John Block: Bounty of Food

By John R. Block

I hope you have a happy Thanksgiving this year. The celebration of Thanksgiving dates back to our ancestors who settled this country. They didn’t have any of the comforts that we take for granted today. They were just thankful to have a roof over their head and food to eat.

Even today, there are people starving in other countries. In many of the African countries, they use 50 percent of their family income just to put food on the table. We used to spend 30 percent, then 20 percent, now less than 10 percent of family income to feed the family.

How much do you think this year’s Thanksgiving dinner will cost? Probably less than $5.00 per person. That includes more than just the turkey. It includes stuffing, sweet potatoes, rolls, peas, cranberries, carrots, celery, milk, and pumpkin pie with whipped cream. According to Bob Stallman, President of the American Farm Bureau, that delicious bounty of food costs less than it did last year.

I’m looking at a Thanksgiving dinner chart going back 25 years. The inflation adjusted cost is actually less than it was in 1986.

According to the Economic Research Service (USDA), the nation’s food price index has risen less than 1 percent this year.

The severe drought that we experienced last year pushed up our food prices but they are back down now. Global grain reserves are up by 13 percent. Course grain reserves that include corn are up by 30 percent.

There are a lot of reasons why food is such a bargain in the U.S. We’re just better at producing than we used to be. When I was 10 years old, one farmer produced enough food to feed 15 people. By 1964, one farmer was feeding 26 people, and today, one farmer supplies food for 155 people. That is a 10-fold increase. And, we do it with less crop acres.

I know we have many reasons to be thankful, but one big reason is that we are not hungry. Thanks to the American farmer.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

A Safe Thanksgiving

By Barbara J. Masters, D.V.M.

I am always amazed each Thanksgiving that my friends have questions on “cooking turkey.”  I am even more amazed that they ask me questions, because I have a solid reputation for not being able to cook anything!  That said, perhaps they ask because I do know how to make certain the turkey makes it safely to the table for Thanksgiving.

Many of us buy a frozen turkey, and the first challenge is remembering to thaw it!  It takes a few days in the refrigerator for thawing.  DO NOT THAW THE TURKEY AT ROOM TEMPERATURE!  If you have already started thawing your turkey, great!  If not, do not panic.  You can place it in the refrigerator right now, and complete the thawing in COLD water.  If you thaw it from a frozen state in cold water, it takes about 30 minutes per pound.  I find many people become impatient with the cold water thawing method and start running warm water to hasten the process.  We should not use warm water for thawing!  Get that bird in the refrigerator today and finish the thawing in COLD water!  Once the turkey is thawed, the giblets can be removed for cooking separately.

The turkey should be cooked in an oven that has been pre-heated to 325°F.  It is recommended that the stuffing be cooked separately from the turkey.  The internal temperature of the turkey should reach 165°F.  A food thermometer should be used to measure the temperature of the turkey, taking the temperature at the thickest part of the breast.  I recommend using a food thermometer even if the turkey has a pop-up timer.   Many of my friends prefer the flavor of the turkey when it is cooked to higher temperature, but it is safe once it has reached 165°F.  It is best to let the turkey stand for approximately 20 minutes before carving.

I have found that the only thing harder than remembering to thaw the turkey is cleaning the table after eating all the yummy food.  However, food safety necessitates that leftovers be refrigerated promptly.  If there is any leftover turkey, it should be put into the refrigerator within 2 hours of removing it from the oven.  The leftover turkey will last in the refrigerator for 3 to 4 days.  If there are a lot of leftovers, they should be placed in the freezer, where they will last for 2 to 6 months.

Following these simple steps should provide for a safe turkey!  Well, these steps, in addition to making sure your hands are clean and you do not cross contaminate the counter…However, if there are remaining questions, the Food Safety and Inspection Service (FSIS) has staff working to make sure everyone can have a safe holiday.  They are available at 1-888-MPHotline or Ask Karen on the FSIS website.  Happy Thanksgiving, and enjoy the safe turkey!

Before joining OFW Law, Dr. Masters served as Acting Administrator and then Administrator for the United States Department of Agriculture Food Safety and Inspection Service (FSIS) from March 2004 through January 2007.

