The
Latest on Labeling
By Lauren Swann, MS, RD, LDN
Vol. 6 No. 1 p. 40
The food product label informs consumers, promotes
the product, and is a point-of-purchase reference piece like no
other because it stays on the product right into the home. It’s
advertising and disclosure all in one and can serve as an integral
resource in nutrition education. Yet, it is also subject to myriad
complex, in-depth laws and regulations that shape the nature of
how the facts are actually expressed.
Two federal bodies regulate the majority of labeling
compliance: Meat and poultry is governed by the U.S. Department
of Agriculture (USDA) Food Safety and Inspection Service (FSIS);
all other foods and supplements are governed by the FDA Center for
Food Safety and Applied Nutrition (CFSAN). However, other agencies
have authority over certain aspects of labeling. For example, the
USDA Agricultural Marketing Service handles grading seals for vegetables,
fruit, meat, dairy, and eggs and rules over the organic labeling
seal via the National Organic Standards Board. Some labeling requirements,
such as storage instructions for refrigerated foods, are subject
to state-level authority.
Recent Labeling Developments
Regulatory affairs activities and decisions that result in food
labeling requirements are dynamic and continuous, particularly amidst
today’s aggressive marketing from industry and the countering
efforts of ever-vigilant watchdog activist groups. Here are some
highlights of recent developments on the labeling scene.
Health Claims
To encourage current and better information for consumers about
their food choices and motivate manufacturers to competitively market
more healthful products, the FDA has implemented a more relaxed
review process for the health claims desired by food companies for
product labels. An interim ranking system is now in place to evaluate
the scientific evidence supporting qualified health claims. The
FDA is using a four-point scale—“A” is the highest
grade and is for unqualified claims with evidence of “significant
scientific agreement.” The remaining levels require qualifiers
that communicate the strength of the evidence to avoid misleading
consumers:
· “B” — Scientific evidence exists but
is inconclusive
· “C” — Evidence is limited and inconclusive
· “D” — Little scientific evidence
Health claims are prioritized for review relative
to evidence and chronic health conditions. Top priorities include
the benefits of eating at least several servings per week of foods
high in omega-3 fatty acids, including certain oily fish such as
ocean salmon, tuna, and mackerel, for reducing the risk of heart
disease and the benefits of substituting nuts for other sources
of saturated fat-containing protein to help reduce the risk of heart
disease. Companies may now include messages about the benefits of
eating five to nine servings per day of fruits and vegetables for
reducing the risk of some cancers and other chronic illnesses and
the benefits of replacing solid fats that are high in saturated
and trans fats with vegetable oils containing unsaturated fats for
reducing the risk of heart disease. Qualified health claims are
currently permitted for the following:
· selenium and cancer;
· antioxidant vitamins and cancer;
· nuts and heart disease;
· walnuts and heart disease;
· omega-3 fatty acids and coronary heart disease;
· B vitamins and vascular disease;
· phosphatidylserine and cognitive dysfunction and dementia;
and
· 0.8 milligrams folic acid and neural tube birth defects.
The FDA is exploring consumer comprehension of the
evidence for varying description levels of qualified claims to ensure
that words, symbols, or other means used to express differences
are understood. In the November 25 Federal Register, the agency
requested public comment on qualified health claim issues, including
three alternative options: 1) turning the current interim procedure
into a regulation; 2) requiring the traditional rulemaking procedure;
or 3) considering them outside of existing regulations—after
they appear on labels—only as false and misleading if they
lack substantiation.
The Federal Register announcement also solicits
comments on other issues related to health claims, including data
and research on a substance/disease relationship, including how
to provide incentives for manufacturers to develop the data needed
to obtain significant scientific agreement; use of phrases such
as “FDA authorized” in qualified and unqualified health
claims; and consumer education about qualified health claims.
Feedback is also sought on defining dietary guidance
statements on conventional food and dietary supplement labels to
distinguish them from health claims; determine the value of statements
referencing the substance vs. the food (ie, calcium vs. yogurt in
an osteoporosis claim); and clear ways to use food category recommendations
for healthier dietary replacements such as “choose seafood,
lean meat and poultry, beans or nuts” instead of “reduce
your intake of saturated fat and cholesterol.” Deadline for
comment submission, which can be done electronically at www.fda.gov/dockets/ecomments,
is January 26, 2004.
