Report not to issue until 2023? Hey, OIG, see below, we need answers sooner and I will give you a head start.
HHS, OIG posted this morning:
The Federal Food, Drug, and Cosmetic Act requires the Food and Drug Administration (FDA) to safeguard the Nation’s food supply, including infant formula, and ensure that all ingredients are safe. As part of its oversight activities, FDA conducts inspections at infant formula manufacturers and can require infant formula manufacturers to recall adulterated infant formula that presents a risk to human health. We will determine whether FDA followed the inspections and recall process for infant formula in accordance with Federal requirements. Specifically, we will review FDA’s actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures to: (1) conduct inspections of the manufacturing facility and (2) oversee Abbott’s initiation of the infant formula recall.
|Announced or Revised
|Expected Issue Date (FY)
|Food and Drug Administration
|Food and Drug Administration’s Actions Regarding the Abbott Infant Formula Recall
|Office of Audit Services
According to the CDC and FDA, at least 4 kids were sickened and of those two died, from drinking Abbott infant formula. Abbott denies the connection. However, the resulting investigation and inspection (and whistleblower documents) uncovered enough problems in the Abbott facility to shutter it causing havoc with supplies of infant formula. The facility is now set to reopen, but not before the U.S. Attorney sued Abbott and several employees. In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements.
Abbott is essentially confessing to the violations in the below consent decree. Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.
Here are the key documents:
Here is the 2019 inspection report at the plant – APPLIED – FOI II – Abbott Nutrition FEI# 1815692 EIR 9-24-2019
Here is the 2021 inspection report at the plant – APPLIED – FOI II – BR Abbott Nutritions- FEI# 1815692 9-2021 EIR.
Here are the whistleblower documents – Redacted Confidential Disclosure re Abbott Laboratories – 10-19-2021_Redacted (1)
Here is the 2022 inspection report at the plant – Updated Final Applied_Unapplied Redactions Abbott Nutrition Sturgis FEI 1815692 FDA 483 1-31022 to 3-16-22 – ISSUED_Redacted
Here is the complaint – abbott_complaint_0
Here is the consent decree – abbott_proposed_consent_decree_0
Please read the above and ask the question: is this how infant formula should have been manufactured?
So, what gives the government the right to charge a company and certain employees with either a felony or a misdemeanor?
Congress passed the Federal Food, Drug, and Cosmetic Act in 1938 in reaction to growing public safety demands. The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce. Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “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.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health. The 1938 Act, and the recently signed Food Safety Modernization Act, stand today as the primary means by which the federal government enforces food safety standards.
Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability. Provisions for criminal sanctions are clear:
Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce. Any person who commits a prohibited act violates the FDCA. A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both.
A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct. Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation. Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.
The legal jargon aside, if you are a producer of food and knowingly or not manufacturer and sell adulterated food, you can (and should) face fines and jail time.