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

First Amendment: Green Light to Off-Label Statements

First Amendment Free Speech-Federal Ct. Gives Green Light to Off-Label Statements

Amarin Pharma Inc v. U.S. Food and Drug Administration, Southern District of New York, No. 1:15-cv-3588. The link to the court opinion is below. It is important to review the Complete Response Letter FDA sent April 27, 2015 to Amarin and relied on by the court.

A New York federal judge ruled August 7 that Amarin Pharma Inc. has a constitutional right to make certain truthful and non-misleading statements about off-label uses of the omega-3 drug Vascepa thus impacting on FDAs restrictions on product marketing of unapproved uses for drugs. In its Complaint for the preliminary injunction, Amarin set forth that the statements were intended for healthcare professionals. This is the same circuit that decided Caronia. The Caronia decision was discussed and or referenced about 88 times in the opinion.

Federal U.S. District Judge Paul A. Engelmayer granted Amarin Pharma Inc.’s motion for a preliminary injunction. The court ruled on August 7 that the company can make certain statements about Vascepa’s potential benefits for patients with “persistently high triglycerides” as long as the statements are truthful and non-misleading.

Issues Raised and Next Steps- What should FDA do? Should FDA “look the other way and turn its back” and permit such off-label statements as long as they are truthful and non-misleading? Should FDA revisit off-label restrictions? Should FDA determine a less arduous approach to approvals of a new use for an already approved drug product ? Should FDA and industry as stakeholders collaborate-and if so how? There are no crystal clear straightforward solutions. In the end, FDA still must uphold the tenets of the Federal Food, Drug and Cosmetic Act which is to protect the public.

Link to Court Opinion Amarin Pharma, Inc. V. U. S. FDA

Sandoz’s Biosimilar Zarxio Marketplace Entry Delayed

Sandoz’s  Biosimilar Zarxio Marketplace Entry Delayed

Patients will need to wait for Zarxio,the biosimilar of Amgen’s cancer treatment Neupogen. Zarxio is the first biosimilar that was approved (March 6, 2015) in the United States under the abbreviated approval pathway of the Biologics Price Competition and Innovation Act (BPCIA).  The direct link to the federal court of appeals opinion is below.

Synopsis—In an Appeal from the United States District Court for the Northern District of California in No. 3:14-cv-04741-RS, the Federal Circuit Court of Appeals on July 21, 2015 interpreted the advance notice provision in a manner that effectively delays marketplace entry. This means that Sandoz’s release of Zarxio, its biosimilar of Amgen’s cancer treatment Neupogen, will not occur until Sept. 2. How the Court of Appeals interpreted the advance-notice provision is a significant victory for brand-name biologics.

District Court Interpretation—The district court had determined that the statute only required it to provide notice 180 days before it commercially marketed the biosimilar and that Sandoz had given Amgen such notice on July 14, 2014, when it filed its biosimilar application with the FDA.

Federal Court of Appeals Interpretation—Yet, the federal court of appeals, determined that notice of a biosimilar must be given to the biologic brand reference product sponsor (RPS) not later than 180 days after the Food and Drug Administration approves/licenses the biosimilar. The court of appeals stated: “We agree with Amgen that, under paragraph (l)(8)(A), a subsection (k) applicant may only give effective notice of commercial marketing after the FDA has licensed its product. That is,the Appeals Court determined that based on the language in the BPCIA, notice be provided after the biosimilar product is licensed by the FDA.

The direct link to the official Federal Circuit opinion is: Amgen, Inc. v. Sandoz, Inc.

Calorie Disclosure FDA Final Rule Effective Date Extended to 2016

Quick Summary-Final Rules for Vending Machines and Restaurant Menu Labelling 

New Effective Date December 1, 2016 for both Rules

Key Links

Background: In December 2014, FDA 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 and are both now effective December 1, 2016.

Reason for Vending Machine Rule-Food Labeling; Calorie Labeling of Articles of Food in Vending MachinesThe purpose  of the final rule is to assist consumers by requiring the availability of point of purchase nutrition caloric information prior to purchasing the food item. 

