A Brief History of the FDA
c  Mark W. Mugler 1996

"It is seldom that liberty of any kind is lost all at once."
(David Hume)

"The road to Hell is paved with good intentions." (anonymous)

The following brief history is adapted from U.S. Food and Drug
Administration, Milestones in U.S. Food and Drug Law History, 1995,
which can be found on the FDA web page.  You should read it.  The
enthusiasm with which the authors trumpet the successive incursions of
the FDA on the liberties of U.S. citizens is morbidly entertaining.

This history focuses on FDA regulation of drugs, medical devices, food
additives, and nutritional supplements.  It minimizes coverage of FDA
regulation of food (except as it affects regulation of food additives
and nutritional supplements), cosmetics, animal drugs and feeds.
It also minimizes coverage of regulation of pesticides, consumer
products, and drug abuse, which are former FDA missions now assigned
to other, equally unpalatable agencies.

DRUG IMPORTATION ACT requires U.S. Customs inspection to stop entry of
adulterated drugs from overseas.  Note the strict construction of the
Federal Government's involvement in interstate commerce.

TEA IMPORTATION ACT provides for Customs inspection of all tea
entering U.S. ports, at the expense of the importers.

The BIOLOGICS CONTROL ACT is passed to insure purity and safety of
serums, vaccines, and similar products used to prevent or treat
diseases in humans.  In 1970, regulation of biologics is transferred
to the FDA.

U.S. Department of Agriculture investigates food adulteration and
pushes for a national food and drug law.  Former USDA officials
organize lobbying efforts to secure a federal law against the
misbranding and adulteration of foods and drugs.  More than 100
food and drug bills are introduced in Congress.  In 1902, Congress
appropriates funds to establish food standards and to study the
effects of chemicals on digestion and health.  Shocking disclosures
are made of the use of poisonous preservatives and dyes in foods and
cure-all claims for worthless and dangerous patent medicines.  An
early example of the Iron Septagon at work.

The original FOOD AND DRUGS ACT prohibits interstate commerce in
misbranded and adulterated foods, drinks and drugs.  The Department
of Agriculture is authorized to seize unsafe substances and prosecute
violators.  Note that in the good old days, "misbranded" meant that
the label did not accurately describe the contents, and "adulterated"
meant that the claimed ingredients had been diluted, (as flour might
be diluted by pea meal).  The intent of the act was to provide penalties
for consumer fraud and to prevent injury and death from poisons.

In U.S. v. JOHNSON, the Supreme Court rules that the 1906 Food and
Drugs Act did not prohibit false therapeutic claims but only false and
misleading statements about the ingredients or identity of a drug.
The decision is consistent with the intent of the act to prevent
consumer fraud.

In the first in a long, sorry history of plugging "loopholes" (one
generation's compromise being the next generation's loophole),
Congress enacts the SHERLEY AMENDMENT to overcome the ruling in
U.S. v. Johnson.  It prohibits labeling medicines with false
therapeutic claims intended to defraud the purchaser, a standard
difficult to prove, as shown in subsequent court cases.

rules that foods containing poisonous or deleterious ingredients are
illegal when the quantity of such ingredients may be injurious.  The
decision is a compromise: it does not require proof of actual injury;
on the other hand, the mere presence of such an ingredient is not
sufficient to make a food illegal.

rules that the Food and Drugs Act condemns every statement, design or
device which may mislead or deceive, even if technically true.  This
decision is notable because the Supreme Court, by legislating from the
bench, begins to erode the Sherley Amendment principle of intent to
defraud, a process continued in 1938 and thereafter.  The decision is
also notable for the government's use of seizure (asset forfeiture) as
a tool to prevent allegedly unsafe products from entering interstate
commerce (note that the defendant in the case is 95 barrels).  The
government was gripped with seizure fever 40 years before the War
on Drugs.

