WARNING: This product contains nicotine. Nicotine is an addictive chemical.

i.nyla is a tobacco heating system intended for use by adult smokers who would otherwise continue using cigarettes. It provides real tobacco taste without fire, ash, or cigarette smoke by heating specially designed tobacco sticks at a controlled temperature. This process releases a nicotine-containing aerosol (commonly referred to as vapor). i.nyla and its tobacco sticks are for adult use only.

⚠️ Important: i.nyla is not risk-free and delivers nicotine, which is addictive. The best way to reduce tobacco-related health risks is to quit tobacco and nicotine use altogether.

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:

1. Reduced Exposure Claim – Showing that the product reduces exposure to certain harmful or potentially harmful chemicals compared to traditional cigarettes.
2. 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.

1. Cigarette smoking causes serious disease and is addictive.
   The most effective way to reduce the health risks associated with tobacco use is to completely stop using all tobacco and nicotine-containing products.
2. Tobacco and nicotine products are for adult use only.
   These products should not be used by minors, youth, or anyone who is legally prohibited from purchasing tobacco products.
3. Smoke-free products are intended only for adults who currently use tobacco.
   They are designed for adult smokers who would otherwise continue smoking or using other nicotine products.
4. Not for non-users or former users.
   Smoke-free products should not be used by individuals who have never used tobacco or nicotine, or by those who have already quit. They are not intended as smoking cessation products.
5. These products are not risk-free and contain nicotine.
   Smoke-free products deliver nicotine, an addictive substance, and their use carries health risks. However, switching completely from cigarettes to a smoke-free product may reduce exposure to certain harmful chemicals.
6. Support and education are key.
   Adult users should receive clear information and guidance to support a full and informed transition to smoke-free alternatives.
7. Complete switching is necessary.
   To achieve potential benefits, consumers must fully switch to the smoke-free product and stop all cigarette smoking. Dual use does not eliminate risk.
8. Safety information must be clearly provided.

Users should have access to comprehensive safety and usage information, including health warnings, product limitations, and proper device handling.

1. ⚠️ Health and Safety Information

   • Tobacco sticks used with this device contain nicotine, which is an addictive substance.
   • This product and its tobacco sticks are not risk-free. The best way to reduce health risks related to tobacco and nicotine is to quit their use entirely.
   • Some individuals using nicotine-containing products may experience adverse effects, including: abdominal discomfort, chest pain, shortness of breath, coughing, dizziness, dry mouth or throat, gum irritation, headache, fatigue, nasal congestion, nausea, palpitations, sore throat, and vomiting.
   • Nicotine-containing products should not be used by individuals who:
     • Have or are at risk of heart disease
     • Have diabetes, epilepsy, or a history of seizures
   • These products should not be used during pregnancy or breastfeeding. If you are pregnant, nursing, or may be pregnant, it is advised to avoid all tobacco and nicotine use.
   • Switching from cigarettes to this product may affect how your body metabolizes certain medications, such as theophylline, clozapine, or ropinirole. Consult your healthcare provider before making changes to your tobacco use.
   • If you have any existing health conditions or concerns, seek medical advice before using this product.

   ⚠️ Usage Guidelines

   • Only use this device with the compatible tobacco sticks provided by the manufacturer.
   • Do not use this device with cigarettes or other tobacco products not intended for it. Doing so may cause injury or damage to the device.

   Do not modify the tobacco sticks or add any other substances. Unauthorized modifications can pose serious safety risks and compromise the intended use of the product.

This device contains a rechargeable lithium-ion battery, which is a consumable component. Over time and with regular use, the battery will naturally degrade, which is a common characteristic of all lithium-ion battery technologies.

As the battery ages:

• Its ability to hold a charge and deliver power efficiently may decrease.
• You may notice a shorter usage time per charge, fewer sessions, or reduced performance during consecutive uses.

Battery performance may also be affected by temperature conditions and charging practices:

• To optimize battery health and lifespan:
  • Charge the device only within the recommended temperature range, as outlined in the user guide.
  • Avoid exposing the device to high or low temperatures, whether in use, during charging, or in storage.
  • Use only the charging cables and power adapters provided or approved by the manufacturer.
  • Do not leave the battery fully discharged for extended periods.

While the device may include battery management software designed to regulate charging and enhance performance, battery degradation over time is inevitable and cannot be fully prevented.

⚠️ Important: Improper handling, unauthorized charging accessories, or extreme environmental conditions may accelerate battery wear or pose safety risks.

For best results, follow all manufacturer-provided safety guidelines and usage instructions.

Tobacco heating systems and vaping products are both considered smoke-free alternatives to traditional cigarettes, but they differ in how they work and what they contain:

• Tobacco heating systems (like i.nyla) heat real, processed tobacco at a controlled temperature to release a nicotine-containing aerosol—not smoke—without burning the tobacco.
• Vaping products (e-cigarettes) use a liquid solution (often containing nicotine and flavorings) that is heated to create an aerosol. These products do not contain tobacco leaf.

⚠️ Important Legal Note: Neither tobacco heating systems nor vaping products are risk-free, and both deliver nicotine, which is addictive.

Any claims regarding reduced exposure or risk must be authorized by the U.S. Food and Drug Administration (FDA) under the Modified Risk Tobacco Product (MRTP) application process. As of now, no such authorization has been granted for i.nyla.

These products are intended only for adult smokers who would otherwise continue using tobacco. The best way to reduce tobacco-related harm is to quit all tobacco and nicotine use.