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.

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.”

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.

P opTart-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

Top 5 Accomplishments— FDA Year in Review and Wish List!

Year in Review—Top 5 (well more than 5) Highlights of FDA Accomplishments and FTC in 2014. Here are just a few top accomplishments in food and drug law in 2014. Last year, the question posed was whether the United States really needs an “FDA”. The role and mission of FDA has been debated for years. The FDA role ranges from that of a regulator, watchdog and facilitator. Commentary ranges from overbearing federal regulation to lack of public protection. Yet, based on these selected accomplishments, FDA provides an important function in keeping with the mission of the Food, Drug and Cosmetic Act and the numerous amendments. Although the FDA has across the board accomplishments, the following are standouts and all involve safety—Ebola, Power Morcellators, Food Safety Modernization Act Supplemental Proposed Rules, Tobacco Enforcement, Calorie Disclosure Rules, Criminal Liability, Sunscreen Innovation Act and Diet Products….just to name a few.

CAFFEINE-INFUSED SHAPEWEAR

Norm Thompson Outfitters and Wacoal America Settle FTC Charges Over Weight-Loss Claims The Federal Trade Commission approved two final orders settling charges that two companies, Norm Thompson Outfitters. Inc., and Wacoal America, Inc., misled consumers regarding the ability of their caffeine-infused shapewear undergarments to reshape the wearer’s body and reduce cellulite. According to the FTC’s complaints, the two companies’ marketing claims for their caffeine-infused products were false and not substantiated by scientific evidence. The products, made with Lytess brand fabrics, were sold via mail order and on the company’s Norm Thompson Outfitters, Sahalie, Body Solutions, and Body Belle websites. FTC alleged that the company made claims that wearing its shapewear would eliminate or substantially reduce cellulite; reduce the wearer’s hip measurements by up to two inches and their thigh measurements by one inch; and reduce thigh and hip measurements “without any effort.” The complaint against Wacoal America contained similar allegations. It charged that the company’s iPants supposedly slimmed the body and reduced cellulite. Specifically, the company made false and unsubstantiated claims that wearing iPants would: substantially reduce cellulite; cause a substantial reduction in the wearer’s thigh measurements; and destroy fat cells, resulting in substantial slimming. http://www.ftc.gov/enforcement/cases-proceedings/132-3095/wacoal-america-inc-matter

EBOLA OUTBREAK

Currently, the standard treatment for patients infected with the Ebola virus is supportive therapy. However, that could change in the near future. NIH reported in late 2014 that an experimental vaccine to prevent Ebola virus disease proved successful in phase I clinical trial in all 20 healthy adults who received it. The vaccine is being developed by the NIH’s National Institute of Allergy and Infectious Diseases and GlaxoSmithKline. Expedited review is in the works for the priority review track as well as immunity protection.The experimental drug ZMapp was used in 2014 to treat a few patients infected with Ebola; however, it is still uncertain to ascertain the effectiveness of ZMapp. According to the manufacturer, the product is in the experimental stages and clinical trials are needed. Besides Mapp Biopharmaceutical Inc., Tekmira, Chimerix and BioCryst Pharmaceuticals have therapeutic products in early developmental stages for clinical trials. See: Peter Loftus and Betsy McKay, Race is On for Ebola Drug, All St. J. A1 (Oct. 18-19 2014); Betsy McKay and Peter Loftus, Wall St. J. A7 Experimental Drugs Are Approved for Use in Fighting Ebola in West Africa (Aug. 13, 2014);http://www.cdc.gov/vhf/ebola/outbreaks/guinea/qa-experimental-treatments.html

http://www.nytimes.com/2014/08/07/business/an-obscure-biotech-firm-hurries-ebola-treatment.html

http://www.washingtonpost.com/blogs/monkey-cage/wp/2014/08/06/ebola-research-ethics-and-the-zmapp-serum/

POWER MORCELLATORS—Warning and Immediate Guidance

Laparoscopic Uterine Power Morcellation: Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators; Guidance for Industry and Food and Drug Administration Staff http://www.gpo.gov/fdsys/pkg/FR-2014-11-25/html/2014-27857.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm

CRIMINAL FELONY CONVICTIONS

Corporate Executive Liability Food Safety—Felony Conviction Peanut Corporation of America Background and Corporate Significance 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. 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.

CALORIE DISCLOSURE FINAL RULES

Vending Machines and Restaurant Menu Labeling Overview and link to final rules. http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm248732.htm

Introduction and Quick Summary FDA released the long awaited two final rules in early December (2014) regarding caloric disclosure The rules were proposed in April 2011 under section 4205 of the Affordable Care Act. The final rule is effective date is December 1, 2015 to afford vending machine operators and affected restaurants time to comply. The final rule summaries issued by FDA are below as well as a direct link and issue to consider. Food Labeling; Calorie Labeling of Articles of Food in Vending Machines Requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exemption.

