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Transcript
Volume 19, No. 5 / May 2005
TODAY
Timely Communications
from the National Nutritional Foods Association
INSIDE
Legal Q&A: New Food Labeling Rules
Science News: Kids Need More Fiber
Food and Nutrition News:
USDA’s New Pyramid
Supplement Company
Wins Ephedra Suit
“No Evidence” Warranting Ban on 10 Milligrams
or Less, Says Court
A
Page 7
Page 12
8th Annual NNFA
Natural Foods Day
Tuesday, April 12, 2005 • Washington, D.C.
Industry Members
Rally in D.C. for
Natural Foods Day
O
district court in Utah recently invalidated part of the Food and Drug Administration’s (FDA) ban on ephedra dietary supplements, telling the agency to revise its
rulemaking as it applies to low dose ephedra. The challengers to the FDA ban,
Nutraceutical Corporation and its subsidiary Solaray, Inc., successfully argued that FDA
could not use a risk/benefit approach under the Dietary Supplement Health and Education Act of 1994 (DSHEA) and that FDA’s evidence did not support a ban on daily doses
of ephedra dietary supplements containing 10 milligrams or less of ephedrine alkaloids.
Many press announcements on this ruling have stated that it is legal to sell ephedra at
any dose. However, the decision does not have such a broad impact. Rather, it affects only
low dose ephedra—it does not alter the ban established by FDA against dosages in excess
of 10 milligrams. This court decision says only that the record before it does not establish
that ephedra at 10 milligrams presents a significant or unreasonable risk of illness or injury.
FDA has the ability to appeal, and continues to have the authority to sue other companies in other districts under the existing final rule, which currently remains in effect and
unchanged.
Moreover, the decision does not alter those states’ laws prohibiting or restricting the
sale of ephedra that remained in effect after FDA published its final rule. Therefore, a careful review of state and local laws must be considered prior to risking a national launch.
The most significant finding of the Utah court is that FDA’s risk/benefit safety analysis, first applied in the agency’s decision to ban ephedra, is not legal. This finding has significant ramifications, as most in the industry agreed that such a test was inappropriate
under DSHEA. ❦
For a news analysis on the court ruling, please turn to page 2.
Page 6
n Tuesday, April 12, 2005, more than
165 natural product industry stakeholders from 37 states and the District
of Columbia gathered on Capitol Hill for the
NNFA’s 8th annual lobbying event, Natural
Foods Day. The attendance of participants
from across the country shattered last year’s
record attendance of more than 120. NNFA
members representing every component of
the natural products industry educated members of Congress and their aides about
NNFA’s legislative and regulatory priorities,
each of which would
help increase consumers’ access to—and
awareness of—safe,
effective, and affordable natural products.
“This year’s event
was NNFA’s most successful lobbying effort
to date,” said NNFA
Executive Director and CEO David Seckman. “With a variety of issues that pose both
opportunities and challenges for our industry,
participants effectively conveyed to our
nation’s leaders the impact of these issues, in
particular, the importance of preserving and
implementing DSHEA [the Dietary Supplement Health and Education Act of 1994].”
(Continued on page 4)
More than
165 industry
stakeholders
gathered on
Capitol Hill
for the NNFA’s
8th annual
lobbying event
REGULATORY & LEGISLATIVE NEWS
News Analysis
Utah District Court Ruling on Ephedra
FDA’s Case:
Risks Outweigh Benefits
The court found
that FDA was
obligated to
demonstrate
that the exact
dose recommended in the
product labeling
presents a
significant or
Under the Dietary Supplement Health and Education Act of 1994
(DSHEA), FDA has authority to remove unsafe dietary supplements and dietary ingredients from the market. DSHEA provides,
among other things, that the agency can remove a supplement
where it “presents a significant or unreasonable risk of illness or
injury under the labeled conditions of use.” FDA has not provided
any further definitions as to what constitutes a “significant or unreasonable risk.” FDA acted under this standard to ban ephedra products when it issued a final rule on dietary supplements containing
ephedrine alkaloids on February 11, 2004. The final rule required all
dietary supplements that contain ephedrine alkaloids at any level be
removed from the market by April 2004.
In the final rule, FDA, for the first time, articulated a “risk-benefit” test for dietary supplements, arguing that the term “unreasonable,” by definition, triggers some measure of utility or benefit of the
product. If the risks of use of a product outweigh the benefits associated with its use, the product is not safe under this standard. In the
case of ephedra, FDA found that the risks outweighed any benefits
from the use of ephedra, and therefore banned the product.
unreasonable Nutraceutical’s Case: FDA Failed to Consider
risk of illness Dosage; Test Invalid
or injury
Nutraceutical filed suit challenging the final rule in U.S. District
Court in Utah seeking to declare the final rule invalid, remand
the issue to FDA for further rulemaking, and enjoin the agency
from enforcing against the marketing of its low dose ephedra
product containing 10 milligrams or less ephedrine alkaloids in a
daily dose. With the recent decision, Nutraceutical succeeded on all
three points.
Nutraceutical’s primary arguments were: that FDA failed to
make a dose-dependent determination of adulteration as required by
DSHEA, as there was no evidence that products recommending 10
milligrams dosages, and labeled with extensive industry-adopted
warnings, were unsafe; and, that the “risk-benefit” test was an
improper analysis under DSHEA and in violation of the Administrative Procedures Act.
The court concluded there was “no evidence in the administrative record pertaining specifically to doses of ephedrine at the
ephedrine-alkaloid levels recommended by the plaintiffs, that is, 10
milligrams per day.” The court found that FDA was obligated to
demonstrate that the exact dose recommended in the product labeling presents a significant or unreasonable risk of illness or injury.
FDA did not do that with respect to 10 milligrams dosages, as FDA
had no direct evidence on that level of ephedrine alkaloids.