Vending Machines-Who Must Comply? 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.

Reason for Food Labeling Rule: 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 to assist consumers by requiring the availability of point of purchase nutrition caloric information for informed decision making prior to purchasing the food item.  See FDA Summary Below.

Menu Labelling-Who Must Comply? 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.

FDA Summary: 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.

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 and Recommendation The caloric disclosure is a step in the correct direction since the obesity rate and diet related diseases has again risen in the United States. Is caloric disclosure sufficient in terms of right to know? What other disclosures should FDA institute?

Lethal Injection “Cocktail” Upheld

The United States Supreme Court (June 29, 2015) held in Glossip v. Gross that states can continue to utilize the controversial lethal injection “cocktail”. The U.S. Supreme Court articulated that  the plaintiffs haven’t shown the drug poses a serious risk of inflicting unconstitutional pain and suffering under the Eighth Amendment. In contrast to the botched execution of Clayton Lockett, the protocol discussed in Glossip uses a much greater dosage of midazolam.

Read the official opinion here:

Future: How will this decision affect pharma companies both nationally and internationally?

FDA Landmark Ban: Partially Hydrogenated Oils and Trans Fat

Partially Hydrogenated Oil and Trans Fatty Acids-GRAS Removal

Landmark Ban from GRAS List:  In June 2015, FDA issued a landmark determination that partially hydrogenated oils (PHOs) are not “generally recognized as safe” (GRAS) for use in food.!docketDetail;D=FDA-2013-N-1317 The “declaratory order” (which has the “force and effect” of a rule) was issued pursuant to 5 U.S.C. 554(e) (section 5(d) of the Administrative Procedure Act (APA)). PHOs are the principal dietary source of artificial trans fat in processed foods. This decision means that the use of these oils in the food supply will be phased out over a number of years and removed from the United States food supply. In so doing, FDA estimates that annually approximately 7,000 deaths from heart would be prevented. FDA received 6000 comments and 4500 letters in response to the November 2013 notice about the FDA tentative determination regarding the GRAS elimination. The Federal Register notice concerning hydrogenated fat was published November 8, 2013 (78 FR 67169) and the comment period was extended until March 8, 2014. Upon review of the comments FDA found that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids (IP-TFA) are generally recognized as safe (GRAS) for any use in human food.

Background: Years ago, studies revealed that the consumption of trans fatty acids contribute to increased blood LDL cholesterol, known as the “bad” cholesterol, thereby raising the risk of coronary heart disease. Trans fatty acids or trans fat are made through the process of hydrogenation that solidifies liquid oils. Types of foods that may contain trans fatty acids include vegetable shortenings, some margarines, some cookies and some snack foods. A citizen’s petition (docket number 94-P0036/CP1), filed in 1994 by the Center for Science in the Public Interest (CSPI), addressed the issue of dietary trans fats and the link to coronary heart disease. A proposed rule was published in the Federal Register (64 FR 62746 November 17, 1999). FDA extended the comment period to April 17, 2000 (65 FR 7806); however, the proposal generated enormous response and the comment period was reopened until January 19, 2001 (65 FR 75887 December 5, 2000). The final rule, (68 FR 41434 July 11, 2003) effective January 1, 2006, required the declaration of trans fatty acids or trans fats on nutrition labels of conventional foods and dietary supplements. However, since implementation of the trans fat regulation, FDA found that although many processed foods have been reformulated to reduce the amount of trans fat, a significant number of products still contain PHOs.

What the Order Means: The FDA Order specific to the PHO ban means that food manufacturers would no longer be permitted to sell PHOs, either directly or as ingredients in another food product, without prior FDA approval for use as a food additive. This means compelling scientific demonstrating that the proposed use is reasonably certain not to present a risk of harm to consumers.  A good review of the Final Order is available at:

Compliance Date:  No later than June 18, 2018.

