If a manufacturer does not file a report by March 22, or cannot substantiate its evidence, the FDA said Wednesday that it could remove the product from store shelves.
The announcement updated the guidance provided to manufacturers in June 2009 as part of enacting the Family Smoking Prevention and Tobacco Control Act.
Manufacturers of any product introduced after March 22 must submit an application and obtain a marketing order from the FDA before placing the product on the market.
The emphasis of the new rules puts R.J. Reynolds Tobacco Co. , the manufacturer of Camel cigarettes , in the bull's-eye because it has been the most prolific developer of tobacco products in recent years, including Camel Snus and the Camel orbs, sticks and film like strips for the tongue.
"No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such," said Dr. Lawrence Deyton, the director of the FDA's Center for Tobacco Products.
"These products will not be safer, but we are required by this law to not allow even more dangerous products to cause further harm to those Americans who use tobacco products."
The FDA defined "substantially equivalent" as "being the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single-predicate product or have different characteristics, but not raise different questions of public health."
Manufacturers that submit evidence will be allowed to continue to market their products "unless the FDA issues an order finding the product to be not substantially equivalent" to the product already in the marketplace.
Bill Godshall, the executive director of Smoke Free Pennsylvania, said he would not be surprised if the FDA uses the substantially-equivalent requirement "to try to ban many or most new tobacco products, especially the least hazardous ones."
"The FDA could claim that substantially equivalent means virtually identical, and/or that a slightly different color, shape, size or even a 5 percent difference in any constituent means the products aren't substantially equivalent,' Godshall said.
The new rules likely cover the dissolvable Camel products that Reynolds placed in test markets in January 2009. Reynolds recently said it is reconfiguring the test markets.
Maura Payne, a spokeswoman for Reynolds, said in June 2009 that the products are substantially equivalent to dissolvable sold by Star Scientific Inc.'s Ariva and Stonewall.
It is not clear whether the rules apply to Camel Snus. Reynolds began test markets for Camel Snus in June 2006 before taking it national in January 2009.
Analysts said that any substantial changes to Camel Snus, including potentially new or altered flavoring, could make it susceptible to the new rules.
Dr. John Spangler, a professor of family and community medicine at Wake Forest University School of Medicine, said that the FDA has clarified its guidance with the update.
"For example, now the FDA states that a new public-health question is whether use of the new product induces nonsmokers to start smoking," Spangler said. "This could pose a roadblock to the introduction of new products if the FDA abides by this strict standard."
"We have submitted several applications on substantial equivalence to the FDA, and we look forward to working together with the FDA on the applications we have submitted, as well as the development of the guidance and proposed rulemaking on exemptions to the substantial-equivalence process," said David Howard, a Reynolds spokesman.
In April, Reynolds complied with an FDA request for information about its dissolvable products.
Deyton wrote in a letter to Reynolds that the Center for Tobacco Products was concerned that "brightly colored" packaging and the "candy like appearance" of the products may appeal to children, as well as "facilitate initiation of tobacco use, nicotine dependence and addiction in adolescents."
Stephen Pope, an industry analyst and the managing partner of Spotlight Ideas in England, said manufacturers face a steep hurdle in trying to get past the FDA requirement that a new product doesn't compel a non-tobacco consumer into use.
"Thinking of tobacco use, of course, the main thrust is that if a product claims to provide all the taste, flavor and enjoyment of a previously available product — with the benefit of a reduced risk — then it may entice more new smokers than would otherwise have been the case," Pope said.
"In my view, the FDA wants to reopen the test books, just to be sure that all that should have been done has been done, and done with vim and rigor."