On the issue of risk/benefit, FDA found that the “plain language
of DSHEA does not require a comparison of benefits and risks.” The
court also found that FDA’s reliance on the device provisions of the
Food Drug and Cosmetic Act was misplaced, and emphasized that
dietary supplements are not to be treated as drugs or medical devices
in terms of their safety review. There is no requirement in DSHEA
that supplements “demonstrate a benefit as a precondition to sale.”
What Does This Mean for Industry?
As a result of the ruling, some companies will be able
to re-launch ephedra products of 10 milligrams per
does or less. However, the prospect of ephedra’s return
to the market has already ignited a firestorm of criticism from the press, members of Congress and consumer groups who have long questioned FDA’s ability
to keep unsafe products off the market under DSHEA.
In fact, one federal legislator has already called for
hearings to revisit the ban and the law, arguing that
the safety standards established by DSHEA do not
provide adequate power to FDA to safeguard consumers from unsafe dietary supplements. ❦
For more information about what retailers and manufacturers can and cannot do as a result of the ban,
please see the article on the next page.
2
www.nnfa.org
NNFA Today, Volume 19, No. 5 / May 2005
REGULATORY & LEGISLATIVE NEWS
Snapshot
What You Need to Know about the Ephedra Ruling
A
s a result of a district judge’s recent ruling that partially
lifted the Food and Drug Administration’s (FDA) ban
on the dietary supplement ephedra, NNFA has been
fielding many questions from its retail and manufacturer members about what the decision means for the industry in both
the long and short term. For instance, NNFA has learned that
retailers are now being approached by ephedra manufacturers
or their representatives about putting ephedra products back
on store shelves. Although the court decision leaves room for
interpretation and an appeal by the FDA is anticipated, following is some clarification and guidance in complying with
the court decision.
Q
A
The decision
only applies
to ephedra
products with
10 milligrams
or less and only
within Utah’s
Was the ban on ephedra overturned?
No. The ban on ephedra products of more than 10 milligrams per dose is still in effect. The ruling only invalidated the ban on ephedra products with 10 milligrams or less
of ephedrine alkaloids and with important restrictions, as indicated below.
Q
A
Can retailers and manufacturers begin
selling ephedra products again?
• The decision only applies to ephedra products with 10
milligrams or less and only within Utah’s Central Division district court jurisdiction. FDA may challenge
sales outside of that jurisdiction.
• Only in single and daily doses of 10 milligrams or less.
• Only in states that have not prohibited or restricted
sale of ephedra.
Q
A
What are the risks of selling ephedra?
Liability. NNFA understands that no insurance companies are currently underwriting coverage for either
manufacturers or retailers who sell ephedra. This means
NNFA Today, Volume 19, No. 5 / May 2005
Central Division
full exposure financially in the event of a civil lawsuit.
To date, there have been numerous lawsuits regarding
the use of ephedra products for damages in the millions
of dollars.
Enforcement action. Those retailers or manufacturers
selling ephedra product in any federal court district
other than Utah’s Central Division can still be sued by
the FDA.
district court
jurisdiction.
FDA may
challenge sales
outside of that
jurisdiction
Ruling reversal. If FDA appeals the ruling, and
indications are it will, there is no guarantee the recent
Utah decision will be upheld. Should the ruling be
overturned, the ban on all ephedra products—regardless
of dosage and where they are sold or manufactured—
will remain in force.
Availability. While the ban on ephedra products of
10 milligrams or less sold in the United States has been
lifted—with important restrictions—an embargo on
imports remains in effect. This means that foreign
shipments of ephedra product to the United States can
be turned away at the point of entry.
As further events develop, NNFA will continue to inform
its members about the effects of this important court ruling. ❦
www.nnfa.org
3
REGULATORY & LEGISLATIVE NEWS
8th Annual NNFA
Natural Foods Day
Tuesday, April 12, 2005 • Washington, D.C.
1
Industry Members Rally in
D.C. for Natural Foods Day
2
3
1) More than 165 participants attend Natural Foods Day 2005.
Morning session guest
speakers: (2) Eric
Juzenas, (3) Kathy
Kulkarni, and (4) Paul
Coates.
5) Attendees pick-up
“goodie bag” leavebehind materials for
their congressional
meetings.
4
5
6) NNFA President
Paul Bennett testifies
before a House subcommittee.
6
4
www.nnfa.org
(Continued from page 1)
The event consisted of an early morning briefing session and
breakfast before participants adjourned to attend pre-arranged
meetings with various congressional leaders. The day concluded
with a reception honoring NNFA’s Congressional Champions.
At the morning session, political insiders, including NNFA’s
lobbyists updated the participants on the industry’s most pressing
legislative issues and provided tips on how to communicate the
industry’s priorities effectively. In addition, attendees were
addressed by key government officials, including Paul M. Coates,
director of the National Institute of Health’s Office of Dietary
Supplements; Kathy Kulkarni, legislative director for Rep. Frank
Pallone (D-N.J.); and Eric Juzenas, former Agriculture Committee
counsel for Sen. Tom Harkin (D-Iowa).
Attendees then spent the afternoon in meetings with lawmakers and key staff members from their districts and states. During
NNFA Today, Volume 19, No. 5 / May 2005
REGULATORY & LEGISLATIVE NEWS
“We need health care, not sick care. Kids can
buy junk food at school, but not vitamins.”
—Sen. Tom Harkin
1
1) Carrol Wells of
Honey Bee Natural
Foods outlines key
issues to a legislative
staffer.
2
2) Todd Hurley (left)
of No Name Nutrition
with Rep. Steve King.
3
3) Bob Norman
of Vitamer Labs
discusses industry
issues.
4
“I’ve always been proud to work with
NNFA, because we have so many of the
same goals. As long as I’m here, DSHEA
is going to live.”
