The FDA updated a warning letter telling Knoxville Vapors LLC, e-cig manufacturer, to stop implying that the FDA has approved Knoxville Vapors manufacturing process for e-cigs. The Center for Tobacco Products (CTP) of the FDA issued the original warning letter to Knoxville Vapor LLC on April 2, 2015, and then updated the warning on April 13, 2015 .
There are many restrictions of conventional tobacco products, e.g. cigarettes, cigars, and snuff that have not been applied to e-cigs. These restrictions include selling to minors, advertising on TV and in magazines, and the requirement to provide health warning labels. Those restrictions have not been applied to e-cigs yet. The major parts of the warning focus on the fact that e-cigs contain nicotine, which qualifies e-cigs as tobacco products that are covered under some of the FDA regulations. Knoxville Vapor also advertises that their products are being made under FDA approval. They are not.
The following quotes come from the letter sent by the FDA to Knoxville Vapors.
Section 301(tt) Violation
FDA has determined that a statement made on the website, http://knoxvillevaporshop.com, regarding your e-liquids violate section 301(tt) of the FD&C Act (21 U.S.C. 331(tt)) which prohibits, in pertinent part:
“[m]aking any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that—
(1) the product is approved by the Food and Drug Administration;
(2) the Food and Drug Administration deems the product to be safe for use by consumers;
(3) the product is endorsed by the Food and Drug Administration for use by consumers; or
(4) the product is safe or less harmful by virtue of—
(A) its regulation or inspection by the Food and Drug Administration; or
(B) its compliance with regulatory requirements set by the Food and Drug Administration…”
Because this statement on your website is directed toward consumers and conveys, or would mislead consumers into believing, that the above-listed tobacco products are endorsed by the FDA or that the products are safe or less harmful by virtue of regulation by FDA, they are in violation of section 301(tt) of the FD&C Act.
The threat in the warning letter is summarized in this brief sentence.
Failure to ensure full compliance with the applicable provisions of the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, criminal prosecution, and/or injunction.
The update to the warning letter clarifies the provisions that apply to e-cig manufacturing claims.
 Certain tobacco products, including e-liquids that contain nicotine, are not yet deemed subject to the tobacco product authorities under Chapter IX of the FD&C Act. However, because your products meet the definition of a tobacco product, they must comply with applicable provisions that are outside of Chapter IX of the FD&C Act, including section 301(tt) of the FD&C Act.
The FDA provides a list of all warning letters that were issued over the past several years. There are numerous warning letters to many different manufacturers under FDA control. These warning letters include e-cig manufacturers as well as conventional tobacco products. The FDA is evaluating the reclassification of e-cigs with regard to regulating them like conventional cigarettes.
The following health impacts of nicotine are well documented. Some of the list comes from an article by Chris Sherwood of eHow that is titled How Does Nicotine Effect the Lungs? Other comments are based upon research from the American Heart Association, National Institute of Health, and the FDA.
- E-cigs appear to be safer than conventional cigarettes regarding lung cancer, but the nicotine poses a risk for other types of cancer, e.g. kidney, bladder and liver organs. Nicotine is a poison that is excreted through these organs.
- E-cigs appear to be safer than snuff and similar products with regard to cancers of the mouth, esophagus, and gum diseases.
- E-cigs are primarily a delivery mechanism for nicotine. Nicotine constricts blood vessels throughout the body, which leads to poor circulation in the heart, lungs and other major organs. Lack of circulation to hands and feet lead to amputations of those with diabetes.
- Nicotine has been proven to change cell structures that lead to the formation of cancers that are independent of any other additives contained in conventional or e-cigarettes.
- Nicotine constricts the blood vessels in the lungs which reduces the lungs’ effectiveness of providing oxygen to the heart and other major organs.
- Nicotine causes additional cell damage that compromises the immune system as well as the health of the organs.
- The propellants used in e-cigs, including propylene glycol and glycerin, chemically decompose under high heat to known carcinogens.
E-cigs are going to be regulated, taxed and restricted in sales to minors and on advertising on TV and printed materials just like the other major nicotine delivery systems. E-cigs are not safe. They are dangerous to health in different ways than conventional tobacco products. Despite the lobbying efforts of the tobacco and e-cig industries, research is now showing that e-cigs have a major health impact upon the public and a high cost for healthcare spread across the population.