Eye Care (Ophthalmic) Products Under Increased Scrutiny

This warning letter is interesting. This is an ophthalmic drug warning letter, but the supplement and cosmetic industries can glean helpful information here. Here, I review these learning opportunities.

• Claims on website and videos.

• Timeline: Could the company have avoided a warning letter?

• Ophthalmic (eye) drug products are under increased scrutiny.

• Manufacturer and distributor responsibilities

Are you interested in a free discussion about high-risk claims on your website? I’ll run my compliance software and share the findings. Book your free session. 

● Claims on website and videos.

FDA has cited seven companies for claims in YouTube videos this year. What makes this interesting is the videos mentioned in this warning letter were embedded on the webpage rather than just on YouTube. This shows me that FDA is going the extra mile to review videos. Also, some of these videos are old, like this one from 2018.

From warning letter. “From your March 16, 2018, YouTube video titled, “MSM Eye Massage (Eye Exercise)” on your… where you demonstrate an eye massage with one of your MSM eye drop products: “This MSM eye massage is great for inflammatory eye conditions, blepharitis, dry-eye, improving the lymph system, and stimulation of tears.”

As a side note, Apex Compliance, my monthly compliance software, scans YouTube video transcripts for compliance issues in seconds. Learn more. 

● Timeline.

FDA tested one of the company’s products and found that it contained microbial contamination, which is very serious for products applied to the eyes.

On August 21stof this year, FDA and the company had a virtual meeting, presumably to talk about the contaminated product. A few days later, the company issued a voluntary recall for this and some of their other products. At some point in August FDA reviewed the company’s website and found many drug claims. At some point in August FDA reviewed their website. If the company would have conducted a website compliance check when contacted by FDA, I wonder if they could have avoided a warning letter.

● Manufacturer and distributor responsibilities.

This company was using contract manufacturers but apparently did not check their work. Here FDA reminds companies that they are responsible for the products they get made by co-manufacturers. If the company had conducted quality checks, they probably would have caught the microbial contamination before it led to a recall and subsequent warning letter.

→From warning letter. “You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities.”

FDA also provides a link to this useful guidance document, Contract Manufacturing Arrangements for Drugs: Quality Agreements.

● Ophthalmic drug products are under increased scrutiny.

There have been 21 ophthalmic FDA warning letters this year, compared with seven last year. This continued enforcement trend has involved some of the largest companies, such as Amazon. I write more about this. 

It sounds like the company did not follow the path of an OTC or other drugs. Anything added to the eyes has a high level of danger and should go through proper regulatory channels.

→From warning letter. “new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect…. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 USC 355, is in effect for these products.”

Read the full warning letter. 

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.