—Sen. Orrin Hatch
5
these meetings, constituents asked members of Congress to support
Rep. Juanita Millender-McDonald’s (D-Calif.) Healthy People,
Healthy Choices Act of 2005 (H.R. 161), which would provide
grants to promote proper nutrition and diet supplementation among
minorities. Participants also emphasized the need for dietary supplements to receive the same tax treatment as drugs and over-thecounter medications, as mandated by the Dietary Supplement and
Healthy Meal Replacement Tax Parity Act (H.R. 1545) recently
introduced by Rep. Chris Cannon (R-Utah). Attendees also
stressed the importance of increased research funding for the NIH
Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine.
The evening concluded with a reception featuring the presentation of NNFA’s 2005 Congressional Champion Awards. On hand
to receive their awards were Sens. Harkin and Orrin Hatch (R(Continued on page 15)
NNFA Today, Volume 19, No. 5 / May 2005
4) Debra Short (left)
of Debra’s…Naturally
meets with her congressperson’s assistant.
5) NFD participants
celebrate the conclusion
of a successful day at
the evening reception.
6) Attendees at the
evening reception where
NNFA honored congressional champions.
6
2005 Congressional Champions
Sen. Harkin
Sen. Hatch
Rep. Barrett
Rep. Cannon
Rep. MillenderMcDonald
Rep. Pallone
www.nnfa.org
5
REGULATORY & LEGISLATIVE NEWS
By Sidley Austin Brown & Wood, NNFA General Counsel
New Food Labeling Rules
The first and
most immediate
food labeling
change is
the new trans
fat labeling
requirement
Q
I heard there are a number of new food
labeling regulations, including a trans fat
listing, allergen labeling and possibly calories
or serving sizes disclosures. Could you tell
me a little about each of them?
A
There are a number of new labeling issues that one should
be aware of to plan for label changes and consumer questions regarding new information.
Trans Fat Labeling
The first and most immediate food labeling
Calori
change is the new trans fat labeling
% requirement. This is the first change
Total Fat 13g
to the Nutrition Facts label since
Saturated Fat 5g
the Nutrition Labeling and EduTrans Fat 2g
cation Act (NLEA) regulations
Cholesterol 30mg
were finalized in 1990. Effective
Sodium 660mg
January 1, 2006, all food products,
Total Carbohydrates
even those for infants and children, must
have a Nutrition Facts listing declaring the quantitative
amount per serving of trans fat, unless the product contains less
than 0.5 gram per serving of total fat, and no claims are being
made about fat, fatty acids, or cholesterol content. Trans fat is
to be listed under saturated fat, and both are indented below
total fat.
Keep in mind:
Calories 260
• This new rule will also apply to dietary supplements
that contain a reportable amount of trans fat (0.5
grams or more per serving).
• There is no established Daily Value amount for trans
fat, and so there will not be a need for percent Daily
Value declaration.
• In addition, because of the absence of a Daily Value
amount, FDA has not permitted nutrient content
claims for trans fat to date.
Food Allergens
A second new label requirement is to declare food allergens on
food labels. In August 2004, Congress passed the Food Aller-
6
www.nnfa.org
gen Labeling and Consumer Protection Act of 2004, which
requires food labeling of the eight major foods or food groups
that are considered allergens. These include
milk, eggs, fish, crustacean shellfish, tree
nuts, peanuts, wheat and soy beans.
Contains
The law requires either: a stand alone
Peanuts
statement that includes the word
“Contains”, followed by the name of the
food source from which a major food allergen is derived; or a listing of the common or usual name of the
major food allergen in the list of ingredients followed, in parenthesis, by the food source from which the major food allergen
is derived. In those cases where there is a specific tree nut, fish
or crustacean, the specific type of nut or species of fish or crustacean is required.
Keep in mind:
• This applies to flavorings, coloring, and incidental
additives that contain allergens, which previously
could have been listed under more general terms.
• This law is self-implementing, and therefore, FDA is
not required to propose additional rules; however, FDA
has stated that it will publish further guidance on the
statute shortly, in order to provide its interpretation of
the requirements.
• This law takes effect January 1, 2006.
New ANPRs
Finally, there are two new Advanced Notices of Proposed
Rulemaking (ANPRs) where FDA is
seeking comment on two areas of
food labeling. These may or may Nutrition Fac
Serving Size 1 cup (228g)
not result in label changes.
Servings per container 2
Calorie Declaration
Amount per serving
Calories
The first ANPR addresses the Calories 260
% Da
prominence of the declaration of the
amount of calories per serving. FDA is questioning whether there should be a new mechanism to highlight
the amount of calories per serving on a food product, either in
(Continued on page 16)
NNFA Today, Volume 19, No. 5 / May 2005
SCIENCE NEWS
Children Need More Fiber
From Healthnotes Newswire, a news service of Healthnotes, Inc.
A
merican preschool-age children do not get enough fiber
from their diets, reports the Journal of the American
Dietetic Association (2005, vol.105: 221–225). Inadequate
fiber intake may increase these
children’s risk of developing heart
disease and other chronic illnesses.
As dietary habits formed before
age two tend to carry into adulthood, it is critical to introduce and
emphasize nutritious foods to children as their tastes develop.
Fiber, the indigestible carbohydrate and woody portion of
plants, comes from foods such as
whole grains (brown rice, whole
wheat), legumes (peas, beans,
lentils), fruits, and vegetables. Eating high-fiber foods can
decrease the risk of heart disease, diabetes, high blood pressure,
and some types of cancer. Adequate fiber intake is also necessary
to ensure regular bowel movements, guarding against constipation and the development of diverticular disease (a disorder of
the colon).
The National Academy of Sciences recommends a daily
fiber intake of 14 grams per 1,000 calories for adults and children. This Dietary Reference Intake (DRI) is higher than the
amount previously recommended by the American Health
Foundation and the American Academy of Pediatrics.
The new study assessed the average daily intake of fiber by
two- to five-year-old children. Foods eaten by over 5,000 children were tracked for two days as part of the Continuing Survey
of Food Intake by Individuals. Average daily fiber and nutrient
intake were then calculated. Dietary intake data of two- to
three-year-olds was compared with that of four- to five-year-olds.
