Young v. Community Nutrition Institute

PETITIONER: Young
RESPONDENT: Community Nutrition Institute
LOCATION: Hardwick's Apartment

DOCKET NO.: 85-664
DECIDED BY: Burger Court (1981-1986)
LOWER COURT: United States Court of Appeals for the District of Columbia Circuit

CITATION: 476 US 974 (1986)
ARGUED: Apr 30, 1986
DECIDED: Jun 16, 1986

ADVOCATES:
Paul J. Larkin, Jr. - on behalf of the petitioner
William B. Schultz - on behalf of the respondents

Facts of the case

Question

Media for Young v. Community Nutrition Institute

Audio Transcription for Oral Argument - April 30, 1986 in Young v. Community Nutrition Institute

Warren E. Burger:

Mr. Larkin, I think you may proceed whenever you are ready.

Paul J. Larkin, Jr.:

Thank you, Mr. Chief Justice, and may it please the Court, this case is here on a writ of certiorari from the United States Court of Appeals for the District of Columbia Circuit.

The question in this case involves the proper construction of two Interrelated sections of the Food, Drug, and Cosmetic Act of 1938, Section 402 and Section 406.

These sections establish alternative enforcement mechanisms that provide the FDA with the ability to prove that food is adulterated.

It is our position and it has been the position of the Food and Drug Administration in the nearly 50-year history that the Act has been in existence that Section 406 authorizes the agency to adopt regulations, known as tolerances, but does not require the agency to do so.

Put another way, Congress authorized the Food and Drug Administration to select between the alternative types of enforcement mechanisms that were established in the 1938 Act.

Byron R. White:

But it could do both.

Paul J. Larkin, Jr.:

Correct.

It could decide that in an individual case it should prosecute under the general adulteration standard, Section 402, or alternatively it could decide to adopt tolerances, regulations that would set precise levels of forbidden contamination, and that would lead to a different type of proof in court in an individual case.

Byron R. White:

But if it did the latter, adopt the tolerances, it couldn't proceed in order to... it couldn't in a specific case insist on a lower tolerance?

Paul J. Larkin, Jr.:

That's correct.

By saying that they could choose between the two, I mean that they can, as a policy matter, decide how to proceed to protect the public health.

Once a tolerance is set, they cannot then proceed under the general adulteration standard.

Byron R. White:

But pending the setting of a tolerance, they could proceed on a case-by-case basis?

Paul J. Larkin, Jr.:

Correct.

Byron R. White:

And by these so-called... what do you call them?

Paul J. Larkin, Jr.:

They are called action levels, Your Honor.

Byron R. White:

Yes, action, they could proceed on that until a tolerance is adopted.

Paul J. Larkin, Jr.:

That's correct.

I would like to summarize the four principal reasons why we believe the Court of Appeals misconstrued the Act in this case.

John Paul Stevens:

May I just interrupt before you do?

Do you contend that the determination of an action level is the promulgating of a regulation within the meaning of 406?

Paul J. Larkin, Jr.:

No, Your Honor.

John Paul Stevens:

You don't.

Okay.

I misunderstood what you said.

Paul J. Larkin, Jr.:

I am sorry, and I would like to be precise about this, because I think respondents have attempted to confuse the two.

Action levels are informal and internal prosecutorial guidelines.

John Paul Stevens:

I understand that, but they are not regulations.

Paul J. Larkin, Jr.:

Correct, they do not have the force and effect of law.