Warning Letters Update

By Mason Weeda

This past week FDA made a number of Warning Letters available on its website, with issues ranging from Juice HACCP to cGMPs for finished pharmaceuticals. A Warning Letter is informal and advisory, with the aim to achieve voluntary compliance and to establish prior notice. It communicates the agency’s position on a matter, but it does not commit FDA to taking enforcement action. Basically, you should read Warning Letters relevant to your industry because they can provide you with examples of what not to do. Here’s a quick run-down of Warning Letters published this week that we thought merited a closer look:

  • FDA issued a March 31, 2015 Warning Letter to Hospira S.p.A. for alleged violations of current good manufacturing practice regulations (cGMP) for finished pharmaceuticals at a manufacturing plant in Italy. The Warning Letter provides that Hospira failed to:
    • establish procedures to prevent microbiological contamination of sterile drug products and include validation of sterilization processes;
    • thoroughly investigate any unexplained discrepancy or failure of any batch;
    • exercise appropriate controls over computer or related systems so that only authorized personnel institute changes in master production/controls records; and
    • ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

The Warning Letter details Hospira’s failure to evaluate certain airflow studies, and its improper rejection of various vials during the manufacturing process without explanation. Ultimately, FDA stated that Hospira’s response to its inspectional observations lacked adequate corrective action.

  • FDA issued March 27, 2015 Warning Letters respectively to Avanti Health Care and Kings Pharmacy regarding deficiencies in their practices for producing sterile drug products. Both firms compound drugs and registered with FDA as outsourcing facilities and, therefore, were required to, among other things, comply with the Compounding Quality Act and cGMP requirements. Though Avanti was cited for six (6) cGMP violations and Kings was cited for three (3), the letters are very similar in many respects. During the inspections of both facilities, respectively, FDA observed that, among many violations, drug products were prepared under insanitary conditions, where operators failed to use proper aseptic technique in designated areas. Both firms also failed to include mandatory labeling for compounded products (i.e., “this is a compounded drug” and “not for resale”). These letters demonstrate FDA’s ongoing effort to more closely regulate and inspect outsourcing facilities. Avanti registered as an outsourcing facility on April 21, 2014, and FDA began its inspection only two (2) months later on June 23; Kings Pharmacy registered on December 23, 2013, and was inspected just three (3) months later.
  • FDA issued a March 25, 2015 Warning Letter to Skin Authority, LLC for making promotional claims on its website that indicate that its products, though labeled as cosmetics, were, in fact, promoted as drugs. The Warning Letter lists examples of drug claims for serums, scrubs and creams made on the website, including, for example, “help inhibit cellular breakdown,” “foster skin growth,” “help counteract infection,” “improve anti-inflammatory response,” and “increase cell growth.” The products were not generally recognized as safe and effective for the uses listed on the website, were not subject to any FDA-approved New Drug Application, and, therefore, were “new drugs” that required FDA approval prior to marketing.

The information that the agency communicates in a Warning Letter can be invaluable as it provides important, cautionary lessons for regulated industry and provides a view into the agency’s current thinking. You can keep tabs on Warning Letters by checking our blog periodically or by looking on FDA’s Warning Letters webpage.

Food Facility Registration Rules To Be Updated by FDA

by Michael J. O’Flaherty

FDA has published a proposed rule that would amend and update its regulatory requirements governing registration of food facilities.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which essentially directed FDA to take steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply, added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Among other actions taken to implement the Bioterrorism Act, pursuant to section 415 the agency established regulations requiring that food facilities register with FDA. These regulations became effective on December 12, 2003.

The FDA Food Safety Modernization Act (FSMA) of 2011 amended section 415 of the FD&C Act to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the U.S. submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. As amended, section 415 also requires food facilities to renew their registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances. FDA has issued a number of guidance documents to assist the industry in complying with the food facility registration requirements. See generally Guidance for FDA Staff: Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food (June 2014); Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition) (rev. Nov. 18, 2014); Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small Entity Compliance Guide (rev. Dec. 17, 2014); and Guidance for Industry: Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories (rev. May 18, 2014)..

Under FDA’s present regulations, certain food facilities, including retail food establishments, are exempted from the requirement to register. The proposed rule would amend the regulatory definition of a “retail food establishment” in a way that would expand the number of establishments that are subject to the exemption. A retail food establishment is currently defined as an establishment that sells food products directly to consumers as its primary function. An establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The proposed rule would clarify that, in determining the primary function of an establishment, the sale of food directly to consumers from an on-farm establishment includes sales by the establishment at such direct sales platforms as roadside stands, farmers’ markets, and Community Supported Agriculture (CSA) programs. Based on currently available data, FDA estimates that there are approximately 71,000 farms that only sell food products directly to consumers in ways that include farmers markets, roadside stands, and CSA programs. [Note: Inasmuch as the amended definition would exempt additional establishments from the requirement to register, these establishments also would not be subject to the requirements of the FSMA preventive controls rulemakings, which apply to facilities that are required to register.] See generally Questions and Answers for Farmers on FSMA Proposed Rule for Food Facility Registration (rev. Apr. 8, 2015).

For food facilities that are not exempt from registration, the proposed rule would add new provisions to the current regulations to codify certain requirements of FSMA that were self-implementing and effective upon enactment of FSMA. Those requirements are:

  • Registrations for domestic facilities must contain the email address of the contact person of the facility, and registrations for foreign facilities must contain the email address of the U.S. agent for the facility.
  • Food facilities that are required to register with FDA must renew their registrations every two years, between October 1 and December 31 of each even-numbered year.
  • All food facility registrations must contain an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

In addition, the proposed rule would add certain new requirements, including:

  • All food facility registrations would be required to be submitted to FDA electronically; however, this requirement would not take effect before January 4, 2016.
  • Registrations would be required to contain the type of activity conducted at the facility for each food product category.
  • The proposed rule would provide for measures to verify certain information submitted in registrations.
  • The proposed rule would identify additional circumstances under which FDA will cancel registrations (i.e., FDA independently verifies that the facility is not required to register; information about the facility’s address was not updated in a timely manner; the registration was submitted by a person not authorized to submit it).

Public comments on FDA’s proposed rule may be submitted electronically or by regular mail until June 8, 2015.

FDA DRAFT Guidance: “Ensuring Safety of Animal Feed Maintained and Fed On-Farm”

By Jolyda O. Swaim

In earlier blogs, I have mentioned having horses and other animals while growing up on a small farm.  Even now, to my husband’s dismay, I have never outgrown being “horse crazy.”  But during all this time, I never remember being concerned about the animal feed I have purchased or used.  I do qualify this statement in that I knew certain things could not be fed to horses and that you better know where your sawdust was coming from to ensure it did not include black walnut.  But as to the commercial feed I purchased – I never gave it a thought.

Recently, the FDA issued a draft guidance entitled “Ensuring Safety of Animal Feed Maintained and Fed On-Farm.”  Comments on the draft are due by June 3, 2015.

This guidance is intended to help animal producers – those who feed animals, including horses – in developing and implementing on-farm practices to ensure animal feed is maintained and fed in a safe manner.  It provides good information for not only those feeding animals commercially, but for those who have one or two animals in the backyard they are raising for personal use.

In general, the guidance encourages people feeding animals to consider and apply the following principals:

  1. Know what feed contaminants may be present in your animals’ feed and the measures known to prevent such contaminants from becoming unacceptable feed risks;
  2. Obtain feed from safe and reliable sources;
  3. Recognize unexpected changes in the feed at your farm (e.g., changes in color, smell, texture, or appearance);
  4. Know where in your production system unacceptable feed risks may occur;
  5. Monitor animal feed products for contaminants during receiving, holding, and handling; and
  6. Be aware that other actions, such as limiting access to the premises to authorized personnel, following feed labeling directions, proper personnel training, and sampling and testing of feed, can help ensure feed safety.

The definition of “feed contaminants” are “any biological, chemical, physical, or radiological agent that if present in feed has the potential to cause illness or injury to animals or humans.”  Appendix A to the draft guidance lists examples to be considered.  When a contaminant rises to the level that is “reasonably likely to cause illness or injury in animals or humans,” this is considered an “unacceptable feed risk.”  Appendix A also lists examples of these.

