The History of the Food and Drug Administration is the second in a four-part series profiling the history, structure and purpose of consumer protection agencies in the United States, including the CPSC, FDA, USDA and NHTSA.
Food production, including the humane slaughter of animals, storage, handling, preparation and all other aspects has been subject to regulation since Biblical times. Apparently, during the early 1200s, it was common to add ground peas, beans, and other “secret” ingredients to bread. This undesirable practice prompted King John of England to proclaim the “Assize of Bread and Ale” law, prohibiting the adulteration of bread with such ingredients, and controlled both quality and pricing of ale, and the weight of a loaf of bread that could be priced at one farthing1. This law remained in force until the 16th century for ale, and the early 19th century for bread.
During the 13th century The Worshipful Company of Bakers, the equivalent of a baker’s Association or Guild, and was given the authority to enforce the regulations of the Assize of Bread and Ale. This gave rise to the “baker’s dozen” or 13 for the price of 12 (also known as the “Devil’s dozen” because of evil associations with the number 13.) Penalties for selling an order of less than the required weight were severe. Bakers, to avoid possibly giving a customer a short-order, would bake 13 loaves to be sure they had enough in case one was dropped, burnt, or the dozen was under the weight limit.
The history of the U.S. Food and Drug Administration (FDA) dates back many centuries in its intent and purpose, and to the original 13 colonies for it’s current identity. Colonists simply brought this expectation with them from their previous culture. The foundation for regulating how food is handled and produced in this country was inherent from this country’s inception. The eventual inclusion of drugs and cosmetics broadened its scope considerably.
Harvey W. Wiley, M.D. http://www.fda.gov/centennial/this_week/26_june_25_july_01.html
The FDA has a huge scope of responsibility, overseeing the safety of human and animal food products (excluding the few covered by the USDA,) drugs used for both humans and animals, medical equipment ranging from consumer-use equipment that emits radiation to home care (durable medical) equipment, to, hospital equipment used for therapy, diagnostics and monitoring, and the safety of cosmetics.
The FDA had its more official beginnings nearly 200 years ago. As with most government agencies, the FDA started with a small task and grew. What follows is a peek at how, given enough time, a small committee of doctors became one of the largest administrations in the U.S. Government.
Documented efforts to regulate drugs in this country began as early as 1820, when eleven physicians established the U.S. Pharmacopoeia. This collection described and standardized drugs used in the United States for the first time. By 1848 the need to prevent importation of adulterated drugs led to the passage of the Drug Importation Act2.
In 1862 Charles M. Wetherill, a chemist, was appointed to the U.S. Department of Agriculture by President Lincoln. The Bureau of Chemistry, the predecessor of the FDA, eventually grew from the work of the chemists holding that position.
Harvey W. Wiley, M.D. was appointed chief chemist of the Bureau of Chemistry in 1883. Though not the first to push for legislation to protect consumers from false drug claims and dangerous drugs, he is recognized as the “Crusading Chemist” and “Father of the Pure Food and Drugs Act.” Between his appointment in 1883 and 1906 many laws were passed including one requiring the inspection of imported tea.
During that same period Dr. Wiley headed the Committee on Food Standards, through which he was instrumental in raising public awareness of problems with adulterated food, and was instrumental in developing standards for food processing. While states were incorporating this committee’s food standards into their statutes, the Biologics Control Act was passed in 1902 to ensure the quality and safety of preventive and therapeutic medications for human use. Efforts to maintain quality in both food and drug production seemed to go hand in hand from the beginning.
Dr. Wiley began doing human research with a group of volunteers tagged “the poison squad.” These men agreed to eat foods containing measured amounts of preservatives for five years to determine if these specific preservatives caused damage.3
Upton Sinclair Archives, Lilly Library (Indiana University, Bloomington, IN.)
