Abbott Under Federal Criminal Investigation Over Baby Formula

Michigan plant at center of probe was temporarily closed by the company last year after potentially deadly bacteria was found. https://www.wsj.com/articles/abbott-under-criminal-investigation-over-baby-formula-11674255871?mod=business_lead_pos1

The Justice Department is investigating conduct at the Abbott Laboratories infant-formula plant in Sturgis, Mich., that led to its shutdown last year and worsened a nationwide formula shortage, people familiar with the matter said.

Attorneys with the Justice Department’s consumer-protection branch are conducting the criminal investigation, the people said. 

The branch, which has criminal as well as civil authority, was involved last year in a settlement with Abbott that allowed its Sturgis plant to resume operations after Food and Drug Administration inspectors found a potentially deadly bacteria there. 

“The DOJ has informed us of its investigation, and we’re cooperating fully,” an Abbott spokesman said.

The investigation signals further scrutiny of Abbott’s operation of the plant, a major source of baby formula in the U.S., and perhaps of the more than $4 billion formula industry.

The Justice Department in the past decade has investigated numerous food companies that have shipped contaminated products that resulted in illnesses or deaths. 

Several have led to criminal prosecutions under the 1938 Federal Food, Drug and Cosmetic Act of companies or executives involved in producing goods from ice cream to peanut butter. The law allows government officials to prosecute entities or individuals who introduce adulterated food into interstate commerce.

In many recent cases, DOJ has been able to successfully prosecute defendantson misdemeanor charges for introducing contaminated food into the market even without proof that officials acted with criminal intent, according to Bill Marler, a Seattle lawyer who represents victims of food-borne illnesses.  

Abbott, based outside Chicago, is one of the biggest manufacturers of baby formula. The company sells Similac, among other brands.

Last January, FDA inspectors found bacteria at the plant after receiving reports of babies who drank the company’s formula and became sick. The inspectors also found standing water, damage to drying equipment and defects in the seams of formula cans, among other problems at the Sturgis plant. 

Federal officials couldn’t conclusively link the bacteria at the plant to the infants’ illnesses, however. Abbott has said genetic sequencing of the bacteria in the sick babies didn’t match the strains found at the plant.

Abbott temporarily halted production at the Sturgis factory in February, and recalled baby formula made at the plant. The moves contributed to an infant formula shortage that sent parents and federal officials scrambling for months.

To bolster supplies, the federal government waived regulatory requirements and tariffs to allow more foreign formula into the country, and the White House organized planes to fly baby formula to the U.S. 

Abbott last May signed a legal agreement, called a consent decree, detailing the steps it would need to take to reopen the plant. 

In the complaint accompanying that civil agreement, the Justice Department said Abbott and several of its employees had caused “adulterated food” to enter interstate commerce.

“Ongoing inadequacies in manufacturing conditions and practices at Defendants’ facilities demonstrate that Defendants have been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants, a consumer group particularly vulnerable to foodborne pathogens,” the department said in the complaint.

In May I wrote:

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 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.