WHOLE GRAIN LABELING

From August 2006 issue of Packaging World magazine


FDA draft guidance ignites debate on package claims regarding the use of whole-grain claims.

Stephen Barlas, Contributing Editor

The Food and Drug Administration’s attempt to referee the whole-grain foods labeling debate has various food companies crying foul.

General Mills, Inc., and a number of allies are using the draft guidance the FDA issued last February as the latest basis for criticizing the agency for refusing to establish a safe harbor for the use of terms like “good” and “excellent” source of whole grains.

General Mills submitted a petition to the agency in 2004 asking to be able to label its cereals and other products as good and excellent sources of whole grains if they met a certain content standard. The FDA never acted on that petition, which didn’t bother the company. In late 2004, GM went ahead anyway and reformulated its breakfast cereals in order to be able to label them as “good” and “excellent” sources of whole grains based on the criterion used by the Whole Grains Council (WGC), a private group made up of various industry associations.

“Cereal companies and baked goods companies are arguing over when a company can use the term ‘whole grain’ on its label.”

To date, the FDA has not defined, in either a guidance document or law, how much whole grain has to be in a serving of a product for the company to be able to use the description “good” or “excellent” source of whole grain on the package. In the draft guidance it issued in February, the agency signaled it intended to stick to that position.

Nonetheless, it isn’t technically illegal to use those terms. The FDA has no law against such descriptive terms on food labels. But neither is use of the label claim exactly kosher, as it would be if the FDA approved guidance on that subject. Doing so would create a “safe harbor” for companies, meaning there would be no chance of FDA enforcement action against them as long as they heeded the terms of the guidance.

In this current grey area environment, companies like General Mills who use those terms run the risk, however slight, of the FDA taking enforcement action against them.

Push for protection

That explains the push by General Mills, the Whole Grains Council and their allies to convince the FDA to change its mind. The WGC has offered members, including GM, use of a stamp design proclaiming a product a “good,” “excellent,” or “100% excellent” source of whole grains.

The stamp was made available in January 2005, just after the U.S. Department of Agriculture published its Dietary Guidelines for Americans, 2005 that recommended that individuals “consume 3 or more ounce-equivalents (48 grams) of whole-grain products per day, with the rest of the recommended grains coming from enriched or whole-grain products.”

“To date, the FDA has not defined, in either a guidance document or law, how much whole grain has to be in a serving of a product for the company to be able to use the description ‘good’ or ‘excellent’ source of whole grain on the package.”

The WGC established 8 grams of whole grains as the amount a product must contain to use a “good” label, 16 grams for “excellent,” and the product must be 100% whole grain to use the “100% excellent” label.

That stamp has proven very popular, providing some evidence that whole-grain labeling of food is becoming the phenomenon that perhaps “low-carb” once was. There were 27 members in the WGC back in January 2005. Today, there are 116, according to Cynthia Harriman, director of food and nutrition strategies.

General Mills uses the stamp on its Cascadian Farm granola bars, although not on its breakfast cereals, many of which do have “good” or “excellent source” label copy on their packages. A few of the other major companies using the whole grain stamp are Kashi (Kelloggs) and American Italian Pasta Co (pasta—Muellers noodles).

Guidance worries

The FDA’s announcement in the draft guidance that it continues to oppose use of “good” and “excellent” source of ingredient claims for whole grains applied new pressure to food manufacturers. It led to a meeting between WGC and FDA officials on March 30.

Subsequently, in June, the WGC announced that it was changing its stamp by requiring users to include language stating either the actual number of whole grain grams in a serving, or the fact that a product has “more than” eight or 16 grams of whole grain. Each of the stamps will also say, “Eat 48g or More of Whole Grains Daily.” General Mills, for example, which doesn’t use the stamp, but does make “good” source claims on its cereal packages, is also adding that quantitative copy to its packages, according to spokeswoman Kirstie Foster.