But, things changed quickly when, on February 27, 1906 the publication of Upton Sinclair’s book, The Jungle, exposed the horrific conditions in the meat packing industry, stirring the public to demand legal protection. Among the book’s shocking revelations were not just the unsanitary conditions of the meat packing plants, but also, the use of poisonous dyes and preservatives. Public outcry made it impossible for Congress not to take action. Eight years later, in 1914 Sinclair starred in the silent movie production based upon his book, The Jungle.4
Dr. Wiley’s, dedication to getting legislation passed to protect people from contaminated and adulterated5 food and drugs paid off. On June 30, 1906, Congress passed the Pure Food and Drugs Act as well as the Meat Inspection Act. The terms “misbranding” and “adulterated” were defined by these laws, as were the penalties for offenses that violated them. “Snake-oil “remedies,” both worthless and dangerous despite being patented, were also covered by these laws. They caused so many problems that they, too, were a significant factor in the passage of these laws.
A very active period of investigation, discovery, and legislation took place between 1907 and 1914. Seven safe food colors were identified as suitable for consumption, the Gould Amendment required packages to be marked clearly with the volume of the contents, and several lawsuits set precedents. U.S. v. Johnson, 1911, ruled that the 1906 Food and Drugs Act prohibited not only false and misleading statements about the ingredients or identity of any drug, but clarified that this law did not prohibit false therapeutic claims! Oops! Big oversight.
The 1912 Sherley Amendment was enacted quickly to remedy that omission, but, it also created a standard that was hard to quantify. It prohibited labeling drugs with false claims “intended to defraud the purchaser.” It now became necessary to prove that there was intent to defraud, not just a fraudulent statement on the label. It took twelve years to correct this oversight. In 1924 a Supreme Court ruling reinforced the intent of the Food and Drug Act regarding truth in labeling, by condemning any misleading wording, illustration or device. Twelve years?
In 1914 in U.S. v. Lexington Mill and Elevator Company the Supreme Court ruled that the government was responsible to show that additives must actually be harmful for them to be banned from foods. That same year the Harrison Narcotic Act required prescriptions for narcotics and increased record keeping by physicians and pharmacists for narcotics prescribed and dispensed.
Between 1924 and 1937 bureau names changed, agencies and their jurisdictions were reorganized and the complete revision of the Food and Drugs Act resulted in a five-year battle. The Bureau of Chemistry had been divided into the Bureau of Chemistry and Soils, and The Food, Drug and Pesticide Administration.
Because so many deaths, disfigurements, and injuries occurred from consumable products, particularly drugs and cosmetics, the FDA prepared gruesome examples of the deaths and damage caused by untested drugs and cosmetics. They presented this collection at the 1933 Chicago World’s Fair, the press, radio, Congress, the White House and others. The press referred to this collection as the “Chamber of Horrors.”6
In 1937 a single event took place that turned things upside down. Previously, sulfanilamide had been given safely in tablet and powder form to treat streptococcal infections. Responding to a demand for a liquid form of this drug, the S.E. Massengill Co. chemists found that sulfanilamide would dissolve in diethylene glycol, and without testing for toxicity, distributed 633 shipments of the new medication throughout the U.S. The lack of a requirement to test drugs for toxicity allowed this lethal elixir to enter the market.7 That year elixir of sulfanilamide killed 107 adults and children, emphasizing the need to end the battle over food and drug legislation, and prove safety prior to releasing drugs for consumption.
The 1938 Federal Food, Drug, and Cosmetic (FDC) Act passed and included control of cosmetics and therapeutic devices, pre-market proof of safety for drugs, establishing safe tolerances for unavoidable use of poisonous substances, setting standards for quality, labeling and content on containers, authorized factory inspections, eliminating the requirement to prove “intent to defraud” from the Sherley Amendment, and included remedies for previous penalties of seizures and prosecutions.
The Wheeler-Lea Act gave oversight of product advertising to the Federal Trade Commission for all products under FDA regulation except prescription drugs.