The guidance provides a number of sources for review that identify feed contaminants that can be associated with particular types of farms and feed activities.  These include:

The guidance also has recommendations for safe feeding practices that farms should consider adopting such as knowing the requirements for animal feed in your state, and  taking steps to prevent or significantly minimize the occurrence of feed contaminants in feed (e.g., pest control measures, regular and adequate cleaning of animal feeding areas and equipment, good storage practices) among others.  Information is even provided regarding your pastures and bedding – think my comment on sawdust!

Many considerations relate to how you store feed, such as the need to ensure use of oldest first, and that the correct feed is used for each animal.  The guidance also has recommendations for farms with intensive animal feeding operations.  Other information includes safe use of pesticides, fertilizers, and other agricultural chemicals, personnel training and sampling and analyzing feed.

Finally, FDA provides information on steps to take if you have a concern about feed safety.  These include:

  1. Take immediate measures to ensure the product is not fed to animals;
  2. Review the FDA website about reporting problems to the agency;
  3. Promptly consult a veterinarian if feed may cause or has caused a negative effect on animal health; and
  4. If you suspect there could be a negative effect on human health from ingestion of food products derived from animals that ate contaminated feed, promptly contact local and state health departments.

The guidance provides thoughtful advice on what should be considered when feeding animals on small or large farms and should be reviewed by anyone with a few animals to many animals.

Tip

At minimum, after you dump that bag of feed into your grain bin, cut off the label with the lot number and maintain it in a plastic bag!  Always keep the current feed’s label(s) in the plastic bag.  This way, if something does go wrong, you have the information on what you last fed your animal/s.  This goes for whatever type of animal you are feeding, including your dogs and cats.  With this information, you won’t be trying to figure out whether or not what you have in that storage container is part of the most recently-announced recall!

Regulatory Round-Up Newsletter, Spring 2015

On behalf of the Agriculture practice group at OFW Law, here is a copy of our Spring newsletter.  We hope you find it useful.  To receive this periodic newsletter by e-mail, please contact Carrie Morgan at cmorgan@ofwlaw.com.

Tonight: Global Child Nutrition Foundation Honors USDA Secretary Vilsack

By Peter B. Matz

Secretary Vilsack

Please join the Global Child Nutrition Foundation (GCNF) and its partners in honoring Secretary Vilsack for his remarkable achievements in child nutrition. GCNF’s Annual Gala has become a signature Washington event, bringing together executives from industry as well as high-level officials from both government and NGO’s.  It will take place tonight, from 5:30-7:30 PM, at the Ronald Reagan Building and International Trade Center in Washington, DC.  Details below.

The Gala raises funds for GCNF’s efforts to end child hunger by helping developing countries establish sustainable school feeding programs. At this moment, over 350 million hungry children live in extreme poverty throughout the world. School feeding programs nourish children, provide an incentive for children to go to school, and help lift children, their families and their communities out of poverty.

Global Child Nutrition Foundation’s Annual Gala Reception Honoring

U.S. Department of Agriculture Secretary Tom Vilsack

Thursday, April 16 2015

5:30pm-7:30pm

The Ronald Reagan Building and International Trade Center

1300 Pennsylvania Avenue Northwest, Washington, DC 20004

More information at www.gcnf.org

Secretary Tom Vilsack

Throughout his long and distinguished career in public service, Secretary Vilsack has demonstrated his commitment to the nutritional well-being of children at home and abroad. As Governor of Iowa, Vilsack created the Iowa Food Policy Council to advance local food systems, enhance family farm profitability, and combat hunger and malnutrition.  At USDA, Secretary Vilsack is a key Cabinet leader on global food security and served as one of the primary architects of President Obama’s Feed the Future Initiative launched in 2009. Under his leadership, USDA has contributed to improved global food security by focusing on capacity building to improve markets information, food safety systems, basic and applied research and innovations in agricultural productivity.

In 2013, Secretary Vilsack led U.S. efforts on the Global Open Data for Agriculture and Nutrition, which seeks to support global efforts to make agricultural and nutritionally relevant data available, accessible, and usable for unrestricted use worldwide in order to improve consumer health and expand economic opportunities for farmers. Building on those efforts, in 2014, Secretary Vilsack led the launch of U.S. participation in the Global Alliance for Climate-Smart Agriculture, a global effort to share knowledge and practices to address climate change and its impact on agriculture and chart a new path forward towards greater global food security.