Children who ate the most fruits, vegetables, and grains
consumed more fiber than children who ate less of these foods.
Two- and three-year-olds consumed less dietary fiber on average
than four- and five-year-olds. Foods like applesauce and fruit
cocktail contributed the most fiber to the children’s diets. Lesser
amounts were obtained from soy and other legumes, high-fiber
cereals, grain-based fatty foods such as pizza, and high-fat salty
snacks. Of note, the consumption of high-fiber fruits and
NNFA Today, Volume 19, No. 5 / May 2005
vegetables (such as blueberries, raisins, squash, and broccoli)
was too low to contribute to total fiber estimates. Fiber intake
was far below the DRI in all of the children, even those who
ate the most fiber. In fact, fiber
intake did not meet previous lower
recommendations.
The high-fiber diets eaten by
the children were also rich in other
nutrients including iron, folic acid,
and vitamins A and C. However,
calcium and vitamin B12 intakes
were lower among those children
with the highest intake of fiber. Vitamin B12 is found in animal products such as dairy products, chicken,
and red meat. The decrease in this
nutrient in the more fiber-rich diets may reflect lower consumption of these foods. High-fiber foods may also have replaced
some calcium-rich dairy products, leading to a lower intake of
this important nutrient in children with high-fiber diets. In
addition, fiber itself may interfere with calcium absorption. The
overall benefits of a high-fiber diet, however, far outweigh any
potential deficiencies. Eating a whole-foods diet that includes
calcium-rich vegetables and some dairy products should ensure
adequate intake of calcium and vitamin B12.
It appears that fiber intake by preschoolers is much lower
than it should be. Public health programs and pediatricians
should emphasize the importance of eating fiber-rich foods
like whole grains, fruits, and vegetables, to young children and
their parents. ❦
Inadequate
fiber intake
may increase
children’s risk
of developing
heart disease
and other
chronic illnesses
—Kimberly Beauchamp, ND
®
Healthnotes Inc. (HNI,
www.healthnotes.com) is
the premier provider of reliable, easy-to-use health, food, and lifestyle information for Web sites and interactive touchscreen kiosks. Used by leading supermarkets, pharmacies, and natural product stores in the United States, Canada,
and the United Kingdom, Healthnotes® Retail Solutions empowers consumers
to make educated decisions and drives product sales—online and in-store. HNI
also generates Web applications that are licensed to e-commerce and healthrelated Internet sites worldwide.
www.nnfa.org
7
SCIENCE NEWS
Sweet Potato Variety Helps Control
Type 2 Diabetes in Clinical Trial
This literature summary is part of the HerbClip, an educational mailing service of the American Botanical Council
Caiapo (Ipomoea
batatas) has
been eaten
in Japan as a
traditional food
for treatment
of anemia,
hypertension,
and diabetes
8
T
ype 2 diabetes is caused by insulin resistance
and impaired insulin secretion.
Treatments include diet, exercise,
medications, and insulin. A white
sweet potato, called Caiapo (Ipomoea
batatas), cultivated in the mountains
of Kagawa Prefecture in Japan, has been
eaten there as a traditional food for treatment of
anemia, hypertension, and diabetes. In recent years, it
has been developed as a nutraceutical product and is consumed and sold as a supplement for the prevention and care of
type 2 diabetes. A preliminary study in men with type 2 diabetes
found that Caiapo (four grams per day for six weeks) lowered the
total and low-density lipoprotein (LDL) cholesterol levels and
lowered blood glucose by increasing insulin sensitivity without
affecting insulin secretion. The objective of the present study
was to verify the findings of the preliminary study and to
increase the number of participants and the study duration.
Sixty-one patients with type 2 diabetes participated in
this placebo-controlled, randomized, double-blind study.
Patients consumed four grams of Caiapo per day or placebo
once a day for 12 weeks. Blood glucose, cholesterol, triglycerides, and HbA1c (a measure of long-term glucose control)
were monitored.
HbA1c significantly decreased after two and three months
of treatment with Caiapo compared to placebo (P<0.001). Both
groups had significant weight loss and statistical analysis could
not rule out the possibility that weight loss contributed to the
improvement in HbA1c. Fasting blood glucose decreased in
both groups, but to a greater degree in the Caiapo group (P =
0.03). After three months of treatment, 48.3 percent of the
patients consuming Caiapo had mean fasting blood glucose levels below the upper normal limit compared to 7.7 percent of
those in the placebo group. Blood pressure did not change. At
the end of treatment, cholesterol levels in the Caiapo group
where significantly lower than those in the placebo group
(P<0.05). There was no significant effect on triglyceride levels.
Caiapo was well tolerated. Adverse events were minimal but
were mainly gastrointestinal.
www.nnfa.org
This study confirmed the beneficial effects of Caiapo on glucose and serum cholesterol levels in type 2 diabetic patients.
The study also showed for the first time an improvement in
long-term glucose control. However, the exact contribution of
weight loss on the effects observed was not quantified. The
authors hypothesize that since glucose levels continued to
decline when the weight loss had stabilized, Caiapo had an
effect on glucose beyond that caused by weight loss. Caiapo may
have increased the body's sensitivity to insulin. Caiapo-induced
improvement in insulin sensitivity would not be responsible for
the decrease in cholesterol levels. Therefore, an unidentified
compound could be responsible for the cholesterol-lowering
effect. The authors conclude that Caiapo aids in the management of type 2 diabetes. ❦
—Heather S. Oliff, Ph.D.
The American Botanical Council provides
this summary and the above article as an
educational service. ABC does not warrant
that the data is accurate and correct, nor does
distribution of the enclosed article constitute
any endorsement of the information contained
or of the views of the authors.
To join ABC, call (512) 926-4900 or visit
www.herbalgram.org.
