From: [w--li--h] at [ix.netcom.com](William House )
Newsgroups: tx.politics,talk.politics.theory,talk.politics.misc,talk.politics.medicine,talk.politics.libertarian,talk.politics.guns,talk.politics.drugs
Subject: History of Food and Drug Laws (Was: Re: Proposal for a "Libertarian" FDA.
Date: 3 Mar 1996 10:36:06 GMT

Milestones in U.S. Food and Drug Law History
http://www.fda.gov/opacom/backgrounders/miles.html

Milestones in U.S. Food and Drug Law History
U.S. Food and Drug Administration
August 1995

From the beginnings of civilization people have been concerned about
the quality and safety of foods and medicines. In 1202, King John of
England proclaimed the first English food law, the Assize of Bread,
which prohibite d adulteration of bread with such ingredients as
ground peas or beans.  Regulation of food in the United States dates
from early colonial times. Federal controls over the drug supply began
with inspection of imported drugs in 1848.  The following chron ology
describes some of the milestones in the history of food and drug
regulation in the United States.

1785 MASSACHUSETTS enacts the first general food adulteration law in
the United States.

1820 Eleven physicians meet in the capitol at Washington to establish
the U.S.  PHARMACOPEIA, first compendium of standard drugs for the
United States.

1848 DRUG IMPORTATION ACT passed by Congress requires U.S.  Customs
inspection to stop entry of adulterated drugs from overseas.

1850 CALIFORNIA passes a pure food and drink law, one year after the
gold rush.

1862 PRESIDENT LINCOLN appoints a chemist, Charles M.  Wetherill, to
serve in the new Department of Agriculture.  This was the begi nning
of the Bureau of Chemistry, now the Food and Drug Administration in
the Department of Health and Human Services.

1879 PETER COLLIER, chief chemist, U.S.  Department of Agriculture,
begins investigating food adulteration. The following year he
recommends a national food and drug law. In the next 25 years more
than 100 food and drug bills were introduced in Congress.

1883 DR.  HARVEY W. WILEY becomes chief chemist of the USDA.  He
immediately assigns members of his staff to expand the studies of food
adulteration.

1897 TEA IMPORTATION ACT passed, providing for Customs inspection of
all tea entering U.S.  ports, at the expense of the importers.

1898 PURE FOOD CONGRESS in Washington focuses attention on the growing
national movement to secure a federal law against the misbranding and
adulteration of foods and drugs. Its leader is Dr. Wiley.

1902 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.  Congress appropriates funds to establish FOOD
STANDARDS and to study the effects of chemicals on digestion and
health.

1906 The original FOOD AND DRUGS ACT of 1906 is passed by Congress and
signed by President Theodore Roosevelt. It prohibits interstate
commerce in misbranded and adulterated foods, drinks and drugs.

The MEAT INSPECTION ACT is passed the same day, June 30.  Shocking
disclosures of insanitary conditions in meat-packing plants, the use
of poisonous preservatives and dyes in foods, and cure-all claims for
worthless and dangerous patent medicines were the major problems
leading to the enactment of these laws.

1907 First CERTIFIED COLOR REGULATIONS, requested by manufacturers and
users, list seven found suitable for use in foods.

1911 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.
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 st andard difficult to
prove.

1912 After 29 years, Dr. Wiley retires as chief of the Bureau of
Chemistry, and is succeeded by Dr.  Carl L. Alsberg.

1913 GOULD AMENDMENT is enacted, requiring quantity of contents to be
stated on food packages.

1914 In U.S. v.  LEXINGTON MILL AND ELEVATOR COMPANY, the Supreme
Court rules that foods containing poisonous or deleterious ingredients
are illegal when the quantity of such ingredients may be injurious.
Although the law does not require proof of actual injury, the mere
presence of such an ingredient is not sufficient to make a food
illegal.

1921 WALTER G.  CAMPBELL becomes acting chief of the Bureau of
Chemistry.

1924 In U.S. v. 95 BARRELS ALLEGED APPLE CIDER VINEGAR, the Supreme
Court rules that the Food and Drugs Act condemns every statement,
design or device which may mislead or deceive, even if technically
true.

1927 A separate law enforcement agency is formed, first known as the
Food, Drug, and Insecticide Administration and then, in 1930, as the
Food and Drug Administration (FDA).

The CAUSTIC POISON ACT requires warning labels and antidotes to
protect children from being injured by lye and other dangerous
chemicals.