Secretary Vilsack continues to be a strong voice for improving the nutritional quality of domestic child nutrition programs and has focused USDA’s McGovern-Dole School Feeding Program on meeting rigorous nutrition and literacy goals. Child nutrition programs in the United States have become global models of excellence under Secretary Vilsack’s leadership and commitment.

2015 Dietary Guidelines Advisory Committee Report Mixes Science and Policy

By Robert A. Hahn

The 2015 Dietary Guidelines Advisory Committee (DGAC) submitted its report to the Secretaries of Agriculture and Health and Human Services last month and disbanded.  It is now up to the USDA and HHS to take the DGAC’s conclusions and recommendations and issue a revised edition of the Dietary Guidelines for Americans.  Interested persons may submit comments on the DGAC report until May 8, 2015.

Some aspects of the DGAC report have been controversial.

  • More than any previous committee, the 2015 DGAC wades heavily into the policy arena. Its report includes a number of controversial policy prescriptions such as the following:
    • FDA should revise the Nutrition Facts label to include a mandatory declaration for Added Sugars, in both grams and teaspoons per serving, as well as a % Daily Value based on a DV of no more than 10% of total calories (e., 50 g);
    • FDA should create a standardized front-of-pack (FOP) nutrition label that would appear on all food products and that would provide clear guidance regarding a food’s healthfulness;
    • FDA should establish mandatory national standards for the sodium content of foods;
    • Federal nutrition assistance programs, including Food Stamps (the Supplemental Nutrition Assistance Program), should be aligned with the Dietary Guidelines; and
    • Governments should use economic and tax policies to encourage the production and consumption of healthy foods and reduce consumption of unhealthy foods (g., by taxing sugar-sweetened beverages, snack foods, and desserts; by restricting marketing of certain foods to children and teens).

We expect USDA and HHS to take these policy recommendations under advisement, but not include them in the Dietary Guidelines.

  • For the first time, the DGAC report includes a chapter devoted mainly to the issue of sustainability. While the committee offers a justification for addressing environmental sustainability in a document about nutrition, some have questioned whether environmental issues are within its mandate.
  • While acknowledging that virtually all foods can be part of a healthy dietary pattern, the DGAC strongly favors a diet higher in vegetables, fruits, whole grains, low and non-fat dairy products, seafood, legumes, and nuts and lower in red and processed meats, sugar-sweetened foods and beverages, and refined grains.  There is a concern that some of the complexities of previous nutritional recommendations may be lost in this emphasis on a healthy dietary pattern.  For example, the emphasis on whole grains might lead some consumers to neglect enriched refined grains, which also play a significant nutritional role.  The emphasis on reducing consumption of red and processed meats may cause some consumers to overlook lean meat as a good source of heme iron, even though the report notes that iron is a nutrient of concern for adolescent girls and premenopausal women.

While these controversial aspects of the DGAC report have received the most attention, there are some other interesting findings and recommendations in the report worth noting:

  • While continuing to recommend reductions in intake of sodium and saturated fat, the 2015 DGAC backs away from the sharper reductions recommended by the 2010 committee. Whereas the 2010 DGAC recommended no more than 1,500 mg/day of sodium, the 2015 DGAC recommends no more than 2,300 mg/day.  Whereas the 2010 DGAC called for gradually reducing saturated fat to <7% of total calories, the 2015 DGAC only recommends reducing saturated fat to <10% of total calories.
  • The report deflates some of the recent concerns expressed by FDA and members of Congress about caffeine. The DGAC concludes that U.S. caffeine intake does not exceed what is currently considered to be a safe level in any group.
  • The DGAC concludes that there is limited and inconsistent evidence that calorie labeling on menus and menu boards affects food selection or consumption.
  • For commonly consumed fish species (g., cod, trout, salmon), the DGAC found that farm-raised seafood contains as much or more of the omega-3 fatty acids EPA and DHA as the same species caught in the wild.

The 2015 Dietary Guidelines is expected to be released in the fall.

