US FDA clears heat-not-burn tobacco device for sale

The US Food and Drug Administration has cleared a heat-not-burn tobacco device designed as an alternative to conventional cigarettes, for sale in the United States.

The product consists of a tube that gently heats up sticks of tobacco instead of burning them, making what is inhaled less harmful than conventional cigarette smoke.

The FDA said the marketing of the devices is “appropriate” for public health because “the products produce fewer or lower levels of some toxins than combustible cigarettes.” The agency also said it has placed stringent marketing restrictions on the products in an effort to prevent minors from using the device.

The review, which took almost 2 years, took into consideration the risks and benefits to the population as a whole. It included how the products may impact youth use of nicotine and tobacco, and the potential for the products to completely move adult smokers away from use of combustible cigarettes.

By using heat instead of flame the device eliminates 90-95% of toxic compounds in cigarette smoke.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA

FDA stops sale of surgical mesh for transvaginal repair of pelvic organ prolapse in the US

Earlier this month, the US Food and Drug Administration (FDA) ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately.

The FDA had reclassified these mesh products as class III (high risk) in 2016 and the manufacturers, Boston Scientific and Coloplast, were not able to comply with the premarket review standard that now applies to them as they could not provide enough evidence as reasonable assurance of their safety and effectiveness. The companies will have 10 days to submit their plan to withdraw these products from the market.

In 2002, the first mesh device for transvaginal repair of POP was cleared for use as a class II moderate-risk device.

A practice advisory issued by the American College of Obstetrics and Gynecology (ACOG) in response to the FDA announcement specified that the FDA announcement applies only to mesh placed vaginally to treat POP. The FDA order does NOT apply to transvaginal mesh for stress urinary incontinence. Additionally, the FDA order does not apply to mesh placed abdominally (sacrocolpopexy via laparotomy or endoscopy) for prolapse repair.

(Source: US FDA, ACOG)

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA