FDA Announces Meeting on Economic Adulteration

By Ricardo Carvajal –      

FDA has announced that it will hold a public meeting on “economically motivated adulteration” to foster discussion about ways that FDA-regulated industries can “better predict and prevent economically motivated adulteration with a focus on situations that pose the greatest public health risk.”  The agency is also requesting comment on the topic.

In recent years, economic adulteration has received little attention from FDA as the agency sought to focus its resources on violations of the FDC Act that presented a clear risk to public health.  The melamine episode made clear that economic adulteration can harm more than just the pocketbook.  Although FDA’s announcement of the meeting suggests that FDA will focus on instances of economic adulteration that pose a risk to health (e.g., those that give rise to a violation of FDC Act section 402(a)(1), under which a food is deemed adulterated if it contains an added poisonous or deleterious substance that may render the food injurious to health), we wonder if FDA will see fit to breathe new life into FDC Act section 402(b).  Under that section, a food is deemed adulterated:

(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom;

(2) if any substance has been substituted wholly or in part therefore;

(3) if damage or inferiority has been concealed in any manner; or

(4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

Section 402(b) gives FDA clear authority to act in cases involving economic adulteration that poses no known risk to public health.  Stay tuned.