The Vilsapp: Secretary Vilsack’s High Tech Solution to Labeling

By Marshall L. Matz, as published in Agri-Pulse

The March edition of the National Geographic Magazine, in its cover story entitled “The War on Science,” notes that “there’s no evidence that GMO’s are harmful to human health.” A recent Pew poll found that 90% of all scientists believe GMO’s are safe but only 37% of the public agrees. In short, the public is skeptical and is seeking more information about foods made with genetic engineering. We live in an era of transparency, open data and the world-wide web. It is difficult to deny consumers the right to know what is in their food. And given the safety of genetic engineering, there is no reason to block that information.

The question on the table is how to do this in a nationally-uniform, unbiased manner? To allow each of fifty states to have its own labeling scheme would be confusing, very expensive, bad public policy and, in my opinion, unconstitutional. It would be as crazy as having fifty different Dietary Guidelines or fifty different Nutrition Facts panels on the foods we buy.

Secretary VilsackAgriculture Secretary Tom Vilsack has a better idea: a smartphone application that can scan a bar code on the food package and tell the consumer what is in the product. He took his idea to Congress last month. His idea is a very modern and clever solution to address the desire for more information about the foods we consume.

There is only so much room on the food label. So, Secretary Vilsack is suggesting a symbol on the food label that connects to a database that can tell those consumers who want such information whether there is an ingredient in the food produced with genetic engineering. According to a recent edition of the Economist, “about half of the adult population owns a smartphone; by 2020, 80% will. Smartphones have also penetrated every aspect of daily life.” For those without smartphones, there could be in-store computers or scanners.

Dr. Cathy Enright, VP for Agriculture at the Biotechnology Industry Organization (BIO), posted a blog last month that said:

“I also support a right-to-know. In 21st century America, consumers are increasingly asking questions about how their food is grown and made. We all need to be working together to provide that information, in a way that doesn’t misinform consumers. Have you seen USDA Secretary Vilsack’s idea….using a bar code or other code on a food package or sticker?”

Last year, Cardinal Peter Turkson, speaking on behalf of the Vatican, said we must use biotechnology to feed the world’s expanding population, but also supported the idea of transparency to provide information to consumers who desire such information. The Vatican seems to be in agreement with the Secretary and those who believe in both the safety of genetic engineering and the moral imperative of using science to feed the hungry, but also the consumers’ right to know.

Nutrition FactsUSDA and HHS will issue a new edition of the Dietary Guidelines for Americans later this year. The Dietary Guidelines Advisory Committee and the FDA are seeking to put more information on the actual food label. It is time to use technology to expand the physical size of the label.

Every industry seems to be using technology to the maximum possible extent. The food industry should follow suit. There are questions that would still have to be resolved as with any app: who would maintain the data base? What would be the definition of genetic modification and would there be some threshold that triggers the GE designation? What happens with foods that used a GE ingredient where it was then processed out of the product and there is no trace in the final food?

These are all challenging questions that would have to be resolved. But this much is clear, there must be federal preemption of state labeling schemes and a uniform national system established. To date, the labeling campaign has been pushed as an attack on genetic engineering as a part of the larger war on science. Information should be provided, not as a scare tactic and warning, but just as factual information for those who care.

Perhaps there is a better idea than the Vilsack App, but this idea sure deserves serious attention. On March 5th, at the House Agriculture Appropriations Subcommittee hearing to review the FDA budget, Dr. Hamburg reiterated that FDA does not see mandatory labeling as appropriate if there’s not a significant change to the product. If the process changes the nature of the product, then it would have to be labeled. She also said FDA supports individual companies that want to voluntarily label products and plans to issue a guidance to guide them in the near future. Dr. Hamburg should include the Vilsapp as a way of providing consumer information and include it in the guidance that FDA issues.

The Wall Street Journal recently published a guide to some of the terms being used on supermarket egg cartons. They include Organic, Cage-Free, Free-Range, All Natural, Pasture Raised, and Vegetarian Fed and Omega-3. The Vilsapp could help the confused consumer better understand these terms as well.

In short, the Vilsapp is a creative idea that could provide the transparency deemed important by consumers and also preempt the need for state legislation. The need for state preemption is paramount and was emphasized by all of the witnesses at the House Agriculture Hearing on March 24th.

