Each month EAS selects one question sent in by readers of EASeNews to answer as part of our Ask the Expert column. This month’s question on how FDA is enforcing Adulterated Foods is answered by Independent Consultant, Joe Famiglietti, who works closely with EAS clients in developing and enhancing food safety programs as well as facilitating recalls in cases where a product is adulterated. If you would like to ask a question of one of our experts, contact us.
Question: What kinds of enforcement actions does FDA take with regards to adulterated foods?
Famiglietti: FDA considers foods to be adulterated if such foods are impure, unsafe, or unwholesome. 21 CFR 117.1(a)(1) identifies two types of food adulteration as described in the Federal Food, Drug and Cosmetic Act (FD&C ACT) as follows:
- Section 402(a)(3) – The food has been manufactured under such conditions that it is unfit for food, in which it is considered to be contaminated.
- Section 402(a)(4) – The food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with
filth,or may be rendered injurious to health.
Enforcement actions FDA can take on domestic adulterated foods include seizing/condemning the product or enjoining persons from manufacturing or distributing such goods. If adulterated foods are in domestic commerce, FDA can require adulterated foods to be recalled. A food processor can sometimes reprocess an adulterated food if FDA agrees to the firm’s reprocessing plan.
FDA does not always require laboratory tests to show that a food is adulterated. Under the FD&C Act, a food can be deemed as adulterated based on insanitary conditions in a facility such as lack of cleanliness, equipment issues, poor maintenance of the facility, improper storage of foods, pest issues, etc.
Examples of recent recalls include an ice cream product because of the potential that the product may be contaminated with foreign objects; mineral spring water recalled due to the presence of arsenic and a spice powder recalled due to contamination with lead. In each case FDA considered the products to be adulterated and had the responsible firms not initiated a recall, FDA could have considered using enforcement actions.
There have been cases whereby FDA documented widespread rodent infestations in food warehouses resulting in mass seizure actions which means that every food item in the facility was placed under seizure. In these cases, where FDA testing documented the presence of rodent filth in the foods (such as fecal matter, urine and rodent hair), these products were seized under Section 402(a)(3). The remainder of the products that were not tested at the affected facilities were seized under 402(a)(4) because they were being held under insanitary conditions with a high probability of becoming contaminated.
It should be noted, FDA regulations authorize the agency to issue Defect Action Levels (DALs) for natural unavoidable defects that at low levels do not pose a human health hazard. Examples are rodent hairs and insect fragments found in foods at minimal levels which are permitted because it is economically impractical to grow, harvest or process products that are totally free of all non-hazardous defects. 21CFR117.110 covers the DAL regulations.
EAS helps firms identify and protect against the introduction of adulteration. Our mock-audit service, one of the most comprehensive in the industry, brings our former FDA investigators onsite to conduct a thorough review of your processes and procedures, just as FDA would in an inspection. We then prepare a documented and detailed report of findings and opportunities for improvement. Additionally, firms needing to conduct a voluntary recall may contact EAS for our rapid-response team that offers step by step assistance in communicating product concerns with FDA, retailers, consumers and media as well as tracking shipments of products both in-transit and in the marketplace.
EAS offers the most comprehensive suite of services compared to any other FDA-regulatory consulting firm. Contact us today to discuss your questions and how we may help you. For more information on intentional adulteration, type “adulteration” into the search bar on the EAS website.