The Federal Food, Drug, and Cosmetic Act (1938) -USA

The year 1938 is highly significant in U.S. law because Congress passed one of its most far reaching acts, the Federal Food, Drug, and Cosmetic Act (FFDCA or just FDCA). It came about following a series of food abuses and the considerable political fall-out that followed as the public began to lose confidence in food safety.

Its principal objective was to categorically state that the health and safety of the public must be protected by preventing the adulteration of food, ensuring food was safe to eat and not abused before sale, and that it should not be mis-sold or misbranded. Whilst there are a number of categories within the Act, the most pertinent in the present day relate to adulteration and food safety generally. For example, section 402(a)(4) of the Act clearly states that a food product is considered to be ‘adulterated’ if the foodstuff has been “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”

The mention of filth clearly refers to contamination by both physical, chemical and indeed microbiological sources. Adulteration also means according to the Act, any poison or ‘deleterious’ substance which makes it unsafe to eat and causes harm.

The 1938 Act and the more recently signed Food Safety Modernization Act are the primary means by which the US federal government enforces its standards of food safety.

The Act also lays out the level of punishment expected if perpetrators are caught. Chapter III needs to be consulted as this assesses the prohibited acts and what can be expected in both civil and criminal liability by the violators. The provisions for criminal (felony) prosecutions cover adulteration and misbranding a food, drug, or device, and placing this into interstate sale or commerce.  Anyone committing such a prohibited act contravenes the FFDCA. Prosecution leads to heavy fines and jail sentences.

If you produce food and put it on sale, whether you knew it was safe or not means that if it is found to be contaminated or dangerous, you can suffer the penalties outlined above if convicted. A misdemeanor conviction under the FFDCA, as opposed to a felony conviction, doesn’t even require proof of fraudulent intent, or of knowing or willful conduct.  Anyone can be convicted if he or she holds a position of responsibility or authority in a firm such that they could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year in prison or fined not more than $250,000, or both.

The Contents Of The Act

The FDC Act has ten chapters:

I. Short Title

II. Definitions

• 201(f) is the definition for a food, which explicitly includes chewing gum
• 201(g) is the definition for a drug
• 201(h) is the definition for a medical device
• 201(s) is the definition of a food additive
• 201(ff) is the definition of a dietary supplement

III. Prohibited Acts and Penalties

This section considers both civil and criminal law clauses. Most violations under the act are civil, though repeated, intentional, and fraudulent violations are covered as criminal law. All violations of the FD&C Act require interstate commerce because of the commerce clause, but this is often interpreted broadly and few products other than raw produce are considered outside of the scope of the act. Notably, the FD&C Act uses strict liability due to the Dotterweich and Park Supreme Court cases. It is one of a very small number of criminal statutes that does.

IV. Food

There is a distinction in food adulteration between those that are added and those that are naturally present. Substances that are added are held to a stricter “may render (it) injurious to health” standard, whereas substances that are naturally present need only be at a level that “does not ordinarily render it injurious to health”

V. Drugs and Devices

• 505 is the description of the drug approval process
• 510(k) is the section that allows for clearance of class II medical devices
• 515 is the description of the (class III) device approval process

VI. Cosmetics

VII. General Authority

• 704 allows inspections of regulated entities. Inspection results are reported on Form 483.

VIII. Imports and Exports

IX. Tobacco Products

X. Miscellaneous