The Iron Septagon succeeds in creating a nexus for a petty regulatory
dictatorship and in nurturing its growth over the years.  A separate
law enforcement agency is formed in 1927, first known as the Food,
Drug, and Insecticide Administration and then, in 1930, as the Food
and Drug Administration (FDA).  FDA is transferred from the Department
of Agriculture to the Federal Security Agency (later known as the
Department of Health, Education and Welfare) in 1940, then to the
Public Health Service, which in turn is incorporated, along with most
of HEW, into the Department of Health and Human Services.  In 1988,
the FOOD AND DRUG ADMINISTRATION ACT officially establishes FDA as
an agency of the Department of Health and Human Services with a
Commissioner of Food and Drugs appointed by the President with the
advice and consent of the Senate.

The petty regulatory dictatorship rolls up its sleeves and gets to
work.  FDA recommends a complete revision of the "obsolete" 1906
Food and Drugs Act.  A five-year legislative battle ensues.  In 1937,
an elixir of sulfanilamide contining a poisonous solvent kills 107
persons, mostly children, dramatizing the need to establish drug
safety before marketing and to enact the pending food and drug law.

act.  It contains new provisions extending control to cosmetics and
therapeutic devices; requiring new drugs to be shown safe before
marketing--starting a new system of drug regulation; eliminating the
pesky Sherley Amendment requirement that intent to defraud must be
proved in drug misbranding cases; providing that safe tolerances
be set for unavoidable poisonous substances; authorizing factory
inspections; and adding the remedy of court injunctions to the
previous penalties of seizures and prosecutions.

FDA regulations create a class of drugs which may be dispensed only
by prescription and only for stated uses.  FDA hangs its hat on its
mandate to stop "misbranding" (once intended to stop consumer fraud,
as you may recall) and on act language stating that labels must state
the uses for which drugs are recommended or prescribed.  Ipso facto,
by FDA logic, some drugs must be prescribed in the first place, and
FDA must approve the stated uses!  These regulations wrest the choice
of drug therapies from the consumer and place it in the hands of the
cartel.  (After a 12-year struggle, the Alberty Food decision in 1950
and the Durham Humphrey amendment in 1951 will endorse and codify
FDA's regulatory action).

INSULIN AMENDMENT requires FDA to test and certify purity and potency
of this life-saving drug for diabetes.

In U.S. v. DOTTERWEICH, the Supreme Court rules that the responsible
officials of a corporation, as well as the corporation itself, may be
prosecuted for violations.  It need not be proven that the officials
intended, or even know of, the violations.  This kind of decision, of
course, casts a pall over innovation.

PUBLIC HEALTH SERVICE ACT covers a broad spectrum of health
concerns, including regulation of biological products and control
of communicable diseases.

PENICILLIN AMENDMENT requires FDA testing and certification of safety
and effectiveness of all penicillin products.  Later amendments
extended this requirement to all antibiotics.  (In 1983 such control
was deauthorized as unnecessary, the Kefauver-Harris amendments of
1962 having required drug company testing and FDA approval prior to

MILLER AMENDMENT AFFIRMS that the Federal Food, Drug, and Cosmetic Act
applies to goods that have moved in interstate commerce all the way to
the ultimate consumer.  Whereas consumer fraud and public safety could
be carried only so far, the link to interstate commerce, an "elastic"
clause in the Constitution if ever there was one, will prove most
useful to the regulatory cartel in the years to come.

In ALBERTY FOOD PRODUCTS CO. v. U.S., the court of appeals rules that
the directions for use on a drug label must include the purpose for
which the drug is offered.  Therefore, a worthless remedy cannot
escape the law by not stating the condition it is supposed to treat.
This decision and the amendments of the following year provide FDA the
basis for its current policies restricting "unapproved" or "off-label"
uses of drugs, as well as the corollary policy of prohibiting health
claims for non-drugs. (By FDA logic, non-drugs become "drugs" if a
health claim is made for them and, if the provider has not run the
regulatory gauntlet, the health claim thereupon becomes an unapproved
use and the distribution of the "drug" is prohibited).  See 1939-40.

