Category: FDA

New FDA Commissioner Hits the Ground Running

Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and Drug Administration (“FDA”).  These run the gamut from improving regulatory science and policies to streamlining clinical trials to spurring innovation on behalf of patients.  Two initiatives, in particular, merit closer attention and discussion: combating opioid abuse and addressing drug price increases through more, accelerated generic competition.

Opioid Regulation

In his first post to the FDA Voice blog, Dr. Gottlieb wrote:

As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. . . .  I believe it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.

First among these steps, the Commissioner is establishing an Opioid Policy Steering Committee, comprised of “some of the agency’s most senior career leaders, to explore and develop additional tools or strategies FDA can use to confront this epidemic.”  The strategies under consideration include (1) mandatory education for health care professionals about (i) appropriate prescribing recommendations; (ii) how to identify the risk of abuse in individual patients; and (iii) how to get addicted patients into treatment; and (2) working more closely with provider groups to develop standards for prescribing opioids in different clinical settings, so that “the number of opioid doses that an individual patient can be prescribed is more closely tailored to the medical indication.”

Limiting the availability of prescription pain medication is a dicey proposition, however.  As Dr. Gottlieb acknowledged, certain situations “require a 30-day supply” and, “[i]n those cases, we want to make sure patients have what they need.  But there are plenty of situations where the best prescription is a two- or three-day course of treatment.”  The individualized medical judgments and circumstances that drive opioid prescribing likely mean that no single approach is likely to strike the proper balance between over-prescribing and ensuring sufficient access to adequate pain management.  Interestingly, the variability between opioid prescribers and patients did not stop the Centers for Medicare and Medicaid Services from proposing hard limits on opioid dosing for non-cancer pain or palliative/end-of-life care (i.e., chronic pain) for Medicare Advantage Organizations and Prescription Drug Plan Sponsors.

In fact, pain patients already have struggled under bright-line limitations on opioids.  As we previously reported, the State of Massachusetts enacted a new law in March 2016 that prohibits “a practitioner [from] issu[ing] a prescription for more than a 7-day supply . . . [w]hen issuing a prescription for an opiate to an adult patient for outpatient use for the first time [or] to a minor,” the first such limitation legislatively imposed by any state.”  Mass. Gen. Laws ch. 94C, § 19D (2016).  Massachusetts physicians surveyed following the law’s enactment complained that “the pendulum has swung too far, depriving pain patients of needed relief,” and that “regulations won’t solve the addiction problem . . . .  Instead, they make doctors reluctant to prescribe opioids.”

Broadly targeting opioids as a class of drugs also may cast too wide a net.  A recent article in the journal Substance Abuse reported “[t]he US opioid epidemic has changed profoundly in the last 3 years” in that “[h]eroin and fentanyl have come to dominate an escalating epidemic of lethal opioid overdose, whereas opioids commonly obtained by prescription play a minor role, accounting for no more than 15% of reported deaths in 2015.”  The article urged that the changing etiology of opioid overdose “require[s] substantial recalibration of the US policy response.”

What is clear—and what Dr. Gottlieb seems to recognize—is that opioid abuse and addiction are dynamic issues that differ from prescriber to prescriber and from one patient to another.  Those variables may make a one-size-fits-all”strategy unviable.

Drug Prices

During a budget hearing before the House Committee on Appropriations, Dr. Gottlieb testified that, “while the FDA does not have a direct role in drug pricing, we can take steps to facilitate entry of lower-cost alternatives to the market.”  He identified policy challenges that the last Congress had attempted to address through legislation designed to expedite access to affordable drugs.  Such legislation included the CREATES Act, which we previously analyzed.  The proposed law sought to prevent brand-name drug companies from using FDA safety rules (i.e., Risk Evaluation and Mitigation Strategies (REMS) and requirements thereunder, e.g., Elements to Assure Safe Use (ETASU)) for medicines with higher risk potential to block or delay generic entry.  “FDA has an important role to play in making sure that its statutory and regulatory processes are working as intended,” Gottlieb told Congress, “not being manipulated in ways that FDA and Congress did not intend.”

In response to growing political pressure in Washington to expedite drug reviews, Dr. Gottlieb assured lawmakers that biomarkers, new technologies, and more efficient clinical trial designs would make it possible to shorten the regulatory process.  But accelerated approval of expensive, investigational (albeit life-saving) therapies has raised concerns among health policy experts.

A recent op-ed published by the New England Journal of Medicine (NEJM) cautioned that

accelerated approval can lead to situations in which private payers may choose not to cover a drug because of high cost and lack of evidence of clinical efficacy, thereby thwarting the pathway’s goal of getting potentially important therapies to patients earlier, while major government payers are forced to cover the product, directing substantial tax dollars to drugs not yet shown to have clinical benefit.

The NEJM article’s authors argue that any biopharma company granted an accelerated approval should be subject to certain price restrictions until the confirmatory trials are completed, reasoning that “the price paid by taxpayers should reflect the strength of the available evidence about the drug’s clinical impact.”  Additionally, they proposed that all drugs moving through an accelerated-approval pathway should be subject to formal economic impact analyses after one to two years on the market, possibly funded by an increase in the user fees for manufacturers that use this pathway.

