FDA Claims EyeScience Marketing New Drugs Without Govt. Approval

WASHINGTON The FDA has accused a company marketing supplements to treat eye disease and other conditions of promoting drugs without prior approval from the federal government.

FDA informed EyeScience Labs, L.L.C. it is violating the Federal Food, Drug, and Cosmetic Act. FDA said its letter concerned the drugs Macular Health Formula," Dry Eye Formula" and Diabetic Vision Formula".

The government agency characterized EyeScience's products as new drugs that require FDA approval before they can be legally marketed in the United States.

In a Sept. 18 warning letter sent to EyeScience CEO and president Jeffrey M. Northup, FDA also asserted EyeScience is offering a product formulated for diabetics that "is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners" and that "adequate directions cannot be written so that a layperson can use the product safely for their intended uses."

FDA also declared one of the company's products failed to include a label "dietary supplement" in violation of federal law and regulations.

Northup could not be immediately reached Tuesday for comment on the warning letter.

FDA instructed Northup to advise the agency within 15 days of the steps the company is taking to remedy the alleged violations. Failure to correct the violations, FDA cautioned, could result in legal action including an injunction.

EyeScience, based in Columbus, Ohio, defines itself on its website as "an ocular health and nutrition company dedicated to finding natural solutions to common eye conditions".

INSIDER's Take

Companies marketing dietary supplements cannot sell products intended to cure, mitigate, treat or prevent a disease because such products are defined as drugs under federal law. Citing EyeScience's own statements on its products, Denver-based food lawyer Justin Prochnow -- a partner with the global law firm of Greenberg Traurig LLP -- said it's clear EyeScience is making explicit disease claims. For instance, EyeScience even refers to "Age-related macular degeneration" as a "hereditary and progressive eye disease" and implies it can prevent the disease for those individuals who are at risk.

Bottom line: EyeScience is likely to change its labeling in order to mollify FDA. "The company can modify its claims so they are not making drug claims anymore," said Prochnow. The alternative, disputing FDA's warning that the company is running afoul of federal law, is most likely a losing argument.

To see a slide show on "Top Ten Warning Letters Lessons", click here.