Other recent health claim regulatory action includes
the following:
· amending authorization—unchanged from the interim
decision—of a health claim on the relationship between beta-glucan
soluble fiber from whole oat sources and reduced risk of coronary
heart disease (CHD) to include an additional eligible source of
whole oat beta-glucan soluble fiber, oatrim, the soluble fraction
of alpha-amylase hydrolyzed oat bran or whole oat flour; and
· developing a final rule that may differ from the broadened
criteria initially listed, requiring manufacturers to change their
labels for compliance for health claims for phytosterols or plant
stanol esters and reduced risk of CHD.
Trans Fat Labeling
Beginning on January 1, 2006, nonmeat and nonpoultry food and some
dietary supplement labels—products containing 0.5 grams or
more of trans fat, such as energy and nutrition bars—must
show the amount of trans fat on a separate line immediately under
saturated fat in the Nutrition Facts label. For regulatory purposes,
the FDA’s chemical definition for trans fatty acids is all
unsaturated fatty acids that contain one or more isolated (ie, nonconjugated)
double bonds in a trans configuration; conjugated linoleic acid
is excluded. The FDA is also pursuing the possibility of the following:
· establishing new nutrient content claims regarding trans
fat, considering the need for qualifying criteria for and disclosure
of trans fat in current nutrient content claims for saturated fat
and cholesterol, lean and extra lean claims, and health claims that
contain a message about cholesterol-raising lipids; and
· considering statements about trans fat, either alone or
in combination with saturated fat and cholesterol, as a footnote
in the Nutrition Facts panel or as a disclosure statement in conjunction
with claims to enhance consumers’ understanding about such
cholesterol-raising lipids and how to use the information to make
healthy food choices.
The USDA plans to propose regulations consistent
with the FDA’s rules on trans fat declarations in the Nutrition
Facts panel for meat and poultry labeling and does not object to
voluntary trans fat declaration in Nutrition Facts panels on meat
and poultry food labels now if the declaration is in compliance
with published FDA regulations.
“Healthy” Claim and
Sodium Levels
To bear the claim “healthy,” the FDA is proposing to
retain the current “first-tier” maximum sodium level
of 600 milligrams—instead of implementing the preestablished
480 milligrams that was to be required by January 1, 2006—for
meal and main dish products.
Olestra
Manufacturers are no longer required to display the 1996 label statement
regarding digestive disturbances on products containing Olestra.
The FDA has concluded that the label statement is no longer warranted.
Hormone-Free Milk
Several manufacturers of milk and ice cream bearing “No Hormones”
or “Hormone Free” labeling statements have received
warning letters from the FDA. The administration considers these
to be false claims because all milk contains naturally occurring
hormones and cannot be processed in a manner that makes them hormone-free.
The FDA advises that milk from cows that is not treated with recombinant
bovine somatotropin can label that on their products.
New Chocolate Standard of Identity
“White chocolate’’ can now be used on labels as
the common or usual name of products made from cacao fat (ie, cocoa
butter), milk solids, nutritive carbohydrate sweeteners, and other
safe and suitable ingredients, but containing no nonfat cacao solids.
Country of Origin Labeling
Under the proposed rule for the mandatory country of origin labeling
(COOL) program, the following food must be labeled at retail to
indicate their country of origin: muscle cuts of beef (including
veal), lamb, and pork; ground beef, ground lamb, and ground pork;
farm-raised fish and shellfish; wild fish and shellfish; perishable
agricultural commodities (fresh and frozen fruits and vegetables);
and peanuts. Additionally, the COOL for fish and shellfish must
include and distinguish between wild and farm-raised fish and shellfish.
Poultry Class Standards of Identity
The FSIS proposes to amend the official poultry definitions and
standards of identity to more accurately describe poultry sold in
the marketplace today. Revised classifications are intended to more
clearly reflect current poultry characteristics, such as age and
breeding, to ensure truthful, nonmisleading label claims.
Dietary Supplements
To help consumers get accurately labeled and unadulterated dietary
supplements, the FDA has proposed a new regulation to require current
good manufacturing practice in manufacturing, packaging, and holding
by establishing minimum requirements that ensure that dietary supplements
and ingredients are unadulterated and accurately labeled based on
the product ingredients.
The FDA recently announced that its latest initiatives
against dietary supplements that bear unsubstantiated or misleading
claims about health benefits resulted in more than triple the comparative
efforts in 2001, including the following:
· 73 warning letters and cyber letters to dietary supplements
marketers;
· nearly $9 million worth of product seizures;
· refusal of 368 imported dietary supplements shipments;
and
· supervision of the voluntary destruction of more than $500,000
worth of dietary supplements promoted with unsubstantiated structure/function
claims.
