Tag: FDA

Top Takeaways from FDA Draft Guidance on Software as Medical Device

FDA software as medical deviceFDA’s proposed adoption of an IMDRF document raises questions.

On October 14, the US Food and Drug Administration (FDA) released a new draft guidance document, Software as a Medical Device (SaMD): Clinical Evaluation (Draft Guidance).[1] The Draft Guidance was developed by the SaMD Working Group of the International Medical Device Regulators Forum (IMDRF),[2] a voluntary group of medical device regulators from around the world, including FDA. This is the first time that FDA has proposed issuing an IMDRF document as an official FDA guidance document.

The Draft Guidance discusses clinical evaluation recommendations for SaMD and focuses on the general principles of clinical evaluation, which include establishing scientific validity, clinical performance, and analytical validity for an SaMD. The Draft Guidance is available for public comment until December 13, 2016. We have highlighted below key takeaways.

1. Cart Before the Horse?

Over the years, FDA has issued several guidance documents attempting to clarify its position on software products. For instance, in 2015, the Agency issued its final guidance on Mobile Medical Applications, which describes when FDA will or will not actively regulate software that can be executed on a mobile platform.[3] However, the Mobile Medical Apps guidance is limited to the specific mobile app examples listed in that guidance, and FDA has yet to issue its long-promised draft guidance on clinical decision support software. Thus, there is no clear overarching policy on when software used for health- or medical-related purposes would be considered SaMD, subject to FDA regulation. In this context, issuing guidance on FDA’s expectations for the clinical evaluation for SaMD seems premature. Software developers need to first understand where the proverbial line is before investing in clinical evaluation activities.

2. New Unadopted Terminology and Reference Documents Used

The Draft Guidance uses terminology defined in other IMDRF documents and also incorporates by reference findings from other IMDRF documents; however, FDA has not officially adopted those other IMDRF documents as FDA guidances. Thus, it is not clear whether FDA intends for this Draft Guidance to be the first volley, followed up by formally issuing other IMDRF documents on SaMD as FDA guidances, or whether FDA would simply consider the terminology and principles in those other IMDRF documents to be adopted by proxy if and when it finalizes this current Draft Guidance. It also is not clear how the principles and terminology in these other IMDRF documents align with FDA’s existing regulations and guidance documents. For instance, the Draft Guidance discusses a system of classifying SaMD based on its intended use and risk; however, it is not clear how this classification system would translate to FDA’s existing device classification system (Class I, Class II, and Class III) and classification regulations. Such an understanding is important for SaMD developers to determine the premarket review standard that will apply (e.g., establishing substantial equivalence vs. safety and effectiveness), because this will inform the goals for SaMD clinical evaluation.

3. Context Is Important

Although this Draft Guidance’s focus is SaMD clinical evaluation, a significant part of its 45 pages is used to provide definitions, general principles, context, and SaMD categorization principles (not to mention the references to other IMDRF documents, as described above). Only Section 6 directly addresses clinical evaluation. On that point, the new Draft Guidance describes clinical evaluation as the process for establishing the scientific validity, analytical validity, and clinical performance of an SaMD and provides recommendations for generating evidence in these three areas. The Draft Guidance further describes how to determine the required level of evidence based on the SaMD’s categorization. With regard to categorization, the Draft Guidance proposes a SaMD categorization scheme based on: (1) how the information generated by the SaMD will be used (for nondiagnostic, diagnostic, or therapeutic purposes), and (2) the criticality of the healthcare situation or condition in which the SaMD is to be used. An SaMD intended to treat or diagnose critical healthcare situations or conditions is considered higher risk and thus would be subject to more rigorous clinical evaluation requirements.

4. FDA Requests for Feedback

In its Federal Register notice announcing the new Draft Guidance, FDA highlighted specific areas for which it would like feedback, including the following:

  • Does the document appropriately translate and apply current clinical vocabulary for SaMD?