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.

TOBACCO ENFORCMENT

Tobacco products are regulated so differently than other FDA regulated products due to the fact they are harmful yet still extensively used consumer products and are responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death. The focus remains on youth and the FDA is faced for 2015 with the Ecigarette issue and deeming. CTP established the Office of Compliance and Enforcement (OCE); however, enforcement is limited as FDA’s regulatory authority is dictated by the FSPTCP. CTP has filed actions for civil monetary penalties mainly for sales to minors. A Civil Money Penalty (CMP) Complaint is used to initiate an administrative legal action against a retailer that can result in the imposition of a fine, termed a Civil Money Penalty. As an example of enforcement efforts, FDA filed approximately 100 civil legal actions. FDA recently sent warning letters to retailers for selling to minors. Here is the direct link:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/Tobacco/ucm424581.htm

FOOD SAFETY

Food Safety Modernization Act Supplemental Proposed Rules: Did you know that much of the food that Americans consume originate from countries outside of the United States? The Food Safety Modernization Act (FSMA), signed into law back in January 2011, addresses imported food as well as food produced in the United States. Several proposed rules were issued in 2013 and now in 2014 supplemental proposed rules. Here is the direct link to the final and proposed rules.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm

SUNSCREEN INNOVATION ACT

Finally, the Sunscreen Innovation Act (SIA), recently signed into law in late 2014, (Public Law No: 113-195 Nov. 26, 2014) establishes a new process for the review and approval of over-the-counter sunscreen active ingredients. The SIA provides FDA with explicit, expedited deadlines for review. The SIA is a major improvement as for example some sunscreen ingredients have been under review for over ten years. Direct Link to SIA is as follows: https://www.congress.gov/bill/113th-congress/senate-bill/2141/text

WISH LISTS

FDA WISH LIST—Congressional Authorization of more resources, i.e. MONEY so FDA can effectively fulfill the mission of the FDCA.

STAKEHOLDER WISH LIST—More Clarity from FDA!

RECOMMENDATIONS—FDA and the FTC did have major accomplishments as the above examples illustrate. They illustrate the necessity for “an FDA” as well as an “FTC”. Hopefully though the proposed rules will be finalized in 2015 and hopefully Congress will revisit FDA regulatory authority for some products such as dietary supplements where FDA can only legally exercise post-enforcement. Stay tuned for more about the role of FDA and for more food and drug law updates in 2015.

FDA Issues Final Rules Vending Machines and Restaurant Menu Labeling Requirements

Caloric Disclosure Final Rules Vending Machines and Restaurant Menu Labeling

Introduction and Quick Summary: FDA just released two final rules regarding caloric disclosure for final publication in the Federal Register. The rules were proposed in April 2011 under section 4205 of the Affordable Care Act. The final rule will be issued on December 1, 2014 and the effective date is December 1, 2015 to afford vending machine operators and affected restaurants time to comply. The final rule summaries issued by FDA are below as well as a direct link and issue to consider.

Vending machine final rule: Requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exemption.

Menu labeling final rule: Applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, offering for sale substantially the same menu items and offering for sale restaurant-type foods.

Food Labeling; Calorie Labeling of Articles of Food in Vending Machines. A final rule was December 1, 2014 is to assist consumers by requiring the availability of point of purchase nutrition caloric information prior to purchasing the food item. (Proposed Rule April 6, 2011).

Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. The purpose of the final rule also published December 1, 2014 is to implement the menu labeling provisions of the Affordable Care Act.

Links to overview and final rules.

http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm248732.htm

Here is What FDA Summarized About These Caloric Disclosure Rules

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm423987.htm

The U.S. Food and Drug Administration has finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments and vending machines to help consumers make informed decisions about meals and snacks.The menu labeling final rule applies to restaurants and similar retail food establishments if they are part of a chain of 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items. A restaurant or similar retail food establishment is generally defined as a retail establishment that offers for sale restaurant-type food, which is generally defined as food that is usually eaten on the premises of the establishment, while walking away, or soon after arriving at another location. Examples of restaurants and similar retail food establishments include sit-down and fast-food restaurants, bakeries, coffee shops and grocery and convenience stores. The menu labeling final rule also requires calorie labeling for certain alcoholic beverages and certain foods sold at entertainment venues such as movie theaters and amusement parks. The FDA also clarifies in the menu labeling final rule that certain foods purchased in grocery stores or other retail food establishments that are typically intended for more than one person to eat and require additional preparation before consuming, such as pounds of deli meats and cheeses and large-size deli salads, are not covered.To help consumers understand the significance of the calorie information in the context of a total daily diet, the FDA is requiring a succinct statement that says, “2,000 calories a day is used for general nutrition advice, but calorie needs vary” to be included on menus and menu boards. The menu labeling final rule also requires covered establishments to provide, upon consumer request, written nutrition information about total calories, total fat, calories from fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars and protein.