Presenting at the Food & Drug Law Institute
(FDLI) January 2003 conference, Robert Moore, PhD, chief of the
Dietary Supplements Branch Division of Compliance and Enforcement,
Office of Nutritional Products, Labeling and Dietary Supplements
(ONPLDS), CFSAN, FDA, stated that the agency has identified certain
products that are clearly problematic and warrant close scrutiny,
including treatments for life-threatening diseases, weight loss,
autism, behavioral disorders, mental retardation, and Down Syndrome,
along with colloidal minerals for fibromyalgia, breast cancer, Alzheimer’s,
and ovarian cancer, supplements for smokers and drinkers, and colloidal
silver products as alternatives to antibiotics intended for serious
infectious diseases and anthrax.
On the Horizon
The following items are gaining momentum that could soon result
in regulatory action.
Menu Education and Labeling Act
If successful, a restaurant labeling bill—intended to help
curb obesity—would ultimately extend nutrition labeling beyond
packaged products to include foods from quick-service and other
chain restaurants for calorie, saturated and trans fat, carbohydrate,
and sodium disclosure on printed menus or boards. Introduced by
Rep Rosa L. DeLauro (D-Conn.), who was joined by the Center for
Science and the Public Interest (CSPI), and Sen Tom Harkin (D-Iowa),
who plans to introduce a companion bill in the Senate, the bill
applies only to standard menu items in chains of at least 20 outlets.
Several states are pursuing similar requirements.
Allergen Labeling
Speaking at the American Dietetic Association (ADA) 2003 Food &
Nutrition Conference & Exhibition (FNCE) session “Allergens:
Recent Developments in an Emerging Food Safety Issue,” Kathleen
J. Pompliano, MS, RD, manager, new business development, NSF International,
cited allergen labeling problems from ambiguity with words such
as “may” or “might contain.” Yet, Felicia
Satchell, director of the Division of Standards and Labeling Regulations,
ONPLDS, CFSAN, reported at the FDLI conference that this is something
that the FDA “is aware of but doesn’t condone.”
Pompliano also pointed out a lack of clarity when allergens are
listed with all ingredients but not addressed in a distinctly separate
warning underneath, asserting that specific ingredients and separate
“contains…” and “processed on lines...”
statements are examples of what’s needed for clear disclosure.
She also noted that “may contain” labeling can create
problems if the list includes many ingredients—when manufacturers
are trying to cover themselves from liability—because this
can result in a child’s diet becoming too restrictive. As
was stressed by Jeff Canavan, FSIS, USDA, at the FDLI conference,
“Voluntary ‘may contain’ labeling does not replace
Standard Sanitation Operating Procedure.”
The Food Allergen Labeling and Consumer Protection
Act (HR 467) introduced by Rep Nita M. Lowey (D-N.Y.) would amend
the Federal Food, Drug, and Cosmetic Act to require that foods containing
spices, flavoring, or coloring derived from meat, poultry, other
animal products (including insects), or known allergens bear labeling
stating that fact and their names.
Nutrition Labeling
To examine available data and identify options for making food labels
more valuable to consumers in managing their weight, the FDA’s
Obesity Working Group held an “Exploring the Link Between
Food Labeling and Weight Management” workshop in Bethesda,
Md., on November 20 and anticipates making recommendations around
mid-February 2004 on nutrition labeling improvements. Officials
are considering requiring calorie declarations for the entire package
as well as revisions that reflect contemporary nutrition research
updates that have evolved since the Nutrition Labeling and Education
Act of 1990.
Low-Carb Buzz
Unlike the Atkins blitz of the ’70s, this time around, carb-conscious
products have exploded into the marketplace, even creating their
own stores. During the ADA FNCE session “Emerging Role of
Glycemic Index and Glycemic Response: A Useful Tool?” several
attendees questioned the “Net Carbs”-type labeling that
commonly appears on such product packages. Low-Carb claims are not
currently defined in the regulations so they cannot be made, and
the FDA has issued numerous violation warning letters for the use
of “low carb” often noting that the Total Carbohydrate
declaration within the Nutrition Facts panel cannot exclude that
which comes from sugar alcohol, glycerin, or polydextrose ingredients.
The National Nutritional Foods Association unsuccessfully petitioned
the FDA a few years ago for carbohydrate nutrient content claims.
The Grocery Manufacturers Association has announced its intent to
pursue this area in 2004. A push for regulatory action in the carb-less
labeling game is likely heating up again, so stay tuned.
— Lauren Swann, MS, RD, LDN, is president
and CEO of Concept Nutrition, Inc., a consulting business in a Philadelphia
specializing in food and dietary supplement labeling and regulatory
issues, marketing communications and freelance writing, and cultural
and ethnic foodways.
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