Honey Bears, Snowmen ...
Exceptions to Food Label Rules
by Paula Kurtzweil

Companies that sell honey in the bear-shaped squeeze container are
finding themselves in a stickier situation than usual these days:
how to comply with FDA's new guidelines for mandatory nutrition
labeling.

It's not that they can't come up with the necessary nutrition
information or that they don't have the means to produce a
readable label. The problem is that the little bear's body doesn't
have ample space for a nutrition label.

It's a problem that hasn't caught FDA unawares. The 898-page
Federal Register document that spells out how FDA requires foods
to be labeled according to the Nutrition Labeling and Education
Act of 1990 contains a provision for just such problems. It's found
in Paragraph 101.9(g)(9) of the regulations.

There, the document specifically addresses foods for which a
complete nutrition label on the package may not be
"technologically feasible or some other circumstance makes it
impracticable." For these foods, FDA will consider alternative
means of compliance.

That is one of several provisions that, until recently, have received
little attention. Now, as manufacturers begin to relabel their
products to meet the May 1994 deadline, those provisions are
getting a closer look.

The regulations, published in January 1993, are known more for:

- establishing mandatory nutrition labeling
- redesigning the format for presenting nutrition information
- defining nutrient claims, such as "low fat" and "high fiber"
- approving the use of seven nutrient-health and nutrient/food-
health claims
- establishing more uniform serving sizes.

They are less noted for addressing the specifics of how to label
uniquely packaged foods or foods with few nutrients, or for
explaining the technicalities of determining a food's nutrient
content. But these provisions are there, and, like their more
prominent counterparts, they, too, will affect what consumers see
on food labels of the future.

Looking in All the Right Places

Some of the specifics deal with placement of the nutrition label,
now called "Nutrition Facts."

For most foods, nutrition information will continue to appear to
the immediate right of the principal display panel, which is usually
the front of the package. But, for the first time, some exceptions
are allowed. Among them:

- Packages with less than 40 square inches available for nutrition
labeling--for example, the standard-size gelatin dessert box--may
carry nutrition information on any panel. This is one of four
options that manufacturers have to help them fit the nutrition
information onto smaller packages.
- Nutrition information for variety-pack food items, such as ready-
to-eat cereals or snacks, may appear on the individual product
where a consumer can readily see it at the point of purchase--or be
listed for each food on the outside wrapper.
 -  Cartons of eggs in shells may carry nutrition information on a
package insert. This exception targets egg cartons in which the top
and bottom conform to the shape of the eggs and thus leave
insufficient surface area for nutrition information.
- Assorted gift packages, such as a holiday gift box of cheeses,
crackers and jellies, may provide nutrition information on a
package insert. In allowing this option, FDA determined it is more
important that the recipient of the gift see the information than the
gift giver because the recipient will benefit more from the
information. This provision also allows the gift box maker to use
the same information for multiple gift boxes that may vary only
slightly in size. (The regulations allow nutrition information for
similar assorted foods to be listed for each item or as a composite
of the entire contents.)
- Nutrition information for foods that are not individually
packaged, such as condiments or cookies sold from bulk
containers, may be presented on counter cards, posters, take-home
brochures, or other written materials at the point of purchase.
These materials also can be used for nutrition information for
game meats. (Under FDA's voluntary nutrition information
program for raw fruit, vegetables and fish, point-of-purchase
materials are the major means of presenting nutrition information.)

Firms Help Develop Options

Under the (g)(9) provision, FDA will consider other labeling
options for other foods that do not lend themselves to the
mandatory nutrition label. The options can range from a smaller
nutrition label to posters and brochures at the point of purchase.
"The alternative can include a lot of things," said Virginia
Wilkening, a registered dietitian and consumer safety officer in
FDA's Office of Food Labeling. "But, it's up to the company to
propose an option for presenting the nutrition information."
The provision requires manufacturers to write to FDA, explain
their labeling problem, and offer a solution. FDA, in turn, will
review the request and decide whether it's justified and reasonable
before giving it an OK.

