The Development of the 2015 Dietary Guidelines for Americans Begins

By Roger R. Szemraj

The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA), announced today that the first meeting of the 2015 Dietary Guidelines Advisory Committee (DGAC) will be held on June 13, 2013 from 8:30 a.m. – 11:30 a.m. E.D.T. and June 14, 2013 from 8:30 a.m. – 3:45 p.m. E.D.T. at the National Institutes of Health (NIH) Clinical Center, 9000 Rockville Pike, Bethesda, MD.  The meeting is open to the public and will be webcast, but registration by June 10 is required.

The Dietary Guidelines for Americans (the Guidelines) is published every five years.  The Office of Disease Prevention and Health Promotion at HHS is the lead entity in developing the 2015 edition, and will work jointly with USDA’s Center for Nutrition Policy and Promotion in Committee in the process.  This will be the 8th edition of the Guidelines.  The DGAC will be composed of experts jointly appointed by the Secretaries of HHS and USDA.

The Guidelines provide science-based diet recommendations for Americans ages 2 years and over.  It also is the baseline for USDA’s nutrition education programs, as well as for meal standards in the National School Lunch Program, the School Breakfast Program, and the currently proposed competitive food rule.   It is also worth noting that the President’s 2014 budget request includes a $2 million proposal for USDA’s Center for Nutrition Policy and Promotion to complete Phase I of developing unified, Federal dietary guidance for infants and very young children from birth to 2 years of age.  If approved, the new edition of the Guidelines could for the first time provide information for this additional group.

The meeting on June 13-14 is the first of five expected meetings.  The agenda for this meeting includes the introduction of the members of the DGAC; a discussion of the respective roles of HHS and USDA; how the Guidelines are used in public policy; and potential topics for the 2015 Guidelines.

While specific dates for future meetings have not yet been announced, over the next year the DGAC is expected to review current scientific evidence and hold additional public meetings.  In the fall/winter period of 2014, the DGAC is to issues its report to the Secretaries of HHS and USDA.  That report will subsequently be made available for public comment.  By the summer of 2015, HHS and USDA are to consider the public comments and prepare the Guidelines policy document.  The new edition of the Guidelines is then expected to be jointly published by HHS and USDA in the fall of 2015.

“Serving Facts” for Alcohol Beverages—FINALLY!

By Richard L. FrankRobert A. Hahn and Gary Zizka

Yesterday, a 9-year effort by consumer and public health groups, and beer, wine and spirits maker Diageo, succeeded when a unit of the Treasury Department issued a ruling permitting voluntary Serving Facts labels for alcohol beverages.

The Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) Ruling 2013-2 allows beer, wine and distilled spirits makers to provide much clearer  and comprehensive information to consumers as to what they are drinking in terms of amount of alcohol per serving, servings per container, and calories, carbs, protein and fat per serving or per container.

Until now, consumers would be hard-pressed to tell you that a 750 ml bottle of 12% alcohol by volume (ABV) wine contained 5 (standard) servings, or that a 750 ml bottle of 40& ABV vodka contains 17 servings. Now they can just look on the label—provided the supplier voluntarily puts Serving Facts on the label!

Alcohol Serving Facts

Under the ruling, the fact that 12 oz of regular beer, 5 oz of table wine and 1.5 oz of vodka all contain the same amount of alcohol, i.e., 0.6 oz, or a “standard drink,” remains somewhat obscured. Perhaps the still-pending rulemaking will address that what TTB now calls a “serving” is, in fact, for all practical purposes, a Standard Drink.

Interestingly, the final impetus for Ruling 2013-2 probably came from another federal agency: the Federal Trade Commission. On February 12th of this year, the FTC issued an order that required Four Loko flavored malt beverages containing more than two “servings” of alcohol to carry an “Alcohol Facts” panel on the back of the container. The FTC said that the Alcohol Facts panel must include the beverage’s serving size, number of servings per container, container size, and %ABV. The FTC’s order was necessitated by the agency’s belief that the makers of Four Loko “falsely” represented that a 23.5 oz can of the product (at 12% ABV) “contains the alcohol equivalent of one or two regular 12-ounce beers, and that a consumer could drink one entire can safely on a single occasion.” This is precisely the kind of situation that the original Serving Facts petition was meant to address.