The 1940s brought amendments and legislation providing further safety regarding purity and potency of medications, transferred the FDA from the Department of Agriculture to the Federal Security Agency, appointment of Walter G. Campbell as first Commissioner of Food and Drugs, regulation of biological products, control of communicable diseases, and the “black book” of procedures for the appraisal of the toxicity of chemicals in food.
In the 1943 U.S. v. Dotterweich Supreme Court ruling, a corporation as well as its responsible officers may be prosecuted for violations, even lacking proof that these officials intended any, or even knew of the violations.
Despite over 130 years of efforts to protect consumers from inscrutable or negligent manufacturers and marketers, problems continued to arise and to be addressed in the 1950s through legislation, legal action and reorganization of the agencies responsible for oversight of these products. Problems included faulty labeling and inadequate communication of the purpose of drugs or the condition it was supposed to treat; definitions of drugs requiring medical supervision; food labeling, such as clarifying that oleomargarine was not butter; investigations of chemicals in foods and cosmetics; issues of communication regarding findings during government inspections, safe pesticide limits.
While the FDA underwent a 1955 review for expansion to increase its capacity to manage its responsibilities, a major event occurred that underscored the need for reorganization. When 260 people contracted polio after receiving a polio vaccine, one that was believed inactivated, the Division of Biologics Control became an independent entity, now under the National Institutes of Health.
The 50s continued to reveal the dangers of food additives. Cancer-causing additives and pesticides used to grow crops became the focus of new recalls and legislation. During this decade, FDA published a list of 200 substances generally recognized as safe (GRAS).
Many of us remember the warnings about red dyes no. 2 and 3 as well as others. The 1960s opened with a major controversy about food colorings, creating suspicion about nearly all color additives for some time. To this day, many people won’t eat red M&Ms, even though, nearly fifty years ago, Congress enacted an amendment that required manufacturers to establish the safety of colorings use in foods, drugs, and cosmetics. The provision prohibiting the use of cancer causing color additives was extended to products used for animals. Again, the need for additional label warnings was legislated and enforced by the FDA.
The 1960s was a scandalous decade, notorious for drugs both legal and illegal. For all the notoriety of drugs, legal and not, the devastation caused by one prescription drug seems to stand out above all the rest. Thalidomide, a sedative and sleep medication caused over 5,000 recognized cases of birth defects and limb deformities in infants born to mothers who took the drug during pregnancy.
These and other incidents gained for Dr. Frances Kelsey, FDA medical officer, sufficient public support to urge Congress to pass the Kefauver-Harris Drug Amendments. These required manufacturers to prove to the FDA that their drugs were effective and safe before they could market them. That same year, President John F. Kennedy gave us the Consumer Bill of Rights, entitling all Americans to the rights to safety, to be informed, to choose, and to be heard.
During the remainder of the 60s many new laws and amendments were enacted to prevent abuse of legal and illegal drugs. FDA initiated evaluations of the effectiveness of drugs approved as far back as 1938. Labeling continued to be problematic, causing passage of more acts, including a ban on hazardous toys and other products, including one that further raised the bar in honesty in labeling.
1970 brought the first FDA requirement for package inserts. Pharmaceutical manufacturers were now required to include information inserts describing risks and benefits of medications, along with other significant information, inside the package. While we take these inserts for granted today, and usually toss them with the packaging, we do have easily accessible information, though it isn’t always easy to understand. Also, new acts that year replaced prior laws concerning drugs with addiction potential.
The well-known EPA (Environmental Protection Agency) was established in 1970 and assumed the FDA responsibilities concerning pesticides. Review of the GRAS list that began in 1969 continued into the 1970s, when saccharin was removed from the list of safe substances.
Again, labeling requirements proved ineffective and came under review, this time involving over-the-counter drugs. By 1973 the U.S. Supreme Court endorsed the FDA to control many products through regulation rather than through litigation. Due to a botulism breakout that year, food-processing regulations were issued. Finally the Consumer Product Safety Commission, (CPSC) was created by Congress to oversee the safety of products and toys, including toxin content and labeling.
