Category: Food Safety

Abbott Laboratories Infant Forumula

Here is the proposed consent decree, press release below, complaint and direct links to those documents. The proposed consent decree which Abbott Laboratories agreed to was filed by the United States Department of Justice. Upon Court approval, this will afford the opportunity for Abbott Laboratories to resume operations though under the parameters of the consent decree. The link to the letter from the United States Department of Justice regarding the safety of infant formula is included below and the final link is to the complaint.

https://www.justice.gov/asg/page/file/1506016/download

https://www.justice.gov/opa/pr/justice-department-files-complaint-and-proposed-consent-decree-ensure-safety-abbott

https://www.justice.gov/opa/press-release/file/1506076/download

Monday, May 16, 2022

Justice Department Files Complaint and Proposed Consent Decree to Ensure Safety of Abbott Laboratories’ Infant Formula

The United States has filed a complaint and a proposed consent decree that, if entered by a federal court in the Western District of Michigan, would allow Abbott Laboratories (Abbott) to resume manufacturing powdered infant formula at its Sturgis, Michigan, facility but also would require the company to take specific measures designed to increase safety and ensure compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and the U.S. Food and Drug Administration’s (FDA) Good Manufacturing Practice Requirements.   

“The actions we are announcing today will help to safely increase the supply of baby formula for families,” said Attorney General Merrick B. Garland. “The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”

In a complaint filed May 16, the United States alleged that Abbott, Division Vice-President of Quality Assurance Lori J. Randall, Sturgis Director of Quality Keenan S. Gale, and Sturgis Site Director TJ Hathaway manufactured powdered infant formula under conditions and using practices that failed to comply with regulations designed to ensure the quality and safety of infant formula, including protection against the risk of contamination from bacteria such as Cronobacter sakazakii. The Cronobacter sakazakii bacteria can live in dry foods, such as powdered infant formulas, and can cause deadly sepsis or meningitis in infants. The complaint further alleged that FDA testing of environmental samples taken in February detected Cronobacter sakazakii in the defendants’ manufacturing facility. 

Abbott has agreed to resolve the complaint in a proposed consent decree of permanent injunction. Under the proposed consent decree, which must still be reviewed and entered by a federal court, Abbott must retain outside expert assistance to bring its facility into compliance with the FDCA and good manufacturing practice regulations. Among other things, the expert will assist Abbott, under FDA supervision, in the development of plans designed to reduce and control the risk of bacterial contamination, and will periodically evaluate Abbott’s compliance with the FDCA, regulations, and the consent decree. The proposed consent decree also follows a thorough FDA inspection of the Sturgis facility and ongoing efforts by Abbott to address observations made during that inspection. The proposed consent decree sets out what Abbott must do to resume safely manufacturing infant formula at the Sturgis facility, which will help to mitigate the shortage of infant formula while also protecting public health.

“Federal laws regarding the safe manufacture of food, particularly food for infants, must be rigorously enforced,” said Principal Deputy Assistant Attorney General Brian Boynton, head of the Justice Department’s Civil Division. “The proposed consent decree underscores the Department’s commitment to protecting our most vulnerable citizens while also ensuring access to an essential product.”

“Parents who feed their babies formula must have confidence these products are safe,” said U.S. Attorney Mark Totten for the Western District of Michigan. “This proposed consent decree aims to protect one of our most vulnerable populations. My office is fully committed to supporting FDA and working with its partners at the Consumer Protection Branch to ensure manufacturers in our district comply with FDA’s safety regulations.”

“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan,” said FDA Commissioner Robert M. Califf, M.D. “The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve. We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation. We are also taking a look at the supply of infant formulas developed by manufacturers across the country and around the world to determine if a reallocation of their distribution can be made to help get the right product to the right place, at the right time.”

All Matters FDA March 31 Virtual Symposium

Food and Drug Law books  published 2022 new editions —Full Print and 12 Subject specific E-Books and a full print E-Book.  Please pass on to colleagues and anyone  you think would benefit.
https://fortipublications.com print and subject specific E-book links

1pm-5pm Virtual

Registration NOW OPEN >

all-matters-fda-2022Download PDF

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace. 