1930 McNARY-MAPES AMENDMENT authorizes FDA standards of quality and
fill-of-container for canned food.

1933 FDA recommends a complete revision of the obsolete 1906 Food and
Drugs Act. The first bill is introduced into the Senate, launching a
five-year legislative battle.

1937 An ELIXIR OF SULFANILAMIDE containing 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.

1938 THE FEDERAL FOOD, DRUG, AND COSMETIC (FDC) ACT of 1938 is passed
by Congress, containing 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 Sherley Amendment requirement to prove intent to
 defraud in drug misbranding cases.
*Providing that safe tolerances be set for unavoidable poisonous
 substances.
*Authorizing standards of identity, quality, and fill-of-container for
 foods.
*Authorizing factory inspections.
*Adding the remedy of court injunctions to the previous penalties of
 seizures and prosecutions.

1939 FIRST FOOD STANDARDS issued (canned tomatoes, tomato puree, and
tomato paste).

1940 FDA TRANSFERRED from the Department of Agriculture to the Federal
Security Agency, with Walter G. Campbell appointed as the first
Commissioner of Food and Drugs.

1941 INSULIN AMENDMENT requires FDA to test and certify purity and
potency of this life-saving drug for diabetes.

1943 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 to know, of the violations.

1944 PUBLIC HEALTH SERVICE ACT was passed, covering a broad spectrum
of health concerns, including regulation of biological products and
control of communicable diseases.

1945 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
found no longer needed and was abolished.

1948 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.

1950 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.

OLEOMARGARINE ACT requires prominent labeling of colored
oleomargarine, to distinguish it from butter.

1951 "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 restric ts their sale to
prescription by a licensed practitioner.

1952 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).

FDA CONSUMER CONSULTANTS are appointed in each field district to
maintain communications with consumers and insure that FDA considers
their needs and problems.

1953 FEDERAL SECURITY AGENCY becomes the Department of Health,
Education, and Welfare (HEW).

FACTORY INSPECTION AMENDMENT clarifies previous law and requires FDA
to give manufacturers written reports of conditions observed during
inspections and analyses of factory samples.

1954 PESTICIDES AMENDMENT spells out procedures for setting safety
limits for pesticide residues on raw agricultural commodities.

1955 HEW SECRETARY OVETA CULP HOBBY appoints a committee of 14
citizens to study the adequacy of FDA's facilities and programs.  The
committee recommends a substantial expansion of FDA staff and
facilities, a new headquarters building, and more use of educational
and informational programs.

1958 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
animals.

1959 U.S. CRANBERRY CROP recalled three weeks before Thanksgiving for
FDA tests to insure freedom from ami notriazole, a weedkiller found to
cause cancer in laboratory animals.

THE FIRST NEW FDA DISTRICT OFFICE in 24 years, and the first in a
building designed for scientific enforcement, opens in Detroit, Mich.

1960 COLOR ADDITIVE AMENDMENTS enacted, requiring manufacturers to
establish the safety of color additives in foods, drugs and cosmetics.

FEDERAL HAZARDOUS SUBSTANCES LABELING ACT, enforced by FDA, requires
prominent label warnings on hazardous household chemical products.

1962 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
regulation.

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. The
amendments also exempt from the Delaney proviso animal drugs that are
shown to induce cancer.

CONSUMER BILL OF RIGHTS is proclaimed by President John F.  Kennedy in
a message to Congress.  Included are the right to safety, the right to
be informed, the right to choose, the right to be heard.

1965 DRUG ABUSE CONTROL AMENDMENTS are enacted to deal with problems
caused by abuse of depressants, stimulants and hallucinogens.

NEW FDA WASHINGTON headquarters laboratory is occupied and dedicated.

1966 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.

CHILD PROTECTION ACT enlarges the scope of th e Federal Hazardous
Substances Labeling Act to ban hazardous toys and other articles so
hazardous that adequate label warnings could not be written.

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.

1968 FDA BUREAU OF DRUG ABUSE CONTROL and Treasury Department Bureau
of Narcotics are transferred to the Department of Justice to
consolidate policing of traffic in drugs that are abused.

REORGANIZATION of federal health programs places FDA in the Public
Health Service.

ANIMAL DRUG AMENDMENTS place all new animal drug regulation under one
section of the Food, Drug, and Cosmetic Act--Section 512--making
approval of animal drugs and medicated feeds more efficient.