"DELANEY COMMITTEE" starts congressional investigation of the safety
of chemicals in foods and cosmetics, laying the foundation for
effective controls over pesticides, food additives, and colors.

DURHAM-HUMPHREY AMENDMENT defines the kinds of drugs that cannot be
safely used without medical supervision and restricts their sale to
prescription by a licensed practitioner.  See 1939-40, 1950.

In U.S. v. CARDIFF, the Supreme Court rules that the factory
inspection provision of the 1938 act is too vague to be enforced
as criminal law (see factory inspection amendment, 1953).

FACTORY INSPECTION AMENDMENT "clarifies" previous law and requires FDA
to give manufacturers written reports of conditions observed during
inspections and analyses of factory samples.  Inspections now can be
used as a hammer.  Another "loophole" closed.

FOOD ADDITIVES AMENDMENT enacted, requiring manufacturers of new food
additives to establish safety.  The Delaney proviso prohibits the
approval of any food additive shown to induce cancer in humans or

U.S. CRANBERRY CROP recalled three weeks before Thanksgiving for FDA
tests to ensure freedom from aminotriazole, a weedkiller found to
cause cancer in laboratory animals.  Recall that the FDA has both
seizure and injunction power and considers itself a law enforcement
agency as well as a regulatory agency.

COLOR ADDITIVE AMENDMENTS enacted, requiring manufacturers to
establish the safety of color additives in foods, drugs and cosmetics.

THALIDOMIDE, a new sleeping pill, is found to have caused birth
defects in thousands of babies born in western Europe.  News reports
on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the
drug off the U.S. market, arouse public support for stronger drug

KEFAUVER-HARRIS DRUG AMENDMENTS PASSED to ensure greater drug safety.
For the first time, drug manufacturers are required to prove to FDA
the effectiveness of their products before marketing them.  On might
ask, how does the requirement to show effectiveness ensure greater
drug safety?  Why not beef up the safety protections?  The answer is
that the effectiveness provisions, by limiting market entry, enable
FDA to exert more complete control over the smaller universe of drugs
that can pass the effectiveness hurdle.  The public got snookered
again.  Talk about consumer fraud!  On the other hand, perhaps it is
reassuring to think that the FDA has our interests at heart, denying
us the use of medicines that might harm us so we won't have to sue the
mean old drug companies should we in fact be harmed, and it's merely
a coincidence that the mean old drug companies, in return for being
shielded from lawsuits by FDA preemption, become completely beholden
to FDA (and to the Congresspersons who oversee FDA's exercize of its
powers) for their continued ability to sell their products.

FDA CONTRACTS with the National Academy of Sciences/National Research
Council to evaluate the effectiveness of 4,000 drugs approved on the
basis of safety alone between 1938 and 1962.  The motivation is clear:
to build a case for retroactively applying Kefauver-Harris to already
approved drugs, create media sensations, and press for laws
"clarifying" Kefauver-Harris.

FAIR PACKAGING AND LABELING ACT requires all consumer products in
interstate commerce to be honestly and informatively labeled, with FDA
enforcing provisions on foods, drugs, cosmetics, and medical devices.

In UPJOHN v. FINCH the Court of Appeals upholds enforcement of the
1962 drug effectiveness amendments by ruling that commercial success
alone does not constitute substantial evidence of drug safety and

OVER-THE-COUNTER DRUG review begun to enhance the safety,
effectiveness and appropriate labeling of drugs sold without

THE SUPREME COURT upholds the 1962 drug effectiveness law and endorses
FDA action to control entire classes of products by regulations rather
than to rely only on presumably more time-consuming litigation.

EARLY 1970's
Faulty intrauterine devices and cardiac pacemakers arouse public
interest in better regulation of medical devices.  See 1976.

MEDICAL DEVICE AMENDMENTS passed to ensure safety and effectiveness
of medical devices, including diagnostic products.  The amendments
require manufacturers to register with FDA and follow quality control
procedures.  Some products must have pre-market approval by FDA;
others must meet performance standards before marketing.

standards limiting potency of vitamins and minerals in food
supplements or regulating them as drugs based solely on potency.  If
you thought your vitamins and minerals are protected by the Proxmire
amendments, you are wrong.  If the manufacturer or distributor dares
to make a therapeutic claim, FDA has been known to seize the offending
substance as an unapproved drug.  More later.

