– OPINiON –
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.
For Abbott, at least 4 kids were sickened and of those two died, from drinking infant formula.
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 be manufactured?
Information in the confidential whistle blower document was provided by a former employee who worked in the production plant in Quality Systems, a subunit of the Quality Assurance organization in Sturgis, MI, as part of Abbott’s Nutritional Division.
The whistle blower document outlines many problems at the Abbott production facility in Sturgis, MI, including the following:
- The Falsification of Records – On multiple occasions, and in various ways, records have been knowingly falsified. In most but not all of the situations, information of a material nature was not disclosed. This included testing seals on empty cans; signing verifications without adequate knowledge; understating or inaccurately describing events so as to limit or avoid oversight; issuing certifications of projection pages bereft of pertinent data; shipping packages with fill weights lower than represented on the labels; failing to maintain accurate maintenance records; and prematurely removing holds in the absence of all requisite approvals.
- Releasing Untested Infant Formula – The Sturgis site performed a time code removal after the discovery of microorganisms (“micros”) in a batch of infant formula. The remaining portion of the batch outside the time code removal was released without additional testing. On another occasion product was not re-called from the market even after management became aware of a nonconformity (“NC”).
- The 2019 FDA Audit – Active efforts were undertaken and even celebrated during and after the 2019 FDA audit to keep the auditors from learning of certain events believed to be associated with the discovery of micros in infant formula at the Sturgis site.
- Clean-in-Place Staffing and Practices – The Sturgis site has continued to permit lax practices associated with clean-in-place (“CIP”) procedures. The Sturgis site failed and continues to fail to have staff in place with sufficient training and experience to review CIP charts. Nor are CIP charts regularly reviewed prior to the release of a batch. CIP checklists do not require signatures of those performing the tasks and are not otherwise subject to audit by QS staff.
- Failure to Take Corrective Measures – The Sturgis site has repeatedly failed to undertake reasonable measures to reduce natural or unavoidable defects to the level feasible as mandated by the current Good Manufacturing Practices (“cGMPs”). Deficient testing procedures known to be prone to causing mistakes have not been corrected. The Sturgis site continues to rely on staff with insufficient training and experience to interact with third-party labs (“TPL”).
- Lack of Traceability – The Sturgis site has ongoing problems associated with the traceability of its products. The automatic labeler frequently failed to work properly and led to significant difficulties in retracing product. QS staff never knew with certainty if an affected pallet was retrieved.
The disclosure document was sent to top food safety officials and other leaders at FDA in October 2021. They included FDA’s top official, then-acting Commissioner Janet Woodcock, Susan Mayne, director of the Center for Food Safety and Applied Nutrition, Judy McMeekin, associate commissioner for Regulatory Affairs, and Catherine Hermsen, assistant commissioner of the agency’s Office of Criminal Investigations. The document was apparently not sent to FDA’s deputy director for food safety concerns, Frank Yiannas.
Things need to change. People need to be held accountable.
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