Before Premarket Approval
Before 1954, the US Food and Drug Administration (FDA) and
its predecessor the Bureau of Foods had relatively little authority over what
chemicals went into food. First of all,
the FDA only had authority over food products that enter into interstate
commerce. Food that does not cross
states lines must only conform to state and local law. Second, the legal tools at the disposal of
the agency were weak and difficult to enforce.
The original statute (now is FFDCA
402) that was introduced in the Pure Food and Drug Act of 1906 allowed the Bureau
to seize food that may be “injurious” when consumed. There were two chief difficulties: First, the law had to be used by prosecuting
individual lots or shipments of food.
Second, the burden of proof lay on the agency to prove harm each and
every time the law was employed. For
example, in a case involving caffeine that was litigated in 1916, entitled
“United States v. Forty Barrels and Twenty Kegs”, the court ruled that whether
or not the necessary standard of harm had been met was a matter of fact that
would need to be determined by jury (Hutt et
al, 2007).
In 1938, the Federal Food, Drug, and Cosmetic Act (FFDCA)
was enacted with a statute (FFDCA
406) was enacted that permitted the agency to set tolerances for added
poisonous or deleterious substances that are “required” in the production of
food or “cannot be avoided by good manufacturing practices”. Because any food found to contain a substance
that exceeded is considered to be legally without the necessity of proving harm
in each and every case, tolerances are far easier to enforce. However, in practice the legal process for
setting tolerances proved to be too cumbersome to be employed on a regular
basis.
Pesticides
In 1954, the Pesticide Control Act as passed that created as
new statute (FFDCA
408) that made it much easier to set tolerances for a pesticides. This was largely accomplished by reversing the
burden of proof: Instead of requiring
the agency to prove harm, pesticide manufacturers had to submit a petition that
would prove to the agency that their product would be safe under conditions of
use. This had three very important
consequences. First, by requiring that
tolerances err of the side of safety, 408 created the notion of the
precautionary principle. Second, the
judgment for evaluating whether or not the necessary standard of proof is met
was delegated to agency scientists rather than the judicial system. However,
the judgment of agency scientists was not left entirely unrestrained. The law described a process that agency
scientists are to follow. Third, the
companies that manufactured the pesticides were required to conduct the
necessary toxicology studies that would demonstrate safety.
The original version of section 408 used to describe the
evaluation process contained language that is virtually identical to a
subsequent act that pertained to food additives. When the U.S. Environmental
Protection Agency was created in 1970, the pesticide regulation program was
transferred from the FDA to the EPA. As
a result, the language section 408 has undergone substantial revision, so that
it now contains terminology used by the EPA rather than the FDA. However, the underlying evaluation processes used
for both pesticides and food additives are largely the same.
Food Additives
The Food Additives Amendment of 1958 created FFDCA section 409. Like the pesticide amendment, this
gave the FDA far more control over substances that are intentionally added to
food. Manufacturers of new food
additives were required to submit a petition to the FDA for approval before
they could be used. Chemicals that could "reasonably be expected" to become part of food were also treated as additives, so that chemicals that would migrate from packaging materials into food also require a petition for agency approval. However, additives already in
use before the act was passed were exempted.
Since the language from the current statute is still
virtually identical to that provided in both the 1954 Pesticide Control Act and
the 1958 Food Additives Amendment, section 409 is more illustrative of the how
the law originally instructed agency scientists to evaluate the safety of both
pesticides and food additives.
(5) In determining, for the
purposes of this section, whether a proposed use of a food additive is safe,
the Secretary shall consider among other relevant factors—
(A) the probable consumption of the
additive and of any substance formed in or on food because of the use of the
additive;
(B) the cumulative effect of such
additive in the diet of man or animals, taking into account any chemically or
pharmacologically related substance or substances in such diet; and
(C) safety factors which in the
opinion of experts qualified by scientific training and experience to evaluate
the safety of food additives are generally recognized as appropriate for the
use of animal experimentation data.
All three of the lettered clauses are important. The first requires the agency the estimate a probable
exposure or dose. The second clause
requires the agency to consider the consequences of long-term exposure to the
chemical. The third clause gives
“safety” a new legal definition: It is whatever “experts qualified by
scientific training” say it is.
The 1958 Food Additives Amendment is also noteworthy for the
insertion of “Delaney clause”:
the Secretary of the Food and Drug
Administration shall not approve for use in food any chemical additive found to
induce cancer in man, or, after tests, found to induce cancer in animals
When John Delaney, a congressman from New York introduced
this clause, it was thought that chemicals that have the ability the cause or
influence the development of cancer were few and far between. That has turned out not to be the case.
References
Hutt PB, Merrrill RA, and Grossman LA (2007). Food and Drug Law: Cases and Materials, 3rd
Ed. Foundation Press, New York
US Food and Drug Administration (2015). FD&C
Act Chapter IV: Food
Official Post Soundtrack
Post Notes
Post Thesis No. 10; part of Regulatory Toxicology thread
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