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TOBACCO REGULATION

Upon the passage of the Family Smoking Prevention and Tobacco Control Act, the FDA was given jurisdiction to regulate tobacco products. The Center for Tobacco was created and subsequently new regulations were promulgated subjecting an already high-profile industry to more regulations by a mostly unfamiliar agency. This new regulatory scheme posed additional challenges to an already regulatory-pressured industry.

Thompson Coburn has long had a much respected tobacco industry practice. We have represented tobacco industry members for more than 20 years in virtually every type of tobacco-related lawsuit that has gone to trial. With the addition of the firm’s life science practice, the firm has now extended its representational experience to FDA compliance. The firm’s life science practitioners have counseled tobacco companies on manufacturing issues, packaging issues and marketing and advertising issues all arising from this regulatory scheme to which the industry is now subject.

Specifically our regulatory counseling to tobacco companies has included:

  • Advising on the “Deeming” of other tobacco products coming under the jurisdiction of the FDA
  • Advising on predicate products, substantial equivalence and premarket tobacco applications as well as the exemptions under 21 C.F.R. 1107.1
  • Advising on packaging, marketing and advertising requirements and restrictions
  • Advising on the applicability of certain regulations concerning e-cigarettes and other tobacco products

Publications

Participate in standard-setting bodies? The enforceability of your patents could be affected

Criminal antitrust prosecutions still loom for employers with ‘no-poaching,’ ‘wage-fixing’ agreements

Supreme Court overturns the Federal Circuit, granting more flexibility to biosimilar makers

Supreme Court heralds tectonic shift in venue selection for patent suits

What to do when the government comes calling: A checklist for handling facility inspections

USPTO launches new proof of use audit program

University patents now immune to inter partes review: Will business come calling?

The shifting standard for IPR estoppel: Where are we now?

5 tips for environmental due diligence in business transactions

D.C. appellate court strikes another nail in the coffin for the Frye test

What U.S. companies need to know about their IP rights post-Brexit

New OSHA reporting and anti-retaliation rules

USPTO publishes new (and largely improved) guidance for subject matter eligibility

Federal Circuit rules objective prong of willful infringement best decided by judge

Blog Posts

DOJ continues to investigate, seek recoveries over compounding pharmacy fraud

Connected medical device vulnerabilities continue to impact manufacturers, health care

Fate of legalized cannabis hinges on key vote

FDA to step up enforcement of homeopathic medicine

Recreational marijuana shake-up: Sessions revokes Cole Memorandum

Clinical trials Part I: The upcoming clinical trials reporting rule

The FDA's new Digital Health Plan

FDA’s Health Software PreCert Program to fast-track innovation

FSVP compliance dates arrive, challenges to food industry increase

Interpreting the renewed Rohrabacher-Farr Amendment: A loophole for enforcement?

TCLE

Statutory Changes, New Regulations, and Compliance Deadlines Under the Food Safety Modernization Act

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