Amazon To Stop Selling Seven Eyedrops After FDA Warning

Amazon said on Wednesday that it was removing seven eyedrops products from its website after the Food and Drug Administration warned the company that the eyedrops had not been recognized as safe and effective. From a report: The F.D.A. said in a letter to Andrew Jassy, Amazon's chief executive, on Monday that Amazon had violated federal regulations by selling the eyedrops, which claimed to help with problems including pink eye, dry eyes, eyestrain and floaters. "These products are especially concerning from a public health perspective," the F.D.A. letter said. "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."

The eyedrops named in the letter are: Similasan Pink Eye Relief, The Goodbye Company Pink Eye, Can-C Eye Drops, Optique 1 Eye Drops, OcluMed Eye Drops, TRP Natural Eyes Floaters Relief, and Manzanilla Sophia Chamomile Herbal Eye Drops. None of the eyedrops appeared to be available for purchase on Amazon on Wednesday morning. The company said in an emailed statement on Wednesday that "safety is a top priority."

Re:FDA is a paperwork burden

[Fly Swatter]

If it is such a burden to a seller perhaps they shouldn't be selling regulated goods. At all.

Amazon needs to adhere to our consumer protection laws. They clearly have no intention of really trying.

Re:

[wyHunter]

Amazon certainly does, but so do the manufacturers. And they don't even try. And we can't possibly make stuff here so it's done abroad, and goodness knows what happens in those places.

Re:FDA is a paperwork burden

[taustin]

Amazon has no intention of doing anything that costs them money, unless not doing it will cost the more. This is especially true of things that require human involvement, because employees cost a lot more than algorithms.

Re:

[jbengt]

The company said in an emailed statement on Wednesday that "safety is a top priority."

Safety is a priority, right behind the priorities of profits and market share.

Re:

[alvinrod]

Safety likely doesn't make the top ten. Saying it's right behind profit and market share suggests that it's number three. The extent to which Amazon cares about safety is limited to how it affects profit. It's like the scene from Fight Club:

A new car built by my company leaves somewhere traveling at 60 mph. The rear differential locks up. The car crashes and burns with everyone trapped inside. Now, should we initiate a recall? Take the number of vehicles in the field, A, multiply by the probable rate of failure, B, multiply by the average out-of-court settlement, C. A times B times C equals X. If X is less than the cost of a recall, we don't do one.

The ultimate problem is that they can only care as much as their competitors because anyone who's willing to undercut will beat them on price. We can pretend we're no so awful and legislate safety requirements, but that just means the work gets shipped somewhere that doe

Re:

[MacMann]

Safety is a priority, right behind the priorities of profits and market share.

Of course safety comes behind safety, why assume any different?

Perhaps putting safety behind profit is specific to for profit entities, to make it more general we'd put the mission first. For example the mission of any military is to defend the nation, personal safety comes second to that or the people involved would not volunteer (assuming an all volunteer service) to serve in the military. If we break things down further then maybe safety comes in third or fourth.

For medications there's a balance betwee

Re:

[SecurityGuy]

We used to have literal snake oil and cough medicine with morphine. OTOH, homeopathic "remedies" that do nothing other than move money from your wallet to someone else's are still allowed, so it's a bit of a mixed bag for sure.

Re:FDA is a paperwork burden

[LazarusQLong]

I am pretty sure the cough medicine with codeine or morphine did, in fact, help you with your cough... Unfortunately they had other, less pleasant side effects, like being sincerely addictive for one. Science doesn't know everything and we learn as we go... That process in the FDA which takes (normally) a long time to get from a new drug discovered/created to a determination that it is safe is onerous to many, those people lobby our regulatory types to push for drugs being released with less testing. Later, we find that more testing may have uncovered x or y side effect and everyone yells at the FDA for doing what our legislators dictated... Yeah, the FDA allows homeopathic 'drugs' as long as they make no concrete medical claims. Probably due to the efforts of congress-weasels from the places where they produce such garbage.

Here we have a story wherein the FDA is doing their job and yet some on here still want to find fault?

Fine.

I can't wait to hear the next commentor talk about how 'caveate emptor' and 'do your research' as if the work done by researchers who spend their lives developing medicines can be then uncovered and found fault with accurately through a 5 minute google search!