A SNAP It’s Not

By Marshall L. Matz with Molly O’Connor, as published by Agri-Pulse

The food stamp program, currently called SNAP (the Supplemental Nutrition Assistance Program) has exploded in size and may now be the biggest hurdle to a farm bill.  As of August, some 48 million Americans participated in the program at a cost of almost $80 billion a year.

The House would like to cut the program by approximately $40 billion over the next ten years. Some advocate separating the SNAP program from the farm bill. Before jumping to any conclusions or deciding on a course of action, however, let’s take a closer look at SNAP and those who rely on the program.

The current SNAP/food stamp program can be traced to the 1969 White House Conference on Food, Nutrition and Health. In 1969, President Nixon addressed the Conference and declared it was time to put an end to hunger and malnutrition in America.  He went on to “accept the responsibility” on behalf of the Administration as a “moral imperative,” but also laid out the practical considerations and identified the economic costs of hunger. As Nixon noted: “A child ill-fed is dulled in curiosity, lower in stamina, distracted from learning.  A worker ill-fed is less productive, more often absent from work.”

After the White House Conference, in 1973 Congress phased out the USDA commodity distribution program in favor of the more nutritious food stamp program and extended it nation-wide.  The Dole-McGovern Food Stamp Reform Act of 1977 then greatly reformed the program.  It eliminated the purchase requirement (so that recipients no longer had to purchase their food stamps), and established a uniform national standard for eligibility and benefits.  It also established a very strong work incentive; recipients who had earned income had their SNAP benefits reduced by only .25 cents for every dollar of income.

As a result, today the SNAP program is the most important nutrition program and income security safety net for low income people across the country.

From 1981 to 2003, participation remained at some 21 million people, with fluctuations during those years. Since 2003, as a result of the recession and higher unemployment rates, participation has increased sharply from 21 million people to 47 million people.  The number of Americans living below the federal poverty level is at an all-time high. That fact is the principal reason there are 47 million people receiving SNAP benefits each month. The program is also reaching a higher percentage of those eligible because of technology that protects the privacy of those in the program.  This change was particularly important to the elderly.

Click to enlarge.

Out of the 47 million SNAP recipients, 87 percent are households with children, seniors or people with disabilities. According to a report by the Center on Budget and Policy Priorities, more than 21 million children live in households that receive SNAP benefits.

And what do those SNAP recipients get; what is the average benefit for those in the program?   Up until a month ago, each participant in the SNAP program received, on average, $1.47 per meal. Then, on November 1, 2013, SNAP benefits were cut by $5 billion per year, or 13.6 percent, under the provisions of the American Recovery and Reinvestment Act.  That was approximately $10/person/month.  The impact was felt immediately as families ran out of food earlier in the month and food pantries saw a spike in participation.   The benefit is now less than $1.40 per person per meal.  That is the bottom line. There is no Thanksgiving feast on barely $1.40 per meal.

Now, in the weeks ahead, the Congress must address two major SNAP issues as a part of the Farm Bill Conference Committee:  1. How much more to cut the SNAP program; and 2. Should SNAP continue to be reauthorized in the Farm Bill or separated into independent legislation?  “At stake,” according to former Senators Bob Dole (R-KS) and Tom Daschle (D-SD) writing in an LA Times Op-Ed, “is the ability of millions of Americans who still struggle in our economy to provide adequate healthy meals for their children and families.”

Historically, the food stamp program and farm subsidies were joined into one bill for both policy and political reasons.  Again, quoting Dole and Daschle, “All of us benefit from the efficiency of our farmers and ranchers. We enjoy a safe and plentiful food system for less than 10 percent of our disposable income. In fact, Americans spend a smaller percentage of our disposable income on food than people in any other country. The special relationship in the legislative process between agriculture and those who need assistance from the SNAP program is also built on this tradition.”

The current size of SNAP makes it an obvious target for budget cuts.  But the Congress should focus on the average benefit of barely $1.40 per person, per meal, before voting on additional cuts to the program. The error rate in the SNAP has declined dramatically and steadily since the 1990’s. Any major cuts in program, as proposed by the House, are going to reduce benefits, not fraud or waste.

