The first food and drug administration (FDA) was established in US in 1906. Before that pharmacies were an unregulated lot. Various products were sold in the name of medicines, and these would promise a cure. It was not necessary for its makers to specify its ingredients, and in-fact it was a tightly protected trade secret. Further, neither was there a requirement to prove safety, or have a quality control during their production. Usefulness, on the other hand was another issue altogether, and it came much later. Philately material has some glimpses of such products.
Gargling oil liniment
In 1833, a US Druggist by the name George W Merchant, brought out a product by the name Merchant’s Gargling Oil. Tag line for this product was “a Liniment for Man and Beast”. This concoction of petroleum, soap, ammonia water, oil of amber, iodine tincture, benzine, and water \was not for gargle, but for local application on the skin. There were two versions of the same product – White for humans (referred to as “man” and Yellow for animals (referred to as “beast”). This product continued to be used till 1927.
Many posters and pamphlets of this product exist. It was intended to treat burns, scalds, rheumatism, flesh wounds, sprains, bruises, hemorrhoids or piles, toothache, sore throat, chilblains, and chapped hands. The product monograms also mentioned that it could also be eaten, to cure Cramps or Spasms of the Stomach, Colic, Asthma, or Internal Pain. Obviously, this widely used product lacked a scientific basis, especially if taken orally.
Multiple products and varied claims
Columbus Pharmacol, Ohio was founded in 1885, and was making variety of medicines. One of these “Tuberculoids” was supposed to cure tuberculosis. The monograph of the product claimed that it contains a new, tested compound, that “restores a person with Tuberculosis to complete health.” In fact these sugar coated tablets had iodine, bismuth, cinnamon and starch. In 1912, these claims were rebuked by the drug administrators in Ohio.
Another products advertised on the same envelope as above, includes “Elliptoid-antiseptic” which was to be used as a vaginal pessary by women. This concoction of boric acid, zinc sulphate, and opium was also a commonly listed product in early 20th century.
Claims and depictions
So a variety of products were available, sold with often attractive labels and pronouncements. A single product, often without listing its contents, claimed wide-ranging cures. This was also true of foods. New food substances were being created that often had doubtful chemicals, added to it, to make money or to improve its shelf-life. This was the reason a “Pure food and Drugs act” was enacted in US in 1906. This act and its evolution was the force behind the current US Food and Drug Administration (USFDA). This system was taken up by other countries quite later.
The person behind the movement
Dr Harvey Washington Wiley (or HW Wiley) was the person behind the origin of “Pure food and Drugs act”. Born in 1844, he completed his medical education from Indiana in US in 1871. Thereafter he traveled to Germany, and worked in and studied at chemical industry. On his return to US in 1882, he was appointed as a chief chemist in US Department of Agriculture.
Wiley started doing chemical analysis of various food substances, and was appalled to find many of these containing significant quantities of harmful adulterants. He formed a team of human volunteers (nicknamed Poison squad), who would consume these substances and demonstrate its harmful effects. This drew attention as well as criticism, as many of these harmful substances (including formaldehyde) were passed of as preservatives. Wiley’s “Pure food” movement led to this “Pure food and drugs act of 1906”.
In 1909-11 Harvey also took up claims of Coca-Cola, and took exception to high doses of caffeine that were added to the product. Despite scientific evidence, public pressure created by the food giant led to Wiley loosing in litigation. He resigned government job in 1912, and started a public Centric “Good housekeeping” seal of approval for food products. He passed away in 1930.
Administration of the act and impact
Initially the act was implemented by the Bureau of Chemistry, Department of Agriculture. With Wiley as its chief he started his crusade against many foods and drugs. In 1907-08 Board of Food and Drug Inspection and the Referee Board was created to cross-check claims and counterclaims. In 1927 this body became Food, Drug, and Insecticide organization, and in 1930 it got its current name “Food and Drug administration”. The initial act could only look if product contained what it claimed. It took few years, for it to get strengthened as we see it today.
Polyglandular preparations and misleading claims (Organo-o-tones)
One of the curious instances is of poly-glandular preparations, that were popularly marketed beginning mid 1920s. Manufactured by Cole Chemical company, each preparation was numbered and its ingredients were available on request. This was in compliance with the FDA rules, about disclosing the ingredients of these medicines.
All of these were poly-glandular preparations, containing a mix of Thyroid, Pituitary, and Ovarian substance (number 19 for obesity); Pancreas, Duodenal, Liver and Duodenum (number 18 for diabetes); Testicular, Thyroid, Pituitary, Adrenal (number 15 for male impotence); or Thyroid, Ovarian, or Pituitary (number 4 for menopause). The company claimed that these were safe (which is mostly true as these compounds would get digested in our stomach, so did not work anyways). The misleading claims of the company for its variety of products were challenged by FDA in 1930s, especially targeting product number 19 as harmful. It took lawsuit judgements in 1943 and later in 1948 to ban the products as well as its marketing post-cards.
In 1938 the act was further strengthened to cover safety. The companies not only had to declare contents, prove safety, and also not make any misleading claims. Things started changing in US beginning 1950s, and the way letters were sent to physicians changed.
Reporting of safety data, MER/ 29 story
As regulations got tightened, pharmaceutical companies now had to prove safety by series of experiments on animals (rats, rabbits, monkeys etc) and even limited human studies. This was all to be reported to FDA before approval of the drug. However, misleading claims, and tampering with safety data still led some drugs to get approval. A case in point is first cholesterol lowering drug Triparanol, that was approved in 1960. The story is known as Triparanol scandal.
The manufacturer Merrell had all the documents about this drug. Its effects were also published in leading medical journals. However within a year after it was launched, cases of cataract and hair loss appeared. Some other people also developed skin diseases. While the company withdrew the drug in 1962, many lawsuits were filed in courts. By 1967, compensation was awarded in eleven of these. It later transpired that adverse safety data from both animals and humans was deliberately hidden to gain approval. The adverse effects were due to a metabolite desmosterol, that had more adverse effects.
Soon after, in 1962 we had Thalidomide tragedy (a drug used to treat vomiting during pregnancy, led to malformations in the fetus). The FDA act was further strengthened. Now it also included efficacy (ensuring that the drug actually works) and ensuring safety in pregnant people and yet-to-be-born children. As drugs and pharmaceutical market grew, task of FDA became more and more important. Over the years FDA was successful to flag many products with misleading claims, and get them banned.
Impact of FDA in other countries
While USFDA was more stringent, other countries followed suit in later years. For instance some preparations could still be available in countries, not governed by USFDA. So in the pharma world USFDA standards are toughest.
Products like these can be available in various countries, but are not USFDA approved.
Various countries including India followed footsteps of USFDA, but stringency is a more recent phenomenon. Drugs and Cosmetic act of 1940, and rules in 1945 started pharma regulation in India. Drug and magic remedies act of 1954, strengthened the regulatory mechanisms further. However, in India a proof of efficacy of a drug became essential only in 1990s, and only in 2019 with Drug and Cosmetics act we had a system that approval is tied to the indication for which it can be used.
As food and drug labels, their claims, and fine print in their advertising, has a history replete with its missteps, various corrective steps in last century have shaped the way current drug regulation works. In a nutshell, it is a struggle between ethics, need for larger good vs commercial interests and what is appropriate.
