You have a recalcitrant client who is manufacturing and marketing a non-corrective lens called "Trekkie Eyes" intended to make a person's eyes resemble the eyes of Data, a character from Star Trek Next Generation.Your client has received a warning letter that states:

"FDA has learned that your firm manufactures and commercially distributes Trekkie Eyes in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Act, 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body."

Later the letter states: "FDA requests that your firm immediately cease activities that result in the misbranding or adulteration of Trekkie Eyes such as the commercial distribution of the device discussed above. Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again "

Your client says he has read the statute codified at 21 USC Section 360j(n) (PL 109-96).He believes Trekkie Eyes are not a device because they are not contact lenses, and therefore neither 21 USC 360j(n) nor 21 USC 321(h) apply to his products.To "prove" his point, he gives you a printout of an on-line dictionary definition of "contact lens" which is "A thin plastic or glass lens that is fitted over the cornea of the eye to correct various vision defects." Your client says Trekkie Eyes do not correct vision defects, and is not "intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body ".He believes he does not need pre-market clearance/approval from FDA because the FDA does not have authority to regulate his products. You show him FDA's "Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers: Decorative, Non-corrective Contact Lenses" which was issued in 2005.Your client is not convinced because the guidance document states that it is non-binding.Also, since the FDA is exceeding its authority by attempting to regulate Trekkie Eyes, he believes he can ignore both the guidance and the warning letter.

What is the first thing you tell your client (other than he had better give you a really big retainer)?How do you advise he respond to the warning letter?Where do you find Congressional intent in enacting PL 109-96 to convince your client that Congress intended FDA to regulate Trekkie Eyes as contact lenses (i.e. devices)?What is your response to his assertion that guidances are non-binding and therefore he can ignore it?What are the possible actions FDA may take if your recalcitrant client continues to be recalcitrant?