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FDA's Jurisdiction to Regulate Apple Cider Production

Alicia Rosamilia
Rutgers Law Student


Today (September 8, 1998) the FDA's cider labeling regulation goes into effect.

This final rule was published two months ago on July 8, 1998. Since then, a

jurisdictional question has been raised and I have looked into it further.


In the final rule, the FDA states that "under the act [Food, Drug, and

Cosmetic Act], FDA's jurisdiction extends to those products, and the

manufacturers and distributors of regulated products, that satisfy a necessary

connection with interstate commerce...Juice that is a product of solely

intrasate activities (e.g., source of components, location of sales, etc.) is

not subject to FDA's jurisdiction and thus, would not be subject to the

warning statement requirement. Nonetheless, in such circumstances, FDA

customarily works with State regulatory agencies such as local health

departments, who, like FDA, have a mission to protect the public health." 63

Fed. Reg. 37046.


I then read in the Great Lake Fruit Growers News, July, 1998, an article,

"Warning Labels Required, HACCP Rules on the Way." The jurisdictional issue

was raised and the article stated that "Jerry Wojtala, MDA [Michigan

Department of Agriculture] science and technology section manager, said his

agency is consulting legal counsel on the jurisdiction question."


I did some research and found that several things are quiet clear:

1. The FDA, as a federal agency, only has jurisdiction to regulate interstate

commerce (meaning that the product crosses state boundaries), not intrastate

commerce (meaning that the product is produced wholly within the state.)

2. However, that jurisdiction is VERY broad, for almost any product is

considered to be in the stream of interstate commerce. In addition, section

379(c) of the Act creates a presumption of existence of jurisdiction.


I contacted the Michigan Deparment of Agriculture to see how they were doing

in looking into the issue. Jerry Wojtala's colleague, John Tilden, informed

me that they worked with their Attorney General and found that cider

production is generally interstate commerce. If ANY part of the production is

purchased from out of state sources, such as the containers, labels,

machinery, etc., then the cider product as a whole is a product of interstate

commerce, subject to FDA jurisdiction.


My discussion with him concurs with my research and the wording of the FDA's

final rule. Because the production of cider requires equipment purchased from

sources out of state, the product is in the stream of interstate commerce, and

subject to FDA jurisdiction to regulate it.