Allow me to close as Dole and Daschle closed their Op Ed:  “In a country struggling to emerge from the worst economic recession since the Depression, this is no time to play politics with hunger.”

*        *        *

Marshall Matz was formerly General Counsel to the Senate Select Committee on Nutrition. He served as Counsel to Senators McGovern and Dole in drafting the Dole-McGovern Food Stamp Reform Act of 1977.  He currently specializes in food and agriculture law at OFW Law in Washington, D.C.  mmatz@ofwlaw.com  Molly O’Connor is a Legislative Assistant at OFW Law.

FDA/CDRH Revamps Structure of its Office of Compliance

By Neil F. O’Flaherty

This past Monday (November 18), the FDA Center for Devices and Radiological Health (CDRH) launched a new webpage describing the revamped structure of its Office of Compliance (OC).  One of the stated goals of the reorganization is to better align OC’s resources to its mission.  While the stated goal in and of itself is fairly generic, the new structure (including new divisions) does provide some interesting insight into what CDRH sees as priorities in 2013 and moving forward.

Besides a “front office” featuring Director Steven Silverman and Deputy Directors Kimber Richter (Medical Affairs) and Jan Welch (Regulatory Affairs), OC is now organized into five separate operating divisions:

1. The Division of Analysis and Program Operations (DAPO);

2. The Division of Bioresearch Monitoring (DBM);

3. The Division of International Compliance Operations (DICO);

4. The Division of Manufacturing and Quality (DMQ); and

5. The Division of Premarket and Labelling Compliance (DPLC).

According to CDRH’s webpage, DAPO “analyzes data, develops policy, drafts processes, collaborates with FDA’s Office of Regulatory Affairs (ORA) on inspection planning and assignments, runs the establishment registration and listing program, and supports recall processing and establishment inspection reviews.”   DAPO has a fairly varied set of responsibilities, including  many that are administrative in nature.

DBM “provides regulatory oversight of medical device clinical investigations, nonclinical good laboratory practice, and institutional review boards in support of the premarket review program,” according to CDRH’s webpage.   It also “coordinates and reviews monitoring inspections of regulated parties and takes necessary action when appropriate. It also investigates and coordinates allegations of research misconduct.”  The division has two separate compliance branches, showing CDRH’s commitment to resources in this area.  Oversight in this area appears to be growing and not shrinking.  Overall, this division represents FDA’s continuing goal of and focus on ensuring quality clinical trials and the protection of study subjects who participate in such trials.  Mentions of good laboratory practices in the division’s description also highlights the recent revitalization of FDA’s focus on good laboratory practices, 21 C.F.R. Part 58, a part of FDA’s regulations that was recently revised, but somewhat forgotten for many years before the revisions.

Per CDRH’s webpage, DICO “focuses on foreign device manufacturer and importer assessment; international audit program, compliance policy, and guidance development; export operations and policy; and stakeholder communication and outreach.”  DICO is broken into three branches: the Foreign Enforcement Branch; the Import Branch; and the Export Branch.  Obviously, in recent years, there has been a growing focus on the quality of foreign-made devices reaching our borders and being placed into commercial distribution.  FDA has addressed this growing focus through foreign inspections and increased import scrutiny.  The creation of this division signals a continued and possibly growing commitment in this area.   As CDRH activity related to international cooperation, especially on the establishment inspection front, grows, so too may the importance of this division.

As for DMQ, the CDRH webpage states that it “leads domestic enforcement activities and recalls related to device quality and safety, and reviews premarket approval application manufacturing sections, site change supplements, and signals and complaints related to product quality.  This division is also the lead on device quality policy.”  This division highlights the significance that CDRH places on the Quality System Regulation (QSR), 21 C.F.R. Part 820, as a primary basis for ensuring safe and effective marketed medical devices.  The QSR enumerates good manufacturing practices for medical devices.

Finally, per CDRH’s webpage, DPLC “enforces premarket clearance and approval requirements, as well as labeling and promotion and advertising requirements for medical devices. This division engages in surveillance of industry practices and responds to urgent or high‐priority public health concerns, such as fraudulent devices marketed during a pandemic.”  Recently, CDRH’s promotion and advertising policy staff has been very small.  The new division could signal this as a growth area for CDRH, with more emphasis on promotion and advertising compliance/enforcement activities.

