The Beginnings of the Modern FDA

By Nathan Elmore

The Food and Drug Administration or FDA plays a major role in public health. Few people understand how or why this agency exists and the importance to our everyday life. Their roots really date back to 18611 but the modern era of the FDA got its official start with the passage of the Pure Food and Drug Act of 1906. So here are a couple questions to answer, how and why was the agency formed? And how do they affect us today? From the 1879 on through until the 1906 about 190 pieces of food or drug legislation was submitted to congress2. Many states in the meantime past "pure food" laws that were meant to protect the public from unsafe or misleading products. Many manufacturers of both pure food and alternative food favored these laws, although for different reasons, as a way to their name and products from less savory sources. For the 'Pure food manufacturers it was to reduce the competition from the often times cheaper products. Butter producers feared that oleomargarine would take their business away more than do harm to the public health. Another example is Straight whiskey versus distilled whiskey. Straight whiskey which has to be aged in barrels to remove the most of the impurities takes quite a while. The distilled Whiskey makers, who had the larger market share, could make their whiskey in considerably less time and cheaper. Makers of distilled whiskey were grouped together and named the Whiskey Trust by Wiley and his

FDA. "About FDA." FDA History. Fda.gov, 9 June 2009. Web. 09 Nov. 2013.

Congressional Opposition to Pure Food Legislation, 1879-1906 Thomas A. Bailey American Journal of Sociology, Vol. 36, No. 1 (Jul., 1930), pp. 52-64 Published by: The University of Chicago Press Article Stable URL: http://www.jstor.org/stable/2767223 Accessed 09/11/2013

straight whiskey allies3. Some of the public support for these laws arose from what Theodore Roosevelt termed "muckrakers", journalist that wrote exposes of various industries. Upton Sinclair exposed the conditions of the meat-packing workers and factory. Muckrakers Sinclair and Samuel Hopkins Adams who reported the mislabeling/misbranding of patent medicines helped to bring public support to Harvey w. Wiley's efforts to pass a federal law against adulterated foods. Wiley was the chief chemist of the Bureau of Chemistry in the department of agriculture who brought together manufactures, medical doctors, pharmacist, researchers, and other reform groups to back the pure food act. At this time food addictives had to be proven harmful before they could be deemed illegal. To prove that some of the adulterous additives were harmful, Wiley got a group of "able bodied" volunteers and had them ingest large quantities of said addictives to measure their harmful effects, these men became known as the poison squad.4 The Pure Food and Drug Act of 1906 gave regulation of adulterated product interstate commerce and enforcement to the bureau of chemistry. The power of the bureau was then diluted by the secretary of agriculture James Wilson who created the Board of Food and Drug Inspection in 1907. After Wiley's resignation in which he cited the industry was corrupting and holding the bureau back, they turned their main focus on adulterated drugs. Upon Wiley's death the bureau was able to make changes it needed to remain viable to the public health5. These

Wiley and the Whiskey Industry: Strategic Behavior in the Passage of the Pure Food Act Jack High and Clayton A. Coppin The Business History Review, Vol. 62, No. 2 (Summer, 1988), pp. 286-309 Published by: The President and Fellows of Harvard College Article Stable URL: http://www.jstor.org/stable/3116002 Accessed 09/11/2013 4 Wiley and the Whiskey Industry: Strategic Behavior in the Passage of the Pure Food Act Jack High and Clayton A. Coppin The Business History Review, Vol. 62, No. 2 (Summer, 1988), pp. 286-309 Published by: The President and Fellows of Harvard College Article Stable URL: http://www.jstor.org/stable/3116002 Accessed 09/11/2013
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FDA. "About FDA." FDA History. Fda.gov, 9 June 2009. Web. 09 Nov. 2013

changes form the basis for the new food, drug and cosmetic act of 1938. The food, drug and cosmetic act brought cosmetics and medical devices under the direction of the Bureau of Chemistry. Other changes were that labeling and directions for taking the medicine were now required for patent medications and two categories for drugs, prescription and over to counter. Prior to this act you only needed a prescription signed by a doctor to get what is now a schedule 1 and 2 medications, cocaine, heroin, opium, and morphine. Most everything else you just went to the pharmacy or chemist and buy the medicine. At first the Bureau of Chemistry was charged with the enforcement of prohibiting the interstate commerce of adulterated food and drug. They also worked to identify adulterous addictives that were harmful to the public health. Wiley focused primarily on food addictives because he felt that they posed a greater health threat than patent medicines. Working the other bureaus in the department of agriculture the Bureau of Chemistry carried out meat inspections, for export to other countries and for domestic consumption. They developed a list of harmful addictives that were prohibited and those that must be listed on the label. This list included Alcohol, cocaine, heroin, morphine, cannabis, previously illegal drugs, and patent medications minus the secret ingredient6. The act was opposed by corrupt businesspeople and politicians as Wiley saw them. Must Southern representatives were opposed to "the extension of the internal revenue system and the alleged abuse of taxing power"7. The Whiskey trust only opposed the act and thus the bureau only after Wiley turned on them and named their product as adulterous. Businesses that would
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FDA. "About FDA." FDA History. Fda.gov, 9 June 2009. Web. 09 Nov. 2013.

