate these rules and most new OTC products released in the last 10 years have advertised their "inactive" ingredients rather than make the investment to follow FDA's process for adding new goodies to the allowable active ingredients list. After all, why spend that kind of money when the FDA clearly doesn't care? (Slap!) Oops. Turns out the FDA does care.

I have monitored the websites of all of the OTC brand name distributors since the Thea and Scope Warning Letters were published.  I noticed that these two recipients immediately rewrote their websites to eliminate their marketing violations, which hopefully will help them get the issue resolved.

Meantime, two months have passed. The summer is almost over and I see that Bausch is still flagrantly violating the exact same rules on products like Biotrue Hydration Boost and Blink Nourish. Ditto Alcon with Systane Pro and Systane Hydration. 

I have been assuming that the FDA is also incubating Warning Letters to the Big 3 and will hatch them in due course.

They need to. It isn't right to single out the newcomers. Yes, I have been complaining about the "active inactive" ingredient trend for a long time and I'm glad the FDA is cracking down, but if they're going to call anybody out, they should call them ALL out - especially the ones that have been doing it the longest.

p.s. Why Dry Eye Shop can't sell these products at present

The payment processors for our internet store have red-flagged all of the products named in the Warning Letters. To put it simply, they wouldn't allow us to use their services unless we delisted the products. So, that was a no-brainer. After the products are cleared of whatever red flags apply, we'll re-instate the affected Optase and Ivizia products in the shop.

Under most circumstances, I would be extremely happy to see e-commerce platforms and payment processors taking action against eye drops that FDA is taking action against. There are far too many scary eye drops out there that are getting a free pass in e-commerce - and now we're seeing some new scary preservative-free salines for scleral lens users too. Those who know me in my DEF alter ego are aware that I'm constantly trying to draw more attention to this issue. 

However, e-commerce infrastructure companies (e.g. Shopify, Stripe, and of course Amazon) have no ability to distinguish between safety-related FDA Warning Letters and other forms of rule-breaking. Even the humans can't do that, let alone the AI. So, Optase and Ivizia got caught in this net. Did they bring it on themselves? Yes. But it's still a bummer.

I really like these products and their companies and people. I sincerely hope they get back to normal soon. 

Where to purchase these products currently

Optase products listed above can be purchased at optase.com, walmart.com, walgreens.com and other online pharmacies.

Ivizia lubricant eye drops can be purchased at walmart.com, walgreens.com and other online pharmacies.