Re:

[MacMann]

I am pretty sure the cough medicine with codeine or morphine did, in fact, help you with your cough... Unfortunately they had other, less pleasant side effects, like being sincerely addictive for one.

Consider this, if these drugs are so addictive and dangerous then why hasn't the government banned their use? Maybe because the FDA has studied the issue and discovered that as bad as they are for human health on the balance we still see a benefit from them. What I suspect that many people don't realize is th

Re:

[LazarusQLong]

I am on your side on this. Knowing who will have an addictive response to a drug and who wouldn't is not an easy call. Me, I had a buddy in the Air Force (I was Army too, 10th Mountain Division, Light Infantry) and he was prescribed something for terrible headaches he would get that lasted weeks.

He became addicted to it (I have no idea what it was, probably an opiate derivative) and once he was medically discharged for a different problem, but he couldn't get that drug anymore because of (reasons. Ask th

Re:

[MacMann]

I had hydrocodone for kidney stones once, when the pain killer took effect, my iphone grew hair.

I'm not sure what "grew hair" is supposed to mean. Were you hallucinating? Or did the drugs just make everything feel "fuzzy" like it was covered in hair? I know that fuzzy feeling and getting just a tiny hint of it tells me I'm getting all the pain relieving benefit I'm going to get from the drug, any more and it's just going to make things get "fuzzier" and make me clumsy and sleepy. I've had some weird effects from some sleeping pills before, instead of taking the pills and lying down immediately lik

Re:

[LazarusQLong]

it meant I began to hallucinate. Fortunately I knew this was a hallucination, and put myself to bed. Ever see the old Humphrey Bogart movie, Key Largo? Yeah, prohibition is great for the people who make money off of something being illegal.

Re:

[taustin]

Some types of "snake oil" - made from actual snakes (specifically, Chinese water snakes) appear to have medicinal uses [pharmaceut...ournal.com], especially anti-inflammatory properties.

The term "snake oil" acquired its current derogatory meaning because most of what was being sold as snake oil was not made from snakes. The 1915 legal case was more about false advertising than medical properties (or lack thereof).

rodent not paid off

[Walt Dismal]

I smell a rat here. Can-C is an anti-cataract eyedrop identical to other eyedrops on the market and it's been out there for at least 15 years.

Re:

[MacMann]

I smell a rat here. Can-C is an anti-cataract eyedrop identical to other eyedrops on the market and it's been out there for at least 15 years.

The fine article is pay-walled so I only have what is in the summary to work with. The summary says pinkeye was a known risk for some of these eye drops, which could include Can-C, which could imply the eye drops weren't sufficiently sterilized and/or contained something that could breed an infection. Wasn't there something on Slashdot some time ago about people getting infections from a bad batch of nasal sprays or something? As I recall it was some really serious stuff too. We've had nasal sprays for

Re:

[EvilSS]

Apparently not in the US. They are going after anything with n-acetyl-carnosine in it that was not submitted for approval for the treatment of cataracts or other conditions. Can-C tried to skirt the rules by listing it as an inactive ingredient. https://www.fda.gov/inspection... [fda.gov]

We note that you list the NAC ingredient as an inactive ingredient or excipient on the label of your “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” products. However, your firm makes many therapeutic claims for NAC that cause it to be considered an active ingredient.4 For example, your website includes a blog post entitled, “The Benefits of N-Acetyl-Carnosine (NAC) for Your Eyes, Especially for Cataracts.” Many other examples of therapeutic claims related to NAC can be found in the various claims cited in this letter above which make it clear that NAC is intended to furnish pharmacological activity or other direct effect, including in the treatment of cataracts, and is thus an active ingredient. As previously stated, NAC is not a permitted active ingredient in Monograph M018 and treating or preventing cataracts is not a permitted indication in Monograph M018.

Not just Amazon

[EvilSS]

The FDA sent letters to CVS, Walgreens, and many other retailers and manufacturers.

Re:

[Fly Swatter]

That letter was because a production facility failed a safety inspection. This letter is because Amazon was selling products that were simply never approved for sale by the FDA.

Renamed

[Hoi Polloi]

Can't-C Eye Drops, Opaque 0 Eye Drops, OccludedMed, The Goodbye Eyes Company