However, even with the addition of the quantity of grams and the USDA recommendations, the WGC stamp would still seem to run afoul of the guidance provided in the February draft document. That is just fine with Campbell Soup Co., the leading opponent of an ingredient content claim for whole grains. Campbell opposed General Mills’ petition in 2004, and has been dogging the cereal giant’s heels ever since. Chor San Khoo, vice president global nutrition & health at Campbell, says, “Campbell supports the FDA in opposing statements that characterize a particular level of whole grains as a good or excellent source.” Campbell argues that whole grains are not a nutrient, so no Daily Value, which is a USDA term of art, exists.

Other concerns

While the debate over ingredient source claims for whole grains is the most controversial issue arising from the draft guidance, it isn’t the only one.

More broadly, cereal companies and baked goods companies are arguing over when a company can use the term “whole grain” on its label. In the draft guidance, the FDA states: “Depending on the context in which a “whole grain” statement appears on the label, it could be construed as meaning that the product is ‘100% whole grain.’ We recommend that products labeled with ‘100% whole grain’ not contain grain ingredients other than those the agency considers to be whole grains.”

“Depending on the context in which a ‘whole grain’ statement appears on the label, it could be construed as meaning that the product is ‘100% whole grain’.”

This doesn’t sit well with manufacturers of frozen pizzas and breads. “Requiring pizza crust to be made with 100% whole-grain flour in order to define a whole-grain pizza will likely delay, if not block, pizza incorporation of significant amounts of whole grain into products,” states Bruce Paterson, vice president of research and development for The Schwan Food Co., which sells Freschetta and Red Baron frozen pizzas, and other frozen foods.

William Matthaei, president of Roman Meal Co., which uses the tagline, “Natural Whole-Grain Goodness,” says the requirement that breads be 100% whole grain to make that claim on the label would pose a problem for his products. Those products employ vital wheat gluten, a concentrated wheat protein that does not contain any of the wheat bran or germ. And those are identified in the draft guidance as part of a whole grain.

New Conflict of Interest Proposal Could Affect Voting on Psychiatric Drugs

From July 2006 Psychiatric Times magazine

A House committee is moving to prohibit members of FDA advisory committees from voting on whether new drugs should be approved when the members have any financial interests in a company proposing a new drug, or in its competitors. That tightening of federal law would have prevented 2 psychiatrists from voting at the last meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC), which took place on March 23 to consider an application by Cephalon Inc to get a label for attention-deficit/hyperactivity disorder (ADHD) for modafinil (Provigil).

Wayne Goodman, MD, chair of the PDAC as well as chair of the department of psychiatry, University of Florida, and Andrew Leon, MD, professor of biostatistics in psychiatry at Cornell Medical School, were granted waivers at that meeting and allowed to vote. Seven permanent members of the committee and 5 temporary members were present. Other members of the PDAC had been granted waivers at previous committee meetings.

Before each PDAC meeting, the FDA staff decides which members qualify for waivers. Generally, waivers are granted when a member's financial interest “is not so substantial as to be deemed likely to affect the integrity of the services that the Government may expect.” The size of the financial interest is a key factor under this standard. But federal law also allows a waiver when the FDA staff determines that “the need for the individual's services outweighs the potential for a conflict of interest.”

The House Appropriations Committee approved a bill in May that sets out funding for the FDA in fiscal year 2007, starting October 1, 2006. That bill included an amendment, sponsored by Rep Maurice Hinchey (D-NY) that would prevent the FDA from granting waivers to advisory committee members prior to a committee meeting.

The March 23 meeting of the PDAC focused on Cephalon's application to get a label for ADHD for modafinil, which is currently marketed to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Cephalon plans to rename the ADHD version Sparlon and wants to label it for children and adolescents. The FDA staff had been concerned about the drug's link to rashes, and the PDAC declined on March 23 to recommend FDA approval, mostly for that reason.

“PDAC advisors are asked to evaluate the safety and efficacy of investigational agents,” stated Leon in an interview. “We are expected to be objective. For that reason, transparency in revealing potential conflicts is critical. Unless our financial or intellectual conflicts are too great, full disclosure serves that purpose.”

