Some people prefer buying organic products from beef made from purely grass-fed cows to sunscreen lotions with all-natural minerals because of their additive-free components, therefore leading to a healthier way of life. But for a product like cigarettes, will it really make a difference whether or not the package is labeled "all-natural"?
Among tobacco manufacturers in the US, three companies are using the labels "all-natural" and/or "additive-free" on their cigarette products - Santa Fe Natural Tobacco Company Inc., Sherman's 1400 Broadway N.Y.C. Ltd., and ITG Brands LLC.
According to the US Food and Drug Administration (FDA) the "all-natural" and "additive-free" labels used by the three tobacco manufacturers are violations of section 911 of the FD&C Act. The FDA announced Aug. 27 it has therefore issued warning letters to the cigarette producers.
Products labeled either "all-natural" or "additive-free" are:
Winston cigarettes labeled "Additive-free" by ITG Brands LLC
Natural American Spirit cigarettes labeled "Natural" and "Additive-free" by Santa Fe Natural Tobacco Company Inc.
Nat Serman cigarettes labeled "Natural" by Sherman's 1400 Broadway N.Y.C. Ltd.
The FDA said that before being legally introduced as "natural" and "additive free," the products need an FDA modified risk tobacco product order.
The agency's warning letter requested the tobacco manufacturers to respond within 15 working days to explain what they plan to do about the violations and what actions they will take to comply with the law. It also asked for supporting information, if the tobacco manufacturers believe they did not violate federal tobacco law.
According to FDA's director of the Center for Tobacco Products Mitch Zeller, the FDA has to ensure that manufacturers do not market their tobacco products in such a way that will make consumers believe that cigarettes with the "natural" and "additive-free" labels come with fewer health risks than those without the added labels, unless scientifically proven.
Authority to regulate cigarettes, cigarette tobacco, as well as roll-your-own and smokeless tobacco is given to the FDA by the FD&C Act which was amended by the Tobacco Control Act. The FD&C Act also allows the FDA to evaluate company requests to market their products as "modified risk."
Section 911 (b)(1) of the FD&C Act defines a "modified risk tobacco product" as "any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products." The product, its label, labeling and advertising the product as substance-free and/or posing a lower risk of diseases associated with tobacco are also considered modified risk.
The FDA explained that a manufacturer seeking to claim fewer risks of its product needs to submit a modified risk tobacco product (MRTP) application to the agency, along with scientific evidence supporting the claim. It has not issued any orders yet permitting the distribution of MTRPs.
This is the first time the FDA has used its authority to pursue regulatory action on the use of the "natural" and "additive-free" labels on tobacco products. The agency said that failure to obey federal laws on tobacco may lead to injunction, seizure, criminal prosecution or civil money penalties.