It will be interesting to see if the restructuring of OC translates into a somewhat changed FDA regulatory landscape for the medical device industry.  Moreover, not every reorganization bears fruit for the Agency.  Hopefully, this revamping will bear positive results for CDRH.

John Block: Farm Bill Conflict

By John R. Block

We don’t have a budget yet. We don’t have a farm bill. House Ag Committee Chairman Frank Lucas (R-OK) hopes to have a draft bill by week’s end. Debbie Stabenow (D-MI), Senate Ag Committee Chair, acknowledges there are a lot of differences to be worked out, but she has hope. They are both hoping.

The most difficult gap to bridge is the level of cuts in the food stamp program. The House cuts $40 billion over 10 years. The Senate cuts $4 billion. That is a difference of $36 billion. Not even close.

Then, we have the country of origin labeling battle. This has been going on for years. Canada and other countries challenged our rule that meat be labeled with the country of origin. The World Trade Organization agreed with Canada. Now, USDA is trying to change the wording in hopes it will pass WTO review. Canada says the new requirement is even more objectionable. I think COOL is a really bad rule.

But, here is the problem. We have hogs born and raised in Canada that are shipped into the U.S. for slaughter. We also have hogs born in the U.S., shipped to Canada to be fed to market weight, and then shipped back to the U.S. for slaughter. To comply with the COOL rule, the processor would have to segregate the animals coming in to be slaughtered. Couldn’t mix the U.S. hogs with those from Canada. Processing lines would have to be segregated. This is all a costly waste of money and facilities. Plus, it’s not fair to the Canadian producers that want to sell in the United States.  Country of origin labeling is not “COOL.”

Another sticking point may be the sugar program. Our sugar program is a throw-back to the old days. In the early ’80s, USDA would make loans to producers for grain, dairy products, etc. If the price didn’t rise above that loan rate for the farmer to pay back the loan, the government just took the grain. Of course, that meant USDA was stuck with millions of dollars worth of grain that wasn’t worth the dollars loaned. Today, USDA is sitting on 300,000 tons of sugar, and will lose millions of dollars.

Most of our farm programs have long-since gotten away from this. Sugar should do the same. Let the markets work.

The last issue I will bring up today is Rep. Steve King’s (R-IA) amendment to stop states from passing laws that restrict trade between states. A specific example is California law that will not allow imports of eggs into California unless the laying hens’ cages meet California cage standards. If legislation like that is allowed to stand, different states with different standards can tie our country in knots.

Chicken eggs will be just the beginning. What’s next – pork, beef, or wine?

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

Achievement Unlocked! Senate Passes Drug Quality and Security Act for a Safer, More Secure Pharmaceutical Supply Chain

By Tish Eggleston Pahl

DrugsIn a time when internecine conflicts within the Congress and between the legislative and executive branch stymie so much important work, the easy passage of the bipartisan Drug Quality and Security Act (DQSA) (H.R. 3204) is cause for celebration.  Having passed the House of Representatives in September on a voice vote, the Senate overwhelmingly voted to pass the DQSA today.  The bill now proceeds to President Obama, who is expected to sign it.

The DQSA amends the federal Food, Drug and Cosmetic Act (FDC Act) to accomplish two goals that have long bedeviled the Food and Drug Administration (FDA) and the pharmaceutical supply chain.  Title 1, Drug Compounding, expands and clarifies FDA’s oversight of compounding pharmacies to address concerns that arose from the fungal meningitis outbreak last year which was traced to contaminated drugs compounded at New England Compounding Center.

Supply ChainTitle 2, Drug Supply Chain Security, establishes a national, interoperable, electronic system to track and trace prescription drugs in the supply chain (“track” generally refers to where a product is in the supply chain; “trace” to where it’s been).  Unlike Title 1, which arose out of crisis, Title 2 is the achievement of many years of steady work by pharmaceutical supply chain stakeholders, FDA and dedicated congressional staff.  The DQSA represents a significant advancement toward greater supply chain security.  Below, we summarize Title 2, the “track and trace” part of this milestone law.