According to the US Dietary Guidelines, people who drink alcohol should do so in moderation, defined as not more than one standard drink per day for women, and two standard drinks per day for men. With TTB’s action yesterday, consumers who choose to drink now have much more easy-to-understand information with which to gauge their drinking.

Consumers can now only hope that the final rulemaking will maintain this general approach, and also finally define a serving for what it is: a “Standard Drink.”

USDA is Right on Carrageenan

By Marshall L. Matz

Kudos to Secretary Vilsack and USDA for basing their regulatory decisions on sound science.  Another recent example is the Proposed Rule published on May 3rd that would re-list carrageenan as appropriate for use in organic food products.  The USDA decision is consistent with a recent decision by FDA affirming the safety of carrageenan for all food products.   Moreover, the World Health Organization (WHO) and many other regulatory authorities around the world have approved carrageenan for use as a food ingredient.

Carrageenan is a natural fiber isolated from red seaweed that has been used in cooking for hundreds of years, and, today, is safely consumed on a daily basis by many millions of people worldwide.  That includes infants growing up on formula products, both organic and conventional, containing the ingredient. Thousands of processed dairy, meat, and other food products in markets around the world have better texture and are more nutritious thanks to carrageenan. Furthermore, carrageenan provides vegetarians and vegans alternatives to gelatin.

Regulatory and policy decisions must follow science if we are going to feed a hungry planet.  While the carrageenan decision might be viewed by some as a minor regulatory decision, it reinforces an important principle: Sound science must trump personal philosophy. USDA is right, and should finalize the rule as proposed.

For those interested in commenting, here is a link to the proposed rule docket.  Public submissions are due by June 3.

Bowman v. Monsanto: Supreme Court Confirms That Soybeans Do Not Grow Themselves, Affirms Seed Biotech Patent Rights

By Gary H. Baise, Stewart D. Fried, and John G. Dillard

In a unanimous decision, the U.S. Supreme Court held that a patent holder’s rights in biotech seeds extend to subsequent generations of crops grown by farmers.  Widely viewed as a victory for biotech seed producers and American farmers, the Court’s decision in Bowman v. Monsanto Co. should provide seed trait developers with the confidence that they will be able to protect their substantial research and development investments in seed biotechnology.

The case revolved around an Indiana farmer’s scheme to avoid paying Monsanto a technology fee for his use of its patented technology.  For almost a decade, Mr. Bowman purchased commodity soybeans from a local grain elevator, planted these beans, and sprayed the resulting crop with Roundup, Monsanto’s patented herbicide (glyphosate).  This unorthodox practice resulted in a crop that contained the patented Roundup Ready gene, which he replanted in subsequent seasons.  Each year, Bowman would spray his fields with Roundup, thereby utilizing Monsanto’s patented Roundup Ready technology without paying a license fee.

The Bowman case presented a novel issue to the Court – self-replication.  The Bowman case revolved largely around “patent exhaustion,” a somewhat obscure intellectual property law concept also known as the “first sale doctrine.”  In a nutshell, the doctrine holds that when a patent holder completes an authorized sale of a patented article, the patent holder ceases to have rights in that article.  Stated differently, the patent holder’s rights in that article are deemed exhausted.  For example, when one purchases a iPhone, Apple no longer maintains the right to control its use, sale, destruction or virtually anything else one does with that device, despite holding a multitude of patents.  However, even after a patent holder’s rights are exhausted, the buyer is prohibited from making or reproducing the patented item without the patent holder’s permission.