Quality control procedures became a pre-market requirement in 1976 to ensure safety and effectiveness of medical and diagnostic devices.
By 1977 the ban on saccharin was lifted and replaced with a requirement to include a warning “saccharin has been found to cause cancer in animals” on the label.
A nuclear power plant emergency triggered FDA action in March of 1979. The nuclear power plant reactor at Three Mile Island overheated, threatening the surrounding areas with the potential for radiation poisoning. While there were no injuries or deaths, the FDA arranged to have about 250,000 bottles of potassium iodide delivered within 72 hours, in case these were needed.
The 1980s addressed the nutrient content of infant formulas, protections for human subjects participating in research projects, food additives (again), patent protections for drugs and easing approval restrictions on production of generic drugs, childhood vaccines, approval of an AIDS test, expanded access to experimental drugs, and promotion of research for rare or serious diseases with no alternative therapies.
The scandal of the 1980s was an incident in 1982 involving deaths from cyanide someone injected into Tylenol capsules already on the shelf of a drug store. This is still an unsolved case, and no one knows who did this or why, but seven people died from ingesting the cyanide-laced capsules.9 FDA issued Tamper-Resistant Packaging Regulations, and in 1983 the Federal Anti-Tampering Act was passed. Now you know why you can’t open that bottle pain reliever you need for the pain in your arthritic wrists.
For all its authority, the FDA was not an agency of the Department of Health and Human Services (DHHS) until 1988, when the Food and Drug Administration Act made it official. New laws that year placed additional marketing restrictions on prescription drugs, including drugs imported or reimported from other countries. Dietary supplements were coming under close scrutiny by 1989, and a link confirming 1,500 cases of Eosinophilia Myalgia Syndrome (EMS), of which 38 victims died and the rest were permanently disabled, resulted in a recall and ban of L-tryptophan.
Although studies indicated that two other, more likely causes existed-impurities introduced during the manufacture of one Japanese brand, and people taking larger-than-recommended doses of L-tryptophan-it wasn’t until 2001 that the FDA lifted many restrictions on domestic production of this supplement. It did so, retaining the restrictions on importation of the supplement, and with a disclaimer about their continuing concern about L-tryptophan10:
“Based on the scientific evidence that is available at the present time, we cannot determine with certainty that the occurrence of EMS in susceptible persons consuming L-tryptophan supplements derives from the content of L-tryptophan, an impurity contained in the L-tryptophan, or a combination of the two in association with other, as yet unknown, external factors11.”
The 1990s saw the FDA reclassification of anabolic steroids as controlled substances, and included black market compounds in this category. As with earlier drug and product labeling, packaged foods now required per-serving nutrition labeling, and an easily understood list of the most important nutrients. Health claims had to meet specific and defined terms, and Federal law preempted state laws on food standards. Specific conditions must, now, be met to use terms such as “low fat.” New regulations required an accelerated drug review for life-threatening conditions. More protections were implemented for subjects of research along with stronger emphasis on compliance.
The Safe Medical Devices Act was passed in 1990 requiring facilities that use medical devices to report incidents involving any medical device to the manufacturer and, under certain circumstances, to the FDA. Manufacturers were made responsible for tracking patients with their implanted devices and to notify them of recalls or other alerts.
The Safe Medical Devices Act was the first federal regulation that required employees of facilities using medical devices to report incidents under penalty of a personal fine or imprisonment or both for failing to do so, although their requirement was to report it to a designated agent within their facility, not to the FDA or manufacturer. Reporting to the manufacturer and, when appropriate, to the FDA was each facility’s designated agent’s responsibility. By 1993 a voluntary reporting system called MedWatch was implemented, which gave consumers a way to report adverse experiences with medical equipment, drugs, supplements, and animal care and food products.
Public concern over the fact that most drug studies included only male patients raised awareness that the differences in male and female chemistry and biology overlooked the effects of medications on women. For all our medical knowledge, it took until 1993 for the FDA to require drug studies to include both male and female patients, with responses noted as a function of gender. In the years that ensued, much data was gathered about heart attacks showing the need for different considerations and treatments for women than men.8
Once again, in 1994, labeling issues are addressed, this time for dietary supplements. U.S. drug patent terms were increased by three years from 17 to 20.