Dr. Gottlieb is also evaluating the generic drug and biosimilar review and approval process.  More specifically, Dr. Gottlieb is looking at measures to  facilitate communication between the industry and FDA, address complex molecules, and to speed up the approval of biosimilar products.

These recommendations are not without some appeal.  Despite seeking to deliver more “bang” for the taxpayer’s “buck,” however, prospectively capping the federal reimbursement for a high-cost drug product still subject to additional clinical trials and/or other R&D may create a financial disincentive to pharmaceutical manufacturers to foot the expense of developing breakthrough drugs to fill an unmet medical need.

Stay Tuned

To deliver on the promises of reducing the incidence of opioid abuse and lowering drug prices, Dr. Gottlieb’s FDA must navigate the competing interests and thorny health policy issues highlighted above.

Jason L. Drori, David L. Rosen and Judith A. Waltz of Foley & Lardner LLP.

“KIND” of Nutritious—FDA Permits “Healthy” Label and Agrees to Rethink Its Definition of “Healthy” Foods

kind bar healthyThe Food and Drug Administration has kindly permitted Kind LLC to use the term “healthy” on its snack bars again, but with the caveat that the term must only be used in text clearly presented as part of Kind’s corporate philosophy, and not as a claim about the products’ nutrient content.

In March 2015, the FDA issued a warning letter to Kind, concerning four of Kind’s snack bars which the FDA said were misbranded as “healthy.” According to the FDA, the Kind snack bars at issue, which contain fruits and nuts among other things, contain more fat and saturated fat than the FDA’s definition of “healthy” allows.  Moreover, the FDA said, the product labels claimed the bars were rich in antioxidants, had no trans fats, and were good sources of fiber without including certain necessary disclosures. The FDA says that after receiving this warning, Kind took corrective actions, including removing and amending certain nutritional content claims on its packaging and labeling. Kind then returned to the FDA to confirm that it was not barred from using the phrase “healthy and tasty” in text “clearly presented as its corporate philosophy, where it isn’t represented as a nutrient content claim, and does not appear on the same display panel as nutrient content claims or nutrition information.”  The FDA agreed not only to this proposal, but also to reconsider how the agency defines “healthy” more generally in response to a citizen petition initiated by Kind in December 2015.

Kind’s citizen petition points out that the FDA’s definition of “healthy” is over 20 years old and excludes foods such as nuts, avocados, olives, and salmon, while embracing fat-free chocolate pudding and some sugary cereals. According to Kind, these outdated food labeling regulations focus on specific nutrient levels of proteins and fats rather than on the nutritional value of the whole foods. Kind therefore asked the FDA to update its existing food labeling requirements to be consistent with the 2010 Dietary Guidelines for Americans and the Scientific Report of the 2015 Dietary Guidelines Advisory Committee, and to amend the definition of “healthy” to emphasize the importance of overall nutrition quality of foods in their whole form rather than specific nutrient levels.  The FDA evidently did not think Kind’s arguments were entirely nutty and, in response, has indicated that it will soon be reexamining how it defines “healthy” food in light of evolving nutrition research, and will be seeking public comment on this issue.

For now, companies may be able to market their food products as part of a “healthy” corporate philosophy in the same manner that the FDA has sanctioned for Kind. But watch this space for more developments as the FDA rethinks what it means to eat healthy.

ARTICLE BY Jennifer Yang & Evelyn Pang of Proskauer Rose LLP

© 2016 Proskauer Rose LLP.

Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

BullmonLast November, we posted that the Food and Drug Administration (FDA) had approved a genetically engineered (GE) salmon: AquaBounty Techonologies’ AquAdvantage Salmon. This approval marked the first time that the FDA authorized selling a genetically engineered animal for human consumption.

Immediate backlash followed the FDA’s November 19, 2015 announcement from environmental and consumer advocacy groups. On March 31, 2016, environmental and food safety groups, as well as fisherman trade associations, sued the FDA and related agencies in federal court in California. The suit seeks to reverse the FDA’s approval of the fish for human consumption.

The complaint alleges that the FDA failed in its statutory duty to take a “hard look” at how GE salmon will impact the environment. The plaintiffs warn that the FDA did not appreciate the risk that the farmed salmon would inevitably escape, “interbreed with wild endangered salmon, compete with them for food and space, or pass on infectious disease . . . .”

The plaintiffs also take aim at the FDA’s authority to regulate GE animals under the Federal Food, Drug, and Cosmetic Act (FFDCA), arguing that, back in 1938, Congress did not expect the FDA to regulate genetically engineered animals for human consumption: “GE animals present enormously different risks and impacts than drugs, requiring different expertise, analyses, and regulation than were contemplated when Congress enacted the FFDCA.”

Whether additional lawsuits will follow this one remains to be seen. In our November post, we predicted that consumers could sue to challenge the labeling of the GE fish. Although the FDA initially determined that AquaBounty would not need to label its salmon as GE, a provision in December’s 2016 Omnibus Appropriations Bill required the FDA to ban GE salmon imports until it published labeling guidelines for the fish. In February, the FDA issued that ban and announced its plans to establish labeling guidelines.