Dr. Nina Fedoroff, the Senior Science Advisor at OFW Law, concluded her testimony with the following: “We will need to produce more crops per drop of water and square meter of land” in order to feed 9 to 10 billion of people. Genetic modification is not a magic bullet but is safe and an important part of the arsenal needed to defeat food insecurity.

A patch quilt of different state labeling schemes would be a barrier to global food security. Transparency and full disclosure is reasonable but it must be done with a national system that is based on sound science and provides objective information.

Mr. Collin Peterson, the Ranking Member, summed it up best: “When it comes to labeling, we need to be able to find a smart way to balance the consumer demand with what we know about the safety of the foods that our farmers produce.” Sounds like a Vilsapp.

Marshall Matz, formerly Counsel to the Senate Select Committee on Nutrition and the Senate Committee on Agriculture, specializes in agriculture and nutrition at OFW Law.

Dietary Guidelines – Confused About Caffeine

By OFW Law founding principal Richard L. Frank, sitting in for former USDA Secretary John R. Block

The news wires have been buzzing lately about the recently released scientific report of the Dietary Guidelines Advisory Committee. One of the hottest topics for discussion is how out of step the report is on a number of issues, including the Committee’s dive into political matters like sustainability, soda taxes, and “added sugar” labeling. These topics are outside the jurisdiction of the Dietary Guidelines and should be addressed by Congress or the FDA.

Today, I want to discuss caffeine consumption. Caffeine is something that has never been addressed before by the Dietary Guidelines for Americans and probably for good reason. First, caffeine is safe…and safety is outside the mandate of the Dietary Guidelines. It is a topic that fits firmly within the jurisdiction of the FDA. Secondly, America seems to know what it’s doing when it comes to caffeine. 85% of Americans consume caffeine every day – and they have done so safely for generations.

In the Committee’s conclusions on caffeine, they suggest that 3 to 5 cups of “Morning Joe” are just fine – up to a moderate intake level of 400 milligrams per day for healthy adults. Inexplicably, however, they seem to suggest that energy drinks with the same amount of caffeine should be avoided.

The Committee’s approach is troubling for a number of reasons, the least of which is that many coffee house chains serve coffee beverages that contain twice as much caffeine per fluid ounce as a standard energy drink. A typical small can of a leading energy drink contains 80 mg caffeine, which is roughly the same as a regular cup of coffee or a 20 ounce bottle of cola.

Why is the Committee treating caffeine in coffee differently from the caffeine in energy drinks? This is puzzling when we consider that caffeine is caffeine is caffeine – whether found in coffee, tea, cola, or energy drinks.

The report acknowledges that the largest sources of caffeine among both adults and children come from coffee, tea, and soda. So why is caffeine in coffee okay, while tea and soda are ignored and energy drinks are vilified? Possibly it’s politics!
The Dietary Guidelines should provide a practical and achievable set of dietary and nutrient recommendations, based on balance, variety, and moderation. It should not delve into political topics that are outside its mandate.

If the Dietary Guidelines are to address topics like caffeine, it should be done holistically and in an unbiased way. Consumers need to understand caffeine in context and be provided information with respect to all sources to enable them to make informed dietary decisions; otherwise they will get confused.

Let’s hope that the USDA and HHS take the lead on the important task of finalizing the 2015 Dietary Guidelines for Americans in a scientific, rather than a political and an emotional, way.

Who Regulates the Advertising of Your App?

By Mason Weeda

We have blogged and hosted numerous webinars on FDA regulation of mobile medical apps (see here, here, here, here and here); but if you are an app developer, you should be aware that FDA is not the only agency looking at your app.  The Federal Trade Commission (FTC) may also be watching how you promote your app.  In fact, on February 23, 2015 the FTC announced that it reached settlements with two firms marketing melanoma detection apps.  The agency was unable to reach a settlement with a third developer and intends to pursue a judgment through litigation.  Both apps claimed to provide an “automated analysis of moles and skin lesions for symptoms of melanoma and increase consumers’ chances of detecting melanoma in its early stages.”  In sum, the FTC alleged in its complaints that the mobile app developers lacked adequate evidence to support such claims.

FTC authority coincides with other agencies in many respects, see e.g. here, and here.   And there is nothing really new with the FTC taking action against mobile app developers.  In 2011, the FTC filed complaints against developers of “acne cure” apps that claimed to treat acne through a light emitted from the device if you held it close to your face. The FTC alleged that those claims were unsubstantiated.

