Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!

June 25, 2013

By Kurt R. Karst – 

It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, enacted by President Theodore Roosevelt less than 32 years before on June 30, 1906.  Clocking in at just under 20 pages of text, the Public Law version of the 1938 FDC Act, 52 Stat. 1049, is a far cry from the 700-plus page behemoth statute of today.  (The June 11, 1938 Conference Report on S. 5, which became the FDC Act, was also quite short – just 24 pages in length.  See our previous post on the expansion of the FDC Act and FDA regulations.)  And the statute will continue to expand with likely changes to the law concerning drug compounding and drug supply chain (i.e., track and trace) currently being debated by Congress. 

Originally termed the “Tugwell Bill” after then Assistant Secretary of Agriculture Rexford G. Tugwell, the bill that was first introduced to change food and drug law, S. 1944, was dropped by New York Senator Royal S. Copeland on June 12, 1933.  A little more than 5 years later, and just days after Senator Copeland’s death, President Roosevelt signed the bill into law. 

As you can imagine, we’ve done our homework in researching the history of the FDC Act for this post.  We’ve looked over records of the FDA maintained by the U.S. National Archives & Records Administration, reviewed FDA’s history website, paged through the 34 volume (including appendices) “A Legislative History of the Federal Food, Drug and Cosmetic Act and Its Amendments” put out by FDA in 1979, and looked over several law review articles.  In celebration of the FDC Act’s diamond jubilee, we’d like to share with our FDA Law Blog readers a couple of the gems we uncovered in our walk through history. 

First up is a firsthand account of the political and legislative wrangling to get the FDC Act enacted.  In “The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions,” 6 Law & Contemp. Probs. 2 (1939), David F. Cavers traces and documents the conception and birth of the law.  The article is chock-full of details interesting to students of food and drug law and its history.  Here are just a couple of excerpts from the article that piqued our interest (and that will hopefully prompt you to give the entire piece a once-over):

Perhaps the most striking characteristic of the history of the Food, Drug, and Cosmetic Act is the fact that this measure, which was of consequence to the health and pocketbook of every citizen of the country and which importantly affected industries whose annual product totals roughly ten billion dollars, never became the object of widespread public attention, much less of informed public interest.  The affected industries were kept posted by their associations and their journals; some national women’s organizations sought to apprise their membership of major developments; but the public at large, including persons ordinarily well-informed on national affairs, knew little or nothing of what was transpiring in Congress. . . .  For the existence of this situation, the nation’s press must stand primarily accountable.  In the long history of the bill, the New York Times seems to have seen fit to give it front-page mention on but a single occasion and then only to report a disturbance in the Senate galleries. . . .

To Rexford G. Tugwell, then Assistant Secretary of Agriculture, must be given credit for initiating the movement for revision of the Act of 1906.  That act had been amended in but five particulars since its adoption, and one of those amendments had served only to restore in part the damage wrought by an unfortunate Supreme Court decision.  Criticism of the Act, emanating both from the Food and Drug Administration (hereinafter termed the “F & DA”) and from students of the field, had been ignored by successive national administrations.  The public was unaware of the limited character of the protection accorded them.  It was not until the success in 1927 of “Your Money’s Worth” by Stuart Chase and Fred Schlink, the creation of  Consumers Research under the latter shortly thereafter, and especially publication of the best-selling “100,000,000 Guinea Pigs” by Kallet and Schlink in 1933 that an appreciation of the deficiencies of the existing law and the advantages taken of them by elements in the industries became at all general.

Mr. Tugwell was acquainted not only with these works but with their authors.  When he came into the Department of Agriculture, he sounded out the Chief of the F & DA, Walter G. Campbell, as to the adequacy of the existing law, and obtained confirmation of weaknesses alleged by its critics.  His next step was to secure Presidential sanction for the revision of the Act.  This was granted, and he then undertook to organize a group to draft a measure designed to correct the defects in the existing law.

The second gem we uncovered is not from the 1930s, but from the 1950s during the Presidency of Dwight D. Eisenhower. 