  • Are there other types of SaMD beyond those intended for nondiagnostic, diagnostic, and therapeutic purposes that should be highlighted or considered in the document?

  • Does the document adequately address the relevant clinical evaluation methods and processes for SaMD to generate clinical evidence?

  • Given the uniqueness of SaMD and the proposed framework, is there any impact on currently regulated devices or any possible adverse consequences?

Next Steps

The Draft Guidance document indicates that it is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the SaMD risk. However, questions remain about how these principles translate to FDA regulatory requirements.

The Guidance Document is available for comment until December 13, 2016 (Docket No. FDA–2016–D–2483).

ARTICLE BY Michele L. Buenafe & M. Elizabeth Bierman of Morgan, Lewis & Bockius LLP
Copyright © 2016 by Morgan, Lewis & Bockius LLP. All Rights Reserved.

[1] 81 Fed. Reg. 71105 (Oct. 14, 2016), https://www.gpo.gov/fdsys/pkg/FR-2016-10-14/pdf/2016-24805.pdf.  

[2] FDA,International Medical Device Regulators Forum (IMDRF) (last updated May 5, 2015), http://www.fda.gov/MedicalDevices/InternationalPrograms/IMDRF/default.htm.

[3] FDA, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff, (Feb. 9, 2015), http://www.fda.gov/downloads/MedicalDevices/…/UCM263366.pdf.

FDA Releases Draft Guidance for Manufacturers on Dissemination of Patient Data from Medical Devices

medical devices health dataOn June 9, 2016, the US Food and Drug Administration (FDA) published draft guidance outlining considerations for the “appropriate and responsible” dissemination of individualized data from medical devices from device manufacturers to patients.

In the draft guidance, FDA clarifies that medical device manufacturers may share “patient-specific information” from legally marketed medical devices with patients at the patients’ request without additional premarket review by the agency, provided such dissemination falls within the lawful scope for which the manufacturer may market the device. For purposes of the draft guidance, “patient-specific information” is any information that is unique to an individual patient or unique to that patient’s treatment or diagnosis that, consistent with the intended use of the device, may be recorded, stored, processed, retrieved and/or derived from that device. Examples of patient-specific information include recorded patient data, device usage/output statistics, provider inputs, alarms and/or records of device malfunctions. Patient-specific information does not, however, include any interpretation of such data aside from interpretations normally reported by the device to the patient or the patient’s healthcare provider.

When sharing patient-specific information with patients, FDA recommends that manufacturers consider the following factors to ensure that such information is usable by patients and to avoid the disclosure of confusing or unclear information:

  • Content of information provided.  The information provided to patients should be comprehensive and up-to-date, and manufacturers should take measures to ensure that such information is easily understood and useful to the patient. Depending on the type and scope of information being shared, the manufacturer should provide supplementary instructions, materials or references to help patients understand the data. In deciding what measures may be necessary, the manufacturer should be sure to consider whether any characteristics of the intended recipient audience (e.g., mental capacity) may affect the interpretability of the information.

  • Context in which information should be understood.  Manufacturers should provide the information in context to avoid situations where the information may be misinterpreted, leading to invalid or inappropriate conclusions.

  • Necessity of access to follow-up information.  Manufacturers should consider what, if any, information they should include about whom to contact for follow-up information.  At minimum, manufacturers should advise patients to contact their health care providers with any questions about their data. Manufacturers should also consider providing their own contact information to facilitate response to patient questions about the device.

The draft guidance is the latest in a line of documents in which FDA has attempted to clarify its expectations for—and in many cases, allay the concerns of—developers of mobile health products. Though short on specifics, developers should find the guidance helpful insofar as they have questions regarding the extent to which they can disseminate medical device data to patients. Notably, however, the FDA does not address how manufacturers should proceed with respect to the dissemination of many patient-specific analyses, likely because the agency intends to address such issues in its long-awaited guidance on clinical decision support software.

ARTICLE BY Michael W. Ryan of McDermott Will & Emery
© 2016 McDermott Will & Emery

“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.