NNFA Today, Volume 19, No. 5 / May 2005
SCIENCE NEWS
Science Briefs
Men Benefit
from Antioxidant
Supplementation
Supplementing with
modest amounts of
antioxidants including
vitamins C and E, betacarotene, zinc, and selenium can help reduce the risk of cancer and all-cause death in men,
according to a study in the Archives of Internal Medicine (2004,
vol.164: 2335-2342). Antioxidants are compounds that protect
cells from damage by free radicals, which are believed to be a cause
of degenerative changes associated with aging and other health
issues. The study included 7,713 healthy women between the ages
of 35 and 60 and 5,028 healthy men between the ages of 45 and 60.
Participants were randomly assigned to receive either an antioxidant supplement combination of vitamin C, vitamin E, betacarotene, selenium, and zinc; or placebo. At the conclusion of the
study researchers determined the risk of cancer was 29 percent
lower, and in all-cause death 36 percent lower, in men taking the
supplement regimen than those taking placebo. No similar effect
was seen in women participants.
Fish Oil Fights Arthritis
According to a study published in Nutrition (2005, vol.21: 131-136),
sufferers of rheumatoid arthritis (RA) can reduce their symptoms by
supplementing with fish oil. Additional benefits can also be gained
by supplementing with olive oil. Fifty-five participants with RA
were randomly assigned into one of three groups taking either fish
oil capsules, fish oil capsules with extra virgin olive oil on salads, or
soy oil placebo. Symptoms and ability to function were assessed at
clinical visits at the start of the study, after 12 weeks, and after 24
weeks. Blood was analyzed to measure markers of inflammation and
disease progression. At the conclusion of the study, both groups taking oils experienced significantly more improvements than the
group taking placebo. Additionally, those taking fish oil and olive
oil had a greater improvement in a blood marker of the disease.
While fish oil fatty acids may help relieve RA symptoms, sufferers
may be advised to add olive oil in their diet as well.
Stroke sufferers
can help
reduce chances
of hip fracture
B Vitamins for Hip Health
in the years
A study published in the Journal of the American Medical Association
(2005, vol.293: 1082-1088), reports that stroke sufferers can help
reduce their chances of sustaining a hip fracture in the years after
their stroke by supplementing with folic acid and vitamin B12.
These vitamins have been effective in combating increases in
homocysteine levels, which earlier studies have suggested is toxic to
bones by reducing both bone density and quality of bone tissue. Two
years after the study, average homocysteine levels among study participants decreased by 38 percent in the group taking folic acid and
vitamin B12, and increased 31 percent in the group taking just
placebo. The study suggests that both folic acid and vitamin B12
can help prevent bone fractures by reducing the level of homocysteine in the body. ❦
after their
stroke with
folic acid and
vitamin B12
Education Event
NNFA Announces Web Conference for Final GMP Rule
Within 72 hours of the Food and Drug Administration’s (FDA) publication of a final regulation on
good manufacturing practices (GMPs) for dietary supplements—which could occur at any
time—NNFA will hold a Web conference highlighting the most important and pressing aspects
of the rule. The conference is ideal for those involved with regulatory affairs, production, quality
assurance/control, and legal functions.
For more information about this event, please visit www.nnfa.org/services/training/webcast.htm
NNFA Today, Volume 19, No. 5 / May 2005
www.nnfa.org
9
FOOD & NUTRITION NEWS
Healthy Essentials
Healthy Essentials is aimed at providing member retailers with valuable health information. Please share this feature with your employees and customers.
A Brief, Brief History of Vitamins
“There occur in various natural foods, substances which cannot
be absent without serious injury to the peripheral nervous
system… These substances are easily disintegrated… which shows
that they are complex substances and cannot be replaced by simple
chemical compounds.”
A
Dutch doctor named Gerrit Grijns made that statement in
the course of his research in the relatively new field of nutrition at the end of the 19th century. The statement would
later become known in the scientific community as the “vitamin
concept.” But it was a biochemist from Poland, Casimir Funk, who,
in the beginning of the 20th century, gave us the term for the substances Grijns described. Funk grouped these trace nutrients, deficiencies in which seemed to be the cause of diseases such as beriberi,
pellagra and scurvy, into a class called “amines.” Since their role in
human health seemed so important, he further coined them “vital
amines,” which was eventually shortened to vitamins.
Building on the mounting research on these nutrients, an
American scientist and contemporary of Funk’s, named Elmer V.
10
www.nnfa.org
McCollum, discovered that one type of nutrient could be dissolved
in fat and another type in water. He called these respectively “factor A” and “factor B,” a naming convention that ultimately lead to
today’s classification of vitamins as either fat-soluble or water-soluble. Since last month’s Healthy Essentials focused on B vitamins,
which constitute all known water-soluble vitamins except vitamin
C, this month’s column will explore the fat-soluble category.
Solubility, So What?
Solubility determines a lot about a vitamin: how it is absorbed into
and transported by the bloodstream, whether it can be stored in the
body, and how easily it is excreted from the body. Water-soluble
vitamins are absorbed directly into the bloodstream and travel freely
throughout the body. They are not stored in tissues in great amounts
and excesses are excreted in urine. Because of this, the risk of immediate toxicities of any of the water-soluble vitamins is not as great as
with fat-soluble vitamins. The latter are absorbed into the lymph
and travel in the blood with protein carriers. Because they can be
stored in the liver or with other lipids in fatty tissues, some fat-soluble vitamins can build up to toxic concentrations.
NNFA Today, Volume 19, No. 5 / May 2005
FOOD & NUTRITION NEWS
It’s Easy as A, D, E … and K
The four fat-soluble vitamins, A, D, E, and K, are found in fats and
oil of foods. They play many diverse roles in the body, including
directing cell conversion, storage and release of substances, regulation of protein production, prevention of oxidative damage to tissues, and allowing blood to clot. They cannot be absorbed in the
body without bile. (In the stomach, enzymes in the watery digestive
juices can’t get at the fats, since they tend to separate from the
watery juices. The gallbladder secretes bile, which emulsifies fats,
allowing the enzymes to bind to and digest them.) Once absorbed,
fat-soluble vitamins are stored in the liver and fatty tissues until the
body needs them. However, this capacity for being stored can also
lead to a build-up of the vitamins to toxic levels.
