Understanding Regener-Eyes’ latest smoke and mirrors

They may tell you*:

“Regener-Eyes has an FDA approved indication for dryness of the eye.”

Why this is smoke and mirrors:

The FDA does not approve indications.

The FDA does not approve OTC drugs.

(Which is what Regener-Eyes is currently claiming to be.)

The FDA approves prescription drugs, including biological products.

The FDA has not approved Regener-Eyes, and Regener-Eyes has never applied for approval.

In fact, the FDA told Regener-Eyes so very clearly in their letter on October 5.

Oh, and by the way…

In case you didn’t know, Regener-Eyes recently re-registered as an OTC product - and right there on the listing it says that the FDA has not evaluated whether it is compliant.

*This is what a very nice customer service person told me on the morning of 10/20/22, three times, when I called Regener-Eyes’ customer service line to ask “Is Regener-Eyes FDA approved?” I called them to confirm what they are saying because people in our community have continued to share stories with us about how Regener-Eyes sales reps describe Regener-Eyes as FDA approved. We also came across a new TikTok video in which an optometrist uses this “FDA approved indication” language.