FDA Outlines Future Medical Device Coordinating Center

FDALogoThe federal Food and Drug Administration’s planning board (Planning Board) for a medical device evaluation system (NMDES) recently recommended the creation of a centralized Coordinating Center to develop a national system to evaluate medical devices. Convened in 2014 by the U.S. Food and Drug Administration and the Brookings Center for Health Policy, the Planning Board emerged out of an FDA action plan in 2012 seeking to strengthen the medical device post-market surveillance system by building a more coordinated and efficient system that would track medical devices and share evidence regarding safety and efficacy.

In the report, issued on April 5, 2016, NMDES is described as a voluntary, coordinated network of partnerships that include government agencies, device manufacturers, provider organizations, health plans, and patient communities that share the common goal of “generating higher quality data and evidence at lower costs to inform and improve patient care.” The Coordinating Center proposed by the Planning Board would be responsible for governing, coordinating, and standardizing efforts among these participants. The Coordinating Center would not have explicit regulatory authority, but FDA’s authorities could authorize and initiate activities through the Coordinating Center.

NMDES as a Coordinated Network of Partners

ll post

This proposed network would build on the currently-existing limitations in obtaining evidence regarding medical devices, such as the absence of a broad adoption of unique device identifiers (UDIs) for tracking purposes, the expense of manual data entry and delays in data extraction, and limited participation in medical device tracking experts by health care providers and patients.

Although the Coordinating Center should be able to meet its objectives of optimizing data sharing, promoting best practices for device evaluation, and developing a process for disseminating safety and efficacy information, the proposed plan still has several hurdles to overcome. Under the timeline proposed in the report, it is “unlikely that a de novo entity can be organized.” Therefore, the Coordinating Center would have to be incubated at an “established hosting entity” with the plan to spin off the Coordinating Center and Governing Board into a “financially stable and independent entity.” Additionally, there is little concrete discussion of the source of early seed funding. Until such organizational and funding details are determined, NMDES and the Coordinating Center will remain aproposed system; however, as the report is the first in a series of papers to be released by the Planning Board, we expect more information to be forthcoming.

Article By M. Leeann Habte & Lindsey E. Gabrielsen of Foley & Lardner LLP

© 2016 Foley & Lardner LLP

FDA Issues Menu Labeling Final Guidance

Tomato labelThe enforcement date will likely begin in May 2017.

The US Food and Drug Administration (FDA) issued its final guidance on April 29 on Menu Labeling (Final Guidance).[1],[2] Importantly, the FDA intends to begin enforcing the Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Final Rule (Menu Labeling Final Rule)[3] one year from the date that the Final Guidance’s Notice of Availability (NOA) is published in the Federal Register. The NOA for the Final Guidance is expected to be published in early May 2016. Thus, enforcement of the Menu Labeling Final Rule will likely begin in May 2017.

The 58-page Final Guidance is largely a reprint of the previous draft guidance of the same name. The Final Guidance contains many nonsubstantive changes from the draft guidance and provides additional examples (as well as several new, revised, and/or reformatted questions and answers on topics such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and record-keeping requirements).
The more notable changes in the Final Guidance include the following:

  • The inclusion of examples for temporary menu items (e.g., jack o’lantern cookies or holiday gift tins of popcorn).

  • Exemptions for private off-site catering events from menu labeling, even where the catered items are standard menu items.

  • Mobile vendors who walk through entertainment venues (such as baseball parks) and sell food and beverages are not considered covered establishments, and thus are not required to comply with the Menu Labeling Final Rule.

  • Additional information provided to explain a menu board, where a “menu board” can include multiple forms of written material. The crucial factor of what constitutes a menu board is whether the written material is or is a part of the primary writing from which a customer makes an order selection.

  • Standalone coupons that can be used to place an order (i.e., the coupon contains the name of the standard menu item, the price, and the phone number/website) must provide calorie declaration. However, if a coupon does not include a web address or phone number for placing orders, then it is not considered a menu, and a calorie declaration is not required.

