In FDA’s latest warnings against using eyedrop products linked to potential contamination, the FDA warns consumers to discontinue using more than 26 over-the-counter eye drop products due to the potential risk of eye infection that could lead to partial vision loss or blindness. The 26 products are from the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up, and Velocity Pharma.
The FDA recommended the manufacturers recall the subject products after FDA investigators discovered insanitary conditions in the manufacturing facility and bacterial contamination in critical drug production areas in the facility. CVS, Rite Aid and Target are removing the products from their store shelves and websites. Products that are branded as Leader, Rugby and Velocity may still be available to purchase in stores and online; however, consumers are advised not to purchase these products.
About two months ago, the Agency advised consumers to stop using two eyedrop products due to bacterial and fungal contamination. Specifically, the drug-resistant bacteria Pseudomonas aeruginosa, Mycobacterium, Mycolicbacterium and Methylorubrum was identified in LightEyez MSM Eye Drops Eye Repair product, and Dr. Berne’s MSM Drops 5% solution was contaminated with Exophiala fungi. The FDA found that the manufacturers’ microbial testing of its eye product was inadequate and were not sterile.
Earlier this year, the Centers for Disease Control and Prevention reported an outbreak of Pseudomonas aeruginosa tied to the contamination of other brands of artificial tears and eyedrops.
While companies may attempt to skirt strict Good Manufacturing Practice (cGMP) compliance by positioning drugs as cosmetics, ultimately, the failure to comply with manufacturing requirements will likely lead to findings by the FDA that the product is adulterated and violative. As a reminder, the FDA regulates eyedrops as drugs, either non-prescription (over-the-counter) or prescription, and not as cosmetics, personal care products, or as “cosmetic pharmaceuticals” or “cosmeceuticals”, a term that FDA does not recognize. OTC eye drops are regulated by FDA through the monograph on Ophthalmic Drug Products for OTC Human Use, which provides information on acceptable active ingredients, doses, formulations, and labeling (e.g. dry eye reliever, itch reliever, etc.) OTC eyedrops are required to comply with the relevant OTC Monograph, a process which establishes Generally Recognized as Safe and Effective (GRASE) conditions for market.
In addition to compliance with the monograph, drug manufacturers must comply with GMP requirements, registration and listing, complete labeling, adverse event reporting, and the new user fees for drug facilities (“OMUFA” fees).
FDA also issued a guidance policy affecting certain ophthalmic products in March 2022, providing that ophthalmic dispensers when packaged with ophthalmic drugs will be regulated as drug-led combination products. However, FDA also advised that with respect to ophthalmic products that incorporate lower-risk device constituent parts, for example, eye dropper bottles/ampules that administer the drug directly to the eye, FDA does not intend to take action with respect to noncompliance with any applicable device Quality System Regulation (QSR) requirements until FDA further considers the application of these requirements to these combination products.
We recommend that OTC-regulated businesses ensure FDA OTC drug compliance, including strict compliance with GMPs to avoid regulatory enforcement, business disruption and loss of consumer confidence. We also recommend consumers discontinue immediate use of the affected products.
For questions on FDA OTC drug compliance and enforcement, please feel free to contact us at info@garg-law.com.
