FDA issues warning to website regarding misbranded ophthalmic drugs, products

The U.S. Food and Drug Administration (FDA) issued a warning letter to an online ophthalmic supplements company citing violations of drug and product branding outlined under federal law.

Macular Health, LLC, (macularhealth.com) of Gardendale, Alabama, was found to sell nine products or supplements online using claims that establish those items under Section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act [United States Code (USC) 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment or prevention of disease.

These products range from dry eye or macular health supplements to eyelid cleansers, using product language that implies their intended use as drugs. The FDA argues these "products are not generally recognized as safe and effective" for their stated uses, making these products 'new drugs' in the eyes of the FDA. Without prior FDA approval, new drugs may not be legally introduced for interstate commerce. Additionally, these products also fail to bear adequate directions for intended use.

The FDA's warning letter, issued April 28, claims these products are therefore misbranded and threatens legal action should the company not take immediate action to remedy these apparent violations.

Click here to read more from the FDA.