Goodman's term ends in June. At the time when this story was written, he had not yet been asked to return. During his 2-year tenure as chairman (he served 1 year previously as a regular committee member), he cast a controversial vote in favor of a black-box warning on antidepressants, which has made him something of a bte noir among colleagues and psychiatric groups. At the March 23 meeting, Thomas Laughren, MD, director, division of psychiatry products, said, “Now, Wayne told me after the September 2004 meeting on antidepressants and suicidality in pediatric patients that he didn't have any friends any more in the academic and clinical community. I just want to assure him that he always has friends here at FDA.”

Crystal Rice, an FDA spokeswoman, said she could not comment on why Goodman had not been asked to continue on the PDAC. “We would not discuss with an outside party why or why not we would ask someone to continue as an advisory committee member,” she responded in an e-mail. “Such a discussion should be between the two parties involved.”

In an interview, Goodman said colleagues and drug company executives censured him privately for his vote in favor of a black-box warning because they felt the warning would discourage young people and their families from seeking treatment for depression. Goodman's vote helps underline some of the muddy assumptions about conflict-of-interest rules. Goodman owns no stock in any drug company, nor does he serve as a principal investigator. His only “conflict” is the fact that colleagues at the McKnight Brain Institute at the University of Florida do have contracts with companies working on psychiatric drugs.

So, even though Goodman nominally had a “conflict,” he nonetheless voted against the interests of the drug industry. Goodman expressed the belief that, in his judgment, all members of the advisory committee cast their votes based on “what is best for the public welfare based on the data at hand.”

Had the amendment adopted by the House Appropriations Committee been in force for the past few years, Goodman would not have been allowed to vote at either the March 23, 2006, or the September 2004 meeting, and probably others in between. Hinchey offered the same amendment last year—outlawing conflict of interest waivers—and it was passed by the House. However, the Senate approved a much weaker conflict-of-interest amendment that eventually prevailed when House and Senate leaders came together to reconcile differences in the 2 versions of the bill.

But Hinchey may have more success convincing the Senate this year. The April issue of the Journal of the American Medical Association included an article detailing the conflicts of interest declared by members of FDA advisory committees. The authors of this study, Peter Lurie, MD, MPH, of Public Citizen's Health Research Group, Washington, DC, and colleagues, collected data from January 1, 2001, to December 31, 2004, by analyzing agendas and transcripts from all FDA Drug Advisory Committee meetings listed on the FDA Web site. “A total of 221 meetings held by 16 advisory committees were included in the study. In 73% of the meetings, at least one advisory committee member or voting consultant disclosed a conflict; only 1% of advisory committee members were recused,” the authors found.

Goodman believes that members of an advisory committee who hold stock in or serve as a principal or co-principal investigator for a sponsor of clinical trials or a company with a rival product should not be able to vote at an advisory committee meeting. Nor should any member be receiving honoraria from drug companies or have stock in those companies—although he argues for “granularity” in the latter category—while sitting on the advisory committee.

