Final Rule Issued: Intended Use ….. Far From the Final Word.

What does FDA say? Recently FDA published a final rule about the following-  “Intended Use”-Products Made from Tobacco. Is my product a Drug, Device and/or Both? Here is the rule summary and link.  Check back  soon for an update.


Food and Drug Administration

21 CFR Parts 201, 801, and 1100 [Docket No. FDA–2015–N–2002]
RIN 0910–AH19

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘‘Intended Uses’’

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.


Check back  soon for an update.

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.