1969 FDA begins administration of sanitation programs for milk,
shellfish, food service, and interstate travel facilities, and for
poisoning and accident prevention, transferred from other units of the
Public Health Service.

1970 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 efficacy.

ENVIRONMENTAL PROTECTION AGENCY established; takes over FDA program
for setting pesticide tolerances.

1971 BUREAU OF RADIOLOGICAL HEALTH transferred to FDA.  Its mission:
protection against unnecessary human exposure to radiation from
electronic products in the home, industry, and the healing arts.

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH is established in the
biological facilities of the Pine Bluff Arsenal in Arkansas. It s
mission is to examine biological effects of chemicals in the
environment, extrapolating data from experimental animals to human
health.

1972 OVER-THE-COUNTER DRUG review begun to enhance the safety,
effectiveness and appropriate labeling of drugs sold without
prescription.

REGULATION OF BIOLOGICS--including serums, vaccines, and blood
products--is transferred to FDA.

1973 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 time-consuming litigation.

LOW-ACID FOOD PROCESSING regulations issued to insure that low-acid
packaged foods have adequate heat treatment and are not hazardous.

CONSUMER PRODUCT SAFETY COMMISSION created by Congress; takes over
programs pioneered by FDA under 1927 Caustic Poison Act, 1960
Hazardous Substances Labeling Act, 1966 Child Protection Act, and PHS
accident prevention activities for safety of toys, home appliances,
etc.

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.

VITAMINS AND MINERALS AMENDMENTS stop FDA from establishing standards
limiting potency of vitamins and minerals in food supplements or
regulating them as drugs based solely on potency.

1977 SACCHARIN STUDY AND LABELING ACT passed by Congress to stop FDA
from banning the chemical sweetener but requiring a label warning that
it has been found to cause cancer in laboratory animals.

1980 INFANT FORMULA ACT establishes special FDA controls to insure
necessary nutritional content and safety.

1982 TAMPER-RESISTANT PACKAGING REGULATIONS issued by FDA to prevent
poisonings such as deaths from cyanide placed in Tylenol capsules. The
Federal Anti-Tampering Act passed in 1983 makes it a crime to so
tamper with packaged consumer products.

1983 ORPHAN DRUG ACT enables FDA to promote research and approval and
marketing of drugs needed for treating rare dise ases, which otherwise
would not be profitable.

1984 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.

DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT expedites the
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.

1985 AIDS TEST FOR BLOOD approved by FDA in its first major action to
protect patients from infected donors.

1986 CHILDHOOD VACCINE ACT requires patient information on vaccines,
gives FDA authority to recall biologics, and authorizes civil
penalties.

1987 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.

1988 FOOD AND DRUG ADMINISTRATION ACT of 1988 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, and spells out broadly the
responsibilities of the Secretary and the Commissioner for research,
enforcement, education, and information.

GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT extends to
veterinary products benefits given to human drugs under the 1984 Drug
Price Competition and Patent Term Restoration Act. Companies can
produce and sell generic versions of animal drugs approved after
October 1962 without duplicating research done to prove them safe and
effective.  The act also authorizes extension of animal drug patents.

1990 NUTRITION LABELING AND EDUCATION ACT
http://www.fda.gov/opacom/backgrounders/foodlabel/newlabel.html

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 of 1990 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, a nd 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 hearings before an Administrative
Law Judge.

1992 GENERIC DRUG ENFORCEMENT ACT imposes debarment and other
penalties for illegal acts involving approval of abbreviated drug
applications.

PRESCRIPTION DRUG USER FEE ACT OF 1992 re quires 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. Unless Congress renews the act, the
user fee law will expire at the end of FY 1997.

MAMMOGRAPHY QUALITY STANDARDS ACT of 1992 required all mammography
facilities in the United States to be accredited and federally
certified as meeting quality standards effective Oct. 1, 1994. After
initial certification, facilities must pass annual inspections by
approved federal or state inspectors.

1994 DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT establishes specific
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.

ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT allows veterinarians to
prescribe extra-label use of veterinary drugs for animals under
specific circumstances. In addition, the legislation allows licensed
veterinarians to prescribe human drugs for use in animals under
certain conditions.

FDA Home Page
http://www.fda.gov/fdahomepage.html

Milestones in U.S. Food and Drug Law History
http://www.fda.gov/opacom/backgrounders/miles.html