Preemption of State “Track and Trace” Laws

One significant motivation for the passage of the DQSA is the patchwork of varying State laws enacted to require the serialization and tracking of pharmaceuticals moving within a single State’s borders.  The DQSA sets out a phased-in approach that will eventually lead to the creation of a national, interoperable electronic system for the tracking and tracing of prescription drugs throughout the supply chain, from manufacturer, through wholesale distributor, to the dispensing site.  The federal system will preempt and replace State and local drug product track and trace requirements.

Unit-Level Serialization in an Interoperable System

Within four years of enactment of the DQSA, product manufacturers must affix or imprint a product identifier to each package and homogenous case of product.  A homogeneous case is a sealed case containing only product that has a single National Drug Code (NDC) number belonging to a single lot.  A product identifier is a standardized graphic that includes, in both human- and machine-readable form, the product’s lot number, expiration date, and standardized numerical identifier (“SNI” – which is a set of characters that uniquely identifies each package or homogenous case and includes the NDC number and a unique alphanumeric identifier of up to 20 characters).

A Phased-in Approach

            1.         Pre-Serialization – Beginning January 1, 2015

The DQSA arguably takes “the long view,” with implementation beginning on January 1, 2015.  The first, interim, step contemplates that a manufacturer must provide a subsequent product owner with a single document (in electronic or paper format) that includes certain information about the transaction:

  • Transaction Information (e.g., name, strength, and dosage form of the product, NDC number, container size, number of containers, lot number, date of transaction/ shipment, name and address of seller and buyer, etc.);
  • Transaction History (i.e., the “pedigree” – all transaction information for each prior transaction going back to the first sale from the manufacturer); and
  • Transaction Statement (e.g., assurances of compliance with the law).

Also as of January 1, 2015, a wholesale distributor must receive a transaction history, transaction information, and a transaction statement for each product it purchases.  What a wholesale distributor must pass on to its downstream customer depends upon whether the distributor purchased the product via non-direct purchase or directly from a manufacturer, the manufacturer’s exclusive distributor, or a repackager that purchased directly from a manufacturer.  If the wholesale distributor made a direct purchase, it must, in turn, provide the following information to a subsequent purchaser:

  • Transaction Statement that the wholesale distributor purchased the product directly from the manufacturer, exclusive distributor of the manufacturer, or repackager that purchased the product directly from the manufacturer; and
  • Transaction History (unlike the requirements on manufacturers, though, the wholesale distributor is not required to include the lot number of the product, the initial transaction date, or the initial shipment date from the manufacturer).

If product is sold to a dispenser, this information must be on a single document in a paper or electronic format.  If sold to another wholesale distributor, this information may be any combination of self-generated paper, electronic data, or manufacturer-provided information on the product package.

If the wholesale distributor obtained the product through a non-direct purchase, it must provide the product’s full transaction history, transaction statement and transaction information to subsequent purchasers.

By July 1, 2015, dispensers must be able to receive the transaction statement, history and information from suppliers.

2.         Interim traceability – Four to Seven Years After Enactment

Beginning no later than four years after enactment of the DQSA, manufacturers must provide for each product transaction, the transaction information, transaction history, and transaction statement in electronic format.

Manufacturers, wholesale distributors, and dispensers must also develop verification and notification procedures for suspect and illegitimate product and the ability to retain samples of suspect product upon request.

3.         An Interoperable System – Ten Years After Enactment

Ten years after enactment, an interoperable, electronic tracing of product at the package level goes into effect.  Transaction information and transaction statements will be exchanged in a secure, interoperable, electronic manner.  Systems and processes should allow for prompt provision of the transaction information and the transaction statement for a product in the event of a recall or in an investigation.  With the interoperable system in place, the requirement to provide the transaction history sunsets.

Other Important Provisions

            1.         Returns

The DQSA addresses returns of product.  For up to six years post enactment of the DQSA, wholesale distributors may accept saleable returns under the terms and conditions of their existing sales agreements and may redistribute the returned product without providing a transaction history for the product.  Thereafter, the wholesale distributor cannot accept a return unless the previous owner provides the transaction history, transaction information, and a transaction statement for the product.

