Originally created 04/14/02

Responding to regulations



A local pharmacist is trying to come up with a new formula of nicotine lollipop that does not use a form of nicotine the Food and Drug Administration has objected to.

Eric Holgate was flipping through clear plastic bags filled with syringes and pill bottles when he came across some bags filled with lollipops.

"Oh, we've got to get rid of those," said Mr. Holgate, a compounding pharmacist at Duramed Medical Services in Augusta.

Such lollipops, intended to help people stop smoking, recently were declared illegal by the Food and Drug Administration because they are made with nicotine salicylate, which has not been approved for that use by the FDA, and because they were sold without a prescription, said FDA spokeswoman Kathleen Kolar.

Three pharmacies brought down the FDA's wrath because they were selling the lollipops over the Internet without a prescription and had not labeled them properly.

"The problem that happened is three guys got greedy," said Mr. Holgate, who sells his NicoStop lollipops only by prescription.

Even with the FDA crackdown, Mr. Holgate said, he's not licked yet. He was working Friday morning to create a new formula with a form of nicotine approved for smoking cessation, a resin called nicotine polacrilex.

He also plans to talk with U.S. Rep. Charlie Norwood, R-Ga., and to try to change the mind of the pop's top critic, U.S. Rep. Henry Waxman, D-Calif. There might still be a clinical trial to test the effectiveness of the lollipops, perhaps in conjunction with doctors at the Medical College of Georgia who already prescribe it for their patients, Mr. Holgate said.

It would be premature to say whether using a different nicotine and making the other changes would make the pops acceptable to sell again, said Ms. Kolar, of the FDA. In general, products claiming to cure or treat disease - what are considered drug claims - need FDA approval.

"Sometimes it's a fine line, but if something is claiming to treat a disease or, in this case, be a smoking cessation product (that) is being marketed to treat nicotine addiction, that may possibly need review," Ms. Kolar said. "But it's a bit premature (to comment)."

Mr. Holgate also tries to walk a fine line, saying the pops are an effective "nicotine delivery system" that would not need FDA oversight.

"This is helping people quit smoking," he said. "And it's the most common sense way to quit."

Reach Tom Corwin at (706) 823-3213 or tomc@augustachronicle.com.