Even if AquaBounty puts FDA-approved labeling on its product, consumers still may sue under failure to warn and related legal theories. The food industry has had some success defending state law food labeling claims based on federal preemption. But the federal Nutrition Labeling and Education Act exempts claims based on the adequacy of safety warnings unless the FDA has actually considered a risk and determined that no warning is necessary. So, the key question in any consumer personal injury suit involving GE salmon likely will be whether the FDA considered the risk of the alleged harm in implementing its new labeling guidelines.

Article By Amy M. Rubenstein & Katia Asche of Schiff Hardin LLP

© 2016 Schiff Hardin LLP

Gluten-Free Go-Round re: Food Labeling

CookiesGingerbreadMenFDA extends comment period on proposed rule for gluten-free labeling of fermented or hydrolyzed foods.

  • FDA issued a proposed rule to address the application of “gluten-free” labeling requirements to fermented and hydrolyzed foods and foods that contain fermented and hydrolyzed ingredients.  The underlying issue is that uncertainty prevails in interpreting the results of current test methods for detecting gluten in such foods.

  • On February 12, FDA announced its intent to extend the comment period for this proposed rule.  Although the comment period technically closes on February 16, FDA will be reopening it to extend the timeframe for an additional 60 days (to be counted from the date that a notice reopening the comment period appears in the Federal Register).

  • The proposed rule would affect the labeling of foods and ingredients such as yogurt, hydrolyzed soy protein, distilled vinegar, and FDA-regulated beers (i.e., beers that are not made from malted barley and hops).  The rule also could affect beers regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), as TTB has indicated that it may revise its own gluten claim policy once FDA has issued a final rule or other guidance.  Interested stakeholders are invited to submit comments via Regulations.gov (Docket Number FDA-2014-N-1021).

Article By Food & Drug at Keller and Heckman LLP

© 2016 Keller and Heckman LLP

Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives.  In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing investigating drug pricing.  Meanwhile, the Energy and Commerce Committee (E&C) held a hearing regarding implementation of biosimilars.  While all the attention will be on the former, the latter was more important, especially for participants in the biosimilar space.

First, the OGR Committee was a media show built around the flamboyant Shkreli.  Shkreli took the 5th when given the opportunity to testify and later tweeted – after being excused from the hearing for refusing to answer any of the Members questions – that the Committee Members were ‘imbeciles’.  The tone of the hearing was very aggressive towards drug pricing and what were described as unsavory business practices. Members were also critical of the FDA generic drug programs.  However, Member interest in strengthening the program to bring competition to the marketplace was clear. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research at the FDA,  stated that funds collected as a result of the Generic Drug User Free Amendments (GDUFA) helped expedite the review process and that by October there will be a 10-month review process on all new applications. The Senate HELP Committee held a hearing last week on reauthorization of GDUFA, which will expire next year, and this bipartisan interest, coupled with the prescription drug cost crisis, could lead to increased resources for the FDA review process. Beyond some public shaming of specific drug companies, there was little suggestion of substantive action on drug pricing.

Second, the E&C Committee was less about drug pricing, but more so about the ability of manufacturers to get new biosimilar products to the market. Notably, Committee Members on BOTH sides of the aisle were critical of CMS for trying to price biosimilars more like generic drugs and categorize different products under a single billing code.  They said the CMS ruling undermines the intent of the Biologics Price Competition and Innovation Act of 2010 (BPCIA) by removing incentives for a robust marketplace. Biologics make up a $200 billion market, so the consequences of policy decisions are significant. Members were also critical of delays in approving more biosimilars and issuing guidance on product labeling. Rep. Frank Pallone (D-NJ) asked if additional appropriations would address these problems, to which Dr. Woodcock replied that she’s more concerned the FDA will be unprepared for a rapid expansion of the biosimilar market.

While 2016 may be devoted to campaigning against drug prices, the Committees responsible for the regulatory regimes for drugs are still very focused on preserving the ability of manufacturers to successfully bring drugs to the market.  That is a much bigger deal than the plethora of Martin Shkreli smirks you will be subjected to in the media.

Article By Rodney L. Whitlock of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

©1994-2016 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Agriculture, Food, and Health Issues to Watch for 2016

Label Food Organic.jpgAs the agriculture and food industries head into the new year, a number of important cases and regulatory issues that have the potential to dramatically affect the industry are front and center. Below, an overview of the status of several of the key cases and issues that related industries should keep an eye on during 2016.

Waters of the United States

On October 9, 2015, following an earlier ruling by the U.S. District Court for the District of North Dakota, the United States Circuit Court for the Sixth Circuit issued a nationwide stay of the so-called “Waters of the United States” or “WOTUS” rule. The stay halted implementation of the WOTUS rule, pending resolution of jurisdictional issues that were the subject of oral argument on December 8, 2015. Those jurisdictional issues are focused on whether the Sixth Circuit is the proper venue to hear challenges to the rule. A ruling is expected in 2016.

A number of district court cases across the country also remain pending, and the District of North Dakota’s earlier injunction against implementation of the WOTUS rule in 13 states, including Missouri, remains in place.