Four years post enactment of the DQSA, a manufacturer that intends to further distribute returned product must verify the product identifier, including the product’s SNI.

Once the interoperable system is in place, an entity may only accept a saleable return if it can associate the product with the transaction information and transaction statement associated with that product.

            2.         Wholesale Distributors and Third-Party Logistics Provider Licensure

The DQSA includes new standards for wholesale distributors.  Wholesale distributors must be licensed by the State from which the drug is distributed, or be licensed by FDA if the State has not established a licensure requirement.  Beginning January 1, 2015:

  • Wholesale distributors must report annually to FDA each State in which they are licensed, and the name, address, and contact information of each facility.
  • Any significant disciplinary actions must be reported to FDA in a reasonable time and manner.
  • FDA must establish a database identifying authorized wholesale distributors.

Within two years of enactment of the DQSA, FDA must establish standards by regulation for the licensing of wholesale distributors, including standards for the revocation, reissuance, and renewal of a license.  Standards should include, among others:

  • the storage and handling of drugs, including facility requirements;
  • recordkeeping;
  • bonding;
  • background checks and fingerprinting of facility managers or designated representatives;
  • qualifications for key personnel; and
  • facility inspections.

The DQSA also includes licensure standards for Third-Party Logistics Providers.

3.         FDA Guidance

FDA is required to (in some instances very swiftly), engage in outreach and public meetings, solicit comment, and issue guidances and regulations implementing the DQSA.  FDA must, among other things:

  • Hold not less than five public meetings to enhance the safety and security of the supply chain, the first of which not to be held not earlier than one year after enactment of the DQSA.
  • Issue a draft guidance document on the standards for the interoperable exchange of information within one year after the date of enactment of the DQSA, after providing at least 60 days for interested parties to comment.
  • Conduct a public meeting and then finalize the draft interoperable electronic system guidance within eighteen months.
  • Incorporate into guidances the use of aggregation and inference as appropriate.
  • Finalize a guidance on standards for waivers, exceptions, and exemptions not later than two years after enactment of the DQSA.
  • Finalize a guidance for grandfathering non-compliant product not later than two years after the date of enactment.
  • Finalize guidance on unit level tracing not later than eighteen months after a public meeting.
  • Issue a guidance document to aid in the identification of suspect product and related required notifications not later than 180 days after enactment of the DQSA.
  • Establish one or more pilot projects with manufacturers, repackagers, wholesale distributors, and dispensers, to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.
  • No later than seven years after enactment of the DQSA, retain a private, independent consulting firm to conduct a technology and software study on the feasibility of small dispensers (twenty-five or fewer full-time employees) implementing interoperable, electronic tracing at the package level.

And so, a heartfelt congratulations to all who have been working so hard to accomplish this landmark legislation.  The DQSA is an enormous feat that demonstrates what can be achieved when regulators, legislators, and stakeholders work together.  The implementation challenges ahead are significant; the benefits will be enormous.  The coming months and years figure to be busy ones for FDA and industry as they move to the next step and implement a truly interoperable data exchange that will yield a safer, more secure, pharmaceutical supply chain.

Anyone want to write a nonfiction book?

When OFW Law’s Ken Ackerman is not providing legal and government affairs representation to the agriculture industry, with a special focus on crop insurance and risk management, he is a prolific nonfiction history writer.  Ken’s published books include critically acclaimed biographies of New York’s Boss Tweed, former-FBI Director J. Edgar Hoover and President James A. Garfield.

This February, Ken will offer his annual six-week workshop at the Writers Center in Bethesda, Maryland, on Narrative Nonfiction book writing.  According to the Writers Center Announcement this week:

The workshop focuses on non-fiction works, primarily book length history and biography. We discuss how to structure a story, avoid tangents, enhance theme, shape a “narrative arc,” evoke times, places and personalities, do research, sustain a narrative and understand the publishing cycle. The goal is tangible progress toward a quality product and a viable work plan. Participants are invited to present a brief outline and/or sample chapter.