ElPaso Rate Hike Closely Watched

From July-August 2006 Energy Biz magazine


ELECTRIC UTILITIES AROUND the country
are watching to see whether interstate natural gas
pipelines file for higher rates, following the lead of El
Paso Natural Gas, which was granted its first new
rates in 10 years. Those rates include new, premium
hourly balancing rates, meant to ensure El Paso
has adequate capacity online to take care of the
peak, hourly needs of utilities in Texas, New Mexico,
Arizona and to a lesser extent, California. The rates
went into effect June 1.
John Shelk, president and CEO of the Electric
Power Supply Association, says the FERC decision
to grant El Paso a menu of new premium rates for
firm hourly service “sends a pretty strong signal to
other pipelines.” He adds, “Our folks outside the
Southwest and California have expressed concern
that the new rates granted to El Paso by FERC
could be interpreted as a generic policy shift.”
Melissa Lauderdale, director of industry legal
affairs for the Edison Electric Institute, says, “The
imposition of hourly balancing rates on generators
across the country could have a significant impact
across the United States.” She worries that FERC’s
approval of the new rates was based on input from
the commission’s natural gas staff only, without input
from the electricity staff, although she doesn’t know
that to be the fact. “Nothing in the Order suggests they
delved into the impact on the electricity generation
market,” she states, referring to the March 23 Order
granting the new rates.
A number of utilities and even El Paso have asked
for a rehearing of some of the issues in FERC’s Order.
While east of California generators are concerned
about gas price hikes, Pacific Gas & Electric, one of
two major electric utilities in California, is concerned
about “a new wrinkle” in the FERC Order which
could allow El Paso to charge a discount-rate shipper
such as PG&E the maximum tariff rate applicable to
its primary delivery point when the shipper seeks to
deliver gas at an alternate upstream delivery point.
Catherine E. Palazarri, vice president of rates and
regulatory affairs at El Paso, explains that her company
largely based its service structure on tariffs previously
approved by FERC for the Gulfstream and Portland
pipelines serving Florida and Maine, respectively.
“Those are states where about 80 percent of gas consumption
is used to produce electricity,” she explains.
“We are not plowing new ground.”
While the major issue, on a national level, is
whether the El Paso rates open the door to pipeline
rate hikes around the country, there is no question that
electricity rates in Texas, New Mexico and Arizona are
on their way up. In a nutshell, El Paso will be offering
four levels of new premium rates — three-, eight-, 12-
and 16-hour — which utilities can contract for above
and beyond their 24-hour ratable service. The new
premium rates allow El Paso to charge more when a
utility’s “take” of gas is over eight hours as opposed to
16 hours, for example. It costs El Paso more to deliver
a utility all of its gas within an eight-hour window than
it does within a 24-hour window. More pipeline volume
is required, up to 300 percent more volume, for an
eight-hour take compared to a 24-hour take. Palazarri
says FERC has approved premium rates where the
rate differential between eight- and 24-hour service is
300 percent. In El Paso’s case, the rate differential
is only about 65 percent. The difference between
12- and 24-hour is about 30 percent.
Palazarri acknowledges that utility customers east
of California have argued that these new rates, which
many electric generators may be forced to swallow,
represent a fairly significant rate increase. “We don’t
necessarily believe that to be true,” she argues. “EP
transportation averages 35 cents per decatherm per
day; that is about five percent of the cost of the gas.”

Choppy Seas Persist for Medicare Outpatient Drug Plan

From July 2006 P&T Journal

The Medicare drug benefit has
encountered rough seas since it
was launched at the beginning of
the year, and the waves are only getting
higher. The turbulence threatens to
upset the proverbial stomachs of a lot of
pharmacy benefit managers (PBMs) and
insurance companies, who are offering
the new Part D benefit. They are on the
defensive because of allegations that they
are riding roughshod over community
pharmacies, which are being shortchanged
because Part D plans funnel
most of the prescription business to mailorder
and big-name chain pharmacies.
Those complaints have already found
the ear of influential Republicans on Capitol
Hill, including Senator Thad Cochran
(R-Mississippi), chairman of the Senate
Appropriations Committee. At the end
of April, he introduced a bill (S. 2563)
that has attracted an influential group of
bipartisan cosponsors; this has spawned
a similar bill in the House (H.R. 5182),
sponsored by Representative Walter
Jones (R-North Carolina).
The bill does three things:
• It forces Part D plans to pay pharmacies
on a fixed schedule.
• It dictates the kind of medicationmanagement
programs that the
Part D plans must use.
• It outlaws the practice of Part D
plans—when they are partners with
a chain drugstore—of putting the
name of the chain on Part D cards
that are sent to the Medicare recipient.

