CDRH Issues Joint FDA/FTC Promotion and Advertising Untitled “Email” to On-line Distributors; Uses Unprecedented Approach to Warn of Possible Criminal Prosecution

March 7, 2013

By Carmelina G. Allis

On February 28, 2013, FDA’s Center for Devices and Radiological Health (“CDRH”) issued what appears to be an unprecedented joint FDA/Federal Trade Commission “untitled letter” in the form of an email (an “untitled email”) to on-line distributors of decorative contact lenses alleging that they have been selling and marketing decorative or cosmetic contact lenses in violation of federal laws, and threatening criminal prosecution if corrective action is not implemented.  Contact lenses (including decorative/color and corrective lenses) are regulated as medical devices pursuant to section 520(n) of the FDC Act.  In general, decorative and cosmetic contact lenses are regulated as Class II prescription devices subject to the 510(k) requirements.

An untitled attachment to the email alleges that the devices are adulterated and misbranded pursuant to the FDC Act because they are being offered for sale in the U.S. without FDA marketing authorization.  It also alleges that the on-line distributors’ sale of contact lenses to consumers without a valid prescription is in violation of the Fairness to Contact Lens Consumers Act, 15 U.S.C. § 7601 et seq., and the Contact Lens Rule, 16 C.F.R. Part 315, both of which are enforced by the FTC.  Violation of the FTC rule may result in significant civil monetary penalties.

According to CDRH’s email, FDA’s Office of Criminal Investigations ("OCI") and FTC reviewed the on-line distributors’ websites and determined that they were offering decorative contact lenses for sale in violation of federal law.  OCI is the office within FDA that conducts and coordinates investigations of suspected criminal violations of the FDC Act and other related statutes, including violations of Title 18 of the United States Code.  The FTC regulates the advertising (as opposed to the labeling) of non-restricted medical devices pursuant to the Federal Trade Commission Act, 15 U.S.C. §§ 52-55.

CDRH’s email to contact lens distributors purports to be an “untitled letter.”  It has been posted on CDRH’s “Promotion and Advertising Untitled Letters” webpage and neither the email nor its attachment says “Warning Letter.”  However, we believe that this email (and attachment) is mischaracterized by FDA as an untitled letter.  It contains language advising that failure to take prompt correction may result in enforcement action, and specifically warns that “[f]irms that fail to take corrective action may also be referred to FDA’s Office of Criminal Investigations for possible criminal prosecution” for violations of the FDC Act and other federal laws.

As described in Chapter 4 of FDA’s Regulatory Procedures Manual ("RPM"), “Warning Letters are issued for violations of regulatory significance.  Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected.”  In contrast, an untitled letter is generally the initial correspondence between FDA and the regulated industry that “cites violations that do not meet the threshold of regulatory significance for a Warning Letter.  Therefore, the format and content of an Untitled Letter should clearly distinguish it from a Warning Letter.”  RPM, Ch. 4.

Companies should not take lightly language threatening criminal prosecution.  We are not aware of similar language contained in other untitled letters issued by CDRH.  We should also note that statements indicating OCI involvement in an enforcement action are generally not included in device Warning Letters.  This CDRH “untitled email” is certainly an unprecedented approach.

As part of CDRH’s Transparency Initiative, the Center has committed to posting on its website advertising and promotion untitled letters issued as of October 1, 2011.  As of the date of this blog, this notification to on-line distributors of decorative contact lenses is the only letter/email posted.