Vermont Act 120

On October 8, 2015, the U.S. Circuit Court of Appeals for the Second Circuit heard oral argument of an appeal filed by the Grocery Manufacturers Association and other plaintiffs seeking review of the U.S. District Court for the District of Vermont’s denial of their Motion for Preliminary Injunction on April 27, 2015. The motion sought a preliminary injunction enjoining implementation of Vermont Act 120, passed on May 8, 2014, with an effective date of July 1, 2016. Act 120 would, among numerous provisions, mandate new labeling requirements on the part of manufacturers and other food processors for any food that is “produced with genetic engineering,” “partially produced with genetic engineering,” or “may be produced with genetic engineering.” Violators of Act 120 are subject to civil penalties of up to $1,000 per day, per product.

A decision is expected in the first two quarters of 2016 in advance of the July 1, 2016, effective date of the law.

Federal Activity Regarding GMOs and the Safe and Accurate Food Labeling Act

The U.S. House of Representatives passed the Safe & Accurate Food Labeling Act (SAFL) on July 23, 2015. The SAFL Act would, among other things, serve to pre-empt any state laws governing labeling of GMO-containing food products, including Vermont’s Act 120 due to become effective on July 1, 2016. Despite pressure on the U.S. Senate to address the SAFL Act and pass a companion or similar bill before the end of 2015, efforts to include any such bill or related provisions in the year-end omnibus spending bill were unsuccessful. Senate Agricultural Committee Group leaders, including Sen. Debbie Stabenow, D-Mich., have pledged to make the issue a top priority in January 2016, and many expect Sen. John Hoeven, R-N.D., to play a role in trying to secure passage of a bipartisan bill.

Food Safety Modernization Act Roll-Out

The Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, and represents the most comprehensive overhaul of the U.S. food safety regulatory scheme since the passage of the Food, Drug and Cosmetic Act in 1938. For nearly five years, the U.S. Food and Drug Administration (FDA) has been developing the seven final rules that implement FSMA. Each final rule impacts a different fundamental area of the U.S. food system.

In September and November 2015, the FDA issued the first five of the seven final rules: (1) Preventive Controls for Human Food; (2) Preventive Controls for Animal Food; (3) Foreign Supplier Verification Program; (4) Standards for Produce Safety; and (5) Accredited Third-Party Certification. The issuance of these rules initiates the countdown for the relevant compliance deadlines for covered entities.

It is anticipated that the final two FSMA rules regarding Sanitary Transportation and Intentional Adulteration will be issued on March 31, 2016. The Sanitary Transportation final rule will establish criteria for the sanitary transportation of food, including criteria targeted at shipping conditions and practices, employee training, and record keeping. The Intentional Adulteration final rule will require domestic and foreign food processing facilities to address vulnerabilities in their operations to prevent acts on the food supply intended to cause large-scale public harm. In 2016, the FDA will also be working with certain alliance groups to further develop FSMA compliance and enforcement guidance.

FDA Menu Labeling Requirements

Section 4205 of the Affordable Care Act charges the FDA with establishing labeling requirements for certain retail food establishments and vending machines. On December 1, 2014, the FDA issued two rules requiring calorie information to be listed on menus and menu boards at retail food establishments if they are a part of a chain of twenty or more locations operating under the same name and offering for sale substantially the same restaurant-type food items.

In July 2015, the FDA announced that the compliance deadline for the menu labeling rule was being extended by one year. All covered establishments (e.g., restaurants, grocery stores, and gas station convenience stores) now have until December 1, 2016, to identify calorie count and other information on their menus and menu boards as required by the FDA menu labeling rules.

Article By Laura A. Bentele, Scott K.G. Kozak & Jonathan D. Valentino of Armstrong Teasdale
© Copyright 2016 Armstrong Teasdale LLP. All rights reserved

2015 FDA Wrap-Up and 2016 Regulatory Priorities

Happy New Year! This article will revisit and update the status of significant regulatory issues in 2015 and assess 2016 FDA priorities in the food area.

2015 Overview

  • Office of Dietary Supplement Programs

    On December 21, 2015, the FDA announced the creation of the Office of Dietary Supplement Programs (ODSP).1 The program was formerly a division under the Office of Nutrition Labeling and Dietary Supplements, now known as the Office of Nutrition and Food Labeling. The Department of Justice brought a significant number of civil and criminal cases against the makers of dietary supplements in 2015. The creation of ODSP supports the mission of monitoring the safety of dietary supplements and taking action against entities that present a risk of harm to the consumer.

  • “Natural” Label Claims

    In 2015, the FDA received three Citizen Petitions asking that the agency define the term “natural” for use in food labeling. The term “natural” has been the subject of many food labeling lawsuits. In direct response to requests from the public, the FDA has extended the comment period on the use of the term “natural” in food labeling to May 10, 2016.2 The Morgan Lewis FDA team is currently working on an analysis of the comments submitted to date. Please contact the FDA team if you are interested in submitting a comment.

  • Food Safety and Modernization Act (FSMA) Regulations

    As discussed in our November 16 post, in late 2015, the FDA published three final rules under FSMA: the Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule),3 the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule),4 and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Accredited Third-Party Certification rule).5 These rules implement sections of FSMA geared toward protecting the US food supply. As discussed below, the FDA plans to take further action to implement sections of FSMA in 2016.