Deficiencies in the fat-soluble vitamins can occur if the body
is consistently deprived of them. Diseases that produce fat malabsorption can cause loss of vitamins dissolved in undigested fat.
In addition, people on diets extremely low in fat run the risk of
being deficient in these vitamins because low-fat diets interfere with
their absorption.
Vitamin A: First of the Fats
While it was the first of the fat-soluble vitamins to be discovered,
vitamin A remains today the focus of much study because of its versatile activity in the body. It has functions in eye health, the
immune system, maintenance of body linings and skin, bone
growth, cell development and reproduction. Three forms of vitamin
A are active in the body. Retinol is stored in the liver, which makes
it available to the body’s cells. The cells convert retinol to its two
other active forms, retinal and retinoic acid.
The most abundant sources of vitamin A are liver and fish oil.
Dairy products and fortified cereals can also be good sources. In
plants, this vitamin only exists in its precursor form as carotenoids.
Once inside the body, the precursors are transformed to the active
vitamin form. Beta-carotene has the highest vitamin A activity of
all the carotenoid precursors.
D, The Non-Essential Essential
This vitamin is distinct among all others because the body can synthesize all it needs with help from sunlight alone. If one gets enough
sun each day, there is really no need of vitamin D from food sources.
In this sense, it is not essential. Because deficiencies in it can lead to
diseases, however, it is essential.
NNFA Today, Volume 19, No. 5 / May 2005
D’s most important role is maintaining blood levels of calcium.
It does this by increasing absorption from food and reducing urinary
excretion of the mineral. Both functions help spare the calcium
stored in bones from being used by the cells of the many other tissues in the body that require calcium and, therefore, preserves bone
integrity. Vitamin D also plays a role in immunity and is needed for
adequate blood levels of insulin. Cod liver oil and foods fortified
with vitamin D are excellent sources of the vitamin, though deficiencies are usually remedied with supplementation.
Vitamin E: Antioxidant Extraordinaire
Vitamin E is on the front lines, so to speak, in the fight against
oxidative damage. It actually sacrifices itself to oxidation to protect
polyunsaturated fats and other vulnerable components of the cells
from being oxidized. In addition to its antioxidant functions,
vitamin E also has a direct affect on inflammation, blood cell
regulation, connective tissue growth, and genetic control of cell
division. Vitamin E is found in many foods. Wheat germ oil, nuts
and seeds, whole grains, egg yolks, and green leafy vegetables all
contain vitamin E.
The main
function of
vitamin K is to
help synthesize
proteins that
help clot blood
K is for Clotting
The main function of vitamin K is to help synthesize proteins that
help clot blood. If blood did not clot (that is, turn from liquid to
solid), wounds would not stop bleeding. Before surgery, clotting time
of a person’s blood is measured. If clotting time is slow, vitamin K
will be administered to reduce bleeding during surgery. Unfortunately, K only helps when there is a deficiency in the vitamin, not
in cases where a person has other bleeding disorders, such as hemophilia. Vitamin K is also necessary for proper bone formation. Working with vitamin D, it helps bones produce a protein that enables
them to bind with minerals they need. Vitamin K can be obtained
from a nonfood source—intestinal bacteria. Food sources include
green, leafy vegetables like spinach, kale, collards, and broccoli.
Other significant sources include soybean, olive, cottonseed, and
canola oils. ❦
Sources: “The Nobel Prize and the Discovery of Vitamins” by Kenneth J. Carpenter (nobelprize.org/medicine/
articles/carpenter); Healthnotes.com; Nutrition Concepts
and Controversies by Frances Sizer and Eleanor Whitney
www.nnfa.org
11
FOOD & NUTRITION NEWS
USDA Reveals New Food Pyramid
T
he U.S. Department of Agriculture (USDA) recently
unveiled MyPyramid, a new symbol replacing the Food Guide
Pyramid introduced in 1992. The new pyramid is part of an
overall food guidance system that emphasizes the need for a more
individualized approach to improving diet and lifestyle.
MyPyramid incorporates recommendations from the 2005
Dietary Guidelines for Americans, released by USDA and U.S.
Department of Health and Human Services (HHS) in January (see
the February and March 2005 issues of NNFA Today for more information on the guidelines). The dietary guidelines provide advice for
and to be active every day. The symbol represents the recommended
proportion of foods from each food group and focuses on the importance of making smart food choices in every food group, every day.
The system emphasizes taking small steps to improve diet and
lifestyle each day, as is suggested by the pyramid’s slogan, “Steps to
a Healthier You.” Physical activity, a new element in the dietary
guidelines, is also emphasized.
The Web site, www.MyPyramid.gov, allows consumers to get
more customized information to help make the recommendations
fit their own needs. Individuals can key in their age, gender and
physical activity level so that they can get a
more personalized recommendation on their
daily calorie level.
Features on MyPyramid.gov
MyPyramid Plan – provides an estimate of
what and how much food one should eat from
the different food groups by entering one’s age,
gender and activity level.
MyPyramid Tracker – provides more detailed
information on one’s diet quality and physical
activity status by comparing a day’s worth of
foods eaten with current nutrition guidance.
Relevant nutrition and physical activity
messages are tailored to the user’s desire to
maintain current weight or to lose weight.
people about how proper dietary habits can promote health and
reduce the risk of major chronic diseases. MyPyramid was developed
to carry the messages of the guidelines and to make Americans
aware of the vital health benefits of simple and modest improvements in nutrition, physical activity and lifestyle behavior.
