PHILIP MORRIS USA v. FDA: DECLARATION OF ANN SIMONEAU, Dec. 8, 2015

December 13, 2015 9:54 pm by Gene Borio

The PDF is Here

EXCERPT:

1. I am currently serving as Director of the Office of Compliance and Enforcement (OCE) in the United States Food and Drug Administration’s Center for Tobacco Products (CTP) . . .

4. FDA’s Regulatory Procedures Manual (RPM), Chapter 10, § 10-2-2 (Prior Notice), provides that “a basic principle of FDA’s enforcement policy is the belief that the majority of persons will voluntarily comply with the law when given information as to what is required, what violations appear to exist, and, in the case of violations of regulatory significance, that failure to comply may result in the initiation of enforcement action.”

. . .

5. To date, FDA has not issued any Warning Letters to Philip Morris USA Inc., U.S. Smokeless Tobacco Co. LLC, R.J. Reynolds Tobacco Co., American Snuff Co. LLC, Santa Fe Natural Co., Inc., ITG Brands LLC, or to any other firm, relating to the issues discussed in the Guidance.

END EXCERPT

FULL TEXT:

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
PHILIP MORRIS USA INC., et al.,

Plaintiffs,

v.

UNITED STATES FOOD AND DRUG ADMINISTRATION, et al.,

Defendants.

Case No. 1:15-cv-01590

DECLARATION OF ANN SIMONEAU

I, Ann Simoneau, hereby declare as follows:

1. I am currently serving as Director of the Office of Compliance and Enforcement (OCE) in the United States Food and Drug Administration’s Center for Tobacco Products (CTP) in Silver Spring, Maryland. I have held this position since January 2011. From July 2009 to January 2011, I served as Acting Director of OCE. In my position of Director of OCE, I am familiar with the enforcement actions FDA has pursued regarding violations of the Family Smoking Prevention and Tobacco Control Act (TCA).

2. Under the TCA, new tobacco products must undergo premarket review. A new tobacco product that does not comply with the premarket requirements of sections 905(j) and 910 of the FD&C Act (21 U.S.C. §§ 387e(j) and 387j) is both adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act (21 U.S.C. §§ 387b(6)(A) and 387c(a)(6)), respectively. The FD&C Act prohibits, among other things, the distribution of an adulterated or misbranded tobacco product in interstate commerce. See 21 U.S.C. § 33 l (a).
3. FDA has not pursued any civil or criminal enforcement actions against any tobacco product manufacturer for violations of the TCA related to any issue addressed in the agency’s recent Guidance, Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 2) (”the Guidance”). For that matter, to the best of my knowledge, to date, the government has not filed any civil or criminal enforcement action against any individual or firm alleging distribution of adulterated or misbranded tobacco products based on the absence of premarket authorization.

4. FDA’s Regulatory Procedures Manual (RPM), Chapter 10, § 10-2-2 (Prior Notice), provides that “a basic principle of FDA’s enforcement policy is the belief that the majority of persons will voluntarily comply with the law when given information as to what is required, what violations appear to exist, and, in the case of violations of regulatory significance, that failure to comply may result in the initiation of enforcement action.” Accordingly, the RPM states, “When it is consistent with the public protection responsibilities of the agency and if a violative situation does not present a danger to health or does not constitute intentional, gross or flagrant violations, it is FDA’s policy to afford individuals and firms an opportunity to voluntarily take appropriate and prompt corrective action prior to the initiation of enforcement action.” RPM § 10-2-3. FDA issues Warning Letters to “to achieve voluntary compliance and to establish prior notice.” RPM Chapter 4, § 4-4-1 (Warning Letter Procedures).

5. To date, FDA has not issued any Warning Letters to Philip Morris USA Inc., U.S. Smokeless Tobacco Co. LLC, R.J. Reynolds Tobacco Co., American Snuff Co. LLC, Santa Fe Natural Co., Inc., ITG Brands LLC, or to any other firm, relating to the issues discussed in the Guidance.

Pursuant to 28 U.S.C. § 1746, I declare under penalty of perjury that the foregoing is true and correct.

Executed this 8th day of December, 2015.
Ann Simoneau

Director, Office of Compliance and Enforcement

Center for Tobacco Products

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