  • Menu Labeling Requirements

    As discussed in our post July 13, 2015, FDA released its final rule on menu labeling in restaurants on December 1, 2014, and later extended the date for compliance from December 1, 2015 to December 1, 2016. The rule will require restaurants and similar retail food establishments that (1) sell “restaurant-type food,” (2) are part of a chain of 20 or more locations, (3) do business under the same name or slight variations of each other, and (4) offer for sale substantially the same menu items as the other business locations, to disclose calorie information on menus and menu boards.

  • New York Sodium Warning

    AThe New York City Department of Health and Mental Hygiene Board of Health (Board of Health) Sodium Warning Label Rule went into effect on December 1, 2015. The Rule requires food service establishments in New York City with 15 or more locations nationwide to provide a warning for menu items that contain 2,300 mg or more of sodium. New York City is the first city in the United States to require chain restaurants to include sodium warnings on menus or menu boards. Chains with 15 or more locations have 90 days to comply with the new rule before they face a $200 fine. The rule elicited responses from the National Salt Institute and the National Restaurant Association. The National Restaurant Association filed suit against the Board of Health, claiming that it did not have the authority to require such a warning. We will monitor this lawsuit and provide updates in 2016.

2016 FDA Regulatory Publication Agenda

On December 15, 2015, the FDA released its Semiannual Regulatory Agenda.6 The Agenda outlines the following outstanding proposed and final rules for 2016 with respect to food:

  • Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods:7

    This proposed rule was published in late 2015. It would establish requirements concerning compliance for using a ‘‘gluten-free’’ labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million gluten in the food. FDA has acknowledged that it is difficult to scientifically detect gluten in fermented and hydrolyzed foods.8 Accordingly, the rule would require manufacturers to make and keep records to show that (1) the food meets the definition for “gluten-free” in 21 C.F.R. 101.91(a)(3), including that the food had less than 20 ppm gluten, before fermentation or hydrolysis; (2) the manufacturer adequately evaluated the processing for any potential for gluten cross-contact; and (3) where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. FDA is accepting comments until February 16, 2016.

  • Food Labeling: Revision of the Nutrition and Supplement Facts Labels:9

    Under the Food, Drug and Cosmetic Act (FD&C Act), this final rule would amend the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The rule would modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. The FDA reopened the comment period for this final rule in October 2015, and anticipates issuing a final rule in March 2016.10

  • Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed (RACCS):11

    Under the Nutrition Labeling and Education Act of 1990 and the FD&C Act, this final rule would modify labeling regulations for foods to provide updated RACCs for certain food categories to assist consumers in maintaining healthy dietary practices. The rule would also amend the definition of single-serving containers; the label serving size for breath mints; and provide for dual-column labeling, which would provide nutrition information per serving and per container or unit, as appropriate. The FDA anticipates releasing the final rule in March 2016.12

  • Focused Mitigation Strategies to Protect Food Against Intentional Adulteration:13

    Under FSMA, the final rule would require domestic and foreign food facilities that are required to register with the FDA to address hazards that may be intentionally introduced by acts of terrorism. Food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. The FDA anticipates releasing the final rule in June 2016.14

  • Sanitary Transportation of Human and Animal Food:15

    Under the 2005 Sanitary Food Transportation Act and FSMA, this final rule would establish requirements for parties and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. The FDA anticipates publication of the final rule in April 2016.

Article By Robert G. Hibbert & Heather A. Dorsey of Morgan, Lewis & Bockius LLP

Copyright © 2015 by Morgan, Lewis & Bockius LLP. All Rights Reserved.

1 U.S. Food & Drug Admin., FDA Creates the Office of Dietary Supplement Programs and Announces New Nutrition Office Leadership (Dec. 21, 2015) http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm478303.htm.
2 80 Fed. Reg. 80178 (Dec. 28, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-12-28/pdf/2015-32471.pdf; 80 Fed. Reg. 69905 (Nov. 12, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-12/pdf/2015-28779.pdf.
3 80 Fed. Reg. 74354 (Nov. 27, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28159.pdf.
4 80 Fed. Reg. 74226 (Nov. 27, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28158.pdf.
5 80 Fed. Reg. 74570 (Nov. 27, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28160.pdf.
6 80 Fed. Reg. 77960 (Dec. 15, 2015).
7 Id. at 77963; 80 Fed. Reg. 71990 (Nov. 18, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-18/pdf/2015-29292.pdf.
8 78 Fed. Reg. 47154.
9 80 Fed. Reg. 77764, 77965 (Dec. 15, 2015).
10 Id. at 77764.
11 80 Fed. Reg. 77765, 77965 (Dec. 15, 2015).
12 Id. at 77765.
13 Id. at 77768.
14 Id.
15 Id. at 77771.

When Cosmetic Becomes Drug re: Food, Drug, and Cosmetic Act

It is estimated Americans will spend over $60 billion on beauty products in 2015. With so much at stake, manufacturers have tried to aggressively promote their products. In many cases, this promotion has resulted in unintentional product misbranding.

