The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) recently reviewed your websites, http://www.alcheminternational.com and http://www.nicselect.com, and determined that you sell, manufacture, or distribute tobacco-derived liquid nicotine and other tobacco-derived nicotine products to customers in the United States. Specifically, your website advertises various concentrations of liquid nicotine (e.g., 1,000 mg/ml, 100 mg/ml, 99% pure liquid nicotine, and 10%, 7.2%, and 5.4% wt/vol dilutions) and other nicotine products. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), these products are tobacco products because they are made or derived from tobacco and intended for human consumption.
Making 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 . . .
Specifically, your websites include statements or representations directed towards consumers that Alchem International, manufacturer of NicSelect, is an FDA-inspected manufacturer and that NicSelect is manufactured in an FDA-inspected facility. On each page of the NicSelect website, http://www.nicselect.com, a text box in the lower-left corner states that “NicSelect® is made by Alchem International, a world-class, FDA-inspected manufacturer of plant-based chemicals for medicines, nutraceuticals and cosmetics” and that “Alchem has been producing pharma-grade liquid nicotine from tobacco plants for nicotine patches and gums, and is now creating vaping-grade nicotine for e-liquid manufacturers.” The “About Alchem” page of the NicSelect website states that “Alchem’s NicSelect® is naturally derived from tobacco plants and manufactured at its WHO [World Health Organization] GMP-licensed and FDA-inspected pharmaceutical production plant.” That same webpage states that “Alchem’s commitment to quality is demonstrated by . . . [being] FDA inspected with excellent relationships and records.” The “FDA Inspection Letter” page of the NicSelect website features what appears to be an FDA inspection letter and highlights the portion of the letter that states “we are classifying your facility as acceptable.” Elsewhere, the NicSelect website states that NicSelect “exceeds USP specifications” and is “FDA Inspected,” “comes from Alchem International’s FDA-inspected facility and is consistent, batch after batch,” and is “[d]erived naturally from pesticide-free tobacco plants in an FDA-inspected facility . . . .” Lastly, the NicSelect website offers customer testimonials, where “Nathan Bryant, [of] Liquid Mayhem” is quoted as stating, “Plus, we’re more confident knowing that it’s coming from an FDA inspected facility.”
The “Nicotine” webpage on the Alchem International website, http://www.alcheminternational.com, states: “Our Nicotine is highly pure, stable and naturally derived. Manufactured at our WHO GMP licensed and US FDA approved pharmaceutical production plant, Alchem’s Nicotine is available at our European and USA warehouses.”
Because these statements on your website are directed toward consumers and convey, 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.
Conclusion and Requested Actions
The violations discussed in this letter do not necessarily constitute an exhaustive list. You should immediately correct the violations that are referenced above, as well as violations that are the same as or similar to those stated above, and take any necessary actions to bring your tobacco products into compliance with the applicable provisions of the FD&C Act.
It is your responsibility to ensure that your tobacco products and all related promotional materials on this website, on any other websites (including e-commerce, social networking, or search engine websites), in any other media in which you advertise, and in retail establishment(s) comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. 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.
Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products and your plan for maintaining compliance with the FD&C Act.
Please note your reference number, RW1500341, in your response and direct your response to the following address:
DPAL-WL Response, Office of Compliance and Enforcement FDA Center for Tobacco Products c/o Document Control Center Building 71, Room G335 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at CTPCompliance@fda.hhs.gov.
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.