FDA Law / Administrative Law

Case Compliments of Versuslaw

FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) - Study Guide

What did the FDA assert authority over that triggered this case?

When did it do it?

How did it classify cigarettes and smokeless tobacco?

Why group did it target?

Why did it target this group?

Think about the politics of the time - who was president and who was FDA commissioner, and who appointed this commissioner.

What is the statutory definition of a drug?

What is the statutory definition of a device?

What is a combination product?

Is a combination product regulated as a drug or a device?

Why such broad language?

What did the proposed regulation restrict?

Did the regulation attract a lot of comments?

Why?

What finding about the effect of nicotine justified classifying tobacco as a drug?

Why are these specific findings the core of justifying a regulation?

How do they relate back to the enabling statute?

Did the FDA find that tobacco manufactures intend for tobacco to have these effects?

How was this intent finding justified?

What was the basis for finding that cigarettes are a combination product?

How did the FDA justify the policy choice of regulating tobacco?

What did the agency find was the only way to reduce tobacco-related illness?

When do most people start smoking?

Why is important as to the issue of a knowing choice to assume the risks of smoking?

What were the access restrictions?

Could this have been enacted by Congress?

What were the promotional restrictions?

Could this have been enacted by Congress?

What was the labeling requirement?

Could this have been required by Congress?

Were these restrictions based on the drug or the device authority?

What does the device statute allow on access restrictions?

What do you think Congress had in mind with this provision?

Who challenged the statute?

Where did they file and why choose that location?

What sort of challenge was this and what was it based on?

Was there a Constitutional claim?

What did the District Court rule on the access and labeling provisions of the regulation?

What did the court rule on the advertising and promotion restrictions?

What did it rule on the implementation of the regulations it found valid?

Why?

What did the 4th Circuit rule?

What was the basis for its ruling?

Why did the 4th Cir read the law differently than the District Court?

Why provision of the FDCA did the court find undermined the FDA's claim of authority over tobacco?

What did the Court believe would be only proper regulatory response to this provision?

Putting aside politics, why would this be a bad idea?

How does the FDA's own history undermine the claim of regulatory authority?

How does this fit in the Barnhart factors?

Is this binding?

What would it require the agency to do to overcome the presumption it had created?

At the Supreme Court

What was the manufacturers' attack on the intent finding by the FDA?

Can you think of products that are bought for the medicinal benefits, but which are not promoted for them?

Should that remove them from FDA jurisdiction?

Look closely at [44] and how the court states the Chevron test.

How does the court justify deference to the agency?

Does the court say that Step one is limited to reading the statute itself?

What else can be considered?

What about common sense?

What did the court decide was the FDAC's core objective?

In this regard, what is the requirement of the statutory language for regulating devices that the FDA used to justify regulating tobacco?

Are there findings in the rulemaking that address the risks of tobacco?

How did the FDA characterize tobacco?

How do the risks of tobacco make it misbranded?

May a misbranded drug or device be sold?

What directions would be necessary on the label to use tobacco safely?

Does the act make provisions for selling a misbranded product?

What is the risk classification scheme for medical devices?

Did the regs classify tobacco?

What class did the court say tobacco would have to fall in?

Once classified, what does the statute require the FDA to show before the product can be marketed?

Could the FDA do this?

What would that mean for tobacco marketing?

When asked about this in the past, what did the FDA say?

Has Congress said anything about the removal of tobacco from the market?

Has Congress provided an alternative regulatory system for tobacco, outside the FDA?

Do these Acts post-date the knowledge that tobacco is dangerous?

What is the Congressional tobacco regulation policy?

Why does this contradict what we know about addiction and the use of tobacco by children?

How did the FDA try to dodge the trap that it cannot allow the sale of dangerous products?

What was the risk of prohibiting tobacco that the FDA used to offset the risk of continuing to sell tobacco?

Does the FDCA allow the FDA to balance the risk of dangerous product against the risks posed by the withdrawal from and demand for that product?

What factors may the FDA consider in determining the safety and effectiveness of a product?

Under these factors, what does the court say are the potential benefits of tobacco?

What would the FDA have to assert about these benefits to justify leaving tobacco on the market?

How does the dissent and the FDA analogize the problem of regulating tobacco to the regulation of dangerous drugs used to treat cancer?

Are these drugs dangerous?

What is their benefit?

How does this compare to the benefits of tobacco?