Restaurants and similar retail food establishments that are covered, including those that voluntarily register with FDA to comply with the menu labeling requirements, will have one year from the date of publication of the menu labeling final rule to comply with the requirements.

The vending machine final rule requires operators who own or operate 20 or more vending machines to disclose calorie information for food sold from vending machines, subject to certain exceptions. Vending machine operators that are covered, including those that voluntarily register with FDA to comply with the vending machine labeling requirements, will have two years from the date of publication of the vending machine labeling final rule to comply with the requirements.

Conclusion The caloric disclosure is a step in the correct direction since the obesity rate has again risen in the United States.

Recommendation Is caloric disclosure sufficient in terms of right to know?

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.

POM WONDERFUL LLC v. COCA-COLA CO.

United States Supreme Court Holding: A competitor may bring a Lanham Act claim(s) that alleges unfair competition from false or misleading labels on food and beverage labels regulated under the United States Federal Food, Drug and Cosmetic Act.
Link to Supreme Court opinion is below.
http://www.supremecourt.gov/opinions/13pdf/12-761_6k47.pdf

Practice of Medicine or Drug Biologic Product—Regenerative Sciences, LLC

“Practice of Medicine” or FDA Authority to Regulate

The Food and Drug Administration and the Authority to Regulate

USA v Regenerative Sciences

Regenerative Sciences, LLC vigorously defended its position that FDA could not regulate the practice of medicine in its Regenexx™ treatment or Regenexx-C™ cultured treatment which uses Mesenchymal adult stem cells (MSCs) that originate primarily from bone marrow. The company promotes the Regenexx™ treatment as a “non-surgical” treatment option for joint or bone pain in the hip, knee, shoulder, back or ankle as well as non-union fractures. The dispute with FDA has been ongoing since at least 2008 when FDA sent correspondence to Regenerative Sciences depicting the cell treatment as a drug or biologic. FDA conducted an inspection and found violations of current Good Manufacturing Practices (cGMPs). The United States Court of Appeals for the District of Columbia Circuit upheld the District Court and the United States Food and Drug Administration’s (FDA’s) argument that Regenerative Sciences “Cultured Regenexx Procedure” was a biological drug subject to FDA approval through the biologics licensing application (BLA) process. The court of appeals upheld the permanent injunction against the use of the biological drug without FDA approval. The issue focused on the practice of medicine versus the regulation by the United States Food and Drug Administration. This distinction has far reaching ramifications.

Issue the Court of Appeals Addressed

In the civil enforcement action, the court of appeals had to decide “whether the appellants—three individuals and a related corporate entity—violated federal laws regulating the manufacture and labeling of drugs and biological products by producing, as part of their medical practice, a substance consisting of a mixture of a patient’s stem cells and the antibiotic doxycycline.” The court of appeals determined that FDA had the authority to regulate the product and affirmed the district court’s judgment and the permanent injunction it entered against appellants.

What Regenerative Sciences, LLC Argued

Regenerative Sciences, LLC (Regenerative Sciences) alleged several arguments that their product did not fall within FDA regulatory authority; however, the court rejected all of the arguments. For example, Regenerative argued that the Federal Food, Drug, and Cosmetic Act (FDCA) did not apply because the product was a procedure overseen by state “practice of medicine”. Another argument advanced by Regenerative Sciences was that the product was exempt from FDA approval because it was a compounded product and further it was a minimally manipulated product. As mentioned, the court of appeals rejected all of the arguments advanced by Regenerative Sciences.

Looking Ahead

This was a long awaited decision. The future is uncertain in terms of how a court will rule about novel therapies such as the issue in this case. However, no doubt as more technological advances occur, FDA will again be challenged as to the agency’s authority to regulate such products and or procedures.The link to the full case is as follows:

USA v Regenerative Sciences

Top 5 Highlights of FDA Accomplishments in 2013—Snapshot Year in Review: Why the United States Needs a Food and Drug Administration.

