Today the FDA announced proposed rules titled ““Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses.”
The document is very intriguing and worth the read for any person seeking more clarity on our products regulatory history and its path as a legal tobacco product. It details how the FDA was going to actually classify tobacco cigarettes as a “drug device combination” and remove them from the market. Brown & Williamson Tobacco Corp successfully litigated against the FDA. The Supreme Court concluded that Congress did not intend to give the FDA the power to regulate tobacco, and that the regulations were therefore invalid.
Partially as a response to this finding, Congress passed in 2009 the Family Smoking Prevention and Tobacco Control Act which expressly granted the FDA the power to regulate the tobacco industry. In 2008, the FDA seized an electronic cigarette shipment bound for Ray Story’s Smoking Everywhere firm. The FDA claimed that these “new” products were an illegal drug device combination and cannot be sold. Ray successfully argued that no, they were actually an old-line tobacco product as their nicotine is derived from the leaf and stem of a tobacco plant (settled as Sottera vs. The FDA). On December 10, 2010 the Washington D.C. Appellate Court agreed stating that the FDA is to regulate as a tobacco product. This from the FDA:
“The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.”
The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.”
There has been confusion and much contention since as to what the FDA would finally do with their new authority overseeing these products. Today’s statements by the FDA clarify their position:
Similarly, FDA does not consider claims suggesting that a tobacco product provides an alternative way of obtaining the effects of nicotine, or that a tobacco product will provide the same effects as another tobacco product–such as “satisfying smoking alternative,” “provides all the pleasure of smoking,” “get your nicotine fix,” or “provides smokers the same delight, physical and emotional feelings”–to fall within its drug and device authority; however, we invite comment on this.
For example, claims related to satisfaction, pleasure, enjoyment, and refreshment have been recognized as euphemisms for the delivery of a pharmacologically active dose of nicotine. While these claims relate to effects on the structure or function of the body, FDA does not consider these tobacco satisfaction and enjoyment claims to fall within its drug and device regulatory authority
We applaud the FDA and hope this position remains ongoing.