  • An additional description for the inclusion of sauce(s) nutrition information served in multiserving standard menu items.

  • Confirmation that the calorie declaration requirements for electronic menus and menus on the Internet are the same as the requirements for printed menus.

  • Clarification that standard menu items in different sizes are not considered variable menu items unless they come in different flavors, varieties, or combinations and are listed as a single menu item.

  • Additional examples of declarations of calories in combination meal products when a meal comes in multiple sizes with multiple choices of sides.

  • Clarification that, if a covered establishment has multiple digital menu boards with rotating displays, then the disclosure statements should appear on each rotating display of each digital menu board to help ensure that the statements are clear and conspicuous to the consumer and posted prominently.

  • Calorie declarations directly on the package of grab-and-go items should declare the calories for the entire package as they are usually prepared and offered for sale (rather than based on reference amounts customarily consumed (RACCs)).

  • Any substantiation records for nutrient values should be maintained either at the covered establishment or the corporate headquarters for the duration of the time that the standard menu items are offered for sale at the covered establishment. FDA also recognizes that it is not necessary to maintain information on nutrient values for foods that are no longer standard menu items and are no longer offered for sale at a covered establishment, because this information is no longer beneficial for consumers if they cannot purchase those items.

  • Further explanation of when FDA-required statements from responsible individuals employed at covered establishments for nutrient determinations are required, along with sample statement language.

  • Additional guidelines for alcohol—

    • For caloric declaration of multiple beers that have the same calorie amounts, a single calorie declaration can be used, provided that the declaration specifies that the calorie amount listed represents the calorie amounts for each individual beer variety.

    • Clarification that, to the extent that beers on tap are not self-serve, they are exempt from the requirements for calorie declarations of standard menu items.

    • Further explanation regarding the acceptability of covered establishments’ reliance on calorie information and nutrition information on alcohol beverage labels consistent with Alcohol and Tobacco Tax and Trade determinations.

    • Discussion about the inclusion of calorie information for “suggested” alcohol pairings.

    • The applicability of the Menu Labeling Final Rule to covered establishments that sell only one type of standard menu item (e.g., beer).

As previously stated, the Menu Labeling Final Rule and Final Guidance provide that the categories of covered establishments include not only restaurants and similar retail food establishments, but also movie theaters, amusement parks, bowling alleys, sports arenas, other entertainment venues, food service vendors, food takeout and delivery establishments, quick service restaurants, table service restaurants, convenience stores, coffee shops, bakeries, delis, grocery stores, supercenters, and fitness clubs.
However, the Common Sense Nutrition Disclosure Act of 2015, which passed in the US House of Representatives and is pending in the US Senate, would

  • direct the secretary of the US Department of Health and Human Services to issue new rules that allow a food establishment to post nutritional information exclusively on its website if the majority of its orders are placed online,

  • clarify that advertisements are not necessarily considered menus, and

  • aim to protect establishments from being sued for human error.[4]

We will continue to monitor congressional and FDA menu labeling activities.

Article By Robert G. Hibbert, Kathleen M. Sanzo, Christine Forgues Schlenker & Hilary L. Lewis of Morgan, Lewis & Bockius LLP
Copyright © 2016 by Morgan, Lewis & Bockius LLP. All Rights Reserved.

[1] FDA CFSAN Constituent Update, FDA Issues Final Guidance on Menu Labeling (Apr. 29, 2016), available here.

[2] A Labeling Guide for Restaurants and Retail Establishments Selling Away From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 C.F.R. 101.11): Guidance for Industry (Apr. 2016), available here.

[3] Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Calorie Labeling of Articles of Food in Vending Machines; Final Rule. 79 Fed. Reg. 71156 (Dec. 1, 2014), available here.

[4] See Text of the Common Sense Nutrition Disclosure Act of 2015, H.R. 2017 (Referred to Senate Committee Feb. 22, 2016), available here.

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.