According to Wilkening, the agency already has received a number
of (g)(9) requests, one of which is from the Sioux Honey
Association, headquartered in Sioux City, Iowa. The association
is asking permission to use a smaller Nutrition Facts panel than
that required in the regulations on the honey bear container. The
label would be attached to a redesigned honey bear, now shown
carrying front and back "billboards." One of the flat billboards,
about 2 square inches, would be used for nutrition information.
FDA received similar requests from several other groups that sell
food in packages with limited label space, Wilkening said. As a
result, in technical amendments published in August 1993, the
agency added a new rule: Packages with less than 12 square inches
available for nutrition labeling may use smaller type to present
nutrition information. The Sioux Honey Association's redesigned
honey bear would fall under that category, she said.

"There really is no place to put the nutrition label on the
traditional honey bear," Wilkening acknowledged. "But there are
several possibilities: The billboard approach with smaller type is
one. A tag around the neck might be another. We'll just have to 
decide each on a case-by-case basis."

Another (g)(9) request under FDA consideration involves 1-liter (1
quart) glass jars of strawberry jam in the shapes of Santa Claus
and a snowman. Because of the containers' roundness and
indentations, Wilkening said, FDA may exempt both products
from nutrition labeling as long as their labels carry a telephone
number or address for consumers to call or write to get the
required nutrition information.

"What they've asked is for their product to be considered a small
package," Wilkening said, citing a provision that allows packages
with less than 12 square inches available for nutrition labeling to
provide an address or telephone number for consumers to get the
required information.

Wilkening said the agency probably will OK the request because
the product is available only for short periods--around Christmas--
and because it is sold next to other jams that will have the nutrition
information. "Even though it may be on another container,
consumers would have access to the same type of nutrition
information," she said.

Determining Exemptions

Not all foods will have to carry nutrition information. The
Nutrition Labeling and Education Act exempts food sold for
immediate consumption and food produced by small businesses if
the food packages don't carry a nutrition claim.
Also exempt are foods that contain insignificant amounts of all the
nutrients that are required in nutrition labeling--as long as the
product's label doesn't carry nutrition claims. A food contains
insignificant amounts of the dietary components required in
nutrition labeling if a serving of the food contains:

- less than 2 percent of the Daily Value for vitamins and minerals
- less than 1 gram (g) of carbohydrate, dietary fiber, and protein
- less than 2 milligrams (mg) of cholesterol
- less than 5 mg of sodium
- less than 0.5 g of fat, saturated fat, and sugars
- fewer than 5 calories.

The food labeling regulations specifically exempt plain coffee and
tea, flavor extracts, food colors, and other foods that are not
significant sources of nutrients.

Most spices are not significant sources of nutrients, either--except
for a few. For example, paprika and chili powder contain vitamin
A and therefore will have to have nutrition labeling. (See
accompanying list.)

In many cases, foods with few nutrients will qualify for the
simplified nutrition label format, in which information about some
nutrients otherwise required in nutrition labeling may be omitted.
The simplified format is allowed when the food contains
insignificant amounts of seven or more of the dietary components
required in nutrition labeling. However, information about
calories, total fat, sodium, carbohydrate, and protein is still
required.

Nutrient Analysis

And how are these nutrient levels determined? That, too, is 
addressed in the regulations.
As before, manufacturers will continue to be responsible for
ensuring the accuracy of the nutrient content information on the
label.

They can use any means they desire to determine a food's
nutritional makeup. Typically, nutrients are analyzed in the
laboratory using one or more chemical tests. In checking the
validity of nutrient information on the label, FDA uses only tests
approved by AOAC International, an association of official
analytical chemists, and other procedures FDA accepts as valid.
Manufacturers are encouraged to use these procedures, too.
FDA does not endorse any set of nutrient data for use in nutrition
labeling. However, in the January 1993 Federal Register
document, FDA expressed interest in working with the food
industry to develop databases for nutrition labeling purposes. It
also announced the availability of the FDA Nutrition Labeling
Manual: A Guide for Developing and Using Databases to help
companies and trade organizations develop and use a database for
nutrition labeling.

