Skip to main content
  • FDA

    With Halloween approaching, officials are warning the public about the dangers associated with counterfeit decorative contact lenses. The Food and Drug Administration's Office of Criminal Investigations, U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI), and U.S. Customs and Border Protection (CBP) are working together to seize illegal and harmful versions of correctable vision lenses and decorative or color contact lenses that are illegally imported and distributed throughout the United States.

    "This is another example of organized criminals trying to make a buck with no regard for the health and safety of the public," said ICE Director John Morton. "Consumers need to be smart and vigilant.  Saving a few dollars is certainly not worth playing roulette with your eyesight."

    Many people are unaware that it is illegal to purchase or sell contact lenses of any kind without a prescription from an ophthalmologist, optometrist or a specially licensed optician under the supervision of an eye doctor. In 2010, the worldwide contact lens market was estimated to be $11.7 billion while the U.S. market was believed to be $2.1 billion.  Decorative and colored lenses are becoming an increasingly larger percentage of the market and elaborate Halloween costumes are one of the most popular reasons.

    Recently, the FDA/OCI, CBP and HSI have begun collaboration to counter the threat of counterfeit contact lenses throughout the country. Working with the National Intellectual Property Rights Coordination Center (IPR Center), HSI and CBP have already made several large seizures and the cases are ongoing.

    The FBI and the U.S. Postal Inspection Service-both partners at the IPR Center-are also contributing to this operation to further identify the entities that are counterfeiting, misbranding and adulterating these products, their exposure to trademark infringement and misrepresentation, and the means by which they are illegally importing, distributing and selling these defective health products.

    For more information about safety tips and locations to buy legitimate and safe contact lenses, consumers are encouraged to visit the FDA's website.