From time to time the question comes up: “Has Congress ever considered rewriting or overhauling the 1938 FDC Act?”  After all, with numerous amendments to the statute over the past 75 years, the FDC Act has gotten  quite complex.  As one judge commented several years ago when trying to plow through just the Hatch-Waxman Amendments to the FDC Act, “There’s a special place in Hell where they torture people who write things like this.”  Well, the answer to whether an overhaul was ever in the works is “yes.” 

In 1954, Congress considered H.R. 9728, titled “A Bill to Revise, Codify, and Enact Into Law, Title 21, of the United States Code, Entitled ‘Food, Drugs, and Cosmetics.’”  The House and Senate Reports of the bill (available here and here) explain:

The purpose of this bill is to revise, codify, and enact into law title 21 of the United States Code.  Revision, as distinguished from codification, means the substitution of plain language for awkward terms, reconciliation of conflicting laws, omission of superseded sections, and consolidation of similar provisions.  The primary purpose of this revision is not to change substantive law, but to put that law in a form which will be more useful and understandable.

Although H.R. 9728 was passed by Congress, the bill never made it past President Eisenhower’s desk.  In a September 3, 1954 “Memorandum of Disapproval of Bill To Revise and Codify the Laws Relating to Food, Drugs, and Cosmetics,” President Eisenhower explained the reasons for withholding his John Hancock on the bill:

I HAVE WITHHELD my approval from H.R. 9728, “To revise, codify, and enact into law, title 21 of the United States Code, entitled ‘Food, Drugs, and Cosmetics.’”

The legislative history of this measure indicates that it was enacted in the view that existing law would not be substantially changed by the bill or that no changes in existing law would be made which would not meet with substantially unanimous approval.

Notwithstanding this, the bill makes one very important substantive change and casts serious doubts on the status and interpretation of other statutory provisions.  The most important change is the deletion from the multiple seizure powers of the present law the authority which the Food and Drug Administration has had for a number of years to make more than one seizure of food, drugs, and cosmetics, where they bear identical labeling which is believed fraudulent or so materially misleading as to injure or damage the purchaser or consumer.  In the cases subject to removal of authority made by the bill, the Food and Drug Administration would be able to seize only one shipment of the articles believed to be so misbranded.  Such a limitation would make it possible for fraud and material deception to continue unabated until the validity of the labeling involved in the seizure case is definitely settled by the courts.

The enactment also contains a new substantive provision affecting the administration of the Federal Food, Drug, and Cosmetic Act, the meaning of which is very uncertain, namely, that the Administrative Procedure Act “shall continue to apply to all activities of the Food and Drug Administration.”  The Administrative Procedure Act already applies to both rule-making and adjudication under this regulatory statute, as it does to other Acts of Congress not expressly excepted.  The Federal courts, I am informed, have discussed on several occasions the relationship of these two enactments.  The new language, unless it should be regarded as mere surplusage, might be held to effect basic changes in existing procedures, thereby placing the Food and Drug Administration under requirements not applicable to any other Federal agency.  Such a change in the scope of the Administrative Procedure Act should not be adopted without full consideration.

The interest of the consumer public is the principal objective of the Federal Food, Drug, and Cosmetic Act.  I believe that substantive changes which may seriously affect the administration of this law should not be placed in the statute books without extending to the responsible enforcement agency, the great industries affected, and the consumer public, the full opportunities for hearing and discussion afforded by the usual operation of the legislative process both in the Committees and in both Houses of the Congress.

Finally, the enactment, through oversight, may nullify the provisions of legislation relating to the importation of animals and poultry into the Virgin Islands, approved on July 22 of this year (P.L. 517).  The enrolled measure apparently does not take into consideration the amendments to the Organic Act of the Virgin Islands which were made by that Act.  Here again the adverse effects would be serious.

In the nearly 60 years since the push to revise the FDC Act, we’re not aware of a similar attempt undertaken by Congress, although the statute could probably use some cleaning up.  At this point, however, an overhaul of the FDC Act seems unlikely.  So, we have what we have. . . .  and celebrate that legislative accomplishment today.