Before the Supreme Court, Bowman argued that Monsanto’s patent rights in its Roundup Ready seed were exhausted when Monsanto (or a licensed dealer) sold it to a farmer.  Bowman asserted that the patent could not be enforced on subsequent generations of soybeans reproduced from patented seeds, arguing that soybeans naturally self-replicated and that the beans themselves – not the farmer — were responsible for copying the patented genetic material.

In a rather succinct and straightforward opinion penned by Justice Kagan, the Supreme Court rejected Bowman’s arguments.  The Court reasoned that planting and harvesting a patented self-replicating crop, such as soybeans, essentially amounted to reproducing a patented seed.  Following this logic, the Court concluded that Monsanto and other seed patent holders have a right to control the reproduction of their patented seed, holding Bowman infringed on Monsanto’s patents after he planted and harvested subsequent generations of soybeans grown from the patented seeds he purchased from the grain elevator.  Furthermore, the Court soundly rejected Mr. Bowman’s “blame-the-bean” defense, noting that he “was not a passive observer of his soybeans’ multiplication” and that the “seeds he purchased … did not spontaneously create eight successive soybean crops.”

OFW Law attorneys Gary Baise, Stewart Fried, and John Dillard drafted an amicus brief on behalf of the American Soybean Association, National Corn Growers Association, National Association of Wheat Growers and other agricultural trade associations in support of Monsanto’s arguments.  The brief explained the importance of biotechnology to agriculture, the societal benefits resulting from the use of biotechnical innovations and the need for patent protection in order to preserve a legal environmental which will foster future agricultural developments.

The Supreme Court’s decision in Bowman v. Monsanto, while short in length, is expected to have broad implications for future agricultural innovations.  Additionally, while the Supreme Court took care to note the limited scope of its ruling, it will likely be cited as persuasive authority in cases involving stem cells, gene therapies, software and other self-replicating technologies.

A copy of the Supreme Court’s opinion is attached here.

New HHS Privacy Rule Conflicts With Congressional Support for Refill Reminder Programs

By Richard L. Frank and Jonathan M. Weinrieb

The Obama Administration (HHS’s Office for Civil Rights) promulgated its new HIPAA Privacy Rule ostensibly to strengthen consumers’ medical privacy rights.  The result, however, is likely to harm patients by restricting clinicians’ and pharmacists’ ability to provide them with compliance and persistence messages – so-called “refill reminders” (about currently prescribed drug therapy).  In fact, as we observed when the final rule came out in January, HHS appears to have sacrificed the delivery of high-quality sponsored medical and health education for, at most, negligible enhancement of patient privacy.  Those concerns are being realized as pharmacies such as CVS, citing new Privacy Rule concerns, end their long-standing sponsored refill reminder programs.

Patients’ failure to comply with clinician-prescribed therapy costs Americans $290 billion annually, results in $100 billion in annual costs for hospitalization alone, and causes 89,000 premature deaths each year.  As the World Health Organization observed, “there is growing evidence to suggest that because of the alarmingly low rates of adherence, increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments.”  HHS clearly recognizes the magnitude of the problem and the importance of patient compliance and persistence programs, actively promoting the communications through its other agencies – e.g., CMS (“meaningful use” and MTMP) and AHRQ (studies and promotes compliance and persistence programs).

As part of the HITECH Act, Congress (led by Senators Kennedy and Harkin) specifically enacted a statutory exception to the requirement for patient authorization for sponsored refill reminder programs.  The sole limitation is that any payment going to the covered entity healthcare provider be “reasonable in amount.”  42 U.S.C. § 17936(a)(2)(A).  The fundamental problem is that HHS’s final rule implementing HITECH is, in at least three separate but related respects, susceptible to restrictive interpretations that are thwarting Congress’s intent to allow these important communication programs to proceed without patient opt-in.

