American Cancer Society Analysis and Review of the Proposed Tobacco Settlement [Binder] [5]
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OCR Page 1 of 26AMERICAN CANCER SOCIETY
extremely time-consuming. Companies could potentially stall review of any
challenged material through the three-judge panel by insisting on a line-by-line
review of the documents. Thus, what is potentially the most critical information
may not reach the public for years, if ever.
The ACS believes that all information on the harmful effects of
smoking -- whether or not it is privileged or trade secret information -- should be
provided to FDA for use in development of Product Standards and reduced risk
products. The FDA has strict requirements relating to non-disclosure of trade
secrets and has vast experience in regulating products on the basis of confidential
information to review documents that are currently protected under attorney-client
privilege or are trade secrets.
Recommended Changes
1.
Congress should ensure that both state and federal courts have
jurisdiction to quickly resolve privilege claims. The burden should
be on industry to demonstrate why documents should not be
disclosed.
2.
Federal legislation regarding disclosure of industry documents
should also explicitly require the industry to release to the FDA all
information -- including research and marketing data -- that is
relevant to public health, safety, and the development of less
hazardous tobacco products.
IV.
SCOPE AND EFFECT / PREEMPTION
Summary of Settlement Provisions (pp. 32-33; 26-27)
The settlement preserves state and local authority to:
(a) restrict or eliminate underage access to and consumption of
tobacco;
(b) further restrict or eliminate ETS exposure in the workplace and
"other public and private places and facilities;" and
(c) restrict or eliminate the sale or distribution of tobacco products.
The terms of the settlement document "preserve" current federal law
providing for national uniformity of warning labels, packaging and labeling
requirements and advertising and promotion requirements related to tobacco and
health. In addition, the preemption provisions of section 521 of the Food, Drug, and
Cosmetic Act (FDC Act), designed to provide uniform regulation of medical devices,
would apply to tobacco products since they will be regulated as devices.
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