recipient.
Leslie Norwalk, Esquire, Deputy
Administrator of the Centers for
Medicare & Medicaid Ser vices
(CMS), has already stated that Part
D cards with drugstore names on
them are on the way out.
However, the CMS has been much
more hesitant to authorize changes in
the medication therapy management
(MTM) program. The program’s general
outlines were “sketched in” by the
Medicare Modernization Act of 2003
(MMA), which established the outpatient
drug benefit. Sketched is the operative
word, because that legislation did
not provide heavy details and the MTM
programs that the Part D plans have
deployed, according to critics, have been
conducted via telephone by the PBMs.
The MMA did not indicate who should
provide MTM services. Oren Harden,
Jr., RPh, Executive Vice President of the
Georgia Pharmacy Association, says that
community pharmacists should be working
directly with patients, face to face, to
manage their medications.
Some Medicare Part D plans do follow
that game plan. MemberHealth, Inc., the
fourth largest stand-alone Part D plan in
the U.S., has set up its Community Care
Rχ (CCRχ) program, whereby the local
pharmacist is enlisted specifically to help
steer consumers to generic drugs.
MemberHealth’s generic incentive program
provides higher dispensing rates to
pharmacies that meet generic dispensing-
rate goals. The CCRχ generic dispensing
rate is about 60%, well above
industry averages.
Mark Merritt, president of the Pharmaceutical
Care Management Association
(PCMA), the PBM industry trade
group, has been working overtime to
ward off the Cochran and Jones bills, the
latter of which had about 110 cosponsors

one month after they were introduced.
On MTM programs, the Jones bill states:
“To the extent feasible, face-to-face
interaction shall be the preferred method
of delivery of medication therapy management
services.”
Mr. Merritt points out that the average
senior adult takes five or more medications
each day and sees at least two physicians
at any one time. He or she may use
any number of pharmacies.
“A complete drug history is critical to
an effective MTM program,” he emphasizes.
“Individual pharmacies often do
not have this history, but the drug plan
does—and therefore can ensure patients
are not taking drugs which cause interactions.”
CMS’s Ms. Norwalk and her boss,
Mark McClellan, MD, PhD, can probably
read the tea leaves. Medicare already
made one significant PBM change a few
months ago, when it told Part D plans to
continue providing members with medications
that had been taken off the plan’s
formulary if the patient’s condition had
been stabilized with that drug—that is,
unless the brand name was taken off the
formulary for one of three reasons:
• A new generic product became
available.
• There was a safety warning.
• New clinical guidelines that affected
that drug were published.
On the other hand, Medicare probably
understands that it makes no sense to tie
the hands of Part D plans too tightly concerning
MTM or anything else. After all,
even the CMS actuaries have said that
PBMs are achieving deeper discounts
than previously anticipated. Reductions
have achieved an average of 27% off the
normal retail price, much better than the
15% discount that had been expected

Cargo shipping draws congressional scrutiny

From May 2006 Government Security News

A new shipping container security program, meant to help U.S. consumer and industrial goods companies shore up their overseas supply chains, is taking on water even before it is established. The House overwhelmingly passed on

May 4 a bill that originated in the Homeland Security Committee and would establish a container security initiative (CSI) and other supply chain programs that would set standards for tracking all consumer and industrial product containers arriving through normal and accelerated-entry “GreenLanes” at U.S. ports. The Senate Homeland Security and Governmental Affairs Committee passed a similar bill on May 5.

But, one week after the House passed the Security and Accountability For Every (SAFE) Port Act (HR 4954) by an overwhelming vote of 421-2, a key House appropriations subcommittee passed a Department of Homeland Security budget bill for fiscal 2007 that would cut the CSI funding by $60 million.

In addition, the appropriations bill reduces funding for the Customs-Trade Partnership Against Terrorism (C-TPAT) program by $5 million to $70.1 million. C-TPAT, for example, has been the vehicle for establishing GreenLanes procedures. After the appropriations subcommittee acted, the top Democrat on that panel, Rep. Martin Olav Sabo of Minnesota , aid, “It is a good reminder that authorization bills passed in the House have very little relation to budget realities.”

In explaining its own rational, the SAFE Port Act says: “Significant enhancements can be achieved by applying a multi-layered approach to supply chain security, in a coordinated fashion.”