In an effort to discourage marketing cigarettes to young people, the FDA declared cigarettes to be drug delivery devices in 1995. After that nice try, the FDA lost its clout with the tobacco industry in 2000 when the U.S. Supreme Court ruled that they didn’t have the authority to regulate tobacco as a drug.
During 1996 an act of Congress (literally) repealed the requirement for cancer warning notices on items containing saccharin. Between 1996 and 1999 were many efforts to reform and update FDA regulations and laws to maintain quality and reduce reporting requirements. Some changes included standardizing the format of over-the-counter drug labels, speeding up the review process, improving safety of medications for children, and eliminating outdated practices dating back to 1938.
In 2000, with the passage of the Data Quality Act, Federal Agencies were made accountable for the “quality, objectivity, utility, and integrity of the information they generate…” Labels never seem to say enough. Labeling for dietary supplements, starting that year, had to adhere to government definitions of the type of statements that could be made about the effect of those supplements on the body.
Many updates and refinements to existing FDA practices and requirements were implemented in 2002. But of special note was the awareness, after the 9/11 terrorist attack, of the need for Emergency Preparedness, Security, and Bioterrorism Preparedness. Congress passed an act that year designed to accomplish these safety measures, and authorized the FDA to issue regulations ensuring the safety of imported and domestically produced commodities.
Our ever-manifesting labeling issues were addressed again in 2003 when the DHHS told the FDA to require food labels to include trans-fat content. Many new programs and publications were released from the FDA on heart-healthy dietary changes. Others addressed obesity and the need to thin Americans down for health.
Many issues were addressed in 2004 in the wake of 9/11 and serious reactions to many drugs. Congressional Acts authorized FDA to take more expedient countermeasures in response to chemical, biological and nuclear threats.
Not surprising was another act requiring additional information on, hmmm, let me guess-food labels! This time it required disclosure of any protein that accounts for any of the major food allergies (peanuts, gluten, eggs, milk, etc.) Due to the rising number of deaths attributed to steroid use, a ban on over the counter steroids and their precursors with stiff penalties for violations was detailed by an act of Congress. This was also the year the FDA also banned ephedrine alkaloids, and other agents, due to deaths and adverse cardiac effects.
While, only 18 years ago, the FDA and Congress took serious steps to hold medical device manufacturers accountable for the devices they made, including taking steps to encourage and simplify the process of consumer complaints, the U.S. Supreme Court has recently invalidated one of the most powerful recourses consumers have against products that injure them or their loved ones. On February 20, 2008 it ruled that medical device manufacturers were not liable for personal injuries providing the FDA approved the device before it was marketed and meets the agency’s specifications. One has to wonder if using MedWatch to file a complaint will have any impact in the future. Just what, exactly, will motivate medical device manufacturers to refine the flaws out of their products if they are not going to be accountable for them? Will consumers be able to hold the FDA accountable? Will consumers be able to sue the FDA? The Supreme Court?
Next on their agenda seems to be similar rulings for the pharmaceutical companies. Hmmm, maybe they’ll lift the ban on buying pharmaceuticals from foreign countries. Since no one will have to be accountable anyway, we should have the choice of paying less for what might well be a pig in a poke.
You can read more about the history of the FDA at http://www.cfsan.fda.gov/~lrd/history2.html.
Contacting US Food and Drug Administration (FDA)
The FDA allows consumers to report dangerous food and drug products through their reporting system at MedWatch Online using form 3500 here http://www.fda.gov/medwatch/.
Consumers should use alternative forms (found on the page above) to report adverse vaccine events, and side effects related to investigational (study) drugs. Consumers who wish to contact the FDA directly can do so at:
U.S. Food and Drug Administration
5600 Fishers Lane, Rockville MD 20857-0001