Does the United States Needs a Food and Drug Administration? Year in Review—Top 5 Highlights of FDA Accomplishments in 2013

Does the United States even need a Food and Drug Administration (FDA)? The role and mission of FDA has been debated for years. The FDA role ranges from that of a regulator, watchdog and facilitator. Commentary ranges from overbearing federal regulation to lack of public protection. Yet, based on these selected accomplishments, FDA provides an important function in keeping with the mission of the Food, Drug and Cosmetic Act and the numerous amendments. Although the FDA has across the board accomplishments, the following are standouts and all involve safety—Food Safety Modernization, Drug Quality and Security, Tobacco Products, Antibiotic-Antimicrobials Use in Food Producing Animals and Dietary Supplement Enforcement.

DRUG SAFETY—DRUG QUALITY and SECURITY ACT

This necessary and milestone legislation (H.R. 3204) enacted towards the end of 2013, addresses federal regulatory authority over pharmacy compounding. Unfortunately, this legislation was enacted in response to the unnecessary deaths associated with large scale compounding. Additionally, this law contains “track and trace” provisions throughout the drug supply chain.

DIETARY SUPPLEMENT OVERSIGHT

Dimethylamylamine DMAA—Muscle Building and Performance Enhancement

Dimethylamylamine commonly known as (DMAA) provides an excellent illustration example of issues related to post-market enforcement. DMAA, a stimulant is used in supplements, promotes weight loss, muscle building and performance enhancement. DMAA, a stimulant is used in supplements, promotes weight loss, muscle building and performance enhancement. According to FDA, medical issues associated with DMAA include elevated blood pressure, potential cardiovascular problems such as heart attack, shortness of breath and tightening of the chest.

The following link contains the FDA warning letters. http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/ucm346576.htm

The following link contains the response letter from FDA to USPlabs. http://1.usa.gov/1lcJC77

ANTIMICROBIAL RESISTENCE

At the end of 2013, FDA issued a guidance and proposed rule about a phase out of antimicrobial drugs in food animals for food production purposes. According to FDA, the agency issued voluntary guidance that promotes the judicious use of antibiotics in food animal production is preferable because of resource limitations; that is, according to FDA, the agency would use fewer resources compared to withdrawing the animal drugs on an individual basis

VETERINARY ACTION—ANTIMICROBIAL VOLUNTARY PHASE OUT

Final Guidance and Proposed Rulemaking Rx Status

http://1.usa.gov/1bHsi92

TOBACCO PRODUCTS REGULATION

Tobacco Product Marketing Orders

http://1.usa.gov/1kCu7aV

Tobacco products are regulated so differently than other FDA regulated products due to the fact they are: harmful yet still extensively used consumer products; and responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death. A company who desires to market a new tobacco product has the following options available.

There were 17 SE orders, 13, NSE orders and 162 Report Withdrawals from pre-June 2013-December. http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm

MODERNIZING FOOD SAFETY

Did you know that much of the food that Americans consume originate from countries outside of the United States? The Food Safety Modernization Act (FSMA), signed into law back in January 2011, addresses imported food as well as food produced in the United States. Major accomplishments include a final rule and five proposed rules.

Final Rule Administrative Detention of Food   Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption which amended the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. A guidance was issued as well titled: Guidance For Industry on Administrative Detention  was issued on March 7, 2013 FDA released revised guidance on administrative detention entitled “Guidance for Industry: What You Need to Know About Administrative Detention of Foods; Small Entity Compliance Guide.”

5 Proposed Food Safety Rules: Preventive Controls; Produce Safety; Foreign Supplier Verification, Third Party Accreditation and Intentional Adulteration Mitigation Strategies.

1. Proposed Rule: Preventive Controls for Human Food — The proposed rule issued January 2013 would implement the requirements of FSMA for covered facilities to establish and implement a food safety system that includes a hazard analysis and risk-based preventive controls.

http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-0001

2. Proposed Rule: Produce Safety— The proposed rule would establish science-based minimum standards for the safe growing, harvesting, packing, and holding of produce on farms. http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0921-0001

3. Proposed Rule: Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals— On July 26, 2013, FDA issued proposed regulations that would greatly strengthen the oversight of foods imported for U.S. consumers. http://1.usa.gov/1jEeD8l

4. Proposed Rule: Third Party Accreditation of Auditors or “Certification Bodies”— On July 26, 2013, the FDA published for public comment its proposed rule to establish a program for accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361903.htm

5. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

This proposed rule would require the food businesses in the United States and abroad to take measures to prevent facilities from being the target of intentional attempts to contaminate the food supply. http://1.usa.gov/1fVCv2p

RECOMMENDATIONS

Despite the federal government shutdown, FDA did have major accomplishments as the above examples illustrate. They illustrate the necessity for “an FDA”. Hopefully though the proposed rules will be finalized shortly and hopefully Congress will revisit FDA regulatory authority for some products such as dietary supplements where FDA can only legally exercise post-enforcement. Stay tuned for more about the role of FDA and for more food and drug law updates in 2014.