Moderator:

■   Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

■   Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas   —   Ethics and Professional Conduct

■   Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.   —   Food Law Cases

■   Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration   —   Enforcement

■   George D. Lapsley  —   Food Safety Expert  —   Court Appointed Expert – Miller’s Organic Farm 

■   Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration   —  
COVID-19 Vaccines

■   Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance   —   Enforcement

■   Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY    —   Pet Product Safety

■   Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School   —  
Symposium Director   —   Year in Review

■   Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration   —   FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

REGISTRATION NOW OPEN! All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Registration NOW OPEN >

all-matters-fda-2022Download PDF

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

■   Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

■   Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas   —   Ethics and Professional Conduct

■   Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.   —   Food Law Cases

■   Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration   —   Enforcement

■   George D. Lapsley  —   Food Safety Expert  —   Court Appointed Expert – Miller’s Organic Farm 

■   Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration   —  
COVID-19 Vaccines

■   Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance   —   Enforcement

■   Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY    —   Pet Product Safety

■   Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School   —  
Symposium Director   —   Year in Review

■   Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration   —   FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

UPDATE! All Matters FDA March 31 Virtual

UPDATE!

Save the Date March 31, 2022

1pm-5pm Virtual

Pre Registration: https://bit.ly/all-matters-fda-2022

all-matters-fda-2022-save-the-date

12th Annual Food and Drug Law Symposium

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Moderator:

■   Christopher Mondics  —  Legal Affairs Journalist, Philadelphia, PA

Invited Speakers:

■   Hon. Giovanni O. Campbell  —   Philadelphia Court of Common Pleas   —   Ethics and Professional Conduct

■   Brook Duer, Esquire  —   Center for Agricultural & Shale Law, Penn State Univ.   —   Food Law Cases

■   Michael Helbing, Esquire  —   Associate Chief Counsel for Enforcement, U.S. Food & Drug Administration   —   Enforcement

■   George D. Lapsley  —   Food Safety Expert  —   Court Appointed Expert – Miller’s Organic Farm 

■   Peter Marks, M.D., PhD.,  —   Director, Center for Biologics Evaluation & Research U.S. Food & Drug Administration   —  
COVID-19 Vaccines    and    Alzheimer’s Aduhelm® Approval

■   Matthew Noonan and Lillian Hsu  —   U.S. Food & Drug Administration FDA Preventive Controls (PC) experts in CFSAN Office of Compliance   —   Enforcement

■   Jessica J. Sleater, Esquire  —   Andersen Sleater Sianni LLC, New York,  NY    —   Pet Product Safety

■   Roseann B. Termini, Esquire  —   Food & Drug Law Legal Scholar, Food & Drug Law Courses, Delaware Law School   —  
Symposium Director   —   Year in Review

■   Julia Tierney, Esquire  —   Chief of Staff, U.S. Food & Drug Administration   —   FDA Through the Pandemic: COVID-19 and Beyond 

4 CLE credits (2 Ethics & 2 Substantive) in DE and PA

All Matters FDA March 31 Virtual

Save the Date March 31, 2022

1pm-5pm Virtual

Find out the latest about COVID-19 from FDA’s Biologics Center Director Dr. Marks and other notable speakers. Other topics include criminal and civil enforcement, mandatory food recalls, vaping, e-cigarettes, unsafe pet products in the marketplace.  Invited Speakers/Designees to date include:

Brook Duer, JD, Pennsylvania State Univ., Center for Agriculture Law

Michael Helbing, JD, Office of Chief Counsel, U.S. Food and Drug Administration

Peter Marks, MD, PhD, Director, Center for Biologics, U.S. Food and Drug Administration

Christopher Mondics, Moderator

Matthew Noonan and Lillian Hsu, FDA Preventive Controls (PC) experts in CFSAN Office of Compliance, U.S. Food and Drug Administration  

Jessica Sleater, Esq. Veterinary Medicine, Pet Products

Roseann B. Termini, Esq., Food and Drug Law Cutting Edge Issues including Vaping

Julia C.Tierney, JD, Chief of Staff, U.S. Food and Drug Administration

Further Info. Roseann Termini: rbtermini@widener.edu

Are you Eating Pop-Tarts® Whole Grain Frosted Strawberry Toaster Pastries for your On-the-Go Holiday Breakfast?

