US FDA Responds to Two Supremes: No Comment on SMOK’s Ongoing Lawsuit

  The U.S. FDA has responded to two inquiries regarding the marketing denial order (MDO) issued for 22 SMOK products.

[Two Inquiries Original] On January 24, Two Inquiries (2FIRSTS) received an email response from Jim McKinney, a press officer at the FDA's media affairs office, regarding the sales ban on 22 SMOK brand vaping products from Shenzhen IVPS Technology Co., Ltd.

The following are the main points from the FDA's response, translated from the original text:

2FIRSTS: The FDA issued a marketing denial order (MDO) on January 16 for 22 SMOK brand vaping products from Shenzhen IVPS Technology Co., Ltd. As we understand, the pods and atomizers that received the MDO do not contain e-liquid. What is the legal basis for the FDA's enforcement?

FDA: The FDA does not comment on potential, pending, or ongoing litigation.

Note: Shenzhen IVPS Technology Co., Ltd. announced on January 18 that it has appealed to the U.S. Fifth Circuit Court of Appeals against the FDA's marketing denial order for SMOK brand open system vaping kits and related components.

2FIRSTS: As the first MDO targeting open system vaping devices, to what extent does the FDA plan to expand the definition of "vaping devices" in the future?

FDA: In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, granting the FDA broad authority to regulate tobacco products. Tobacco products are defined as products made or derived from tobacco, or any product containing nicotine from any source intended for human consumption, including any component, part, or accessory of tobacco products.

 

In 2016, the FDA finalized a rule extending its authority to all products that meet the statutory definition of "tobacco products" in the Federal Food, Drug, and Cosmetic Act, except for accessories considered tobacco products. Therefore, the rejected products are classified as tobacco products and not medical devices, and the FDA has not evaluated these products as medical devices.

 

Businesses can refer to this webpage to help determine whether their products are classified as medical devices, including whether the products are "intended for diagnosing disease or other conditions, or for curing, mitigating, treating, or preventing disease."

 

The FDA evaluates each premarket tobacco product application (PMTA) on a case-by-case basis according to public health standards, which consider the risks and benefits of the product to the entire population.

2FIRSTS: Gregory Conley, Director of Leg & Ext Affairs, commented on the recent MDO, stating that the FDA is now "attempting to ban open system vaping products on the grounds that they 'may' be used with flavored e-liquids." What is the FDA's response to this?

FDA: The FDA assesses products on a case-by-case basis to ensure that any new tobacco products, including open or closed systems, meet the standards set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act).

 

At each stage of the premarket application process, each application undergoes individual, independent review, and the agency makes decisions based on the evidence provided in the application. Under the PMTA pathway, manufacturers must demonstrate that the marketing of new tobacco products is appropriate for the protection of public health. This standard requires the agency to consider the risks and benefits to the entire population—as Congress specified in the FD&C Act—including both users and non-users of tobacco products. Applicants are responsible for providing the necessary information to demonstrate compliance with appropriate public health standards.

 

Specifically, for vaping devices, the data in their applications must indicate that their benefits (including benefits to adult smokers) outweigh the risks (including risks to youth), thus providing a net benefit to public health. For example, the agency's evaluation includes reviewing the ingredients, components, additives, and health risks of tobacco products, as well as the methods of production, packaging, and labeling. We also consider the impact of marketing restrictions and other measures aimed at reducing the risk of youth initiation of smoking and tobacco use, such as advertising and sales restrictions and device usage limitations. #p#分页标题#e#