Glass jars filled with delicious apple juice. The label depicts two beautiful, fresh Grade A apples — implying that apples such as these were used to make this yummy looking apple juice. One problem, “rotten, wormy, moldy, black — whatever shouldn’t happen to an apple had happened to those apples” were used to make the juice.

FDA decided to keep this product out of the market, but how exactly does the product violate the Food, Drug, and Cosmetic Act. Which of the following charges should FDA use:

(1) Adulterated – the food consists of filthy, putrid, or decomposed substance, or otherwise unfit for food – a Section 402(a)(3) charge.

(2) Adulterated – the food was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth – a Section 402(a)(4) charge.

(3) Misbranded – the food’s labeling is false or misleading in any particular – a Section 403(a)(1) charge.

The filthy food (Section 402(a)(3)) charge would not likely stick here. The manufacturing process removed the filthy, putrid, and decomposed aspects from the apples so that the finished product (apple juices) was “clean.”

FDA originally charged that the apple juice was adulterated because it was prepared under insanitary conditions whereby it may have become contaminated with filth (a Section 402(a)(4) charge). Yet before the trial, FDA questioned whether this allegation would work given that the judge was “technical.” The defense was prepared to argue that the this violation pertains to facility conditions (like mice and insects) affecting the food, as compared to the raw materials themselves being contaminated and then cleaned.

Instead, FDA looked to the misbranding allegation that the labeling was misleading because it failed to disclose a material fact (Section 403(a)(1) charge). Unlike the delicious apples on the label, the product was made from rotten, wormy, moldy, black apples. This allegation proved to be successful and FDA successfully won the case.

This charge worked because this violation is highly flexible. If the label or labeling is misleading in any particular, then the product is misbranded. Under this clause, a technically true statement may still be violative if it misleads. Additionally, a statement does not need to actually mislead to be violative, it only needs to maybe mislead the consumer. Lastly, the misleading statement does not need to be material to the product, a misleading statement in any particular is sufficient to condemn a product. See discussion regarding liquor flavored candy (another story for another day).

Against this backdrop that any representation on a label that may mislead the consumer (possibly under an ignorant, unthinking, and credulous consumer standard), the apple juice was found in violation and FDA successfully kept this product out of the market.

Taken from interview with Arthur Dickerman, a principal attorney with FDA who started in 1942. The full interview can be found here.