Ken has taught the Workshop each of the past four years, and is glad to report that it has produced a number of published and soon-to-be-published works.

Could yours be next?

For more info and to register, here’s the link to the Writers Center web page.

Also, check out Ken’s Viral History blog!

Regulatory Mismanagement of Medical Foods?

By Michael J. O’Flaherty

FDA published in yesterday’s Federal Register notice of a 30 day (albeit 60 days had been requested) reopening of the comment period on its Draft Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition, updated in August 2013.  Prior versions of the guidance document had been published in May 1997 and May 2007.

The August update differed significantly from earlier versions, in particular, by addressing FDA’s thinking relating to use of medical foods under supervision by a physician; whether medical foods should be sold by prescription only; and the types of diseases and conditions that a medical food could be used to manage.  It made clear that FDA’s continued regulation of medical foods through updates to a question and answer guidance document is problematic.

The term “medical food” is defined by section 5(b)(3) of the Orphan Drug Act, as amended in 1988:

The term ‘‘medical food’’ means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

21 U.S.C. § 360ee(b)(3).

In November 1996, FDA published an advance notice of proposed rulemaking (ANPR) specific to regulation of medical foods; however, in 2003, FDA withdrew the ANPR, purportedly due to a lack of resources and change in priorities.  FDA also has published a Compliance Program Guide on medical foods, implemented in August 2006 and completed in September 2008.  These regulatory undertakings, while incomplete and of short duration, were nevertheless reasonable.

The real misstep in regulatory management of medical foods started when, in implementing sections 2 and 3 of the Nutrition Labeling and Education Act of 1990 (NLEA), FDA promulgated a regulation delineating characteristics of medical foods that exceeded the statutory definition, and culminated when these characteristics were used (in the August guidance document) to address the types of diseases and conditions that a medical food could be used to manage.

NLEA § 2 exempted from mandatory nutrition labeling “medical food as defined in section 360ee(b) of this title [emphasis added],” and NLEA § 3 similarly exempted from legal requirements for nutrient content claims and health claims “medical foods as defined in section 360ee(b) of this title [emphasis added].” See generally 21 U.S.C. § 343(q)(5)(A)(iv), (r)(5)(A).  Although the NLEA was explicitly clear about use of the “medical food” definition established by Congress in the Orphan Drug Act, FDA evidently had its own agenda:

The agency considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food.

56 Fed. Reg. 60,366, 60,377 (Nov. 27, 1991).  To ensure that this narrow constraint was made effective, in promulgating its regulation to implement the mandatory nutrition labeling exemption, FDA codified requisite characteristics of a medical food as including:

  • “It is intended for the dietary management of a patient … who has … special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone [emphasis added]”; and
  • “It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food [emphasis added].”

21 C.F.R. § 101.9(j)(8).

These eligibility requirements to qualify as a “medical food” plainly are not in the statutory definition.  Oral rehydration products, explicitly noted as a category of medical food in FDA’s Compliance Program Guide, would be ineligible under the requirements (a still unexplained inconsistency).  Moreover, these eligibility requirements were established as part of a rulemaking about mandatory nutrition labeling, not about regulation of medical foods.

The medical foods industry seemingly would be better served prospectively by a rulemaking specifically focusing on eligibility and regulatory requirements for its products, than by further revision of a guidance document premised on questionable grounds.

John Block: Down on the Farm

By John R. Block

I was on the farm earlier in the week and I am now in Kansas City at the National Association of Farm Broadcasters convention. Harvesting our crop at the farm this fall has been so smooth. However, spring planting season was so difficult. It seemed to rain all the time. Most of our crop ground is upland, but we do have about 300 acres along Spoon River. That low ground was flooded 3 times. We finally wrapped up our soybean planting on June 15. And – surprise! – the bean yield was better than 60 bushels per acre. Our corn has proven to be just as good – in the 200 bushel range.

The quality of seed, production technology, precision farming today is unbelievable. Look back 20 or 30 years – we could not have come close to matching these yields. USDA reports that, nationwide, we are harvesting near record crops of corn and soybeans.

I bring this up because the ag industry needs to stand tall and protect our new technology. We can’t go back to farming the way my grandfather did or like they do in Africa, where they’re starving.