While NNFA supports the overall recommendation in the
guidelines that Americans meet their nutritional needs by consuming healthier foods, such as whole grains and by avoiding processed
foods, the association believes the guidelines take only a small step
in the right direction in recognizing the role of dietary supplements
in an adequate diet, particularly for populations with special needs.
According to the USDA press release, the MyPyramid symbol
is designed to encourage consumers to make healthier food choices
12
www.nnfa.org
Inside MyPyramid – provides in-depth
information for every food group, including
recommended daily amounts in commonly
used measures, like cups and ounces, with
examples and everyday tips. The section also
includes recommendations for choosing
healthy oils, discretionary calories and physical activity.
Start Today – provides tips and resources that include
downloadable suggestions on all the food groups and physical
activity, and a worksheet to track what one is eating.
Future enhancements to the new food guidance system will
include features that make it possible for consumers to make specific
food choices by group, look at everyday portions of favorite foods,
and adjust their choices to meet their daily needs.
Additional information about USDA’s MyPyramid is
available at www.MyPyramid.gov. The 2005 Dietary Guidelines for
Americans and consumer brochure are available at
www.healthierus.gov/dietaryguidelines ❦
NNFA Today, Volume 19, No. 5 / May 2005
INTERNATIONAL NEWS
INTERNATIONAL UPDATE
British Judge Finds
Proposed EU Ban on
Supplements “Invalid”
The British health food industry
won a major victory recently
when a senior judge ruled that a
bid by the European Union
(EU) to ban hundreds of vitamins and food supplements was
flawed and therefore, “invalid.”
Critics of the directive, including the more than one million
Britons who signed a petition
opposing it, welcomed the
judge’s decision. The proposed
ban was part of the Food Supplements Directive, approved
by EU governments in 2002,
which was designed to tighten
controls on products in the
health foods market including
natural remedies, vitamin supplements and mineral plant
extracts. The judge concluded the ban was unscientific and
infringed basic EU principles of “legal protection, legal certainty
and sound administration.”
Contentious Codex Meeting Ends in Positive
Outcome for Industry
Contributed by Jim Roza, an NNFA International Committee
member, who attended this meeting.
A recent meeting of a Codex Alimentarius committee ended
without a consensus on a proposed draft of its Principles for Risk
Analysis for Food Safety due to drawn-out, contentious debate
over whether it was even the charge of the committee (the
Codex Committee on General Principles, or CCGP) to develop
risk analysis guidelines. The deeply divided delegations ultimately agreed to move the risk analysis assessment a step backward in the process, during which time a working group would
attempt to identify the object and scope or risk analysis.
One of the major stumbling blocks of the proposed draft
centered on the inclusion of the precautionary principle in portions of the document. The precautionary principle is a regulatory/legal principle widely used in Europe to preemptively
prevent or remove a product from the market due to a lack of
NNFA Today, Volume 19, No. 5 / May 2005
scientific certainty regarding a
product’s safe use; even though
there may be none to the contrary. The use of the precautionary principle could negatively
impact supplements when establishing maximum upper limits
under Codex guidelines. It could
be used to keep supplement levels at RDA potencies even
though there is no scientific evidence of harmful effects at
higher levels.
Although high potency
dietary supplements have a history of safe use throughout the
world and stand in stark contrast
to the deaths and illnesses cause
by drugs, foreign regulatory
agencies in Europe and elsewhere have employed the precautionary principle under the guise that a lack of scientific
certainty exists that impugns safety of dietary supplements.
Some feel this paradigm is flawed because, practically speaking,
one could never show that under any and all conditions a product would be safe all the time.
The working group charged with determining the scope of
the new draft guidelines will be co-chaired by the U.S. delegation along with delegations from Malaysia and Morocco. After
all committee delegations have responded and the working
group reviews and evaluates the draft content, a physical working group will be convened and their work will be considered at
next year’s CCGP meeting.
The impact of the committee’s work could have far reaching effects if the precautionary principle is not kept out of the
document. Because precaution is inherent in any risk analysis,
the inclusion of any term or footnote referring to prudence, caution or uncertainty can be an interpreted as the precautionary
principle and thus could be used in a pejorative fashion against
dietary supplements. Although the precautionary principle is
still a potential threat, the push back a step in the process for a
reworking by a committee, the majority of which opposes the
precautionary principle and the committee’s involvement with
risk analysis, is a positive outcome. ❦
The judge
concluded the
ban was
unscientific and
infringed basic
EU principles of
“legal protection,
legal certainty
and sound
administration”
www.nnfa.org
13
TRADE SHOW NEWS
Significant Actions and Motions
T
he following significant actions and motions were approved at the April 11, 2005
meeting of the NNFA Board of Directors:
• An amendment to the Policies and Procedures that removes the requirement that at
least one supply director be a broker and at least one be a distributor
• Association support of the Healthy People, Healthy Choices Act, a bill from the
House of Representatives (H.R. 161) For more information on this bill, please visit
NNFA’s online Advocacy Action Center at www.capwiz.com/nnfa/issues/
• Association support of the Dietary Supplement and Healthy Meal Replacement Tax
Parity Act, a draft Senate bill (H.R. 1545) For more information on this bill, please
visit NNFA’s online Advocacy Action
Center at www.capwiz.com/nnfa/issues/
• Sands Expo and Convention Center
in Las Vegas, Nev. as the site of
NNFA 2006 and NNFA 2007, the
association’s annual trade show and
convention ❦
NNFA Board of Directors
Executive Committee:
Paul Bennett, President
Harvest Moon Natural Foods, Olathe, KS
David Taylor, President-Elect
Nature’s Harvest Market & Deli, Tampa, FL
Gary Hume, Treasurer
Nutraceutical Corp., Park City, UT
Debra Short, Chair, Retail Council
Debra’s…Naturally, Shawnee, OK
Board of Directors:
Gary Barrows
Bluebonnet Nutrition Corp., Sugar Land, TX
Randy Dennin
Capsugel, Greenwood, SC
Ryan Drexler
Country Life/Desert Essence, Hauppauge, NY
Mark A. Fox
Ideasphere, Inc., Grand Rapids, MI
Soodi Kick
Nuts ’N Berries, Atlanta, GA
Richard League
Mothers Cupboard Natural Foods, Spokane, WA
Greg Leonard
Tree of Life, St. Augustine, FL
Jim Lewis
Sunseed Natural Foods, Inc., Juneau, WI
Mission Statement
NNFA Today is the official publication of the
National Nutritional Foods Association (NNFA). It serves as a
comprehensive, authoritative source for practical information that
natural food retailers and suppliers need to succeed in the marketplace.
