FDA Notices of Judgment Archives

Collection

Identifier: MS C 608

Abstract

Correspondence, legal records, lab reports, product labeling, photographs and other documentary evidence accumulated in case files by federal attorneys used to prosecute violations of the 1906 Pure Food and Drug Act and the 1938 Food, Drug, and Cosmetic Act.

Dates

1907-1966

Extent

2696.42 Linear Feet (2,166 boxes)

Creator

United States. Food and Drug Administration (Organization)

Physical Location

Materials stored offsite. 30 days prior notice required for delivery. Retrievals made last Friday of the month. Contact the NLM Support Center for scheduling.

Language of Materials

Collection materials primarily in English

Access Restrictions

No restrictions on access.

Copyright and Re-use Information

Donor's copyrights were transferred to the public domain. Archival collections often contain mixed copyrights; while NLM is the owner of the physical items, permission to examine collection materials is not an authorization to publish. These materials are made available for use in research, teaching, and private study. It is the user's responsibility to research and understand any applicable copyright and re-publication rights not allowed by fair use. NLM does not grant permissions to publish.

Privacy Information

Archives and manuscript collections may contain materials with sensitive or confidential information that is protected under federal or state right to privacy laws and regulations. Researchers are advised that the disclosure of certain information pertaining to identifiable living individuals represented in any collection without the consent of those individuals may have legal ramifications for which the National Library of Medicine assumes no responsibility.

Historical Note

The Pure Food and Drug Act of 1906 was the first of a series of significant consumer protection laws enacted by the Federal Government and led eventually to the creation of the Food and Drug Administration. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by The United States Pharmacopeia or The National Formulary. Initially concerned with ensuring products were labeled correctly, it evolved to include the outlaw of certain products that were not safe nor effective. It also required that drugs such as alcohol, cocaine, heroin, morphine, and cannabis, be accurately labeled with contents and dosage. Previously many drugs had been sold as patent medicines with secret ingredients or misleading labels.

Bureaucratically, the NJs formed into four categories as represented in the online edition: Combined Foods and Drugs; Foods; Drugs and Devices; Cosmetics. Not represented here is a fifth category Caustic Poison, Naval Stores, and Insecticides. These categories represent the evolution of the Act and its authorities.

Collection Summary

Correspondence, legal records, lab reports, product labeling, photographs, and other documentary evidence accumulated in case files by federal attorneys used to prosecute violations of the 1906 Pure Food and Drug Act and the 1938 Food, Drug, and Cosmetic Act.

The physical collection is not arranged by NJ case number. Instead it is arranged chronologically by an alphabetical suffix, then numerically according to evidence control numbers as recorded in the published NJs. (Sample Nos., S. Nos., Interstate Sample (I.S.) Nos.). Users must first identify the relevant sample numbers then locate the box containing the appropriate number range.

A single prosecution can often be comprised of several, non-consecutively numbered sample numbers. Oftentimes the case files are filed according to the first sample number with the subsequent sample numbers combined within. These combinations or missing files are noted as best as possible for each box.

Series 10: Food Standards records and reports, appear to be related to food standards work. They record factory inspection data and product sampling chemistry with breakdowns of substances contained in the product formularies, notes on manufacturing processes, and sales and price information by state. FDA first received authority to establish food standards "in the interest of consumers" in the 1938 Food, Drug, and Cosmetic Act. The earliest records date to 1935, most likely done in anticipation of and in preparation for implementation of food standards provisions of the Act. The remainder were most likely samples taken in support of either establishing or enforcing food standards.

Series 11: Manufacturers' Index Cards contains cards organized alphabetically by defendant listing the substances, evidence numbers, and dates collected for all the prosecutions against the defendant.

A collection of the published NJs is also available.

Additional Description

Abstract

Physical Location

Materials stored offsite. 30 days prior notice required for delivery. Retrievals made last Friday of the month. Contact the NLM Support Center for scheduling.

Custodial History

The collection was originally transferred from FDA to NARA and scheduled as non-permanent records. When the scheduled destruction date came due in 1999, the FDA (via its History Office) and NLM agreed to a formal records transfer through a memorandum of understanding.