|
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.
|
|