Life gets hectic over the holidays, and many choose an on-the-go breakfast. The question becomes—Are you Eating “Pop-Tarts®” for your Holiday Breakfast?  Specifically, are you eating the “Whole Grain Frosted Strawberry Toaster Pastries”? If so, take a look at the recently filed lawsuit. Here is a link to the full complaint.

PopTart-Lawsuit-NY – PDF

Russett et alia. V. Kellogg Sales Co.,  Case 7:21-cv-08572-NSR

Allegations:

In this multi-million dollar lawsuit there are allegations of Deception as well as False and Misleading labeling 

Here plaintiff is alleging that the front of package labelling fails to disclose that the product is not 100% Strawberry. Rather, “Pop-Tarts®”, a popular breakfast favorite, contains dried pears too! Backed up with the labelling and competitor brands the plaintiff alleges that:

1. “Kellogg Sales Company (“defendant”) manufactures, labels, markets, and sells “Whole Grain Frosted Strawberry Toaster Pastries” under its “PopTarts®” brand (“Product”). (Complaint p.1)

2. “The packaging only depicts strawberries, in words and images, and shows the Product’s bright red filling, matching the color of strawberries.“ (Complaint p.1)

3. “The strawberry representations are misleading because the Product has less strawberries than consumers expect based on the labeling.“ (Complaint p.1)

Let’s take a look at the Front of Packaging Label.

The plaintiff alleges that the name: “Whole Grain Frosted Strawberry Toaster Pastries,” is false, deceptive, and misleading, because it contains mostly non-strawberry fruit ingredients. Here is the ingredient listing descending order of prominence of each ingredient. The question is why does the product name include Strawberry when in fact it is way down on the list of ingredients and follows apples and pears? Should the product be labelled Fruit filled Toaster Pastries? How about what the complaint suggests using percentages?

Ingredients:
Whole wheat flour, sugar, corn syrup, enriched flour (wheat flour, niacin, reduced iron, vitamin B1 [thiamin mononitrate], vitamin B2 [riboflavin], folic acid), dextrose, soybean and palm oil, bleached wheat flour, polydextrose, glycerin. Contains 2% or less of fructose, wheat starch, calcium carbonate, salt, leavening (sodium acid pyrophosphate, baking soda), vegetable juice for color, dried pears, dried apples, dried strawberries, sodium stearoyl lactylate, citric acid, modified wheat starch, DATEM, cornstarch, gelatin, xanthan gum, brown rice syrup, paprika extract color, soy lecithin, vitamin A palmitate, niacinamide, reduced iron, vitamin B6 (pyridoxine hydrochloride), vitamin B2 (riboflavin), vitamin B1 (thiamin hydrochloride). 

The lawsuit details consumer love of strawberries alleging they are the “world’s most popular berry fruit (Complaint #7. p. 2) and the label is misleading to consumers. Essentially, plaintiff alleges the product is not in federal compliance under 21 CFR sect. 102.5 which details the common or usual name.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=102.5

Would a listing of percentages of fruit solve the problem?  Ex. the Complaint states:

29. “One example of this disclosure could be, “Whole Grain Frosted Strawberry Toaster Pastries – 80% Non-Strawberry, 20% Strawberry.” 21 C.F.R. § 102.5(b).” (Complaint p.7)

Here is what 21 C.F.R. § 102.5(b). 

“The common or usual name of a food shall include the percentage(s) of any characterizing ingredient(s) or component(s) when the proportion of such ingredient(s) or component(s) in the food has a material bearing on price or consumer acceptance or when the labeling or the appearance of the food may otherwise create an erroneous impression that such ingredient(s) or component(s) is present in an amount greater than is actually the case.”

The complaint depicts competitor brands— Clover Valley from Dollar Tree and Great Value from Walmart- still labelled as “Strawberry  though these companies include legal terminology of “Naturally and Artificially Flavored”.

The complaint concludes with what a reasonable consumer expects and relies on in terms of honest identification of ingredients as well as the premium price.

54. “Reasonable consumers must and do rely on a company to honestly identify and describe the components, attributes, and features of a product, relative to itself and other comparable products or alternatives.” (Complaint p.11).