The FTC regulates many types of advertising and protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace. Under the Federal Food Drug and Cosmetic Act, the Food and Drug Administration (FDA) has regulatory authority over the labeling of all medical devices. Labeling includes any “written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article…”   Sections 502(q) and 502(r) of the FD&C Act authorize FDA to regulate the advertising of certain devices, which are known as restricted devices.  Section 502(r) also states that restricted devices are not subject to FTC’s broad authority over advertising under 15 U.S.C. § 52-55.

Dr. Jeffery Shuren, Director of FDA’s Center for Devices and Radiological Health, summarized the FTC/FDA division of authority best: “FDA regulates the advertising of restricted medical devices while the FTC regulates the advertising of non-restricted devices.”   A device becomes a “restricted device” when:

  1. FDA by regulation restricts a device to sale, distribution or use only upon the authorization of a practitioner licensed by law to administer or use such device, or upon other conditions that FDA prescribes in the regulation, if FDA determines that there cannot otherwise be reasonable assurance of the device’s safety and effectiveness.  (Note that prescription devices may or may not be restricted devices).
  1. FDA requires, as a condition of approval of a Class III device, that its sale and distribution be restricted, but only to the extent that the sale and distribution of the device may be restricted by a regulation.
  1. FDA establishes, as part of a performance standard promulgated in accordance with section 514(b) of the FD&C Act, requirements that restrict  the sale and distribution of a device, but only to the extent that the sale and distribution of the device may be restricted by a regulation.

Based on FTC’s description of the melanoma detection apps, it appears that the app developers are likely required to obtain premarket approval (PMA).  FDA’s Mobile Medical Application Guidance provides that the Agency intends to actively regulate mobile apps that “use the mobile platform’s built in features, such as… a camera, to perform medical device functions.”  The melanoma apps use the device platform (i.e. the camera) to collect and review an image for use in providing a diagnosis.   Furthermore, this type of app appears to perform the same medical device functions of an “optical diagnostic device for melanoma detection” which FDA classifies as Class III under product code OYD, which requires a PMA.  In addition, FDA premarket approval letters indicate that “optical diagnostic devices for melanoma detection” are restricted devices pursuant to 21 C.F.R. § 801.109.

It appears that FDA would, upon premarket approval, treat these types of melanoma apps as restricted devices and therefore would have authority to regulate the app’s advertising.  However, it remains that these app developers never submitted a premarket application or received premarket approval from FDA.  Therefore, the Agency was not able to require, as a condition of approval, that their sale and distribution be restricted.  As such, FDA does not have the ability to regulate the advertising of these apps.

The instant FTC complaints and settlements appear relatively minor compared the potential FDA issues involving marketing a product without approval. More importantly, FDA is in no way foreclosed from taking action so we will see if and when FDA acts in the coming months against the app developers.

No Horsing Around – Nevada Federal Judge Dismisses Burro Suit Against Interior Dept.

By Stewart D. Fried

The serious environmental problems caused by unchecked wild horse populations on western rangelands are well known to state and local governments, Native American tribes, ranchers and farmers.  Efforts, however, to prompt the U.S. Department of Interior (“Interior Dept.”) and its Bureau of Land Management (“BLM”) to address widespread environmental damage and other impacts caused by wild horse overpopulation have been largely unsuccessful.  Environmental and other issues caused by thousands of wild horses on federal lands are perhaps most pronounced in Nevada.  The Silver State is estimated to be home to nearly half of the country’s wild horse population.   Because BLM is not doing enough to address exponential population growth, wild horse herd sizes are increasing by 20% annually.

The Wild Free-Roaming Horse and Burros Act, 16 U.S.C. §1331 et seq., (“Wild Horse Act”) governs the Interior Dept.’s duties with respect to wild horses on federal lands.  The Wild Horse Act mandates that the Interior Dept. protect and manage wild horses and burros, including the responsibility to “maintain a current inventory of wild free-roaming horses and burros on given areas of the public lands.” 16 U.S.C. §1333(b)(1).  Under the Wild Horse Act, a “natural ecological balance” among wild horse and burro populations, domestic livestock, wildlife and vegetation must be achieved.

