Center for Tobacco Products News

A new tobacco approval process that mimics device 510(k) clearance procedures could also require that industry supply clinical trial data and other information as the agency implements a mandate from the 2009 law that brought tobacco regulation under FDA’s purview. The equivalence review process, issued Wednesday, will likely lead to new data requirements for an industry that is not accustomed to FDA’s regulatory environment, especially because the agency is still learning about the products, an industry attorney said.

The agency said Wednesday (Jan. 5) that tobacco products marketed or altered after Feb. 15, 2007 will be reviewed through a substantial equivalence process. Companies will have until March 11 to submit information comparing their products to a predicate product grandfathered into the system before February 2007 to prove that they are as safe or safer than tobacco products already on the market.

According to a guidance document, companies must submit information regarding ingredients, materials and the heating source, but the agency can request additional data, including clinical, consumer perception, toxicology and abuse liability data. Products that have characteristics different from the predicate must prove that they do not raise different questions of public health through the additional data.

“I think any tobacco manufacturer has to be thinking about clinical trials in the mid-term, if not near-term,” an industry attorney said.

While Congress and the agency always had intentions of mimicking the device 510(k) process with the equivalence requirements outlined in the Tobacco Control Act, the attorney said the additional data requirements — such as extensive information derived from clinical trials — are reserved for devices requiring premarket approval.

Although the agency has not given any indication of review requirements for new tobacco products without a predicate, given the innate changes of an agricultural product, the attorney said he was optimistic that a full-blown approval process would be reserved for significant changes. “The whole game is going to be tying things to the past,” the attorney said.

The agency, which has little experience regulating tobacco, will likely request more data, but the tobacco industry, which likewise is inexperienced with the agency and dominated by small companies, will be ill-equipped to handle the new requirements, the attorney said. “Not only is there not the experience within the tobacco industry for basically a regulatory system that mimics that of devices or drugs, there also aren’t the resources,” the attorney said.

FDA officials acknowledged the tight deadline and said they would work with companies to comply if they submit information before March 11. “It is our intent to allow manufacturers, who have acted diligently, a reasonable amount of time to supplement their reports,” said Lawrence Deyton, director of the Center for Tobacco Products, during a conference call with reporters. Officials said there would be additional guidance about modified risk products and how to determine whether a product had changed after the required date.

Products introduced after February 2007, but before the submission deadline, will remain on the market unless FDA determines they are not equivalent to the predicate. Products introduced after March 11 will have to seek approval at least three months before going to market.

Matthew Myers, president of Campaign for Tobacco-Free Kids, lauded the implementation of the new requirements, saying they will prevent manufacturers from making their products more harmful.

“This new requirement is an important complement to other critical provisions of the new law. The law also requires tobacco manufacturers to disclose detailed information about all tobacco products to the FDA, including all ingredients and additives by brand and information about the health effects of the products,” he said in a statement. “The FDA also has authority to require changes in all tobacco products — both existing and new — to protect public health, such as reduction or elimination of harmful chemicals or changes in nicotine levels.“

If the agency is forced to bring the electronic cigarettes under tobacco rules, the heavily debated products could face the review process. FDA attempted to regulate electronic cigarettes as a drug-device combination last year, but a federal court ruled in December that the products are derived from tobacco and should be regulated as such. The agency petitioned for a rehearing.

Unless electronic cigarettes were marketed prior to Feb. 15, 2007, they will face the approval process as a tobacco product, if the agency is forced to change its course of action. Court documents from the lawsuit state that the company involved in the case had been importing and selling the products since 2007. — Alaina Busch ( abusch@iwpnews.com This e-mail address is being protected from spambots. You need JavaScript enabled to view it )