According to The Los Angeles Times it’s not often a tobacco company gets released from government regulation without asking.
But that’s apparently what happened to Star Scientific Inc. after it asked the Food and Drug Administration to treat two versions of its smokeless, dissolvable tobacco lozenges as “modified risk” because they contain lower levels of carcinogens than other tobacco products.
The FDA responded that the products aren’t considered smokeless tobacco at all and don’t come under the 2009 tobacco law, according to a Star Scientific announcement on Wednesday.
“We were very surprised. We obviously believed that these were smokeless tobacco products under the act,” said Sara Troy Machir, Star Scientific’s vice president for communications and investor relations.
Why FDA judged Ariva-BDL and Stonewall-BDL exempt from the tobacco law is a mystery.
Both the FDA and Star Scientific declined to release copies of the agency’s decision because they said it contained confidential commercial information.
Machir said the FDA cited “details of the manufacturing process” — which are secret – in exempting the products from oversight.
In a statement, the FDA said it recognizes that “there are uncertainties regarding the regulatory status of a variety of nicotine-containing products” including whether they should be regulated as drugs or tobacco.
The agency said it’s “considering its legal and regulatory options regarding these products.”
As more smokeless products hit the market patients need to be aware that many do contain nicotine. Dr. O’Toole emphasizes the need for full disclosure from patients with regards to their nicotine intake, whether it be smoking, or smokeless tobacco use. It is unclear as to how little nicotine affects surgical results. Procedures in which delayed wound healing can be an issue such as abdominoplasty, breast lift, and facelift patients must take heed to the risk of nicotine regardless of the amount.
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