Looking Ahead: There is a three-year phase-out period for reformulation and product relabeling. Did FDA utilize the correct approach? Apparently, it is a long time in coming and FDA is mandated under the Food, Drug, and Cosmetic Act to protect the public. Valid scientific evidence exists today that the GRAS removal is long overdue. The issue is whether industry will comply without legal challenges. Yet, it is likely that litigation will result from the FDA Order and Determination to Ban PHOs from the GRAS list.

Affordable Care Act Tax Credits Upheld by the U. S. Supreme Ct.

The U.S. Supreme Court, June 25, 2015,  in King v. Burwell, a 6-3 majority, upheld the federal tax subsidies under the  Affordable Care Act. Chief Justice John G. Roberts Jr.  wrote for the majority. Justice Roberts settled that the tax credits are necessary for the Federal Exchanges to act like their State Exchange counterparts, and to avoid the sort of disastrous result that Congress clearly meant to prevent.

Pay for Delay Settlement- Teva Pharmaceutical Industries, Ltd.

Pay-for-Delay Settlement-$1.2 Billion Announced May 28,2015

FTC v. Cephalon, Inc., E.D. Pa., No. 2:08-cv-2141

Teva Pharmaceutical Industries Ltd. (Teva) agreed to pay $1.2 billion in a Settlement with the Federal Trade Commission.   Teva acquired Cephalon, Inc. in 2012. The settlement resolves claims that Cephalon Inc., hindered generic drug competition.

FDA TOP NOTABLES- Mobile Med. Apps., Reprocessed Medical Devices, Guilty Plea, Consent Decree, Biosimilar Approval, 23andMe Direct to Consumer Test Kits



Guidance Issued-Infection Prevention and Safety


McNeil-PPC Inc. a subsidiary of Johnson & Johnson-Guilty Plea March 10, 2015 $25 million manufacturing adulterated Infants’ and Children’s Tylenol and Children’s Motrin. 


The Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff issued February 9, 2015 supersedes the September 25, 2013 issued guidance. It was updated for consistency with the guidance document Medical Devices Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices issued on February 9, 2015. See: 76 Fed. Reg. 140 (July 21, 2011).

Examples of Mobile Apps-FDA Enforcement Discretion


23andMe, Inc. submitted a revised 510(k) application for its direct-to-consumer genetic testing service focusing on a single rare inherited condition. In 2015 (Feb.) FDA authorized marketing of 23andMe’s Bloom Syndrome carrier test, a direct-to-consumer (DTC) genetic test to determine whether a healthy person has a variant in a gene that could lead to their offspring inheriting the serious disorder. Additionally, FDA classified carrier screening tests as class II. Further, the FDA exempts these devices from premarket review. Interestingly, 23andMe received a two year $1.3 million NIH grant in 2014 (July) to support further development of its Web-based database and research engine to stimulate genetic discoveries. According to 23andME, the funding will enable it to use its stored genetic data on thousands of diseases and traits for over 400,000 people to pursue research endeavors and detect novel and rare genetic associations with health conditions.


The first biosimilar drug for cancer named Zarxio by Novartis AG received approval in early 2015. The ramifications of the approval of Novartis AG’s form of Amgen Inc.’s cancer drug, Neupogen, are huge. That is, this biosimilar approval means lower costs and patient access to less expensive treatments. Zarxio received FDA approval for all five conditions to treat associated to white blood cell counts. Novartis agreed to delay selling the biosimilar in the United States until April 10, 2015 due to a lawsuit with Amgen. An unresolved issue it that of naming. Generic drugs are named after the active ingredient for uniformity. The active ingredient in Neupogen is filgrastim and FDA determined that Zarxio’s name is filgrastim-sndz.


A consent decree entered against Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. Veterinarians should be aware that Specialty Compounding also manufactured products intended for use in animals, and that these products are also affected by the consent decree. Specialty Compounding ceased sterile drug manufacturing operations in August 2013, and recalled all lots of its unexpired sterile drug products distributed since February 1, 2013.

STAY TUNED! Will post updated news next quarter 2015!

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. 


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.


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);

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

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication


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.


Vending Machines and Restaurant Menu Labeling Overview and link to final rules.

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 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:


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.


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:


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


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.