Under federal law, a “modified risk tobacco product” is a product whose label or advertising represents that the product presents lower risk of tobacco-related disease or is less harmful than other commercially-available products. 21 USC 387k. In order to legally market a product as a modified risk tobacco product (MRTP), an order must first be issued by the FDA permitting the marketing as a MRTP. To date, FDA has not issued a single MRTP order.

According to the FDA’s Warning Letter, found here, JUUL representatives allegedly made statements suggesting its products were safe and were safer than cigarettes. If made, these statements would cause JUUL’s products to be marketed as MRTPs, in violation of federal laws and FDA requirements. As with all warning letters issued by the FDA, the Company has 15 business days to respond to the allegations.

The FDA regulates tobacco products under the Family Smoking Prevention and Tobacco Control Act (Act), which was signed into law by President Obama in 2009. The Act grants FDA the authority to regulate various tobacco products, including electronic delivery nicotine systems or “ENDS”, like JUUL products. ENDS and all covered tobacco products must meet FDA requirements, including labeling and marketing requirements and in many cases premarket notification or authorization requirements. If you have questions about marketing tobacco products, please contact us at contact@sglawfl.com.

Getting a FDA Warning Letter for your tobacco business can be confusing. Responding to a FDA Tobacco Warning Letter can be even more confusing and time-consuming for a business. Although people often look to us for a sample response for their FDA Tobacco Warning Letter, unfortunately it is not that simple. While there are some common “Do’s” and “Don’ts”, there is no one-size-fits-all approach in responding to a FDA Tobacco Warning Letter. Accordingly, what we do is offer a tailored plan for responding to and resolving FDA Tobacco Warning Letters.

First, it is important to understand the underlying issues that prompted the Letter. Was it failure to check identification and underage sales or is the problem with labeling, etc.? Depending on the exact issues cited in the Tobacco Warning Letter, there are different measures that should be taken in order to adequately respond. For example, where there are labeling issues, label reviews and updates may be necessary in addition to submitting a response to the FDA to the Tobacco Warning Letter. If the issue is underage sales, there are other corrective measures that can help you bring your business into compliance with FDA requirements.

Once the issues that prompted the Tobacco Warning Letter are fully understood and corrective actions are completed, then a complete response detailing these measures must be addressed to the FDA. In Response to the FDA Tobacco Warning Letter, the Agency will want to see that all regulatory requirements are being addressed in a proactive way and that the business will be able to follow all regulations moving forward. Because these letters are often lengthy and technical in nature, we often provide these services to clients to help them ensure that they address any pending matters that may be of concern to FDA and allow them to get back to business.

For more information about responding to a Tobacco Warning Letter or how we may be able to help, you can contact us at (866)785-0873 or contact@sglawfl.com.