Checking Compliance

FDA checks the accuracy of nutrition labeling information by
conducting its own nutritional analyses and applying several
guidelines for determining the accuracy of the nutrition
information.

For nutrients that are considered desirable--that is, vitamins,
minerals, protein, total carbohydrate, dietary fiber, other
carbohydrate, polyunsaturated fat, monounsaturated fat, and
potassium--and that are present naturally in the food, the FDA-
determined analytical value must be at least 80 percent of the value
declared on the label.

For naturally occurring dietary components for which lower
intakes are sometimes advised--that is, calories, sugars, total fat,
saturated fat, cholesterol, and sodium--FDA's analytical values
must be no more than 20 percent higher than the label values.
 For nutrients added to a food, FDA's determined values must be
at least equal to the values stated on the label.

Enforcement

Before initiating enforcement action, the agency will consider
factors such as the seriousness of the violation, information
obtained during an establishment inspection, consumer complaints,
and the firm's compliance history.

According to Elizabeth Campbell, director of the division of
programs and enforcement policy in FDA's Office of Food
Labeling, a warning letter to the company often puts an end to
many violative practices. "Usually that's enough," she said. "We
don't need seizures and prosecutions if we get a complying label."
FDA won't be the only agency checking food labeling compliance.
Under the Nutrition Labeling and Education Act, state
governments may now enforce federal food labeling laws. The act
for the first time prohibits states from enforcing their own labeling
requirements on food in interstate commerce, unless those
requirements are the same as FDA's. Thus, a state can adopt
provisions identical to FDA's and enforce those regulations either
at the state or federal level.

However, state involvement means that FDA will have to inform 
each state of any additional changes, exemptions and exceptions it
makes to the nutrition labeling regulations and policies. Such
changes would include decisions about the honey bear, snowman
and Santa. 

Paula Kurtzweil is a member of FDA's public affairs staff.
For More About Food Labeling ...
For more information about FDA's food labeling regulations, see:
- "Nutrition Info Available for Raw Fruits, Vegetables, Fish"
(January-February 1993 FDA Consumer)
- "Ingredient Labeling: What's in a Food?" (April 1993 FDA
Consumer)
- "Good Reading for Good Eating," "Starting This Month: Look
for 'Legit' Health Claims on Foods," "'Nutrition Facts' to Help
Consumers Eat Smart," and "'Daily Values' Encourage Healthy
Diet" (May 1993 FDA Consumer)
- "A Little 'Lite' Reading" and "The Food Pyramid Food Label
Connection" (June 1993 FDA Consumer).
These articles are reprinted together in the FDA Consumer special
report Focus on Food Labeling. To order one free copy, write to
FDA, HFI-40, 5600 Fishers Lane, Rockville, MD 20857. Ask for
order number FDA 93-2262. n
Surprising Candidates for Nutrition Labeling
- Baking powder. A quarter teaspoon has 110 milligrams (mg)
sodium and 60 mg calcium.
- Blackstrap molasses. A 1-tablespoon serving gives 55 calories, 14
grams (g) carbohydrate, and 140 mg calcium.
- Chili powder. A quarter teaspoon provides about 4 percent of the
Daily Value for vitamin A and 5 mg of sodium.
- Paprika. A quarter teaspoon provides about 6 percent of the Daily
Value for vitamin A.
- Salt. It provides 575 mg sodium per quarter teaspoon.
- Bottled water, if it naturally contains 5 mg or more sodium per
8 fluid ounces (240 milliliter [mL]), or if it is labeled "sodium-
free," "minerals added," or carries some other nutrient claim.
- Wine coolers. An 8-ounce (240 mL) serving provides more than
the cutoff level for total carbohydrate and calories. (FDA regulates
wine with less than 7 percent alcohol, such as wine coolers; so,
these products are bound by the food labeling regulations. The
Bureau of Alcohol, Tobacco, and Firearms oversees all other
alcoholic products, and FDA regulations do not apply.)
- Prepackaged deli foods, if they were primarily prepared and
processed at a site other than the store in which they are sold.

--P.K.