First, Congress granted statutory authority to HHS to define what constitutes “reasonable in amount.”  HHS, in turn, required that “any financial remuneration received by the covered entity in exchange for making the communication [be] reasonably related to the covered entity’s cost in making the communication.”  45 C.F.R. § 164.501 (definition of “marketing,” ¶ (2)(i)), 78 Fed. Reg. 5566, 5696 (Jan. 25, 2013) (emphasis added).  Although it lacks the force and effect of law, HHS’s preamble to its final rule suggests a highly restrictive approach to that “reasonably related” language, limiting acceptable costs to those of “labor, supplies, and postage to make the communication. . . . [and, for example,] only the pharmacy’s cost of drafting, printing, and mailing the refill reminders . . . .”  78 Fed. Reg. at 5597.

Given the importance of these vital refill reminder programs, HHS needs to promptly issue its promised guidance, 78 Fed. Reg. at 5596.  HHS needs to explain that it intends the “reasonably related” limitation on the statutory exception for refill reminders to be comprehensive in nature and comprise a multitude of healthcare providers’ costs necessary to effectively provide patients with compliance and persistence messaging.  Specifically, “reasonable” costs of labor, supplies, postage, drafting, printing, and mailing the communications should be deemed to include an appropriate portion of all associated expenses – e.g., pharmacy personnel, developing messaging content, managing patient records, computer hardware and software, IT infrastructure and maintenance, facility infrastructure and maintenance, utilities, printing supplies and equipment, outside accounting and legal consultants, payments (including a reasonable profit) to third-party business associates, and overhead, including rent, taxes, insurance, and employee benefits.  (A reasonable estimate of the cost to produce and deliver a refill reminder message to a patient by mail is between $2.25-$2.50 for large pharmacy chains and much more for smaller chains and independents.)  Without clarification, these critical compliance and persistence programs will continue to wane and completely frustrate Congress’s goal of safeguarding the public health.

Second, in an effort to define the scope of the refill reminder exception, the Department offered several important examples of what constitutes a refill reminder – i.e., generic equivalents, communications encouraging patients to take medication as prescribed, messages related to drug delivery systems (e.g., insulin pumps).  A more expansive interpretation is nevertheless needed to ensure a broad interpretation of the refill reminder exception consistent with Congressional intent.

For instance, to ensure that Congress’s intent is realized, HHS needs to clarify that improved versions of existing drugs (e.g., extended release of the same active ingredient) are well within the scope of the statutory exception.  Because such improved formulations typically offer advantages such as less-frequent dosing, they improve patient compliance and persistence with prescribed therapies and, therefore, squarely comport with Congressional intent underlying the statutory exception.

Likewise, even where a prescription has “expired,” chronic-use therapies are equally appropriate subjects that HHS should expressly recognize as falling within the statutory exception.  Clearly, in cases of chronic-use medications, the prescriber intends for the patient to remain on therapy – such patient-directed messaging increases patients’ chances of doing just that.

Moreover, “ask your doctor” communications concerning so-called “adjunctive” therapies (i.e., those designed to treat the same underlying condition or a side effect of another current therapy) also play a key role in improving patient compliance and persistence with prescribed therapies.  Because they target the same medical condition or work to alleviate side effects from existing therapies, patients naturally are more likely to remain on their medications and take them as prescribed and dispensed.

A third and final issue that needs prompt clarification concerns covered entities’ use of HIPAA business associates to assist them in administering their refill reminder programs.  The preamble contains confusing language that could be read to disqualify business associates from working with the covered entity healthcare providers to deliver these important compliance and persistence messages.  E.g., 78 Fed. Reg. at 5595 (“where a business associate . . . as opposed to the covered entity itself, receives financial remuneration from a third party in exchange for making a communication about a product or service, such communication requires prior authorization.”).

If taken out of context, HHS’s statement suggests that business associates could never be used for otherwise permissible messaging programs that do not require patient opt-in.  This makes no sense.  Clearly, covered entities such as healthcare providers are permitted to use business associates to help administer refill reminder and similar programs.

