A Medical Device Daily

The Federal Trade Commission (FTC) said Friday that an operation selling Chinese herbal supplements is banned from claiming its products treat or cure diseases and will settle charges that it violated a previous court order.

The FTC alleged that the sellers of Dia-Cope, a pill claimed to prevent, treat and cure diabetes, violated the order by misrepresenting the health benefits of their product and saying that clinical trials proved their claims. The defendants will give up ill-gotten gains of $120,396 – which the FTC said are the assets received from the sale of Dia-Cope.

The defendants originally sold Sagee, a Chinese herbal supplement that they said could improve memory and concentration, repair damaged brain cells, slow the aging of the brain, increase the learning ability of people with mental handicaps and treat various diseases and conditions related to brain function, including Alzheimer's disease, senile dementia, schizophrenia, autism, cerebral hemorrhage, stroke, epilepsy and Parkinson's disease.

The supplements were sold by distributors on the Internet and in some stores – 90 capsules for $60.

The FTC in January 2005 entered an order prohibiting the company from making unsupported claims. But the defendants then began advertising Dia-Cope on web sites, available in seven languages, saying its claims were supported by clinical trials and that the FDA had approved the product.

Air flight recommendations for diabetics

In response to new terror alerts for commercial flights and the series of restrictions for carry-on items, dLife (Westport, Connecticut) last week issued tips on traveling by air with insulin and other diabetes medications.

According to the Transportation Security Administration, all necessary medications, including insulin, are exempt from this ban. Prescription medications should be labeled as such, and the name on the label must match the name on the passenger ticket. In addition, dLife recommends that those with diabetes traveling with an insulin pump should carry a letter from their physician on letterhead explaining what the device is and why it should not be disconnected.

Paul Ford Martin, managing editor of dLife, said, “Keep insulin vials and pens in their original packaging and let security personnel know you have diabetes and are carrying insulin and testing supplies. It's important to give yourself adequate time to get through security. And call your airline before traveling to check on any additional restrictions that may be imposed at the carrier level.”

dLife – For Your Diabetes Life – is a division of LifeMed Media providing information through dLifeTV, dLife.com, dLifeRadio and dLifeDirect.

Celsion reports PMA-supplement approval

Celsion (Columbia, Maryland) reported that the Center for Devices and Radiological Health of the FDA has approved its PMA supplement requesting changes in the manufacturing and inspection process for components in its disposable catheter kit for the Prolieve Thermodilatation system and also cleared commercial distribution of the modified product.

Dr. Lawrence Olanoff, Celsion's CEO, said, “[w]e are arranging to start shipments of the finished catheter kits to our distributor Boston Scientific immediately.”

Celsion is developing heat-activated treatment systems for cancer.