On my first day on the farm this week, I was happy to note that we had 4 new litters of pigs. Those babies are so cute.

We have had a good year. That makes me think – what about next year? There is always something threatening a farmer’s success. As an example, there is a serious swine virus (PEDV) that has taken a toll on many farms. Another example – I feel sorry for the ranchers in South Dakota who lost so many cattle to an unexpected huge snow storm. I feel sorry for the cattle that suffered also. Mother Nature can be brutal but to lose 10,000 to 20,000 cattle as reported is devastating.

Farming is not an easy ride. Ride the prices up and they come down. Raise a big crop and the next year you have a drought. But, farmers are resilient and persistent. We keep coming back.

I said our harvest is all but finished, but bringing in the crop after a whole year of effort and hard work is just over the top satisfying. There is nothing like it.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

FSIS Rule Expanding Generic Label Approval Should Benefit Industry, but at What Cost?

By Brett T. Schwemer

Last week, the Food Safety and Inspection Service (FSIS) published a final rule to significantly expand the categories of meat and poultry labels that may be generically approved without formally submitting them to FSIS for approval, as well as a Labeling Compliance Guidance regarding the final rule.  Currently, labels that are applied to meat and poultry products must be submitted to FSIS for label approval unless the type of label, or a type of modification to a previously approved label, is specifically listed as “generically approved” in FSIS regulations.  Beginning on January 6, 2014, all meat and poultry labels and any modifications to such labels will be considered generically approved, unless they fall into one of the following four categories:

  • Labels for temporary label approval;
  • Labels for products produced under a religious exemption;
  • Labels for products for export with labeling deviations (other than printing in foreign language and quantity of contents statements); and
  • Labels with “special statements and claims”, defined as:
    • Natural claims;
    • Negative claims;
    • Additional claims, logos, trademarks, and other symbols that are not defined in the FSIS meat and poultry regulations or the FSIS Food Standards and Labeling Policy Book (except for Child Nutrition (CN) boxes).

FSIS predicts in the final rule that it will experience a 69 percent reduction in the volume of labels submitted for review and approval due to the final rule.  This estimate may be artificially high because the final rule still allows firms to voluntarily submit to FSIS labels that qualify for generic approval (these labels will receive less priority for label review).  Notwithstanding, the final rule is expected to significantly reduce the amount of labels that FSIS will have to review, thereby reducing the turnaround time for reviewing and approving labels that are required to be submitted (currently at 7 weeks).  It should also allow many establishments to get their products to the market in a more timely fashion.

This is not to say there will be no costs associated with the final rule.  Establishments that previously submitted labels to FSIS for approval, but now take advantage of the new generic approval regulations, will no longer have a formal approval from the FSIS’ Labeling and Program Delivery Staff (LPDS) in case there is a labeling dispute with in-plant inspection personnel.  Without such approval, inspection program personnel may be more inclined to retain product when they believe that a label does not meet FSIS labeling requirements or is otherwise false or misleading (at least until the establishment can appeal the decision, convince the LPDS to intervene or obtain a temporary label approval).  Based on our discussions with FSIS officials, it is our understanding that FSIS will conduct training and issue guidance to inspection personnel instructing them to focus on labeling issues of public health significance and to check with the LPDS in situations were there is a valid dispute on label compliance.  However, FSIS will not deter inspection personnel from retaining product when they believe labels do not meet FSIS requirements.   This could result in unnecessary costs to the industry.

For the above reasons, establishments that choose to generically approve their labels should be extra diligent in reviewing their labels for compliance with FSIS requirements.  Special attention should be paid to ensuring that:

  • The product meets any applicable standard of identity;
  • The label bears all required features;
  • All ingredients listed on raw materials and used in the product formulation (especially ingredients of public health significance) are identified on the label unless FSIS has expressly determined the substance qualifies as an incidental additive; and
  • Claims comply with requirements set forth in the FSIS regulations or the Policy Book.

Should inspection personnel still retain product in error, establishments should immediately contact the LPDS staff for assistance, or if not available, appeal the regulatory control action to their Front Line Supervisor and/or District Office.