Although it is a well-accepted principle under HIPAA that a business associate cannot carry out a function using PHI that the covered entity could not do on its own, no sound reasoning supports any conclusion that would preclude the use of a business associate (e.g., a mail house) – or the making of a profit by that business associate – to deliver otherwise permissible refill reminder messages.  Indeed, without the ability to use business associates to provide both operational expertise and scale, most chains would not be able to offer these programs.

Put simply, nothing in the legislative history of the HITECH Act suggests that Congress intended the statutory exception for refill reminders – in terms of scope, the use of business associates, or the “reasonable in amount” limitation – to be interpreted narrowly or in any way that would reduce the prevalence or effectiveness of compliance and persistence messaging programs.  Indeed, Congress enacted the statutory exception to strengthen the legal foundation for these communications.  HHS needs to clarify these issues quickly as contrary interpretations will serve only to hamper these important public health programs and lead to a rise in healthcare costs – results that Congress sought to avert as part of its efforts under HITECH.

First Son: The Biography of Richard M. Daley

Reviewed by Kenneth D. Ackerman, as published by the Washington Independent Review of Books

First Son

History and public opinion rarely turn a kind face toward children of famous people. We usually just love to knock them down — a combination of jealousy, envy and vanity, the presumption that each of us could have done better given the same advantages.

We love stories about the sons who never lived up to the father’s reputation (think Robert Todd Lincoln), or became depressed, alcoholic or magnets for bad luck (think Kennedys), or became general embarrassments to their fathers (think Charlie Sheen). When children of famous parents succeed, we easily dismiss them because of their advantages (think George W. Bush, the Vanderbilt offspring or some of the Adamses). How irritating, then, to come across someone like Richard M. Daley, son of epic Chicago mayor Richard J. Daley. How dare he turn out to be a perfectly good guy who not only out-performed his father in his signature achievement (longevity as Chicago mayor) but also avoided his father’s controversial weaknesses.

To read this review in its entirety, please click here.

Warning: FDA Tightens Up Regulations for Tanning Beds

By Mason Weeda

You have probably heard that on May 6, 2013, FDA issued a proposed rule requiring warning labels to be affixed to tanning beds.  It has been all over the news – FDA’s Center for Device and Radiological Health (CDRH) was like a moth to a tanning bed light bulb, touting its latest warning requirement to the media.

A more important point that the media largely did not focus on is that the proposed rule would also reclassify tanning beds, in addition to the warning requirement. Currently, tanning beds are class I devices that are exempt from the premarket review process.  Originally, these devices were classified as class II devices.  Slowly, over the years, FDA loosened restrictions. In 1988, UV tanning lamps were classified as class I; then, in 1994, they were exempt from premarket clearance.  Now, FDA is now planning to take it all back, and proposes to make tanning beds class II devices, subject to a 510(k) application and clearance.

FDA’s proposal to ratchet up tanning bed regulation is due to safety concerns.  The media quoted various parts of FDA’s two-page discussion of safety concerns contained in the proposed rule.  See 78 Fed. Reg. 27119-20. Based on these safety concerns and the level of safety focus on FDA’s consumer webpage, “Indoor Tanning: The Risks of Ultraviolet Rays,” one could speculate that there will be more regulation in the future for these products.

During a conference call with reporters, CDRH Director, Jeffrey Shuren, made a statement that confirms FDA may well intend to provide additional regulation in the future.  Dr. Shuren stated that “we view this as a first step,” and “nothing is off the table.”  While he did not state what the next steps would be, there has been pressure on FDA from numerous trade and professional associations to restrict use of tanning beds to those 18 years or older (e.g. American Academy of Pediatrics, American Academy of Dermatology, Skin Cancer Foundation).  Interestingly, Dr. Mary Maloney, who chairs the American Academy of Dermatology Association’s regulatory policy committee, was on the conference call with Dr. Shuren.  She agreed that this rulemaking is an important first step, but that her group would continue to push for a ban on the sale and use of tanning beds for people under age 18.  While FDA has not, at least 7 states restrict minors from use of tanning beds, and many others have the ban in their legislative or regulatory pipeline.