Congressional Opposition to Pure Food Legislation, 1879-1906 Thomas A. Bailey American Journal of Sociology, Vol. 36, No. 1 (Jul., 1930), pp. 52-64 Published by: The University of Chicago Press Article Stable URL: http://www.jstor.org/stable/2767223

lose big if the act passed were involved in manufacturing and supplying the addictives and products named as adulterous, poisonous and dangerous. They succeeded to get a list of harmful substances banned, and several listed as limited use. One problem the Bureau of Chemistry had was that they had to prove a product was harmful before they could restrict or ban them. The Bureau of Chemistry could not do anything against a manufacture or producer unless they tried to transport their product across state lines. The states were still in charge of the rules of in state commerce. As long as the company followed the state rules then they could legally sale their goods. Conditions highlighted in Sinclair's The Jungle improved with inspections. They standardized the meat industry and got many food and drink companies to reduce or stop using harmful addictives. In 1912 after about six years of going after these companies Wiley resigned from the bureau. Later he said that the whiskey trust and other industries subverted the act8. It was not until after the death of Wiley that the Bureau of Chemistry was finally able to make changes and get a new law to replace the pure food act9. The food, drug, and cosmetics act of 1938 brought medical devices and cosmetics under the jurisdiction of the Bureau. Other changes included, makers now have to proven that their product was safe to use. It also required ingredient labeling for all food, drugs, and cosmetics. Put into place national industry standards for food, drugs, cosmetics, and medical devices. Regulations and procedures are created by the FDA with congressional oversight. Drugs are divided into two categories - prescriptions and over the counter. Many but not all of the drugs that have by proven to be harmful are removed from the market. Substances added to food must
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Wiley and the Whiskey Industry: Strategic Behavior in the Passage of the Pure Food Act Jack High and Clayton A. Coppin The Business History Review, Vol. 62, No. 2 (Summer, 1988), pp. 286-309 Published by: The President and Fellows of Harvard College Article Stable URL: http://www.jstor.org/stable/3116002 Accessed 09/11/2013
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FDA. "About FDA." FDA History. Fda.gov, 9 June 2009. Web. 09 Nov. 2013

be proven to be safe for consumption before they can be used. Enforcement is done by the FDA directly or jointly with the DEA in the case of Controlled medicines, and the Department of Agriculture for animal feed and meat inspections. The FDA does research to protect the public health and investigates any claims harmful addictives, food, cosmetics, medical devices, and drugs. Approval from the FDA is still needed for new products, which are proven to the FDA that they are safe. The wording on the labels must not be misleading or misrepresent the product or the quality.

Worked Cited
FDA. "About FDA." FDA History. Fda.gov, 9 June 2009. Web. 09 Nov. 2013. The Origins of State Pure Food Regulation Marc T. Law The Journal of Economic History, Vol. 63, No. 4 (Dec., 2003), pp. 1103-1130 Published by: Cambridge University Press on behalf of the Economic History Association Article Stable URL: http://www.jstor.org/stable/3132366 Regulatory Agency Discretion among Competing Industries: Inside the FDA Mary K. Olson Journal of Law, Economics, & Organization, Vol. 11, No. 2 (Oct., 1995), pp. 379-405 Published by: Oxford University Press Article Stable URL: http://www.jstor.org/stable/765003 50 Years of Food and Drug Protection George P. Larrick Public Health Reports (1896-1970), Vol. 71, No. 6 (Jun., 1956), p. 557 Published by: Association of Schools of Public Health Article Stable URL: http://www.jstor.org/stable/4589465 Congressional Opposition to Pure Food Legislation, 1879-1906 Thomas A. Bailey American Journal of Sociology, Vol. 36, No. 1 (Jul., 1930), pp. 52-64 Published by: The University of Chicago Press Article Stable URL: http://www.jstor.org/stable/2767223 Wiley and the Whiskey Industry: Strategic Behavior in the Passage of the Pure Food Act Jack High and Clayton A. Coppin The Business History Review, Vol. 62, No. 2 (Summer, 1988), pp. 286-309 Published by: The President and Fellows of Harvard College Article Stable URL: http://www.jstor.org/stable/3116002 Accessed 09/11/2013