The Indian media Times of India column talked about the US FDA's supervision of e-cigarettes that may affect India’s views on e-cigarettes. The following is the full text.

The biggest move of the world tobacco market finally happened. A decision made by the US Food and Drug Administration earlier this month is significant in all respects and has a profound impact on India. The US FDA announced that it has authorized the sale of three new tobacco products, which marks the first set of electronic nicotine delivery system (ENDS) products to obtain FDA authorization through the pre-market tobacco product application (PMTA).

The decision in the US market is likely to reach India soon across the seven oceans, where there are nearly 267 million tobacco users. On paper, despite increasing evidence that e-cigarettes are not without risks, the Indian government continues to ban them, which can reduce the risk of diseases such as lung cancer and COPD by as much as 95%.

Therefore, now that the US FDA has nodded, the Indian Ministry of Health is likely to sit down and pay attention to e-cigarette products.

Derek Yach, president of SMOKe Free World, responded. He believes that India and other countries should follow in the footsteps of the US FDA, research science and take more measures to ensure that all smokers have access to smoking cessation solutions.

Yach argued that the US FDA’s decision to allow the sale of British American Tobacco’s Vuse Solo closed electronic nicotine delivery system and three tobacco-flavored cartridges marked the third time the agency has used scientific evidence in less than two years. Approve the harm of tobacco. For him, this is important because the agency's decision on VUSE products is based on data showing that manufacturers have proven that the marketing of these products is suitable for protecting public health.

In short, serious data-when it comes to health issues-is always important.

Needless to say, the US FDA's decision is driven by data. The company has submitted data to the U.S. FDA to prove that the marketing of these products is suitable for protecting public health, and authorized to allow these products to be legally sold throughout the United States.

Experts said that this move will ensure that all new tobacco products undergo a strong and scientific pre-market evaluation by the FDA. The manufacturer’s data shows that its tobacco-flavored products can benefit addicted adult smokers who switch to these products by reducing exposure to harmful chemicals—whether it is a complete or significant reduction in cigarette consumption.

It is worth mentioning that the US market regulator will remain vigilant about the authorization and monitor the marketing of the product, including whether the company has failed to comply with any regulatory requirements, or whether there is reliable evidence that individuals who have not previously complied with any regulations have used it in large quantities. Tobacco products, including young people.

Then, the authorization imposed strict marketing restrictions on the company, including digital advertising restrictions and radio and television advertising restrictions, to greatly reduce the possibility of young people being exposed to tobacco advertising for these products.

This is good information for India, because the law enforcement in India is always puzzling.

Under the PMTA route, manufacturers must prove to the agency that, among other things, the marketing of new tobacco products is suitable for protecting public health. These products were found to meet this standard because among several key considerations, the agency determined the harmful and potentially harmful ingredients (HPHC) that were exposed to research participants who used only authorized products compared to users of burning cigarettes less.

In addition, based on the comparison of existing data and the results of non-clinical studies, the toxicology assessment also found that the toxicity of the aerosol of the authorized product is significantly lower than that of the burning cigarette.

In addition, the US FDA considers the risks and benefits to the entire population, including users and non-users of tobacco products, and most importantly, youth. This includes reviewing available data on the likelihood of young people using the product.

For these products, the US FDA determined that if applicants follow post-marketing requirements designed to reduce youth exposure and product exposure, the potential benefits to smokers who completely or significantly reduce cigarette use will outweigh the risks to youth.

In addition, it should be remembered that, in addition to obtaining permission, the US FDA has also issued 10 marketing denial orders (MDO) for flavored ENDS products. Due to potential confidential business information issues, the US FDA will not publicly disclose specific flavoring products. The US FDA stated that it has evidence that, compared with users of non-tobacco-flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products and then switch to high-risk products, such as burning cigarettes.

US FDA data also shows that most youths and young people who use ENDS start to use flavors such as fruit, candy or mint instead of tobacco flavors. These data reinforce the FDA's decision to approve tobacco-flavored products because these products are less attractive to young people, and approval of these products may be beneficial to adult burning cigarette users who switch to ENDS completely or significantly reduce cigarette consumption.

Prev : Aberdeen, UK Electronic Cigarette News

Next : British and American e-cigarette news

Email:sales@mlifevapor.com

WhatsApp:+86 13871529372

Email:sales@mlifevapor.com

WhatsApp:+86 13871529372

Tel：+86 13871529372

Add：6 / F, block B, building 2, Fuyong Tongtai times center, Bao'an District, Shenzhen

Language：简体中文 | >

Tel：+86 13871529372

Add：6 / F, block B, building 2, Fuyong Tongtai times center, Bao'an District, Shenzhen Website