Food and Drug Administration
is investigating 97 companies, including
, as part of a probe into companies that sell devices such as contact lenses and hearing aids by mail.
Eric Latish, chief of the FDA's Dental, Ear, Nose, and Throat and Ophthalmic branch, told me the agency has targeted companies (most of them presumably private) that sell prescription devices to the public. The agency's intention, he says, is to clamp down on companies that sell such products without a prescription.
"Some play legitimately," Latish says. But others don't.
Latish confirmed that 1-800 Contacts was part of the sweeping inquiry in a discussion we had after an item
here last week pointed out that 1-800 Contacts volunteered in SEC documents that "a significant portion" of its sales don't comply with state laws governing the sale of prescription contact lenses. The company -- which bills itself as a leading direct marketer of replacement contact lenses -- claims it tries to verify prescriptions, but that many doctors refuse to release prescription data, forcing the company to ship the lenses without confirmation. That may be true, Latish says, "but the law is the law."
Which brings us to an FDA probe. I asked Los Angeles attorney Garth Vincent, who represents 1-800 Contacts, whether 1-800-Contacts is part of a probe into whether companies verify prescriptions. In a written response, he said: "We are not aware of any allegation by the FDA or anyone else that 1-800 Contacts has failed to comply with any federal law or regulation. Any specific prescription requirement regarding the sale of contact lenses is a matter of state law, not federal law. As far as we are aware, the FDA has never contended otherwise."
When I pressed him further about whether 1-800 Contacts was aware of a probe, he wrote in response: "We are not aware of any investigation of 1-800 Contacts by the FDA. Although the FDA indicated nearly one month ago that it might want to inspect the company's facility in the future, it indicated that it would notify the company in writing if it decided to request an inspection, and if it believed it had the authority to do so." He added that was the last the company had heard from the agency.
Latish, however, tells a different story. While declining to comment specifically on the details of the investigation, he says 1-800 Contacts is "aware" of the FDA's concerns -- so much so that the company itself states in SEC documents it is "not complying with federal laws."
To be sure, while states
regulate the prescription sale of drugs, the FDA oversees the labeling of drugs. And according to the company's week-old 10-K (rehashing what the company has previously disclosed): "Although the FDA has not objected to the sale of contact lenses without a written prescription ... it is possible that the FDA will consider contact lenses that are sold in such a fashion to be misbranded," which could lead to any number of actions, from a simple warning letter to seizure of inventory or prosecution.
The FDA also regulates contact lenses, and as such, Latish says, it has the right to visit any warehouse where lenses are held -- especially if they're being shipped in "contradiction to regulations and the states can't or won't take action." What's more, the FDA is charged with ensuring that all domestically sold lenses are manufactured in compliance with good manufacturing practices. Latish says there can be no assurance that all of the lenses sold by 1-800 Contacts comply with good manufacturing practices because the company itself discloses (also in its 10-K and other documents) that it buys "a substantial portion of its products from unauthorized distributors."
One other point: My original column said that 1-800 Contacts went public last year. It went public two years ago. The company complains that the information I originally cited came from two-year-old documents. Actually, it all came from an eight-month-old document tied to a secondary stock offering that was canceled; much of the same data is included in its recent 10-K.
If I were an investor in "the markets," I would start getting awfully nervous when armchair market timers start to be right. That armchair market timer would be me. On last week's
show, I predicted that the
this week would touch 4100. OK, it got down to only 4188 yesterday. But a few weeks ago, I predicted it would fall to 4400, and that week it got to 4475
getting hit by last Tuesday's wind shear, which took it below 4400. Beginner's luck! And don't go asking me where it goes from here
because I don't have a clue!
Of course, neither do most of the other pundits, but that never stops them!
Don't forget to check out my later column, also posted this morning.
Herb Greenberg writes daily for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, though he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. He welcomes your feedback at
firstname.lastname@example.org. Greenberg also writes a monthly column for Fortune.
Mark Martinez assisted with the reporting of this column.