Are the benefits of tobacco really the just treating the side-effects of tobacco addiction?

How is this different from the cancer drugs?

Has the FDA identified a therapeutic use for tobacco?

Why does it matter to the Chevron analysis that tobacco does not fit into the FDA statutory scheme?

What does the Romani case tell us about how and when later federal laws modify earlier ones?

Congress enacted at least six laws on tobacco since the FDCA. Do any of those address the same issues as the FDA regulations.

Did Congress specifically consider and reject proposals to give the FDA jurisdiction over tobacco?

How do we regard such reconsiderations by the legislature when we are construing a statute?

When did the Surgeon General release the report on Smoking and Health?

What did the report tell us officially, for the first time?

Has the FDA raised any issues about the effects of tobacco that were not discussed as part of that report?

Why did is this important in deciding whether Congress fully considered the issues when they declined to extend the FDA's authority to include tobacco?

What agency did take regulatory action based on this report?

Did Congress support this rule?

What was the FDA's position in the subsequent Congressional hearings?

The original FDCA was passed in 1938.  Had Congress considered allowing the FDA's predecessor (Department of Chemistry) to regulate tobacco?

Was there any mention of tobacco when the 1938 bill was passed?

Did the FCLAA contemplate restrictions on the sale of tobacco?

What is the basis for the claim that the FCLAA specifically preempts some of the FDA tobacco regulations?

What laws was Congress really targeting with this preemption? (Hint - Cipollone v Liggett Group, Inc. 505 U.S. 504 (US 1992))

Who was the FCLAA really protecting?

What is the warning label on liquor bottles?

Who does that protect?

What did Congress do when a court found that the Consumer Products Safety Commission had the power to regulate tobacco?

What did Congress make clear at that time that affects the analysis in this case?

What did the FDA say in response to a petition for rulemaking on tobacco in 1980?

What did the FDA's general counsel tell congress about how tobacco fits in the FDA's authority during hearings in 1988?

What does the Court say is the significance of this history of tobacco regulation?

Does the court say that an agency cannot change its legal position?

What does the court say is the significance of the long term position of the FDA regarding its authority over tobacco?

Why does this limit subsequent FDA interpretations of the statute?

Key Chevron Issue: What does the court say is the effect of an ambiguous statute when applying Chevron?

What did Justice Breyer say in a law review article about this, that the majority quotes in response to Justice Breyer's dissent?

How does the special history of tobacco argue that it is exactly this is exactly the sort of case Justice Breyer had in mind in his article?

The Dissent

Look hard at [152] - Is this really true?  Does Breyer have a real example? The FDA has allowed the phase out of important drugs found to be dangerous to allow an orderly transition to other drugs, but it has never kept a drug on the market because of fears of a black-market substituted.

In [154] Breyer asserts that a device does not need to be in Class III if regulations can make it safe to use.  While this is true, does the FDA assert that its regulations will make tobacco safe?

Is the assertion in [158] true?  Wonder what Breyer would say if the FDA approved smoking as an obesity treatment?

In [160] Breyer makes an argument that the regulations will reduce the risk of smoking in the community, thus it will be safer than if smoking were banned.  He then analogizes to the regulation of methadone as a replacement for heroin. Putting aside that methadone is an approve drug because it is an effective, long lasting painkiller, having nothing to do with its use as a heroin substitute, why does this analogy fail?

What is your answer to Breyer's question posed in [161]?

Are there other agencies that regulate products, including drugs and devices? How does this affect the arguments in [162]?

How does Breyer address the assumption that since Congress failed allow the FDA to regulate tobacco when asked?

Does this really cut to the heart of the politics?

Why hasn't Congress regulated tobacco itself?

What did the history of the FDA Modernization Act of 1997 say about tobacco?  Why did congress dodge the issue, which was then in litigation?

What does Breyer say about the limits of the FCLAA preemption?

At [180] Breyer says that the FDA's denial of authority was based on not having evidence that tobacco manufacturers intended to sell their products for their health effects.  Are there old advertisements that undermine this claim?

What Changed?

What did Justice Rehnquist say in State Farm that Breyer cites as support?

How does this explain the views of previous FDA commissioners, and even the previous views of Kessler?

The majority believes that such a major change should be done Congress. How does Breyer argue that it is also properly the president's call?

Why does Breyer say that the a possible tobacco ban should not resolve the step one analysis?