The House bill -- and the pending Senate bill – try to accomplish that goal by establishing a number of programs aimed at forcing foreign ports to screen all U.S.-bound containers for radiological and nuclear presence, by providing eligible U.S. companies with additional supply chain information through a new, secure electronic data interchange system and by setting standards for both container seals and advanced container intrusion detection systems. Use of the latter would enable U.S. importers to use GreenLanes in American ports.
The emerging dispute between congressional authorizing and appropriating committees about the proper level of federal financial commitment to any new cooperative private-public seaborne supply chain program seems to fly in the face of the Dubai Ports World firestorm earlier this year and indications that current U.S. shipping container monitoring programs are highly ineffective. But Congress will put some new container security/supply chain verification program in place if for no other reason than extreme frustration with the DHS’s inability to get a program up and running on its own.

“DHS is long overdue in establishing cargo security standards and transportation worker credentials,” said Sen. Patty Murray (D-WA), the sponsor of GreenLanes legislation in the Senate. “We need to hold DHS accountable, and our bill provides the infrastructure to ensure accountability and coordination.”

As both congressional bills traveled through the House and Senate, the key issue motivating legislators was the fact that currently only six percent of the 27,000 containers reaching U.S. ports every day are inspected to determine whether they contain weapons of mass destruction or other deadly cargo (including terrorists themselves.)

In the recent past, officials of the DHS have argued that Customs and Border Protection’s (CBP) Automated Targeting System (ATS) is so precise that the U.S. knows which containers arriving on foreign docks are “high risk.” So, potentially most dangerous containers are theoretically inspected at those foreign ports. ATS profiling is based on paper filings of cargo waybills and an extensive historical risk scoring algorithm derived from years of data about containers and inspections.

But Clark Kent Ervin, former inspector general of the DHS, told the House Homeland Security Committee last April that foreign inspectors often refuse to inspect containers that the CPB deems to be high-risk. “Less than a fifth of the containers that we believe should be inspected abroad -- 17.5 percent to be precise -- are in fact inspected by foreign ports,” Ervin said.

That’s why members of Congress believe it is important to know whether container seals -- and eventually all six sides of a container -- have been breached in transit.

The House and Senate bills at this point have some important differences. The House bill seems to be the tougher one, and unequivocal at that. It would force the secretary of DHS to set standards for container seals within 180 days of enactment. Two years from enactment, the DHS secretary must require the enforcement of those standards on all containers entering the United States. In the report accompanying passage of the bill, the House committee voiced its concern “that the state of current technology in this realm is currently insufficient.” The House bill sets a de facto standard which states: “It is critical that new technologies for securing containers minimize false positive readings, and ideally incorporate a false-positive of less than one percent.”

The Senate bill (S 2459) seems more limited, requiring container security devices only for importers participating in a pilot program involving three foreign ports, which would be named in the future. Importers’ containers, loaded on ships in those foreign ports, would be subject to “integrated” scanning, including the use of container “security or sealing devices.” Presumably, that CSI pilot would eventually be rolled out to other foreign ports.

The Senate bill also has a provision setting up GreenLanes at U.S. ports. The use of those lanes would be contingent upon an importer utilizing a more advanced container security device specified by the DHS. The House bill also includes a GreenLanes program (called Tier Three) whose cost of entry would be the use of “container security devices, policies, or practices that exceed the standards and procedures established by the Secretary…”

The thought of Congress delivering a kick in the pants to DHS on container security devices has made retail and consumer product associations nervous. Both the Chamber of Commerce and the Retail Industry Leaders Association (RILA) pleaded with both House and Senate committees this spring to go slowly. Jonathan Gold, vice president for global supply chain policy at the RILA, stated, “Congress should outline policies and goals and let DHS find the smartest and most effective way to meet those goals rather than being forced into deploying unproven gadgets.”

But there is near unanimity in Congress that DHS’s marathon foot-dragging must come to an end