FDA on NRTsBelow is a message from Bill Godshall, Director at Smokefree Pennsylvania:
The FDA will hold a public hearing December 17 at Silver Spring, MD (and requests written comments) “on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and to request input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence.”
Please Note December 6 Deadline to sign up to testify.
Tobacco harm reduction advocates are encouraged to testify and/or submit written comments.  To register to testify, please send an e-mail to Section918PublicMeeting@fda.hhs.gov requesting to testify, and provide your contact information as stipulated in the FDA’s announcement.
The hearing will likely attract many drug companies, drug industry funded researchers and drug industry funded anti tobacco groups to endorse NRT products (gums, lozenges, patches) for tobacco harm reduction, somewhat similar to the FDA conference that was held in October, 2010 (see below).
Suggested recommendations for FDA:
– Acknowledge and inform smokers that long term use of nicotine poses negligible if any disease risks,
– Approve NRT products for long term and temporary use as a harm reduction substitutes for cigarettes,
– Amend warning labels on NRT products to provide more helpful information (as current NRT warning labels confuse and scare many readers to believe that NRT and nicotine are as hazardous as cigarettes),
– Acknowledge and require NRT warnings to inform consumers that NRT products are NOT very effective for treating tobacco dependence (as NRT products have >95% failure rate treating nicotine dependence).
– Acknowledge and inform smokers that all smokefree tobacco/nicotine products (including smokeless tobacco and electronic cigarettes) are far less hazardous alternatives to cigarettes.
– Acknowledge and inform smokers that evidence indicates millions of cigarette smokers have quit smoking and/or sharply reduced cigarette consumption by switching to e-cigarettes, smokeless tobacco products and/or NRT,
– Propose a regulation to eliminate the intentionally deceptive warning on smokeless tobacco products “This product is not a safe alternative to cigarettes,”
– Correct/clarify all false, misleading and fear mongering propaganda about the health risks of smokeless tobacco products and e-cigarettes at each of the following FDA and DHHS websites:
Below is my testimony at FDA’s conference in 2010.  I’ll be pleased to assist anyone in drafting their testimony for the December 17 hearing.

Food and Drug Administration

Center for Drug Evaluation and Research


Risks and Benefits of Long-Term Use of

Nicotine Replacement Therapy Products


October 27, 2010




William T. Godshall, MPH

Executive Director

Smokefree Pennsylvania

1926 Monongahela Avenue

Pittsburgh, PA 15218

I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable for their egregious past actions, preserve civil justice remedies for those injured by cigarettes, increase cigarette tax rates, fund tobacco education and smoking cessation services, and inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes.

For disclosure, neither I nor Smokefree Pennsylvania have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.

I’m here to urge the FDA to stop protecting cigarettes from market competition by far less hazardous smokefree nicotine and tobacco products. 

More than ninety nine percent of all tobacco attributable mortality and more than ninety nine percent of tobacco attributable health care costs in the US are caused by repeated inhalation of tobacco smoke, while <1% are caused by the use of noncombustible tobacco and nicotine products.  Existing evidence also indicates that cigarettes are at least 100 times more hazardous than the smokefree nicotine and tobacco products marketed in the US, including smokeless tobacco products, electronic cigarettes and nicotine products marketed to treat tobacco dependence. 

While quitting all tobacco/nicotine use may be the best way for smokers to improve their health, switching to smokefree tobacco/nicotine products reduces smoker’s health risks nearly as much as quitting all tobacco/nicotine use.  Surveys indicate that more than a million smokers have quit smoking by switching to smokeless tobacco products, and sales reports indicate that nearly a half million smokers have switched to electronic cigarettes in just the past several years.  Nonsmokers also benefit when smokers switch to or substitute smokefree alternatives, as they emit NO tobacco smoke.

As currently regulated by the FDA to treat tobacco dependence, nicotine products have had a 95% failure rate.  But these products are deceptively promoted by drug companies, public health agencies and drug industry funded anti-tobacco organizations as the most effective way to quit smoking

Although the FDA has only approved nicotine products for short term (10-12 weeks) usage to treat tobacco dependence, research and sales data indicate that a large percentage (probably a majority) of nicotine gum and lozenges are used for “off label” purposes as either long term or temporary nicotine maintenance alternatives to cigarettes.

But instead of taking actions to reduce current “off label” usage of nicotine products, the FDA should encourage and approve the marketing of nicotine products to smokers as long term and as temporary cigarette alternatives, similar to the way smokeless tobacco and electronic cigarettes are marketed to smokers.

Concurrently, the FDA should eliminate the current warning on nicotine products that urge consumers to discontinue use if they also use a tobacco product, and instead should encourage smokers to continue substituting nicotine products for cigarettes as often as possible.

The FDA also should allow the sale of $5-$10 packages of nicotine products, allow sales at all retail stores that sell cigarettes, and allow higher levels of nicotine in the products to satisfy the cravings of most smokers. 

If the FDA doesn’t take these long overdue actions to protect public health, the most effective way for companies to increase nicotine product usage by smokers would be to market their products as tobacco products under the FSPTCA.

The FDA also should stop trying to ban electronic cigarettes by misclassifying them as drug devices, which Federal Judge Richard Leon has already struck down, and instead the FDA should classify and reasonably regulate e-cigarettes as tobacco products in accordance with the FSPTCA. 

Josh Sharstein’s misleading fear mongering claims about e-cigarettes at a July 22, 2009 press conference also should be clarified and corrected by the agency.

The FDA has an ethical duty to inform smokers that nicotine is addictive, but that all smokefree tobacco and nicotine products are far less hazardous long term and temporary alternatives to cigarettes.

Smokers have a human right to truthful health information and legal access to far less hazardous alternatives.  The FDA should provide for that.

One thought on “FDA Hearing on Nicotine Replacement Therapies

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