Increased FDA Scrutiny of Eye Care Category 

By Alvin J. Lorman, AAHP Counsel 

The Food and Drug Administration (FDA) last week continued its heightened surveillance on ophthalmic drug products sold without FDA approval or without complying with an applicable OTC monograph.  FDA sent Warning Letters to eight companies, including two mass marketers, one diet supplement supplier, one allopathic manufacturer, and four homeopathic manufacturers or distributors.  In a press release issued Sept. 12, 2023. FDA said that it “is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.”   

Six of the letters were sent to manufacturers or marketers of homeopathic products and claimed that the eye products were unapproved new drugs.  Four of the six were also cited for claimed CGMP violations.  Two of the recipients were cited solely for the sale of unapproved new drugs. This is only the second product category in which FDA has sent Warning Letters that did not cite CGMP violations or reported safety concerns in addition to unapproved new drug status. The first category, in 2020, was prescription-only injectable homeopathic products.  FDA’s 2022 guidance on homeopathic drugs lists route of administration as one of the areas which will receive heightened regulatory attention.  CVS Health and Walgreens Boots Alliance received Warning Letters for private label homeopathic products, claiming manufacturer CGMP issues as well as unapproved new drug status.  Imported products mentioned in the Warning Letters were added to FDA’s Import Alert list. 

Despite homeopathic products being involved in six of the eight Warning Letters, it would be premature to consider this action part of an FDA targeting homeopathy.  FDA has been concerned about eye care products for several years.  Last month, the agency warned consumers to immediately stop using two allopathic unapproved eye drops due to bacterial contamination, fungal contamination, or both.  Other eye products were the subject of regulatory action in March 2023, and September 2022. 

The recipients of Warning Letters last week were Boiron, Inc., CVS Health, DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, Similasan AG, TRP Company, Inc., and Walgreens Boots Alliance, Inc.