60. “Similar whole grain frosted toaster pastries which have equivalent amounts of strawberries to Defendant’s Product are, or would be sold for, approximately $4.09 per box of six pouches of two pastries six pastries (20.3 oz or 576g).” (Complaint p.12).

Concluding Commentary– hard to state with certainly how this case will proceed and be decided. What do you think? Ask yourself- is the labeling accurate? Would consumers be deceived by the labeling?

FDA Matters Symposium Virtual March 24

https://delawarelaw.widener.edu/about/news-events/events/event/3681/

Prison Sentences- Peanut Corp.of America Salmonella Tainted Peanut Products

Update-Sentences Affirmed on January 23, 2018 Corp. Executive Liability Sentence Largest Ever in Food Safety History 

AFFIRMED:  See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018)  Click on the link for the appellate court decision. Court of Appeals Opinion

Former Peanut Corporation of America (PCA) President and Owner Stewart Parnell received a criminal prison sentence of 28 years in connection with the 2009 salmonella poisoning outbreak of 700 reported cases in 46 states. Expert evidence presented at trial detailed that there were nine deaths linked to PCAs tainted products. Parnell’s brother Michael received a 20 year prison sentence. The Quality Assurance employee received a 5 year sentence. They were sentenced based on their roles at PCA by shipping salmonella-positive peanut products and by falsifying microbiological test results.  A federal jury convicted the Parnell brothers in September 2014 on several counts of conspiracy, mail and wire fraud as well as selling misbranded food. Stewart Parnell was also convicted for introducing adulterated food into interstate commerce.  Stewart Parnell and Quality Assurance Manager Mary Wilkerson were also convicted of obstruction of justice. According to U. S. Justice Attorney Moore, “The sentence that was handed down today [Sept. 21, 2015] means that executives will no longer be able to hide behind the corporate veil”. The direct link to the sentences in the Parnell Salmonella Tainted Peanut Product case is below and court of appeals opinion above.

AFFIRMED:  See: United States v. Parnell, et. al, No. 15-14400 (11th Cir. Jan. 23, 2018 (affirmed)). Click on the link Court of Appeals Opinion

http://www.justice.gov/opa/pr/former-peanut-company-president-receives-largest-criminal-sentence-food-safety-case-two

Corporate Accountability Food Safety Felony Conviction

Corporate Executive Liability Food Safety—Felony Conviction

Peanut Corporation of America Background

The former owner of Peanut Corporation of America Peanut Corp.) Stewart Parnell was convicted on September 19, 2014 of conspiracy and other charges in connection with a deadly salmonella outbreak that occurred in 2008-2009. According to the Centers for Disease Control and Prevention, nine people died and over 700 others became ill in 2008-09 after eating peanut butter or other products prepared at the company’s plant in Georgia. Mr. Parnell, was found guilty on several counts, including wire fraud and obstruction of justice. The indictment was centered on a conspiracy to conceal that several of Peanut Corp.’s products were contaminated with salmonella. Others involved and convicted included the brother of Stewart Parnell, Michael Parnell, a food broker who worked on behalf of Peanut Corp. and the quality assurance manager, Mary Wilkerson, for obstruction of justice. Two other former Peanut Corp. employees has previously pled guilty to multiple charges.

Prosecutors alleged that Peanut Corp. not only defrauded customers but also defrauded several national food companies by failing to inform them about the presence of food-borne pathogens in laboratory tests, including salmonella. According to prosecutors, in some instances, despite these results, Peanut Corp. officials totally falsified lab results, maintaining peanut products were safe for consumption. Further, at times, the Peanut Corp. failed to even perform testing.

Corporate Liability Significance

Although for years, corporate executives have been charged with misdemeanor offenses under the strict criminal liability theory known as the Park doctrine, this case is distinguishable. The Peanut Corp. case represents a felony prosecution under the Federal Food, Drug and Cosmetic Act. The Peanut Corp. prosecution serves as a wake up call to the regulated food safety industry.

Outcome and Sentencing

Peanut Corp. filed for Chapter 7 bankruptcy protection weeks after the outbreak began. The felony convictions mean the possibility of a extensive prison sentence and fines.