The Food, Drug, and Cosmetic Act (FD&C Act) provides the Food and Drug Administriation (FDA) with regulatory authority over cosmetics to ensure they are not adulterated or misbranded. See 21 U.S.C. § 361, 362. While the market for non-essential beauty products has increased dramatically over the past couple of decades, the FD&C Act has changed very little since its enactment nearly 80 years ago.

This could be changing with the introduction of the Personal Care Products Safety Act (PCPSA), which seeks to significantly expand the FDA’s authority over cosmetic products sold in the United States and eliminate many of the regulatory differences between cosmetics and drugs. Nevertheless, the PCPSA fails to address the issue of unintentional product misbranding in the context of product marketing.

Cosmetic or a Drug 

The FD&C Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Cosmetics include “skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, cleansing shampoos, permanent waves hair colors, and deodorants,” or any of their component parts. Cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the FD&C Act.

By contrast, drugs are defined as products that are “intended for use in diagnosis, cure, mitigation, treatment or prevention of a disease.” FD&C Act, sec. 201(g)(1). Some products are both a cosmetic and a drug. An example of this is an SPF moisturizer, which acts as both a cosmetic in its moisturizing function and a drug in its ultraviolet protection. Products that are both cosmetics and drugs are often referred to as “cosmeceuticals,” and must comply with both the drug and cosmetic provisions of the law.

The focus in defining both cosmetics and drugs is on their intended use. Intended use can be established through marketing, consumer perception, or the ingredients used. In regulating the cosmetics industry, the FDA has spent a considerable amount of energy focusing on the product labeling, advertising, internet, or other marketing activities that may operate to establish the product as a drug based upon its intended use. When companies market anti-aging products as having a physiological impact on the body or one’s appearance, the cosmetic becomes a drug.

Regulatory Overview

If a manufacturer’s product is classified as a drug, the manufacturer is subject to a whole host of regulations it would not otherwise be subject to if the product is classified as a cosmetic. Under the FD&C Act, there is no FDA review of cosmetics prior to marketing, with the exception of color additives. Further, unlike pharmaceuticals and medical devices, there is no testing by the FDA of cosmetics prior to their sale to consumers. By contrast, if a product is categorized as a drug and is not generally recognized as safe and effective, the cosmetic manufacturer must subject their “cosmeceutical” product to a rigorous New Drug Approval (NDA) process, which includes safety and efficacy testing.

Another difference between cosmetics and drugs is that cosmetic manufacturers have no obligation to engage in adverse event reporting. While cosmetic manufacturers are encouraged to engage in adverse event reporting, there is no requirement under the FC&A Act to report adverse events, regardless of their severity. Since the creation of the FC&A Act, cosmetic manufacturers have controlled the safety testing of their products. Further, if they choose not to engage in safety testing, they only need to indicate in the product labeling the safety of the product has not been adequately substantiated prior to marketing. By contrast, if a product is categorized as a drug and is not generally recognized as safe and effective, the cosmetic manufacturer must subject their product to a rigorous New Drug Approval (NDA) process, which includes safety and efficacy testing.

Misbranding: Conversion of Cosmetics to Drugs

Along with the rise in beauty product use, the cosmetics industry has also seen a rise in FDA interest in the marketing of such products. This interest has lead to the increased issuance of FDA Warning Letters.

In the Fall of 2012, the FDA issued a Warning Letter to Lancôme, a subsidiary of L’Oreal, addressing claims made by the manufacturer on its website regarding some of its anti-aging creams. Claims that “[U]nique R.A.R.E oligopeptide helps re-bundle collagen,” “[B]oosts the activity of genes and stimulates the production of youth proteins,” and “[I]nspired by eye-lifting surgical techniques . . . helps recreate a younger, lifted look in the delicate eye area” were deemed “intended to affect the structure or any function of the body,” rendering the products drugs under Sec. 201(g)(1)(C) of the FDCA. The FDA went on to state that because certain of Lancôme’s anti-aging creams are not generally recognized by experts as safe and effective for their intended use, the products are new drugs that could not be legally marketed without prior approval from the FDA through the NDA process. In the alternative, the FDA gave Lancôme fifteen days to take corrective action with regard to existing claims and to discontinue making such claims in the future. Lancôme chose to take corrective action and discontinue future claims. Only two weeks after the issuance of this warning letter, a putative class action was filed against L’Oreal and Lancôme asserting consumer fraud claims, based upon the same marketing representations identified in the FDA Warning Letter.

The FDA also issued a Warning Letter to Cell Vitals on November 24, 2014. In the letter, the FDA informed Cell Vitals it had reviewed the cosmetic company’s website with regard to its “ReLuma Advanced Stem Cell Facial Moisturizer,” “ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser,” and “Reluma Stem Cell Eye Cream,” and determined that the products “appear to be promoted for uses that cause these products to be drugs.” Some of the advertising examples cited by the FDA include: “Tetrahexyldecyl Ascorbate: [an ingredient in your product] … protects cells from …inflammation” and “Camellia Sinesis Extract [an ingredient in your product] is anti-bacterial and … anti-cancer.” Ultimately, the products were deemed misbranded, requiring an FDA approved NDA.