The proposed rule would allow industry time to plan as the rule, if finalized, would not be effective for another 15 months.  The industry will likely lobby and attempt to influence the proposed rulemaking.  To influence this rulemaking, industry will need to beef up arguments regarding safety and suggest alternative ways to ensure safe products are on the market. As always with the rulemaking process, the final outcome is tough to predict so we will have to wait and see.

Increased FDA Testing of Pet Foods May Provide More Support for the FSMA Proposed Rule on “Preventive Controls for Animal Food”

By Jolyda O. Swaim

When I was growing up on a farm in Pennsylvania, my twin sister and I always savored the sweet feed that we fed to our horses.  We would also occasionally “chew on the oats,” but Sis and I never found our way to eating the dog or cat food.  This was not the case, however, with my son and my nephew—who always tasted the dog and cat food!  At the time, I never thought much of the kids eating the pet food.  Looking back, I realize that we were all very lucky we did not get ill.  While animal food is technically supposed to be free from pathogenic organisms, recent outbreaks prove this is not always the case.

Recently, the FDA’s Center for Veterinary Medicine (CVM) issued a nationwide field assignment to collect samples of domestic pet foods (not including canned pet foods), pet treats and pet nutritional supplements to be analyzed for SalmonellaSee

The CVM issued this assignment because of its concern “about animal feeds serving as vehicles for transmitting pathogenic and antibiotic-resistant bacteria.”  There have been a number of large outbreaks linked to various pet treats and feeds in the past several years – in the United States as well as Canada.  In 2012, an outbreak of Salmonella infantis was linked to dry dog food produced at a facility in South Carolina with 49 associated illnesses.

In the assignment, the Director of the Office of Surveillance and Compliance indicates that Districts are to immediately initiate procedures to remove any pet foods found positive for Salmonella, alert the manufacturer to take corrective action, and recommend the issuance of a Warning Letter.  In addition, investigations of the facility are to occur within 90 days of the confirmation of a positive Salmonella sample.

The above concerns – especially if there are positive product tests and related recalls – provides further support of the need for FDA’s soon-to-be issued proposed rule on Preventive Controls for Animal Food which implements a portion of the Food Safety Modernization Act (FSMA).   The proposed rule is expected to closely mirror the proposed rule for Preventive Controls for Human Food published on January 16, 2013.   In fact, my understanding is that the only notable differences will be that the proposed rule for animal food would establish cGMP’s, would not address allergens, and might have different definitions of a “very small business.”

Based on this information, it would be prudent for any manufacturer of pet treats or foods to spend time now reviewing the proposed rule for Preventive Controls for Human Food, and begin putting together their preventive controls plans based on what is in that proposed rule.  While FDA estimates there are almost 4,500 manufacturers of pet foods and treats, it believes that about 4,440 would be considered small (less than 500 employees) or very small.  Knowing where many small FDA-regulated human food manufacturers are in understanding and developing preventive controls plans, I would expect small pet food manufacturers are even further behind.  With FDA now out in the field testing, many may find they will have a much earlier “deadline” on addressing pet food or treat safety. Launches New Ag & Food Community

By Gary Zizka

In conjunction with the opening of the G-8 Open Data for Agriculture conference on April 29, USDA Secretary Vilsack announced the newest “Community” on the government’s data access point the Food, Agriculture and Rural Community.  Coincidentally, April 30 is the 20th anniversary of the release of the World Wide Web’s core standards for free use by anyone, so the promise of that day 20 years ago is being met in spades.

The federal government’s website itself will be 4 years old on May 21. Established after President Obama’s first-day-in-office Executive Order on open government, the site now has about 450,000 databases, which provide access to literally millions of public datasets.

The Food and Agriculture Community on hit the ground running, with over 300 data sets as well as numerous apps, tools and statistical products that illuminate nearly every imaginable aspect of food and production, from the local to the global.

It’s a must-visit site for anyone with an interest in the agricultural world.