Got questions? We’ve got answers.

No. The i.nyla system heats tobacco without burning it, so it does not produce smoke. Instead, it generates a nicotine-containing aerosol, commonly referred to as vapor.

Important: While it avoids combustion, i.nyla is not risk-free and delivers nicotine, which is addictive.

i.nyla is a tobacco heating system that heats specially designed tobacco sticks at a controlled temperature, rather than burning tobacco like regular cigarettes. Because it avoids combustion, i.nyla does not produce smoke, ash, or the strong smell associated with cigarette use. Instead, it releases a nicotine-containing aerosol (also referred to as vapor).

Important: i.nyla is not risk-free and delivers nicotine, which is addictive. It is intended only for adult smokers who would otherwise continue using combustible tobacco products.

Nicotine is an addictive chemical naturally found in tobacco. While it is not the primary cause of smoking-related diseases such as cancer or lung disease, it can have harmful effects, particularly for:

• Adolescents, due to effects on brain development
• Pregnant or breastfeeding individuals
• People with heart disease, high blood pressure, or seizure disorders

Nicotine may also interact with certain medications and contribute to dependence and sustained tobacco use.

Important: Products that deliver nicotine, including heated tobacco systems, are not risk-free and should be used only by adult smokers who would otherwise continue using tobacco. The most effective way to reduce tobacco-related health risks is to stop using all tobacco and nicotine-containing products.

No. i.nyla is not a smoking cessation product and is not authorized by the U.S. FDA for use in quitting smoking. It is intended for adult smokers who would otherwise continue using combustible tobacco products.

Important: The best way to reduce the health risks of smoking is to quit all tobacco and nicotine use entirely. Individuals seeking to quit should consult a healthcare professional or use FDA-approved smoking cessation therapies.

No. i.nyla is not safe or risk-free. It delivers nicotine, which is addictive, and the use of tobacco-containing products, including heated tobacco systems, still poses health risks.

While i.nyla heats tobacco instead of burning it, which may reduce exposure to certain harmful chemicals compared to cigarette smoke, it has not been proven to reduce disease risk.

Important: i.nyla is intended only for adult smokers who would otherwise continue using combustible tobacco. The best way to reduce health risks is to quit all tobacco and nicotine use completely.

MRTP stands for Modified Risk Tobacco Product. Under Section 911 of the U.S. Family Smoking Prevention and Tobacco Control Act, a tobacco product may be authorized by the U.S. Food and Drug Administration (FDA) to be marketed with modified risk claims, but only if the manufacturer provides robust scientific evidence that meets strict criteria.

There are two main types of MRTP claims:

• Reduced Exposure Claim: showing that the product reduces exposure to certain harmful or potentially harmful chemicals compared to traditional cigarettes.
• Reduced Risk Claim: showing that the product reduces the risk of tobacco-related disease to individual users and benefits public health.

To receive MRTP authorization, a product must undergo a thorough FDA scientific review, and the manufacturer must demonstrate that marketing the product:

• Will not mislead consumers, especially youth
• Will benefit the health of the population as a whole
• Includes clear disclaimers and conditions as specified by the FDA

Important: MRTP authorization does not mean the product is safe or FDA-approved. It only means that specific, FDA-reviewed claims about risk or exposure can be made legally, and only as approved by the FDA.

The U.S. Food and Drug Administration (FDA) is a federal agency within the Department of Health and Human Services responsible for protecting public health by ensuring the safety, effectiveness, and proper labeling of a wide range of products, including:

• Food and dietary supplements
• Prescription and over-the-counter drugs
• Medical devices
• Vaccines and biologics
• Cosmetics
• Tobacco products

Under the Family Smoking Prevention and Tobacco Control Act, the FDA regulates the manufacture, marketing, and distribution of tobacco products sold in the United States. This includes oversight of:

• Health warnings and labeling
• Advertising and promotion restrictions
• Premarket tobacco product applications (PMTAs)
• Modified Risk Tobacco Product (MRTP) applications

Important: FDA regulation of a tobacco product does not mean the product is safe or FDA-approved. Products that deliver nicotine, including e-cigarettes and tobacco heating systems, are not risk-free and should be used only by adult tobacco users.