Similarly, the FDA issued a Warning Letter to Golden Caviar Skin Care on July 13, 2015 stating Golden Caviar Skin Care promoted a number of dietary supplements in a manner that caused the products to be drugs under the FD&C Act. An example of this misbranding included online marketing with regard to the company’s Caviar Lifting & Firming Serum with Zinc, where the company claimed “[i]t helps repair damaged tissues and heal wounds. Great for anyone wanting to do away with old acne scars or suffering from Rosacea…..We have found the solution.” The FDA reasoned the labeling for the product failed to bear adequate directions for use, and such “products are offered for a condition that is not amendable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely” for its intended purpose.

The increase in FDA issued Warning Letters in the cosmetic industry has lead to a rise in consumer class actions based upon allegedly deceptive cosmetic labeling. Cosmetic companies must continue to be cautious in creating product labeling and other advertisements, electronic or otherwise, to ensure the representations do not open the door to an FDA Warning Letter or potential consumer fraud class action.

Reform: The Personal Care Products Safety Act

On April 20, 2015, Senators Dianne Feinstein, a Democrat from California and Susan Collins, a Republican from Maine introduced the Personal Care Products Safety Act. The Personal Care Products Safety Act aims to modernize what is now mostly a self-regulating industry, and brings cosmetic regulation closer to that of drugs. The bill, which has broad support from industry and consumer groups, proposes a number of significant changes to the FD&C Act, including but not limited to: the registration of cosmetic facilities and ingredient statements, ingredient review and approval, reporting of serious adverse events, record inspection and FDA recall authority, FDA review of cosmetic ingredients and non-functional constituents, the development and implementation of good manufacturing practices (GMPs), and animal testing alternatives. For those larger companies who already engage in extensive safety testing, the impact may not be as great. In fact, many companies are behind the legislation.

Despite the issuance of numerous FDA Warning Letters to cosmetic corporations, the Personal Care Products Safety Act, as currently proposed, does little to provide guidance to beauty care companies with regard to the marketing and promotion of personal care products. In the past several years, the issuance of FDA Warning letters has lead to an increase in consumer class action lawsuits against cosmetic companies. Without a product labeling approval process or an avenue by which cosmetic companies can seek pre-marketing opinions regarding product advertising, it is likely consumer class action suits will continue.

Getting Serious about Palcohol: Powdered Alcohol

“Imagine a Margarita on a counter. And then imagine if you could snap your fingers and it would turn into powder.  That’s Palcohol….without the magic.”

So says Mark Phillips, the creator of Palcohol.  Phillips created Palcohol, a witty play on “Powdered Alcohol,” so that he could have a drink while “hiking, biking, camping and kayaking” without carrying a heavy bottle around.  According to the product’s website, “Palcohol is just a powder version of vodka, rum and three cocktails….with the same alcoholic content.” The powder is available in vodka, rum, cosmopolitan, “powderita” and lemon drop flavors.  The site discusses applications in medicine, energy, hospitality, the military, and manufacturing. Phillips’ company, Lipsmark, says the product is expected to hit store shelves later this summer.

Palcohol is sold in a flat 1-ounce pouch measuring approximately 4 inches by 6 inches.  Consumers would mix this powder into a glass of water, soda or juice to create an instant mixed drink.  Critics warn that the product’s main feature — how easy it is to store and carry — is also its biggest flaw.  For example, Dr. Pat Charles, the Superintendent of Middletown, CT Schools  stated, in support of a Connecticut ban of the product, “[t]he ability to conceal powdered alcohol is problematic for schools and law enforcement.  The ease of transporting it and the flavors proposed also make me concerned that it would lead to abuse, not just by young people but even for those of age.  This product must not be allowed to come into our state.”

After federal regulators approved Palcohol nationally in March, a number of states also moved to regulate Palcohol. According to the National Conference of State Legislatures, 39 states and Washington, D.C. have either passed bills or have bills under debate to restrict powdered alcohol.

“With packets small enough to fit into a child’s pocket, it will be harder for schools and parents to identify and confiscate this substance from our youth,” said Grace Barnett, spokeswoman for Texans Standing Tall, at a House Licensing and Administrative Procedures Committee hearing in March.  Texans Standing Tall is a nonprofit that advocates against youth drug and alcohol use.  Educators are fearful that youth may abuse powdered alcohol.  For example, NASPA, Student Affairs Administrators in Higher Education, recently hosted a series of seminars titled, “Addressing Palcohol: Comprehensive Prevention Tactics for Novel Alcohol and Substance Abuse Concern.”

State regulators have voiced concerns over the ease in which Palcohol can be inconspicuously sprinkled onto food or snuck into venues such as concert halls and stadiums. Vermont Liquor Control director Bill Goggins recently expressed this in an interview with a New York news station, adding that this feature adds to the appeal of powdered alcohol to underage individuals.

Senator Chuck Schumer (D, N.Y.) has even asked the Food and Drug Administration for an outright ban on the substance, calling it “the Kool-Aid of teenage binge drinking,” and said the product “is nearly guaranteed to promote unsafe drinking among teenagers and young adults, among others.”

Concertgoers, underage students, spiking drinks, snorting powder – can somebody please tell me what does any of that has to do with insurance?

In a post-palcohol world, consider whether any of the following are far-fetched:

  • What coverage exists for a concert venue when a concertgoer is injured by someone who ingested Palcohol that security did not confiscate, and sues the arena.  Does it matter that it is nearly impossible to control covert smuggling?

