FDA Denies Citizen Petition to Change a Smokeless Tobacco Warning Statement
FDA has denied a Citizen Petition from R.J. Reynolds Tobacco Company and American Snuff Company, LLC. The petition asked FDA to initiate a rulemaking to change one of the four smokeless tobacco warning statements currently required by the Comprehensive Smokeless Tobacco Health Education Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009.
The Citizen Petition was received on July 29, 2011, asking FDA to change the current statement, “WARNING: This product is not a safe alternative to cigarettes.” to “WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”
FDA denied the Citizen Petition after thoroughly reviewing the available scientific evidence and public comments. The agency determined there is insufficient evidence to demonstrate that a change in the warnings would promote greater public understanding of the risks associated with the use of smokeless tobacco products.
A manufacturer who seeks to claim that its product poses fewer risks than other tobacco products may submit a modified risk tobacco product application with scientific evidence to support that claim. In 2012, FDA issued draft guidance on submitting applications for modified risk tobacco products, view here.
FDA Issues Draft Guidance on a No-Tobacco-Sale Order
Today, FDA issued a draft guidance regarding FDA’s authority to issue a No-Tobacco-Sale Order (NTSO). Essentially, an NTSO is a ban on selling tobacco products for a period of time for retailers who have repeatedly violated certain restrictions on the sale and distribution of tobacco products.
The draft guidance, Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order, discusses topics intended to help retailers better understand and comply with NTSOs, such as:
- when FDA may seek to issue an NTSO;
- the time period covered by an NTSO;
- what happens after an NTSO has been imposed on a retailer; and
- how a consumer can learn which retailers have received NTSOs.
In conjunction with this draft guidance, FDA has also updated a previously-released guidance to reflect additional information about NTSOs. The updated guidance, Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers Responses to Frequently Asked Questions, offers answers to common questions about civil money penalties (CMPs) and NTSOs. The NTSO draft guidance will be open for public comment for 45 days beginning tomorrow, May 13, 2015.
For more information on these documents, please visit our Guidance web page.