It provides thought-provoking, timely information on all aspects of
the natural products industry and NNFA encourages dialogue among
members on professional concerns and views.
The views and opinions presented by contributors to NNFA Today
are their own and not necessarily those of NNFA. Further, NNFA makes no
warranty or representation as to the accuracy or sufficiency of the information
contributed by outside sources,and assumes no responsibility or liability
regarding the use of such information.
Adrienne Mastrobattista
The Organic Warehouse, Stroudsburg, PA
Richard Merriam
GCI Nutrients, Burlingame, GA
Marianne Morgan
Health Habit, San Andreas, CA
Matt Murray
Green Acres Natural Foods Market, Wichita, KS
Scott Presnall
Advantage Sales & Marketing, Irvine, CA
Pat Sardell
Country Vitamins, Corvallis, OR
Jim Smith
Apple-A-Day Health World, Gadsden, AL
Editorial Director: Tracy Taylor
Executive Editor: George Sun
Editor: Amanda Thomason
Graphic Designer: Kimberly Harrigan
Printing: Network Printing, San Dimas, CA
14
www.nnfa.org
Send inquiries to NNFA at:
2112 E. Fourth Street, Suite 200,
Santa Ana, CA 92705
(800) 966-6632 Fax: (714) 460-7444
e-mail: [email protected]
Carrol Wells
Honey Bee Natural Foods, Brownwood, TX
John Venardos
Atkins Nutritionals, Inc., Ronkonkoma, NY
NNFA Today, Volume 19, No. 5 / May 2005
REGULATORY & LEGISLATIVE NEWS
Industry Members Rally In Washington, D.C. for Natural Foods Day 2005
(Continued from page 5)
Utah); Reps. Gresham Barrett (R-S.C.), Chris Cannon, and Frank
Pallone. Unable to attend, but also recipients of awards were Sen.
Rick Santorum (R-Penn.) and Reps. Dan Burton (R-Ind.) and
Juanita Millender-McDonald.
At the ceremony, several of the honorees lauded NNFA for
its effective leadership in ensuring the vitality of the natural
products industry.
“I strongly believe that all of you can make a difference,” Rep.
Pallone said. “You are doing a great job at getting your message out.”
“We need health care, not sick care,” Sen. Harkin said. “Kids
can buy junk food at school, but not vitamins.”
“I’ve always been proud to work with NNFA, because we have
so many of the same goals,” Sen. Hatch said. “As long as I’m here,
DSHEA is going to live.”
In a related event, NNFA President Paul Bennett testified
before the House Appropriations Subcommittee on Labor, Health
and Human Services, Education, and Related Agencies on Thursday, April 14. In his testimony, Bennett outlined NNFA’s support for
enhanced funding of the Office of Dietary Supplements and the
National Center for Complementary and Alternative Medicine.
Bennett also urged immediate approval of final good manufacturing
practices (GMPs) by the Food and Drug Administration (FDA),
and called for greater resources for FDA to fully implement and
enforce the GMP regulations required by DSHEA.
“Dietary supplements are allowing millions of American consumers to take charge of their own good health by safely and effectively preventing and treating a host of illnesses and conditions,”
Bennett said. “NNFA urges the committee to fortify the congressional mandate expressed in DSHEA by investing in the scientific
research which holds the key to our knowledge of the remarkable
importance and value of dietary supplements.” ❦
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15
Legal Q&A
(Continued from page 6)
the Nutrition Facts or on some other part of the label. FDA has
gathered information that indicates that the public is concerned
about calories, as well as about many other aspects of nutrition information such as saturated fat, cholesterol, carbohydrates and sodium.
On April 4, 2005, FDA posed a series of questions seeking information from industry and others regarding the need for highlighting
calories more specifically. Comments are due by June 20, 2005.
Serving Sizes for Foods
The second ANPR, also published on April 4, 2005 and open for
comments until June 20, 2005, addresses serving size declarations of
food products. Since the passage of the NLEA, FDA has based serving sizes on Reference Amounts Customarily Consumed (RACCs).
The existing RACCs were developed in the 1970s and 1980s to
establish standardized amounts upon which all nutrition information would be provided. The intention was to provide for easy food
choice comparisons for consumers. FDA now is questioning
whether there is a need to update those reference amounts and if so
how to do that. FDA also wants to know whether there should be
new rules governing when a product can be labeled as a single serving container.
Finally, the Federal Trade Commission (FTC) submitted comments to FDA recommending that FDA permit truthful, non misleading claims that compare different portion sizes of foods. FDA’s
current regulations regarding nutrient content claims require
all comparisons to be based on a uniform amount of food. FDA is
now revisiting this and requesting industry’s reaction to the
FTC proposal. ❦
The National Nutritional
Foods Association’s
California office has moved
to a new location!
California
NEW S!
RES
ADD
National Nutritional Foods Association
2112 E. Fourth Street, Suite 200
Santa Ana, CA 92705
Ph: (714) 460-7732 / (800) 966-6632
Fax: (714) 460-7444
Washington, D.C.
E
SAM S!
RES
ADD
16
www.nnfa.org
National Nutritional Foods Association
1220 19th Street NW, Suite 400
Washington, D.C. 20036
Ph: (202) 223-0101
Fax: (202) 223-0250
NNFA Today, Volume 19, No. 5 / May 2005