  • What claims will arise if a school finds that teens bring Palcohol to school to get intoxicated in class? Are any of them covered?

Palcohol may be a paradigm shifting product. Society is all too aware of the methods and problems of underage drinking and excessive drinking among adults.  All these current problems with alcohol are based upon a highly regulated liquid that is also hard to conceal in any material quantity.  Palcohol, and certainly additional products that will mimic Palcohol’s design, disrupts that model.  With this disruption arrives new realities of unexpected liability for companies, municipalities, schools and others.  We all know where they will turn next.

Article By Patrick M. Harrington & Sandra K. Jones of Drinker Biddle & Reath LLP

©2015 Drinker Biddle & Reath LLP. All Rights Reserved

Amarin Ruling Solidifies Off-Label Marketing Options but Raises Questions About False Claims Act Enforcement Action

The Southern District of New York recently ruled in Amarin Pharma, Inc. et al. v. Food and Drug Administration, et al. that a drug company may engage in “truthful and non-misleading speech” about off-label uses of an approved drug without the threat of a misbranding action under the Federal Food, Drug, and Cosmetic Act. No. 1:15-cv-03588 (S.D.N.Y., Aug. 7, 2015). This important decision—which arose out of Amarin’s constitutional challenge seeking to make certain statements about unapproved uses of a triglyceride-lowering drug, Vascepa—builds on recent Second Circuit precedent that allows drug makers more regulatory latitude, at minimum in the Second Circuit, to provide truthful and non-misleading scientific information about unapproved uses for their products. However, the ruling also serves as a reminder of potential False Claims Act (FCA) liability associated with off-label marketing of pharmaceuticals and devices.

Amarin filed its complaint against the Food and Drug Administration (FDA) after the company received a Complete Response Letter (CRL) from the FDA in connection with its application for approval of a new indication. The CRL indicated that, while clinical studies revealed that Vascepa reduced triglyceride levels, based on its data review, the FDA advised that additional clinical data would be needed before it could approve the drug for additional uses beyond the original approval for “very” high levels of triglycerides. Despite the fact that Amarin sought to make truthful and non-misleading statements about its product to “sophisticated healthcare professionals,” including the physicians who joined Amarin in the lawsuit, the FDA concluded there was insufficient support for approval of the supplemental application for a new indication and stated that any communications about off-label uses of Vascepa could result in enforcement action.

While the FDA described Amarin’s First Amendment claims as a “frontal assault on the framework for new drug approval that Congress created in 1962,” the court rejected all of the government’s counterarguments. Relying on the Second Circuit’s decision in United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), the court held that Amarin could engage in the following activity:

  • Distribute summaries and reprints of the relevant studies in a manner or format other than that specified by the FDA

  • Articulate, in connection with Vascepa, the off-label claim permissible for use on chemically similar dietary supplements

  • Make proactive truthful statements and engage in a dialogue with doctors regarding the off-label use

While the Amarin decision is welcome news for the industry, drug manufacturers must still take care to analyze promotional statements to ensure that the content can be successfully defended as “truthful” and “non-misleading” speech. As the Amarin court acknowledged, manufacturers not only face potential criminal exposure for “false” or “misleading” misbranding, but the promotion of off-label use can give rise to civil claims under the FCA. FCA enforcement in off-label cases—which proceed on a theory that a company caused false claims to be submitted to government health care programs for non-covered and non-FDA-approved uses—have been a huge source of FCA recoveries in recent years. In FY2014, for example, the Department of Justice (DOJ) recovered over $2.2 billion in FCA actions against pharmaceutical and medical device companies stemming from off-label promotion. Regulatory enforcers and qui tam whistleblowers will not hesitate to allege FCA violations where circumstances, for example, allow the inference that narrowly couched promotional statements may have been “truthful” but still factually incomplete and, thus, misleading. The Amarin decision highlights the fact-specific nature of the risk analysis. Amarin relied on truthful statements about Vascepa’s off-label use that were largely derived from an FDA-approved study and writings from the FDA itself on the subject. Rather than shooting from the marketing “hip,” Amarin appears to have invested in building a defensible factual scientific record and preemptively sought an FDA opinion regarding the off-label use of Vascepa before engaging in those communications.

While it remains unclear whether the FDA will appeal the Amarin decision to the Second Circuit, the agency’s decision to let Caronia stand without further appeal suggests that there may be reluctance on the part of regulators to risk a higher court expanding the reach of the Caronia holding across the country. Pharmaceutical and device manufacturers should still proceed cautiously as the FDA determines how it will respond following the Amarin ruling. For example, the FDA updated its draft guidance regarding the dissemination of scientific and medical journal articles following the Caronia decision in February 2014 and agreed in June 2014 to conduct a “comprehensive review [of its] regulatory regime governing communications about medical products,” with the intent of issuing new guidance by June 2015. As the Amarin court noted, this revised guidance is still forthcoming and may be further revised in light of this decision.

ARTICLE BY T. Reed Stephens & Amandeep S. Sidhu of McDermott Will & Emery

© 2015 McDermott Will & Emery