In order to achieve that balance, the Interior Dept. determines whether Appropriate Management Levels (“AMLs”) should be achieved by the removal or destruction of excess animals.  BLM describes as “the number of wild horses and burros which can graze without causing damage to the range.”  In establishing AMLs, BLM relies on studies of grazing utilization, trends in range condition, weather data and other factors.  BLM also takes into consideration populations of wildlife, permitted livestock and wild horses and burros in the area. Id.  BLM sets AMLs following public involvement through an in-depth environmental analysis and decision process. Id.  In enacting the Wild Horse Act, Congress expressly required the Interior Dept. to “immediately remove excess animals” from the range so as to achieve AMLs when it is determined that “an overpopulation exists on a given area of the public lands and that action is necessary to remove excess animals.”  16 U.S.C. §1333(b)(2).

With these seemingly clear statutory mandates in mind, several Nevada counties, farming and ranching associations and other interested parties have attempted, with limited success, to prompt BLM to address the problem of wild horse overpopulation on Nevada rangelands.  Based on BLM’s inaction and ever-worsening damage to public resources and increased threats to private water rights, the Nevada Association of Counties and the Nevada Farm Bureau (“Counties”) sued the Interior Dept. in federal court in Reno during December 2013, alleging constitutional violations and seeking judicial review under the Administrative Procedures Act (“APA”).

On February 12, 2015, Federal District Court Judge Miranda Du issued her opinion in Nevada Association of Counties v. Interior Dept., dismissing the Counties’ complaint with prejudice.  Judge Du concluded that she lacked subject matter jurisdiction over the case because the Plaintiffs’ amended complaint “failed to identify a final agency decision” by BLM that was being challenged.  The Court noted that the Wild Horse Act does not provide for a private cause of action and that any challenge to federal action brought under the APA must be based either on “final agency action that warrants judicial review or any inaction that may be compelled.”  Order, at 4.

The crux of the Court’s decision was founded on its determination that the plaintiffs “sought review of flaws in the entire program” to “compel compliance with the Act and refashion [BLM’s] management of wild horses and burros in Nevada.” Id., at 7.  In describing the Counties’ lawsuit as a “programmatic attack” on the entire BLM program, the Court focused on the Plaintiffs’ failure to allege that BLM failed to set “a single AML or inventory” or any another specific final agency action.  Judge Du also dismissed the Counties’ constitutional claims because the amended complaint failed to allege a property interest that was taken or otherwise affected by BLM’s mismanagement of wild horses, or how BLM’s responses to the Plaintiffs’ notices that wild horses were outside designated management areas or were interfering with water access fell short of due process.

The dismissal of the Counties’ lawsuit is the latest chapter in a lengthy and still unfinished book about wild horses on the Western range.  Although BLM has removed over 100,000 wild horses during the past decade from federal lands, the equine overpopulation problem continues to expand in every state and most tribal lands from the Cascades to the Mexican border.  Congress has again foreclosed horse slaughter as an option for reducing herd size, despite a thriving market abroad and several domestic facilities that received (or were eligible to receive) FSIS grants of inspection during 2012.  While an appeal of the decision is possible, this is likely an uphill battle it would need to be filed in the generally unfriendly Ninth Circuit Court of Appeal.

In light of the District Court’s decision, states, tribes and other stakeholders may need to go back to the drawing board.  Because Judge Du took issue with the Plaintiffs’ failure to identify particular BLM decisions with respect to specific inventories or AMLs, next steps could include identification of specific herd management areas where BLM has failed to conduct inventories or set AMLs or identifying herd management areas where severe erosion and other ecological damage exists, conducting wild horse herd population surveys in those areas (assuming data does not already exist), and then filing petitions with BLM seeking the establishment of inventories or AMLs and demanding that the Bureau conduct removal activities in accordance with the Wild Horse Act.  This will take considerable time and effort, all while wild horse populations will continue to increase and environmental and other harms from equine foraging, especially to water quality, will not be addressed.  What is clear is that there likely will be no swift resolution to the environmental and animal welfare problems associated with this hotly-debated symbol of the West.

A copy of the District Court’s decision in Nevada Association of Counties v. U.S. Department of Interior can be found here.