FDA issues deceptive Draft Guidance for Industry Applications for Premarket Review of New Tobacco Products

[Bill Godshall]

Today the FDA issued a "Draft Guidance for Industry Applications for Premarket Review of New tobacco Products" at
Draft Guidance for Industry Applications for Premarket Review of New Tobacco Products


But in this document, for which there is a 90 day public comment period, the FDA once again deceitfully misrepresented Section 910 (and other sections of Chapter IX) of the FSPTCA as applying to ALL tobacco products, including those NOT subject to Section 910 (i.e. small cigars, large cigars, pipe tobacco, shisha/hookah, electronic cigarettes (e-cigarettes), e-liquid, nicotine skin cream, nicotine water, at least two dissolvable tobacco products, and likely other soon-to-be-introduced tobacco products).

The FDA's deception includes the following statements in red.

III. Definitions

This section provides definitions of certain terms used in this guidance.
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A. Tobacco Product

Tobacco product means “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” (section 201(rr) of the FD&C Act; 21 U.S.C. 321(rr)). Thus, the term is not limited to products containing tobacco, but also includes components, parts, or accessories of tobacco products, whether they are sold for further manufacturing or for consumer use.

B. New Tobacco Product
A new tobacco product means “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007” (section 910(a)(1) of the FD&C Act).

IV. Discussion

A. Who Submits a PMTA?

Persons seeking a marketing authorization order under section 910(c)(1)(A)(i) must submit a PMTA to FDA.

The term "new tobacco product" is defined in section 910(a)(1) of the FD&C Act and includes any regulated tobacco products, including their components, parts, or accessories, whether sold for further manufacturing or for consumer use.

At this time, FDA intends to limit its enforcement of the requirements of section 910 to finished, regulated tobacco products. These finished, regulated tobacco products include the products named in section 901(b) (i.e., cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco) and tobacco products that may be deemed by regulation to be subject to the FD&C Act, as well as the component parts of regulated tobacco products sold or distributed for consumer use (e.g., cigarette rolling papers, filters, or filter tubes sold separately to consumers or as part of kits). To avoid the submission of duplicative information, FDA does not intend at this time to enforce the requirements of section 910 for components of regulated tobacco products that are sold or distributed solely for further manufacturing into finished tobacco products.​

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By claiming (in the previous paragraph) that:
At this time, FDA intends to limit its enforcement of the requirements of section 910 to finished, regulated tobacco products. These finished, regulated tobacco products include the products named in section 901(b) (i.e., cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco) and tobacco products that may be deemed by regulation to be subject to the FD&C Act, the FDA is deceiving the public (and attempting to intimidate tobacco companies and consumers) to inaccurately believe that Section 910 currently applies to unregulated tobacco products (i.e. small cigars, large cigars, pipe tobacco, shisha/hookah, electronic cigarettes (e-cigarettes), e-liquid, nicotine skin cream, nicotine water, at least two dissolvable tobacco products, and likely other soon-to-be-introduced tobacco products).

Along with similarly deceptive statements claiming that Section 911 (the MRTP provisions), Section 902 & Section 903 also applied to ALL tobacco products at Health Fraud, the FDA is clearly attempting to deceive the public about Chapter IX of the FSPTCA (and to intimidate tobacco companies from developing new unregulated tobacco products) in order to pave the way for the FDA to propose (and subsequently approve) a regulation to apply Chapter IX to ALL currently unregulated tobacco products, just as the FDA stated its intent to do the day it conceded to comply with Judge Richard Leon's ruling that e-cigarettes are tobacco products instead of unapproved drug devices (as long as the manufacturer/importer make no therapeutic claims) at
Regulation of E-Cigarettes and Other Tobacco Products

I plan to submit comments to the FDA informing the agency of these (and other) intentional misrepresentations of the legal implications and ramifications of Chapter IX of the FSPTCA and urging them to be corrected/clarified, and I encourage others to similarly submit comments exposing these misrepresetations of fact by the FDA.

 

[Placebo Effect]

Thanks for finding this Bill.