ORPHAN DRUG ACT enables FDA to speed up and stremaline approval and
marketing of drugs needed for treating rare diseases, which otherwise
would not be profitable.  The first of many amendments necessitated by
FDA's hammerlock on market entry (see also 1984 and 1992).

FINES ENHANCEMENT LAWS of 1984 and 1987 amend the U.S. Code to greatly
increase penalties for all federal offenses.  The maximum fine for
individuals is now $100,000 for each offense and $250,000 if the
violation is a felony or causes death.  For corporations, the amounts
are doubled.  Thank you, Uncle Sam, I feel safer now.

availability of less costly generic drugs by permitting FDA to approve
applications to market generic versions of brand-name drugs without
repeating the research done to prove them safe and effective.  At the
same time, the brand-name companies can apply for up to five years
longer patent protection for the new medicines they developed to make
up for time lost while their products were going through FDA's
approval process.

AIDS TEST FOR BLOOD approved by FDA in its first major action to
protect patients from infected donors.

CHILDHOOD VACCINE ACT requires patient information on vaccines, gives
FDA authority to recall biologics, and authorizes civil penalties.

THE PRESCRIPTION DRUG MARKETING ACT bans the diversion of prescription
drugs from legitimate commercial channels.  Congress finds that
the resale of such drugs leads to the distribution of mislabeled,
adulterated, subpotent, or counterfeit drugs to the public.  The new
law requires drug wholesalers to be licensed by the states; restricts
reimportation from other countries; and bans sale, trade or purchase of
drug samples, and traffic or counterfeiting of redeemable drug coupons.

LATE 1980's
Fractures of the Bjork-Shiley convexo-concave heart valve are
reported.  See 1990.

NUTRITION LABELING AND EDUCATION ACT requires all packaged foods
to bear nutrition labeling and all health claims for foods to be
consistent with terms defined by the Secretary of Health and Human
Services.  The law preempts state requirements as to food standards,
nutrition labeling, and health claims.

SAFE MEDICAL DEVICES ACT requires medical device user facilities such
as hospitals and nursing homes to report promptly to FDA incidents
that reasonably suggest a probability that a medical device caused
or contributed to the death, serious illness, or serious injury of
a patient.  The act requires manufacturers to conduct post-market
surveillance on devices that are permanent implants and whose failure
may cause serious health consequences or death, and to establish
methods for tracing and locating patients depending on such devices.
The act authorizes FDA to order device product recalls, to issue "stop
use" notices to health professionals and user facilities, and to
impose civil penalties (fines) after administrative hearings.

EARLY 1990's
Reports of leaking silicone gel breast implants prompt FDA to
undertake a hyperagressive enforcement campaign.

GENERIC DRUG ENFORCEMENT ACT imposes debarment and other penalties for
illegal acts involving approval of abbreviated drug applications.

PRESCRIPTION DRUG USER FEE ACT requires drug and biologics
manufacturers to pay fees for drug and biologics applications
and supplements.  In addition, these firms must pay an annual
establishment fee and annual product fees.  FDA will use these funds
to hire more reviewers to assess applications.  Drug companies
suppported this extortion, figuring they would lose less in fees
than in foregone profits from FDA stonewalling and delay.

labeling requirements, provides a regulatory framework, and authorizes
FDA to promulgate good manufacturing practice regulations for "dietary
supplements" and "dietary ingredients" and classifies them as food.
The act also establishes a commission to recommend how to regulate
label claims.

Facing House and Senate committee bills that would force it to
streamline its procedures for drug and device approval, the FDA
employs a classic political divide and conquer strategy: it approves
streamlined procedures only for AIDS drugs, cancer drugs, and
certain medical devices, thereby appeasing key interest groups
and undercutting efforts to achieve broader reform.